B. Braun Medical Inc.

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B. Braun Medical Inc. Drugs

Lidosite

Lidosite

LidoSite™ Controller can only be used with the LidoSite™ Patch as the complete LidoSite™ System, and LidoSite™ Patches should only be used with a LidoSite™ Controller.

LidoSite™ System should be applied only by a health care practitioner in a health care setting.

One LidoSite™ Patch is to be used with one LidoSite™ Controller. Do not use a damaged or altered patch. To administer, see the “LidoSite™ Topical System Instructions” contained in this package insert. Following iontophoresis and patch removal, the treatment site should be cleansed according to standard practice prior to the medical procedure. Disinfecting agents containing heavy metal ions (mercury, zinc, copper, etc.) should not be used for skin disinfection prior to iontophoresis as they have been associated with swelling and edema.

LidoSite™ Controller should not be subjected to any sterilization procedure.

LidoSite™ Controller should be disposed of in a trash receptacle.
Recommended Dose: Each iontophoretic treatment delivers lidocaine and epinephrine at the 5-cm2 site below the circular reservoir. Only one LidoSite™ Patch should be used at a time. Application: See “LidoSite™ Topical System Instructions” Apply patch immediately after opening pouch. The LidoSite™ Patch reservoirs must remain in complete contact with the skin during treatment to ensure maximal safety and efficacy. A new patch may be applied to a different skin site after30 minutes. The LidoSite™ Patch is for single use only. Treatment Duration: Current delivery lasts for 10 minutes following actuation of the LidoSite™ Controller. In clinical studies the medical procedure was initiated within 10 minutes of patch removal. Patch Disposal: LidoSite™ Patch should be disposed of as medical waste. Storage Conditions: Store LidoSite™ Patches at controlled room temperature (20°C-25°C; 68°F-77°F).
Milrinone Lactate In De...

Milrinone Lactate In Dextrose

CAUTION: DO NOT ADMIX WITH OTHER DRUGS.

MUST NOT BE USED IN SERIES CONNECTIONS.

Milrinone Lactate in 5% Dextrose Injection should not be used for administering a loading dose. The information regarding loading doses for milrinone shown below is for informational purposes only.

A loading dose of milrinone lactate injection (1 mg [base]/mL) should be administered followed by a continuous infusion (maintenance dose) according to the following guidelines:

LOADING DOSE

50 mcg/kg: Administer slowly over 10 minutes

The table below shows the loading dose in milliliters (mL) of milrinone (1 mg/mL) by patient body weight (kg).
Loading Dose (mL) Using 1 mg/mL Concentration Patient Body Weight (kg) kg 30 40 50 60 70 80 90 100 110 120 mL 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0
The loading dose may be given undiluted, but diluting to a rounded total volume of 10 or 20 mL (see Maintenance Dose for diluents) may simplify the visualization of the injection rate.

MAINTENANCE DOSE
Infusion Rate Total Daily Dose (24 Hours) Minimum 0.375 mcg/kg/min 0.59 mg/kg Administer as a continuous intravenous infusion. Standard 0.50 mcg/kg/min 0.77 mg/kg Maximum 0.75 mcg/kg/min 1.13 mg/kg
The infusion rate should be adjusted according to hemodynamic and clinical response. Patients should be closely monitored. In controlled clinical studies, most patients showed an improvement in hemodynamic status as evidenced by increases in cardiac output and reductions in pulmonary capillary wedge pressure.

Note: See "Dosage Adjustment in Renally Impaired Patients." Dosage may be titrated to the maximum hemodynamic effect and should not exceed 1.13 mg/kg/day. Duration of therapy should depend upon patient responsiveness.

The maintenance dose in mL/hr by patient body weight (kg) may be determined by reference to the following table.
Milrinone Infusion Rate (mL/hr) Using 200 mcg/mL Concentration Maintenance Dose Patient Body Weight (kg) (mcg/kg/min) 30 40 50 60 70 80 90 100 110 120 0.375 3.4 4.5 5.6 6.8 7.9 9.0 10.1 11.3 12.4 13.5 0.400 3.6 4.8 6.0 7.2 8.4 9.6 10.8 12.0 13.2 14.4 0.500 4.5 6.0 7.5 9.0 10.5 12.0 13.5 15.0 16.5 18.0 0.600 5.4 7.2 9.0 10.8 12.6 14.4 16.2 18.0 19.8 21.6 0.700 6.3 8.4 10.5 12.6 14.7 16.8 18.9 21.0 23.1 25.2 0.750 6.8 9.0 11.3 13.5 15.8 18.0 20.3 22.5 24.8 27.0
When administering milrinone by continuous infusion, it is advisable to use a calibrated electronic infusion device.

Dosage Adjustment in Renally Impaired Patients

Data obtained from patients with severe renal impairment (creatinine clearance = 0 to 30 mL/min) but without congestive heart failure have demonstrated that the presence of renal impairment significantly increases the terminal elimination half-life of milrinone. Reductions in infusion rate may be necessary in patients with renal impairment. For patients with clinical evidence of renal impairment, the recommended infusion rate can be obtained from the following table:
Creatinine Clearance(mL/min/1.73 m2) Infusion Rate(mcg/kg/min) 5 0.20 10 0.23 20 0.28 30 0.33 40 0.38 50 0.43
The PAB® plastic container system contains milrinone equivalent to 200 mcg/mL milrinone in 5% Dextrose Injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if cloudy or precipitated or if the seals are not intact.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Use sterile equipment. It is recommended that the intravenous administration apparatus be replaced at least once every 24 hours.

Directions for Use of PAB® Plastic Container System

CAUTION: DO NOT ADMIX WITH OTHER DRUGS.

MUST NOT BE USED IN SERIES CONNECTIONS.

For intravenous infusion only.

Store the individual container in the storage carton until ready to use.

Aseptic technique is required.
Caution – Before use, perform the following checks: (a) Read the label. Ensure solution is the one ordered and is within the expiration date. (b) Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.
Check for minute leaks by squeezing solution container firmly. Use only if solution is clear and container and seals are intact.

Single dose plastic container. Discard unused portion.

Consult Package Insert for complete product information.
2. Caution – IV admixtures containing this solution and other drugs should be avoided. Additives should not be introduced into this solution. If used with a primary intravenous fluid system, the primary solution should be discontinued during milrinone infusion. 3. To Attach Administration Set Remove the set port closure. Hold the container below the set port and grasp cap between thumb and forefinger, then roll cap upward (see Figure A). Push the spike into and through the diaphragm of the port (see Figure B). Continue with Directions for Use for the administration set. Suspend the container using the hole in the lower flap.
Sorbitol Irrigant

Sorbitol Irrigant

As required for urologic irrigation.

3.3% Sorbitol Irrigation should be administered only by the appropriate transurethraI urologic instrumentation.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
Balanced Salt

Balanced Salt

The irrigating solution should be used according to standard format for each surgical procedure. Note: Use an administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow directions of the particular administration set to be used. Remove the aluminum tab. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.
Dextrose Solution

Dextrose Solution

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Trimethobenzamide Hydro...

Trimethobenzamide Hydrochloride

2.1 Adult and Pediatric Patients (Who Require the Full Adult Dose)

Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX® Container should be used only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. Ceftazidime for Injection USP and Dextrose Injection USP should be administered intravenously (IV) over approximately 30 minutes.

The guidelines for dosage of Ceftazidime for Injection USP and Dextrose Injection USP are listed in Table 1. The following dosage schedule is recommended.
Table 1: Recommended Dosage Schedule for Creatinine Clearance greater than 50 mL/min Adults Dose Frequency Bone and joint infections 2 grams IV every 12hr Uncomplicated pneumonia; mild skin and skin-structure infections 500 mg*–1 gram IV every 8hr Serious gynecologic and intra-abdominal infections 2 grams IV every 8hr Meningitis 2 grams IV every 8hr Very severe life-threatening infections, especially in immunocompromised patients 2 grams IV every 8hr
* Use this formulation of ceftazidime only in patients who require the entire 1 or 2 gram dose and not any fraction thereof.

2.2 Pediatric Population

Ceftazidime for Injection and Dextrose Injection in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftazidime. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of ceftazidime [see Use in Specific Populations (8.4)]

2.3 Patients with Renal Impairment

Ceftazidime for Injection and Dextrose Injection in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftazidime. To prevent unintentional overdose, this product should not be used in patients with creatinine clearance less than or equal to 15 mL/min who require less than a 1 g dose of ceftazidime.

In patients with impaired renal function (creatinine clearance less than or equal to 50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of Ceftazidime for Injection USP and Dextrose Injection USP may be given. An estimate of creatinine clearance should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 2.
Table 2: Recommended Maintenance Dosages of Ceftazidime for Injection USP and Dextrose Injection USP in Renal Insufficiency Creatinine Clearance (mL/min) Recommended Unit Dose of Ceftazidime for Injection USP and Dextrose Injection USP Frequency of Dosing 50–31 1 gram every 12hr 30–16 1 gram every 24hr
NOTE: IF THE DOSE RECOMMENDED IN TABLE 1 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN TABLE 2, THE LOWER DOSE SHOULD BE USED.

When only serum creatinine is available, the following formula (Cockcroft's equation)5 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:
Males: Creatinine Clearance (mL/min) = Weight (kg) × (140-age) 72 × serum creatinine (mg/dL) Females: 0.85 × above value
In patients with severe infections who would normally receive 2 grams IV every 8hr of Ceftazidime for Injection USP and Dextrose Injection USP were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency may be increased appropriately. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organism.

The creatinine clearance should be adjusted for body surface area or lean body mass, and the dosing frequency should be reduced in cases of renal insufficiency.

In patients undergoing hemodialysis, a loading dose of 1 gram is recommended, followed by 1 gram after each hemodialysis period.

2.4 Preparation for Use of Ceftazidime for Injection USP and Dextrose Injection USP in DUPLEX® Container

This reconstituted solution is for intravenous use only.

Do not use plastic containers in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use only if solution is clear and container and seals are intact.

DUPLEX® Container Storage
To avoid inadvertent activation, the DUPLEX® Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
Apply patient-specific label on foil side of container. Use care to avoid activation. Do not cover any portion of foil strip with patient label. Unlatch side tab and unfold DUPLEX® Container (see Diagram 1). Visually inspect diluent chamber for particulate matter. Use only if container and seals are intact. To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber (see Diagram 2). Protect from light after removal of foil strip.Note: If foil strip is removed, the container should be re-folded and the side tab latched until ready to activate. The product must then be used within 7 days, but not beyond the labeled expiration date.
Reconstitution (Activation)
Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use. Unfold the DUPLEX® Container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber (see Diagram 3). Agitate the liquid-powder mixture until the drug powder is completely dissolved.Note: Following reconstitution (activation), product must be used within 12 hours if stored at room temperature or within 3 days if stored under refrigeration.
Administration
Visually inspect the reconstituted solution for particulate matter. Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port (see Diagram 4). Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be compromised. Using aseptic technique, peel foil cover from the set port and attach sterile administration set (see Diagram 5). Refer to directions for use accompanying the administration set.
Important Administration Instructions
Do not use in series connections. Do not introduce additives into the DUPLEX® Container. Administer Ceftazidime for Injection USP and Dextrose Injection USP intravenously over approximately 30 minutes. Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of Ceftazidime for Injection USP and Dextrose Injection USP, it is advisable to discontinue the other solution. Vancomycin solution exhibits a physical incompatibility when mixed with a number of drugs, including ceftazidime. The likelihood of precipitation with ceftazidime is dependent on the concentrations of vancomycin and ceftazidime present. It is therefore recommended, when both drugs are to be administered by intermittent IV infusion, that they be given separately, flushing the IV lines (with 1 of the compatible IV fluids) between the administration of these 2 agents.Note: Parenteral drug products should be inspected visually for particulate matter before administration whenever solution and container permit. Solutions of Ceftazidime for Injection USP and Dextrose Injection USP should not be added to solutions of aminoglycoside antibacterials because of potential inactivation. If concurrent therapy with Ceftazidime for Injection USP and Dextrose Injection USP and an aminoglycoside is indicated, each of these antibacterials should be administered separately to the same patient. The IV route is preferable for patients with bacterial septicemia, bacterial meningitis, peritonitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or pending.
Potassium Chloride In D...

Potassium Chloride In Dextrose

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

If the serum potassium level is greater than 2.5 mEq/liter, potassium chloride should be given at a rate not to exceed 10 mEq/hour in a concentration less than 30 mEq/liter. The total 24-hour dose should not exceed 200 mEq.

If urgent treatment is indicated (serum potassium level less than 2.0 mEq/liter with electrocardiographic changes or paralysis), potassium chloride may be infused at a rate of 40 mEq/hour. As much as 400 mEq may be administered in a 24-hour period while monitoring blood electrolyte concentrations carefully.

Dextrose may be administered to normal individuals at a rate of 0.5 g/kg/hour without producing glycosuria. At the maximum infusion rate of 0.8 g/kg/hour, approximately 95% of the dextrose is retained.

Pediatric Dosage and Administration

There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. See WARNINGS and PRECAUTIONS.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Potassium Chloride In D...

Potassium Chloride In Dextrose And Sodium Chloride

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Usually, up to 40 mEq of potassium per liter daily is sufficient to replace normal loss in adults. Typical infusion rates should not exceed 10 mEq per hour or 120 mEq per day. Pediatric patients may require 2 to 3 mEq per kg of body weight daily. See WARNINGS and PRECAUTIONS for pediatric use.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Dextrose may be administered to normal individuals at a rate of 0.5 g/kg/hour without producing glycosuria. At the maximum infusion rate of 0.8 g/kg/hour, approximately 95% of the dextrose is retained.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Sodium Chloride Irrigan...

Sodium Chloride Irrigant

As required for irrigation.

When used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
Potassium Chloride In S...

Potassium Chloride In Sodium Chloride

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride).

Usually up to 40 mEq of potassium per liter daily is sufficient to replace normal loss in adults. Infusion rates should not exceed 10 mEq per hour or 120 mEq per day. A liter of fluid containing 40 mEq of potassium should be administered over an 8-hour period.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Pediatric Dosage and Administration

There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results.

See WARNINGS and PRECAUTIONS.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Indomethacin

Indomethacin

The objective of nutritional management of patients with liver disease is the provision of sufficient amino acid and caloric support for protein synthesis without exacerbating hepatic encephalopathy.

The total daily dose of HepatAmine® depends on daily protein requirements and on the patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements. Dosage should also be guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response.

The recommended dosage is 80–120 grams of amino acids (12–18 grams of nitrogen) as HepatAmine® (8% Amino Acid Injection) per day. Typically, 500 mL of 8% HepatAmine® appropriately mixed with 500 mL of 50% dextrose supplemented with electrolytes and vitamins is administered over an 8–12 hour period. This results in a total daily fluid intake of approximately 2–3 liters. Patients with fluid restrictions may only tolerate 1–2 liters. Although nitrogen requirements may be higher in severely hypercatabolic or depleted patients, provision of additional nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance.

In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose solutions are abruptly discontinued.

Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat free TPN.

The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is required for optimum utilization of amino acids. Approximately 60–180 mEq of potassium, 10–30 mEq of magnesium, and 10–40 mmole of phosphate per day appear necessary to achieve optimum metabolic response. In addition, sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given. In patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate salts to provide bicarbonate precursor. The electrolyte content of HepatAmine® must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.

Pediatric Use

Use of HepatAmine® in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).

Hypertonic mixtures of amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, and gradually increased to the recommended 60–125 mL/hr. If administration rate should fall behind schedule, no attempt to "catch up" to planned intake should be made. In addition to meeting protein needs, the rate of administration, particularly during the first few days of therapy, is governed by the patient's glucose tolerance. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of glucose levels in blood and urine.

For patients in whom the central venous route is not indicated and who can consume adequate calories enterally, 8% HepatAmine® may be administered by peripheral vein with or without parenteral carbohydrate calories. Such infusates can be prepared by dilution of 8% HepatAmine® with Sterile Water for Injection or 5%–10% dextrose to prepare isotonic or slightly hypertonic solutions for peripheral infusion. It is essential that peripheral infusion be accompanied by adequate caloric supplementation. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Care must be taken to avoid incompatible admixtures. Consult with pharmacist.
Sterile Water

Sterile Water

Irrigation

Use as directed by physician.

This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Nutrient Mixtures

Sterile Water for Irrigation USP may be used to prepare non-intravenously administered nutrient mixtures. It contains no electrolytes or other added substances. Refer to preparation instructions of particular mixture to be used. The plastic container may be used for administration of non-intravenous nutrient mixture to the patient as appropriate.
Amlodipine Besylate

Amlodipine Besylate

This solution is for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride).

There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. Follow recommendations of appropriate pediatric reference text. (See PRECAUTIONS, Pediatric Use.)

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

0.9% Sodium Chloride Injection USP may also be administered intravascularly as a priming fluid in hemodialysis procedures.

When Sodium Chloride Injection USP is used as a diluent for infusion of compatible drug additives, refer to dosage and administration information accompanying additive drugs.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Glycine Irrigant

Glycine Irrigant

As required for irrigation.

1.5% Glycine Irrigation USP should be administered only by the appropriate transurethraI urologic instrumentation.

It has been reported that absorption is significantly increased if the container is higher than 60 cm (24") above the patient.

This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Physiolyte

Physiolyte

As required for irrigation.

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the directions of the additive's manufacturer should be followed.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
Hyperlyte Cr

Hyperlyte Cr

Not for direct patient injection.

Hyperlyte® CR (Multi-Electrolyte Concentrate) in Pharmacy Bulk Package is for prescription compounding of intravenous admixtures only. Not for direct patient injection. Dilute to appropriate strength with suitable intravenous fluid prior to administration.

For adults, one 20 mL dose of Hyperlyte® CR should be added to each liter of amino acid/dextrose solution (TPN) or other suitable intravenous solution.

Hyperlyte® CR contains no phosphate. It may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium and magnesium ions in this solution should be considered when phosphate is present in the additive solution in order to avoid precipitation.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.
Cefuroxime And Dextrose...

Cefuroxime And Dextrose

This product is intended for intravenous administration only.

Dosage

Adults

The usual adult dosage range for cefuroxime is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days. In uncomplicated urinary tract infections, skin and skin-structure infections, disseminated gonococcal infections, and uncomplicated pneumonia, a 750 mg dose every 8 hours is recommended. In severe or complicated infections, a 1.5 gram dose every 8 hours is recommended.

In bone and joint infections, a 1.5 gram dose every 8 hours is recommended. In clinical trials, surgical intervention was performed when indicated as an adjunct to cefuroxime therapy. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of cefuroxime.

In life-threatening infections or infections due to less susceptible organisms, 1.5 grams every 6 hours may be required. In bacterial meningitis, the dosage should not exceed 3 grams every 8 hours. For preventive use for clean-contaminated or potentially contaminated surgical procedures, a 1.5 gram dose administered intravenously just before surgery (approximately one-half to 1 hour before the initial incision) is recommended. Thereafter, give 750 mg intravenously every 8 hours when the procedure is prolonged.

For preventive use during open heart surgery, a 1.5 gram dose administered intravenously at the induction of anesthesia and every 12 hours thereafter for a total of 6 grams is recommended.

Impaired Renal Function

A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism (see Table 2).
Table 2: Dosage of Cefuroxime in Adults with Reduced Renal Function Creatinine Clearance(mL/min) Dose Frequency * Since cefuroxime is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis. >20 750 mg–1.5 grams q8h 10–20 750 mg q12h <10 750 mg q24h*
When only serum creatinine is available, the following formula2 (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
Males: Creatinine clearance (mL/min) = Weight (kg) × (140 - age) 72 × serum creatinine (mg/dL) Females: 0.85 × male value
Note: As with antibiotic therapy in general, administration of Cefuroxime for Injection USP and Dextrose Injection USP should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment for several weeks; and doses smaller than those indicated above should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

Pediatric Patients Above 3 Months of Age

Administration of 50 to 100 mg/kg/day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to cefuroxime. The higher dosage of 100 mg/kg/day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.

In bone and joint infections, 150 mg/kg/day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hours. In clinical trials, a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of cefuroxime.

In cases of bacterial meningitis, a larger dosage of cefuroxime is recommended, 200 to 240 mg/kg/day intravenously in divided doses every 6 to 8 hours.

In pediatric patients with renal insufficiency, the frequency of dosing should be modified consistent with the recommendations for adults.

Cefuroxime for Injection USP and Dextrose for Injection USP in the DUPLEX® Container is designed to deliver a 750 mg or 1.5 g dose of cefuroxime. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose.

For intermittent IV infusion with a Y-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing Cefuroxime, it is advisable to temporarily discontinue administration of any other solutions at the same site.

Solutions of cefuroxime, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

However, if concurrent therapy with cefuroxime and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

Use sterile equipment.

Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

DUPLEX® Drug Delivery System Directions for Use
To avoid inadvertent activation, DUPLEX® Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
Apply patient-specific label on foil side of container. USE CARE to avoid activation. Do not cover any portion of foil strip with patient label. Unlatch side tab and unfold DUPLEX® Container. (See Diagram 1.) Visually inspect diluent chamber for particulate matter. Use only if container and seals are intact. To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber. (See Diagram 2.) Protect from light after removal of foil strip.
Note: If foil strip is removed, product must be used within 7 days, but not beyond the labeled expiration date.
The product should be re-folded and the side tab latched until ready to activate.
Reconstitution (Activation)
Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use. Unfold the DUPLEX® Container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber. (See Diagram 3.) Agitate the liquid-powder mixture until the drug powder is completely dissolved.
Note: Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 days if stored under refrigeration.

Administration
Visually inspect the reconstituted solution for particulate matter. Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port. (See Diagram 4.) Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired. Using aseptic technique, peel foil cover from the set port and attach sterile administration set. (See Diagram 5.) Refer to Directions for Use accompanying the administration set.
Precautions
As with other cephalosporins, reconstituted Cefuroxime for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected. Use only if prepared solution is clear and free from particulate matter. Do not use in series connection. Do not introduce additives into the DUPLEX® Container. Do not freeze.
Nephramine

Nephramine

The objective of nutritional management of renal decompensation is the provision of sufficient amino acid and caloric support for protein synthesis without greatly exceeding the renal capacity to excrete metabolic wastes.

Three grams of nitrogen per day provided as essential amino acids with adequate calories produce nitrogen equilibrium in many stable patients with chronic uremia. Although nitrogen requirements may be higher in stressed or acutely uremic patients, or those on dialysis, provision of additional nitrogen may not be possible due to fluid intake limits or glucose intolerance.

The usual methods of determining individual patient requirements for amino acids such as nitrogen balance or daily body weight are difficult to perform or interpret in the uremic patient. Therefore, dosage is guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as metabolic and clinical response. Rate of rise of blood urea nitrogen generally diminishes with infusion of essential amino acids. However, excessive intake of dietary protein or increased protein catabolism may alter this response.

Adult Use

Generally, 250 to 500 mL of 5.4% NephrAmine® (Essential Amino Acid Injection), containing approximately 1.6 to 3.2 grams of nitrogen (in 13.4 to 26.8 grams of essential amino acids), are given daily. Adequate calories should be provided simultaneously. Each 250 mL of NephrAmine® is typically mixed aseptically with 500 mL of 70% dextrose to yield a solution of 1.8% NephrAmine® in 47% dextrose. This mixture provides a calorie-to-nitrogen ratio of 744:1.

Solution administrated by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).

Pediatric Use

Initial total daily dose should be low and increased slowly. As the dose is increased, frequent laboratory and clinical monitoring is strongly recommended, especially in very young patients, to avoid clinically significant elevations of serum ammonia and plasma amino acid levels. Dosage of NephrAmine® above one gram of essential amino acids per kg of body weight per day is not recommended. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

Use of 5.4% NephrAmine® in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day.

See INDICATIONS AND USAGE, WARNINGS, PRECAUTIONS, Pediatric Use, and Special Precautions in Pediatric Patients.

Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat free TPN.

Electrolyte supplementation may be required. Undiluted NephrAmine® (Essential Amino Acid Injection) contains 5 mEq/liter of sodium. Elevated serum potassium, phosphorus, and magnesium levels generally decrease during treatment with NephrAmine®. Although these effects are beneficial, especially in acute renal failure, in some instances the reduction may be so great that supplementation of these electrolytes is required, especially in the presence of cardiac arrhythmias or digitalis toxicity. During periods of anuria or oliguria, electrolyte supplementation should be done with caution, even if serum levels are in the low normal range.

Compatibility of electrolyte additives to the 5.4% NephrAmine®/hypertonic dextrose mixture must be considered, and potentially incompatible ions such as calcium and phosphate may be added to alternate infusion bottles to avoid precipitation. In patients with hyperchloremic or other metabolic acidosis, sodium and potassium may be added as acetate or lactate salts to provide bicarbonate precursor. The electrolyte content of NephrAmine® must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.

If a patient's nutritional intake is primarily parenteral, vitamins, especially the water soluble vitamins, should also be provided.

Hypertonic mixtures of essential amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, generally 20–30 mL/hour. Increases by increments of 10 mL/hour each 24 hours are recommended to a maximum of 60–100 mL/hour. If administration rate should fall behind schedule, no attempt to "catch up" to planned intake should be made.

Administration rate is governed by the patient's nitrogen, fluid, and glucose tolerance. Uremic patients are frequently glucose intolerant, especially in association with peritoneal dialysis, and may require the administration of exogenous insulin to prevent hyperglycemia. Blood glucose levels must be determined frequently. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose infusions are abruptly discontinued.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Care must be taken to avoid incompatible admixtures. Consult with pharmacist.
Isolyte S In Dextrose

Isolyte S In Dextrose

This solution is for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

The presence of magnesium ions in this solution should be considered when phosphate is present in the additive solution, in order to avoid precipitation.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Directions for Use of EXCEL® Container

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

Before use, perform the following checks:
Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. Use only if solution is clear and container and seals are intact.
Preparation for Administration
Remove plastic protector from sterile set port at bottom of container. Attach administration set. Refer to complete directions accompanying set.
To Add Medication Before Solution Administration
Prepare medication site. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.
To Add Medication During Solution Administration
Close clamp on the set. Prepare medication site. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject. Remove container from IV pole and/or turn to an upright position. Evacuate both ports by tapping and squeezing them while container is in the upright position. Mix solution and medication thoroughly. Return container to in use position and continue administration.
Theophylline In Dextros...

Theophylline In Dextrose

These solutions are for intravenous use only.

General Considerations

The steady-state serum theophylline concentration is a function of the infusion rate and the rate of theophylline clearance in the individual patient. Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a serum theophylline concentration in the 10–20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance. For a given population there is no single theophylline dose that will provide both safe and effective serum concentrations for all patients. Administration of the median theophylline dose required to achieve a therapeutic serum theophylline concentration in a given population may result in either sub-therapeutic or potentially toxic serum theophylline concentrations in individual patients. The dose of theophylline must be individualized on the basis of serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects.

When theophylline is used as an acute bronchodilator, the goal of obtaining a therapeutic serum concentration is best accomplished with an intravenous loading dose. Because of rapid distribution into body fluids, the serum concentration (C) obtained from an initial loading dose (LD) is related primarily to the volume of distribution (V), the apparent space into which the drug diffuses:

C=LD/V

If a mean volume of distribution of about 0.5 L/kg is assumed (actual range is 0.3 to 0.7 L/kg), each mg/kg (ideal body weight) of theophylline administered as a loading dose over 30 minutes results in an average 2 mcg/mL increase in serum theophylline concentration. Therefore, in a patient who has received no theophylline in the previous 24 hours, a loading dose of intravenous theophylline of 4.6 mg/kg, calculated on the basis of ideal body weight and administered over 30 minutes, on average, will produce maximum post-distribution serum concentration of 10 mcg/mL with a range of 6–16 mcg/mL. When a loading dose becomes necessary in the patient who has already received theophylline, estimation of the serum concentration based upon the history is unreliable, and an immediate serum level determination is indicated. The loading dose can then be determined as follows:

D=(Desired C−Measured C) (V)

Where D is the loading dose, C is the serum theophylline concentration, and V is the volume of distribution. The mean volume of distribution can be assumed to be 0.5 L/kg and the desired serum concentration should be conservative (e.g., 10 mcg/mL) to allow for the variability in the volume of distribution. A loading dose should not be given before obtaining a serum theophylline concentration if the patient has received any theophylline in the previous 24 hours.

A serum concentration obtained 30 minutes after an intravenous loading dose, when distribution is complete, can be used to assess the need for and size of subsequent loading doses, if clinically indicated, and for guidance of continuing therapy. Once a serum concentration of 10 to 15 mcg/mL has been achieved with the use of a loading dose(s), a constant intravenous infusion is started. The rate of administration is based upon mean pharmacokinetic parameters for the population and calculated to achieve a target serum concentration of 10 mcg/mL (see Table V). For example, in non-smoking adults, initiation of a constant intravenous theophylline infusion of 0.4 mg/kg/hr at the completion of the loading dose, on average, will result in a steady-state concentration of 10 mcg/mL with a range of 7–26 mcg/mL. The mean and range of steady-state serum concentrations are similar when the average child (age 1 to 9 years) is given a loading dose of 4.6 mg/kg theophylline followed by a constant intravenous infusion of 0.8 mg/kg/hr. Since there is large interpatient variability in theophylline clearance, serum concentrations will rise or fall when the patient's clearance is significantly different from the mean population value used to calculate the initial infusion rate. Therefore, a second serum concentration should be obtained one expected half life after starting the constant infusion (e.g., approximately 4 hours for children age 1 to 9 and 8 hours for nonsmoking adults; see Table I for the expected half-life in additional patient populations) to determine if the concentration is accumulating or declining from the post loading dose level. If the level is declining as a result of a higher than average clearance, an additional loading dose can be administered and/or the infusion rate increased. In contrast, if the second sample demonstrates a higher level, accumulation of the drug can be assumed, and the infusion rate should be decreased before the concentration exceeds 20 mcg/mL. An additional sample is obtained 12 to 24 hours later to determine if further adjustments are required and then at 24-hour intervals to adjust for changes, if they occur. This empiric method, based upon mean pharmacokinetic parameters, will prevent large fluctuations in serum concentration during the most critical period of the patient's course.

In patients with cor pulmonale, cardiac decompensation, or liver dysfunction, or in those taking drugs that markedly reduce theophylline clearance (e.g., cimetidine), the initial theophylline infusion rate should not exceed 17 mg/hr unless serum concentrations can be monitored at 24-hour intervals. In these patients, 5 days may be required before steady-state is reached.

Theophylline distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight.

Table V contains initial theophylline infusion rates following an appropriate loading dose recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for final theophylline dosage adjustment based upon serum theophylline concentrations. Application of these general dosing recommendations to individual patients must take into account the unique clinical characteristics of each patient. In general, these recommendations should serve as the upper limit for dosage adjustments in order to decrease the risk of potentially serious adverse events associated with unexpected large increases in serum theophylline concentration.
Table V. Initial theophylline infusion rates following an appropriate loading dose. Patient population Age Theophylline infusion rate(mg/kg/hr)*† * To achieve a target concentration of 10 mcg/mL. Aminophylline = theophylline/0.8. Use ideal body weight for obese patients. † Lower initial dosage may be required for patients receiving other drugs that decrease theophylline clearance ( e.g., cimetidine). ‡ To achieve a target concentration of 7.5 mcg/mL for neonatal apnea. § Not to exceed 900 mg/day, unless serum levels indicate the need for a larger dose. ¶ Not to exceed 400 mg/day, unless serum levels indicate the need for a larger dose. Neonates Postnatal age up to 24 days 1 mg/kg every 12 hours/‡ Postnatal age beyond 24 days 1.5 mg/kg every 12 hours/‡ Infants 6–52 weeks old mg/kg/hr=(0.008)(age in weeks) + 0.21 Young children 1–9 years 0.8 Older children 9–12 years 0.7 Adolescents (cigarette or marijuana smokers) 12–16 years 0.7 Adolescents (nonsmokers) 12–16 years 0.5§ Adults (otherwise healthy nonsmokers) 16–60 years 0.4§ Elderly Greater than 60 years 0.3¶ Cardiac decompensation, cor pulmonale, liver dysfunction, sepsis with multi-organ failure, or shock 0.2¶ Table VI. Final dosage adjustment guided by serum theophylline concentration. Peak Serum Concentration Dosage Adjustment * Dose reduction and/or serum theophylline concentration measurement is indicated whenever adverse effects are present, physiologic abnormalities that can reduce theophylline clearance occur ( e.g., sustained fever), or a drug that interacts with theophylline is added or discontinued (see WARNINGS). Less than 9.9 mcg/mL If symptoms are not controlled and current dosage is tolerated, increase infusion rate about 25%. Recheck serum concentration after 12 hours in pediatric patients and 24 hours in adults for further dosage adjustment. 10 to 14.9 mcg/mL If symptoms are controlled and current dosage is tolerated, maintain infusion rate and recheck serum concentration at 24-hour intervals.* If symptoms are not controlled and current dosage is tolerated consider adding additional medication(s) to treatment regimen. 15–19.9 mcg/mL Consider 10% decrease in infusion rate to provide greater margin of safety even if current dosage is tolerated.* 20–24.9 mcg/mL Decrease infusion rate by 25% even if no adverse effects are present. Recheck serum concentration after 12 hours in pediatric patients and 24 hours in adults to guide further dosage adjustment. 25–30 mcg/mL Stop infusion for 12 hours in pediatric patients and 24 hours in adults and decrease subsequent infusion rate at least 25% even if no adverse effects are present. Recheck serum concentration after 12 hours in pediatric patients and 24 hours in adults to guide further dosage adjustment. If symptomatic, stop infusion and consider whether overdose treatment is indicated (see recommendations for Chronic Overdosage). Greater than 30 mcg/mL Stop the infusion and treat overdose as indicated (see recommendations for Chronic Overdosage). If theophylline is subsequently resumed, decrease infusion rate by at least 50% and recheck serum concentration after 12 hours in pediatric patients and 24 hours in adults to guide further dosage adjustment.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Sodium Chloride

Sodium Chloride

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride).

There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. Follow recommendations of appropriate pediatric reference text. (See PRECAUTIONS, Pediatric Use.)

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

0.9% Sodium Chloride Injection USP may also be administered intravascularly as a priming fluid in hemodialysis procedures.

When Sodium Chloride Injections USP are used as diluents for infusion of compatible drug additives, refer to dosage and administration information accompanying additive drugs.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly.

Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Lactated Ringers

Lactated Ringers

This solution is for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

The presence of calcium ions in this solution should be considered when phosphate is present in additive solutions, in order to avoid precipitation.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Acetic Acid Irrigant

Acetic Acid Irrigant

As required for urologic irrigation.

0.25% Acetic Acid Irrigation USP may be administered by gravity drip via an administration set connected to an indwelling urethral catheter designed for continuous or intermittent two-way flow.

For continuous or intermittent irrigation, the rate of administration will correspond roughly to the rate of urine flow and should be adjusted to maintain a urinary effluent pH of 4.5 to 5.0.

Nitrazine or other pH paper may be used to monitor pH, preferably at least four times daily. Drip rate should be adjusted as necessary to maintain desired pH; increasing flow rate reduces pH value and vice versa. With continuous or intermittent irrigation, each patient will require a volume of approximately 500 to 1500 mL per 24 hours.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Isolyte P In Dextrose

Isolyte P In Dextrose

This solution is for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Lidocaine Hydrochloride...

Lidocaine Hydrochloride And Dextrose

Therapy of ventricular arrhythmias is often initiated with a single IV bolus of 1 mg/kg of Lidocaine Hydrochloride Injection USP. Following acute treatment by bolus in patients in whom arrhythmias tend to recur and who are incapable of receiving oral antiarrhythmic agents, intravenous infusion of Lidocaine Hydrochloride and 5% Dextrose Injection USP is administered continuously.

Rate of Administration

Adults (20 to 50 mcg/kg/min):
Average 70 kg adult mg/min mL/hr mL/min 0.4% Lidocaine Hydrochloride and5% Dextrose Injection USP(4 mg lidocaine hydrochloride/mL) 1–4 15–60 0.25–1.0 0.8% Lidocaine Hydrochloride and5% Dextrose Injection USP(8 mg lidocaine hydrochloride/mL) 1–4 7.5–30 0.12–0.5

Pediatric Patients (30 mcg/kg/min).1

Pharmacokinetic data indicate reduced elimination of lidocaine after prolonged infusion (24 hours) with resultant prolongation of the half-life to approximately three times that seen following a single administration. Failure to adjust the rate of infusion in keeping with this altered ability to eliminate lidocaine may result in toxic accumulation of the drug in the patient's serum.2

Intravenous infusions of lidocaine hydrochloride must be administered under constant ECG monitoring to avoid potential overdosage and toxicity. Intravenous infusion should be terminated as soon as the patient's basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. It should rarely be necessary to continue intravenous infusions beyond 24 hours. As soon as possible and when indicated, patients should be changed to an oral antiarrhythmic agent for maintenance therapy.

Caution: Concentrated solutions of lidocaine hydrochloride (greater than 0.2%) should be administered by carefully calibrated infusion devices.
1 Standards and Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiac Care (ECC). American Heart Association, JAMA 244 (5):453–509, 1980. 2 LeLorier J, Grenon D, Latour Y, et al.: Pharmacokinetics of lidocaine after prolonged intravenous infusions in uncomplicated myocardial infarction. Ann Int Med 87:700–702, 1977.
Pediatric Use

Therapy should be initiated with a single IV bolus of 1 mg/kg of Lidocaine Hydrochloride Injection USP. A maintenance intravenous infusion of Lidocaine Hydrochloride and 5% Dextrose Injection USP administered at a recommended infusion rate of 30 mcg/kg/min may be given.1

Geriatric Use

Patients with reduced hepatic function or diminished hepatic blood flow (as in heart failure and after cardiac surgery), or those over 70 years of age should receive half the usual loading dose and also should be given lower maintenance levels of intravenous lidocaine. Patients over 65 years may benefit from dosing based upon body weight (see CLINICAL PHARMACOLOGY and PRECAUTIONS, Geriatric Use).

Lidocaine hydrochloride should not be added to blood transfusion assemblies.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Cefotetan And Dextrose

Cefotetan And Dextrose

Cefotetan for Injection USP and Dextrose Injection USP in the DUPLEX® Container is intended for intravenous use only.

Treatment

The usual adult dosage is 1 or 2 grams of Cefotetan for Injection USP and Dextrose Injection USP administered intravenously every 12 hours for 5 to 10 days. Proper dosage should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organism.
General Guidelines for Dosage of Cefotetan for Injection USP and Dextrose Injection USP Type of Infection Daily Dose Frequency and Route * Klebsiella pneumoniae skin and skin structure infections should be treated with 1 or 2 grams every 12 hours IV. † Maximum daily dosage should not exceed 6 grams. Urinary Tract 1–4 grams 500 mg every 12 hours IV 1 or 2 g every 24 hours IV 1 or 2 g every 12 hours IV Skin & Skin Structure Mild – Moderate* 2 grams 2 g every 24 hours IV 1 g every 12 hours IV Severe 4 grams 2 g every 12 hours IV Other Sites 2–4 grams 1 or 2 g every 12 hours IV Severe 4 grams 2 g every 12 hours IV Life-Threatening 6 grams† 3 g every 12 hours IV
If Chlamydia trachomatis is a suspected pathogen in gynecologic infections, appropriate antichlamydial coverage should be added, since cefotetan has no activity against this organism.

Prophylaxis

To prevent postoperative infection in clean, contaminated, or potentially contaminated surgery in adults, the recommended dosage is 1 or 2 g of Cefotetan for Injection USP and Dextrose Injection USP administered once, intravenously, 30 to 60 minutes prior to surgery. In patients undergoing cesarean section, the dose should be administered as soon as the umbilical cord is clamped.

Impaired Renal Function

When renal function is impaired, a reduced dosage schedule must be employed. The following dosage guidelines may be used.
DOSAGE GUIDELINES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine ClearancemL/min Dose Frequency * Dose determined by the type and severity of infection, and susceptibility of the causative organism. > 30 Usual Recommended Dosage* Every 12 hours 10 – 30 Usual Recommended Dosage* Every 24 hours < 10 Usual Recommended Dosage* Every 48 hours
Alternatively, the dosing interval may remain constant at 12 hour intervals, but the dose reduced to one-half the usual recommended dose for patients with a creatinine clearance of 10–30 mL/min, and one-quarter the usual recommended dose for patients with a creatinine clearance of less than 10 mL/min.

When only serum creatinine levels are available, creatinine clearance may be calculated from the following formula. The serum creatinine level should represent a steady state of renal function.
Males: Weight (kg) × (140 - age) 72 × serum creatinine (mg/100 mL) Females: 0.9 × value for males
Cefotetan is dialyzable and it is recommended that for patients undergoing intermittent hemodialysis, one-quarter of the usual recommended dose be given every 24 hours on days between dialysis and one-half the usual recommended dose on the day of dialysis.

Intravenous Administration

The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

Using an infusion system, Cefotetan for Injection USP and Dextrose Injection USP may be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. Butterfly or scalp vein-type needles are preferred for this type of infusion. However, during infusion of the solution containing Cefotetan for Injection USP and Dextrose Injection USP, it is advisable to discontinue temporarily the administration of other solutions at the same site.

NOTE: Solutions of Cefotetan for Injection USP and Dextrose Injection USP must not be admixed with solutions containing aminoglycosides. If Cefotetan for Injection USP and Dextrose Injection USP and aminoglycosides are to be administered to the same patient, they must be administered separately and not as a mixed injection.

Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

DUPLEX® Drug Delivery System Directions for Use
To avoid inadvertent activation, DUPLEX® Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
Apply patient-specific label on foil side of container. USE CARE to avoid activation. Do not cover any portion of foil strip with patient label. Unlatch side tab and unfold DUPLEX® Container. (See Diagram 1.) Visually inspect diluent chamber for particulate matter. Use only if container and seals are intact. To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber. (See Diagram 2.) Protect from light after removal of foil strip.Note: If foil strip is removed, product must be used within 7 days, but not beyond the labeled expiration date. The product should be re-folded and the side tab latched until ready to activate.
Reconstitution (Activation)
Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use. Unfold the DUPLEX® Container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber.(See Diagram 3.) Agitate the liquid-powder mixture until the drug powder is completely dissolved.Note: Following reconstitution (activation), product must be used within 12 hours if stored at room temperature or within 5 days if stored under refrigeration.
Administration
Visually inspect the reconstituted solution for particulate matter. Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port. (See Diagram 4.) Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired. Using aseptic technique, peel foil cover from the set port and attach sterile administration set. (See Diagram 5.) Refer to Directions for Use accompanying the administration set.
Precautions
As with other cephalosporins, reconstituted Cefotetan for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected. Use only if prepared solution is clear and free from particulate matter. Do not use in series connection. Do not introduce additives into the DUPLEX® Container. Do not freeze.
Dextrose In Lactated Ri...

Dextrose In Lactated Ringers

This solution is for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

The presence of calcium ions in this solution should be considered when phosphate is present in additive solutions, in order to avoid precipitation.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Pediatric Use

There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. See WARNINGS and PRECAUTIONS.
Dextrose

Dextrose

These solutions are for intravenous use only.Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Sodium Chloride Solutio...

Sodium Chloride Solution

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride).

There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. (See PRECAUTIONS, Pediatric Use.)

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

0.9% Sodium Chloride Injection USP may also be administered intravascularly as a priming fluid in hemodialysis procedures.

When Sodium Chloride Injections USP are used as diluents for infusion of compatible drug additives, refer to dosage and administration information accompanying additive drugs.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Ceftriaxone And Dextros...

Ceftriaxone And Dextrose

2.1 Adult Population

Ceftriaxone for Injection and Dextrose Injection in the DUPLEX® Container should be used only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. The recommended adult dosages are outlined in Table 1. Ceftriaxone for Injection and Dextrose Injection should be administered intravenously (IV) over approximately 30 minutes.

The usual duration of therapy is 4 to 14 days; in complicated infections, longer therapy may be required. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.
* Patients with hepatic impairment and significant renal impairment should not receive more than 2 grams per day of ceftriaxone.
Table 1: Recommended Dosing Schedule for Ceftriaxone for Injection and Dextrose Injection

Site and Type of Infection

Dose

Frequency

Total Daily Dose

Usual Adult Dose

1 g to 2 g

once a day or in equally divided doses every 12 hours

should not exceed 4 g*

Surgical Prophylaxis

1 gram IV once

1/2 to 2 hours before surgery

Skin and Skin Structure Infections

50 to 75 mg per kg

once a day or in equally divided doses every 12 hours

should not exceed 2 g

Meningitis

100 mg per kg

once a day or in equally divided doses every 12 hours

should not exceed 4 g*

Serious Infections other than Meningitis

50 to 75 mg per kg

every 12 hours

should not exceed 2 g

2.2 Pediatric Patients

Ceftriaxone for Injection and Dextrose Injection in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftriaxone. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of ceftriaxone. [see Use in Specific Populations (8.4)]

2.3 Preparation for Use of Ceftriaxone for Injection and Dextrose Injection in DUPLEX® Container

This reconstituted solution is for intravenous use only.

Do not use plastic containers in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use only if solution is clear and container and seals are intact.

DUPLEX® Drug Delivery System Storage
To avoid inadvertent activation, the DUPLEX® Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
Apply patient-specific label on foil side of container. Use care to avoid activation. Do not cover any portion of foil strip with patient label. Unlatch side tab and unfold DUPLEX® Container (see Diagram 1). Visually inspect diluent chamber for particulate matter. Use only if container and seals are intact. To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber (see Diagram 2). Protect from light after removal of foil strip.Note: If foil strip is removed, the container should be re-folded and the side tab latched until ready to activate. The product must then be used within 7 days, but not beyond the labeled expiration date.
Reconstitution (Activation)
Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use. Unfold the DUPLEX® container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber (see Diagram 3). Agitate the liquid-powder mixture until the drug powder is completely dissolved.Note: Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 days if stored under refrigeration.
Administration
Visually inspect the reconstituted solution for particulate matter. Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port (see Diagram 4). Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be compromised. Using aseptic technique, peel foil cover from the set port and attach sterile administration set (see Diagram 5). Refer to directions for use accompanying the administration set.
Important Administration Instructions
Do not use in series connections. Do not introduce additives into the DUPLEX® Container. Administer Ceftriaxone for Injection and Dextrose Injection intravenously over approximately 30 minutes. After the indicated stability time periods, unused portions of solutions should be discarded. Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible with ceftriaxone in admixtures. When any of these drugs are to be administered concomitantly with ceftriaxone by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with 0.9% sodium chloride injection or 5% dextrose in water (D5W)) between the administrations. Ceftriaxone for Injection and Dextrose Injection should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs due to possible incompatibility. [see Drug Interactions (7.1)] Precipitation of ceftriaxone-calcium can also occur when Ceftriaxone for Injection and Dextrose Injection is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone for Injection and Dextrose Injection must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, Ceftriaxone for Injection and Dextrose Injection and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. [see Warnings and Precautions (5.2)] There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).
Cefoxitin And Dextrose

Cefoxitin And Dextrose

Cefoxitin for Injection and Dextrose Injection in the DUPLEX® Container is intended for intravenous use only.

TREATMENT

Adults

The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 3 for dosage guidelines).

If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoxitin sodium has no activity against this organism.

Cefoxitin for Injection and Dextrose Injection may be used in patients with reduced renal function with the following dosage adjustments:

In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.

When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
Males: Weight (kg) × (140 − age) 72 × serum creatinine (mg/100 mL) Females: 0.85 × above value
In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.

Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

Pediatric Patients

The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 4).

PREVENTION

Effective prophylactic use depends on the time of administration. Cefoxitin for Injection and Dextrose Injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

Adults

2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

Pediatric Patients (3 months and older)

30 to 40 mg/kg doses may be given at the times designated above.

Cesarean section patients

For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)
Table 3 - Guidelines for Dosage of Cefoxitin for Injection Type of Infection Daily Dosage Frequency and Route * Including patients in whom bacteremia is absent or unlikely. Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection 3–4 grams 1 gram every 6–8 hours IV Moderately severe or severe infections 6–8 grams 1 gram every 4 hoursor 2 grams every 6–8 hours IV Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene) 12 grams 2 grams every 4 hoursor 3 grams every 6 hours IV Table 4 - Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function Renal Function Creatinine Clearance(mL/min) Dose(grams) Frequency Mild impairment 50–30 1–2 every 8–12 hours Moderate impairment 29–10 1–2 every 12–24 hours Severe impairment 9–5 0.5–1 every 12–24 hours Essentially no function <5 0.5–1 every 24–48 hours
ADMINISTRATION

The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

Cefoxitin for Injection and Dextrose Injection may be administered through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing Cefoxitin for Injection and Dextrose Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

Solutions of Cefoxitin for Injection and Dextrose Injection, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, Cefoxitin for Injection and Dextrose Injection and aminoglycosides may be administered separately to the same patient.

CAUTION: Do not use plastic containers in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

DUPLEX® Drug Delivery System Directions for Use
To avoid inadvertent activation, DUPLEX® Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
Apply patient-specific label on foil side of container. USE CARE to avoid activation. Do not cover any portion of foil strip with patient label. Unlatch side tab and unfold Duplex® Container. (See Diagram 1.) Visually inspect diluent chamber for particulate matter. Use only if container and seals are intact. To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber. (See Diagram 2.) Protect from light after removal of foil strip.
Note: If foil strip is removed, product must be used within 7 days, but not beyond the labeled expiration date.
The product should be re-folded and the side tab latched until ready to activate.
Reconstitution (Activation)
Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use. Unfold the DUPLEX® Container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber. (See Diagram 3.) Agitate the liquid-powder mixture until the drug powder is completely dissolved.
Note: Following reconstitution (activation), product must be used within 12 hours if stored at room temperature or within 7 days if stored under refrigeration.

Administration
Visually inspect the reconstituted solution for particulate matter. Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port. (See Diagram 4.) Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired. Using aseptic technique, peel foil cover from the set port and attach sterile administration set. (See Diagram 5.) Refer to Directions for Use accompanying the administration set.
Precautions
As with other cephalosporins, reconstituted Cefoxitin for Injection and Dextrose Injection tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected. Use only if prepared solution is clear and free from particulate matter. Do not use in series connection. Do not introduce additives into the DUPLEX® Container. Do not freeze.
Dextrose And Sodium Chl...

Dextrose And Sodium Chloride

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of fluid containing 0.9% sodium chloride (154 mEq each of sodium and chloride).

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Pediatric Use

There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. See WARNINGS and PRECAUTIONS.
Heparin Sodium In Dextr...

Heparin Sodium In Dextrose

Heparin Sodium in 5% Dextrose Injection is for intravenous use only. Do not use Heparin Sodium in 5% Dextrose Injection as a "catheter lock flush" product.

Heparin Sodium is not effective by oral administration and Heparin Sodium in 5% Dextrose Injection should not be given orally.

This product should not be infused under pressure.

The dosage of heparin sodium should be adjusted according to the patient's coagulation test results. When heparin sodium is administered by continuous intravenous infusion, coagulation tests should be performed approximately every 4 hours during the early stages of therapy. Dosage is considered adequate when the activated partial thromboplastin time (APTT) is 1.5 to 2 times normal or when the whole blood clotting time is elevated approximately 2.5 to 3 times the control value.

Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration.

When an oral anticoagulant of the coumarin or similar type is to be begun in patients already receiving heparin sodium, baseline and subsequent tests of prothrombin activity must be determined at a time when heparin activity is too low to affect the prothrombin time. This is about 5 hours after the last IV bolus and 24 hours after the last subcutaneous dose. If continuous IV heparin infusion is used, prothrombin time can usually be measured at any time.

In converting from heparin to an oral anticoagulant, the dose of the oral anticoagulant should be the usual initial amount and thereafter prothrombin time should be determined at the usual intervals. To ensure continuous anticoagulation, it is advisable to continue full heparin therapy for several days after the prothrombin time has reached the therapeutic range. Heparin therapy may then be discontinued without tapering.

Although dosage must be adjusted for the individual patient according to the results of suitable laboratory tests, the following dosage schedules may be used as guidelines:
Method of Administration Frequency Recommended Dose* * Based on 150-lb. (68-kg) patient. Initial dose 5,000 USP units by IV injection Continuous Intravenous infusion Continuous 20,000 – 40,000 USP units/24 hours
Pediatric Use

There are no adequate and well controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience. In general, the following dosage schedule may be used as a guideline in pediatric patients:

Initial Dose                  75 to 100 USP units/kg (IV bolus over 10 minutes)

Maintenance Dose     Infants: 25 to 30 USP units/kg/hour; Infants less than 2 months have the highest requirements (average 28 USP units/kg/hour)

                                    Children greater than 1 year of age: 18 to 20 USP units/kg/hour; Older children may require less heparin, similar to weight-adjusted adult dosage

Monitoring                    Adjust heparin to maintain aPTT of 60 to 85 seconds, assuming this reflects an anti-Factor Xa level of 0.35 to 0.70.

Geriatric Use

Patients over 60 years of age may require lower doses of heparin. (See PRECAUTIONS.)

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Heparin Sodium In Sodiu...

Heparin Sodium In Sodium Chloride

Heparin Sodium is not effective by oral administration and Heparin Sodium in 0.9% Sodium Chloride Injection should not be given orally.

This product should be administered by intravenous infusion. Do not use Heparin Sodium in 0.9% Sodium Chloride Injection as a "catheter lock flush" product.

This product should not be infused under pressure.

Note: Small doses of heparin can alter tests for activated partial thromboplastin time (APTT). A baseline value for APTT should be obtained prior to administration of this solution.

Maintenance of Catheter Patency

Although the rate of infusion of the 2 USP units/mL formulation is dependent upon the age, weight, clinical condition of the patient, and the procedure being employed, an infusion rate of 3 mL/hour has been found to be satisfactory.

Geriatric Use

Patients over 60 years of age may require lower doses of heparin. (See PRECAUTIONS.)

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Metronidazole Solution

Metronidazole Solution

In elderly patients the pharmacokinetics of metronidazole may be altered and therefore monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly.

TREATMENT OF ANAEROBIC INFECTIONS

The recommended dosage schedule for Adults is:
Loading Dose 15 mg/kg infused over one hour (approximately 1 g for a 70-kg adult). Maintenance Dose 7.5 mg/kg infused over one hour every six hours (approximately 500 mg for a 70-kg adult). The first maintenance dose should be instituted six hours following the initiation of the loading dose.
Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Close monitoring of plasma metronidazole levels and toxicity is recommended.3

In patients receiving metronidazole injection in whom gastric secretions are continuously removed by nasogastric aspiration, sufficient metronidazole may be removed in the aspirate to cause a reduction in serum levels.

The dose of Metronidazole Injection USP should not be specifically reduced in anuric patients since accumulated metabolites may be rapidly removed by dialysis.

The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.

PROPHYLAXIS

For surgical prophylactic use, to prevent postoperative infection in contaminated or potentially contaminated colorectal surgery, the recommended dosage schedule for adults is:
15 mg/kg infused over 30 to 60 minutes and completed approximately one hour before surgery, followed by: 7.5 mg/kg infused over 30 to 60 minutes at 6 and 12 hours after the initial dose.
It is important that (1) administration of the initial preoperative dose be completed approximately one hour before surgery so that adequate drug levels are present in the serum and tissues at the time of initial incision, and (2) Metronidazole Injection USP be administered, if necessary, at 6-hour intervals to maintain effective drug levels. Prophylactic use of Metronidazole Injection USP should be limited to the day of surgery only, following the above guidelines.

Parenteral therapy may be changed to oral metronidazole when conditions warrant, based upon the severity of the disease and the response of the patient to treatment with Metronidazole Injection USP. The usual adult oral dosage is 7.5 mg/kg every six hours.

A maximum of 4 g should not be exceeded during a 24-hour period.

CAUTION: Metronidazole Injection USP is to be administered by slow intravenous drip infusion only, either as a continuous or intermittent infusion. IV admixtures containing metronidazole and other drugs should be avoided. Additives should not be introduced into this solution. If used with a primary intravenous fluid system, the primary solution should be discontinued during metronidazole infusion. DO NOT USE EQUIPMENT CONTAINING ALUMINUM (E.G., NEEDLES, CANNULAE) THAT WOULD COME IN CONTACT WITH THE DRUG SOLUTION.

Metronidazole Injection USP is a ready-to-use isotonic solution. NO DILUTION OR BUFFERING IS REQUIRED. Do not refrigerate. Each container of Metronidazole Injection USP contains 13.5 mEq of sodium.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if cloudy or precipitated or if the seals are not intact.

Use sterile equipment. It is recommended that the intravenous administration apparatus be replaced at least once every 24 hours.
Carvedilol

Carvedilol

This solution is for intravenous use only after admixture or dilution.

70% Dextrose Injection USP is designed for use with automated compounding devices for preparing intravenous nutritional admixtures or for the filling of empty sterile syringes. Dosages will be in accordance with the recommendation of the prescribing physician. 70% Dextrose Injection USP is not intended for direct infusion. Admixtures should be made by, or under the direction of, a pharmacist using strict aseptic technique under a laminar flow hood. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Pediatric Use

The dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.
Hespan

Hespan

Dosage for Acute Use in Plasma Volume Expansion

HESPAN® is administered by intravenous infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost and the resultant hemoconcentration.

2.1 Adults

The amount usually administered is 500 to 1000 mL. Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required. Higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred [see Warnings and Precautions (5)].

2.2 Leukapheresis

250 to 700 mL of HESPAN® (6% hetastarch in 0.9% sodium chloride injection) with citrate anticoagulant is administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. The HESPAN® and citrate should be thoroughly mixed to assure effective anticoagulation of blood as it flows through the leukapheresis machine.

2.3 Direction for use for HESPAN®
Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use only if solution is clear and container and seals are intact. Intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Withdraw or expel all air from the bag through the medication port prior to infusion if administration is by pressure infusion.
For single use only. Discard unused portion.

CAUTION: Before administering to the patient, review these directions:

Visual Inspection
Do not remove the plastic infusion container from its overwrap until immediately before use. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.
To Open
Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If any leaks are found, discard solution as sterility may be impaired.
Preparation for Administration
Remove plastic protector from sterile set port at bottom of container. Attach administration set. Refer to complete directions accompanying set.
When stored at room temperature, HESPAN® admixtures of 500-560 mL with citrate concentrations up to 2.5% were compatible for 24 hours. The safety and compatibility of additives other than citrate have not been established.
Facilipro Hand Sanitize...

Facilipro Hand Sanitizer

6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection is administered by intravenous infusion only. The daily dose and rate of infusion depend on the patient's blood loss, on the maintenance or restoration of hemodynamics and on the hemodilution (dilution effect). 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injectioncan be administered repetitively over several days. [see Warnings and Precautions (5)]

The initial 10 to 20 mL should be infused slowly, keeping the patient under close observation due to possible anaphylactoid reactions. [see General Warnings and Precautions (5.1)]

2.1 Adult Dose

Up to 50 mL of 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection per kg of body weight per day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight). This dose is equivalent to 3500 mL of 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection for a 70 kg patient.

2.2 Pediatric Dose

The dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status.

In 41 newborns to infants (< 2 years), a mean dose of 16 ± 9 mL/kg was administered. In 31 children from 2 to 12 years of age a mean dose of 36 ± 11 mL/kg was administered. The dose in adolescents > 12 is the same as the adult dose. [see Pediatric Use (8.4)]

2.3 Directions for Use of EXCEL® Container

Caution: Do not use plastic container in series connection.

If administered by pressure infusion, air should be withdrawn or expelled from the bag through the medication/administration port prior to infusion.

To OpenTear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired.

Note: Before use, perform the following checks:
Read the label carefully. Do not remove the plastic infusion container from its overwrap until immediately before use. While the overwrap is intact, identify the solution as 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, the lot number, and the expiration date. Check that the solution is clear. Inspect the intact unit for signs of obvious damage. If present, the unit should not be used. Use only if solution is clear and container and seals are intact.
Preparation for Administration1. Remove plastic protector from sterile set port at bottom of container.2. Attach administration set. Refer to complete directions accompanying set.
Dextrose And Sodium Chl...

Dextrose And Sodium Chloride

This solution is for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Pediatric Use

There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. See WARNINGS and PRECAUTIONS.
Sodium Chloride

Sodium Chloride

This solution is for intravenous use only.

Do not use plastic container in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations.

There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. See PRECAUTIONS, Pediatric Use.

When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information of the drug to be used.

Addition of medication should be accomplished using aseptic technique in order to assure sterility.

Physicochemical studies have shown that the container and solution can withstand freezing.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Sterile Water

Sterile Water

This solution is for intravenous use only. Do not inject until made approximately isotonic by addition of appropriate solute.

The dosage and administration of Sterile Water for Injection USP is dependent upon the recommended dosage and administration of the solute used. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Mannitol

Mannitol

This solution is for intravenous use only.

The total dosage, concentration, and rate of administration should be governed by the nature and severity of the condition being treated, and the patient's fluid requirement and urinary output. The adult dosage ranges from 50 to 200 g in a 24-hour period, but in most cases an adequate response will be achieved at a usual dosage of approximately 100 g/24 hours. The rate of administration is usually adjusted to maintain a urine flow of at least 30 to 50 mL/hour. Lower mannitol concentrations and solutions containing sodium chloride are useful in preventing dehydration and electrolyte depletion. This outline of administration and dosage is only a general guide to therapy.

Dosage requirements for patients 12 years of age and under have not been established. As with adults, dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text.

Test Dose

A test dose of mannitol should be given prior to instituting therapy for patients with marked oliguria or those believed to have inadequate renal function. Such test doses may be approximately 0.2 g/kg body weight (about 75 mL of a 20% solution) infused in a period of 3 to 5 minutes to produce a urine flow of at least 30 to 50 mL/hour. If urine flow does not increase, a second test dose may be given. If response is inadequate, the patient should be reevaluated.

Prevention of Acute Renal Failure (Oliguria)

When used during cardiovascular and other types of surgery, 50 to 100 g of mannitol may be given.

Treatment of Oliguria

The usual dose for treatment of oliguria is 100 g administered as a 20% solution.

Reduction of Intraocular Pressure

A dose of 1.5 to 2.0 g/kg as a 20% solution (7.5 to 10 mL/kg) may be given over a period as short as 30 minutes in order to obtain a prompt and maximal effect. When used preoperatively the dose should be given one to one and one-half hours before surgery to achieve maximal reduction of intraocular pressure before operation.

Reduction of Intracranial Pressure

Usually a maximum reduction in intracranial pressure in adults can be achieved with a dose of 0.25 g/kg given not more frequently than every six to eight hours. An osmotic gradient between the blood and cerebrospinal fluid of approximately 10 mOsmol will yield a satisfactory reduction in intracranial pressure.

Adjunctive Therapy for Intoxications

As an agent to promote diuresis in intoxications, mannitol is indicated. The concentration will depend upon the fluid requirement and urinary output of the patient.

Measurement of glomerular filtration rate by creatinine clearance may be useful for determination of dosage.

It is recommended that 20% Mannitol Injection USP be administered through a blood filter set to ensure against infusion of mannitol crystals.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

This solution is intended for intravenous administration using sterile equipment.

The use of supplemental additive medication is not recommended.
Ringers

Ringers

This solution is for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. The usual adult dose is one to two liters per day.

In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride).

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Sodium Chloride

Sodium Chloride

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Maximum intravenous dosage should be 100 mL given over a period of one hour. Before additional amounts are given, the serum electrolyte concentrations, including chloride and bicarbonate, should be determined to evaluate the need for more sodium chloride.

Intravenous administration of these solutions should not exceed 100 mL/hour or 400 mL/24 hours.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Freamine Iii

Freamine Iii

The total daily dose of 10% FreAmine® III (Amino Acid Injection) depends on daily protein requirements and on the patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements.

While Recommended Dietary Allowances of protein are approximately 0.8 g/kg of body weight for a healthy adult and 1.4 to 2.2 g/kg for healthy growing infants and pediatric patients. It must be recognized that protein as well as caloric requirements in traumatized or malnourished patients may be substantially increased. Daily amino acid doses of approximately 1.5 g/kg of body weight for adults and 2 to 3 g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Higher doses may be required in severely catabolic states. Such higher doses, especially in infants, must be accompanied by frequent laboratory evaluation. Fat emulsion may be supplied to help meet energy requirements.

Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat free TPN.

For protein sparing in well-nourished patients not receiving significant additional calories, amino acid dosages of 1.0 to 1.7 g/kg/day significantly reduce nitrogen losses and spare body protein. If rises in BUN exceed 20 mg% in 48 hours, amino acid infusion should be discontinued or rate of administration reduced.

The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is also required for optimum utilization of amino acids. Approximately 60–180 mEq of potassium, 10–30 mEq of magnesium, and 20–80 mEq of phosphate per day appear necessary to achieve optimum metabolic response. In addition, sufficient quantities of the major extracellular electrolytes (sodium, calcium, and chloride) must be given. In patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate or lactate salts to provide bicarbonate precursor. The electrolyte content of 10% FreAmine® III (Amino Acid Injection) must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.

If a patient's nutritional intake is primarily parenteral, vitamins, especially the water soluble vitamins, and trace elements should also be provided.
Isolyte S Ph 7.4

Isolyte S Ph 7.4

This solution is for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Isolyte® S pH 7.4 (Multi-Electrolyte Injection) may be admixed with solutions which contain phosphate or which have been supplemented with phosphate.

The presence of magnesium and phosphate ions in this solution should be considered when phosphate is present in the additive solution, in order to avoid precipitation.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Isolyte S

Isolyte S

This solution is for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Isolyte® S (Multi-Electrolyte Injection) contains no phosphate. It may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium and magnesium ions should be considered when phosphate is present in the additive solution, in order to avoid precipitation.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Procalamine

Procalamine

ProcalAmine® is a convenient source of nonprotein calories to preserve lean body mass, amino acids, maintenance electrolytes, and water for adult patients.
Determination of nitrogen balance and accurate daily body weights (corrected for fluid balance) are probably the best means of assessing individual protein requirements. Approximately three liters per day of ProcalAmine® will provide a total of 90 grams of amino acids, 390 nonprotein calories and the recommended daily intake of principal intra- and extracellular electrolytes for the stable patient. Therapy can begin with three liters of ProcalAmine® on the first day with close monitoring of the patient. As with all intravenous fluid therapy, the goal is to provide adequate water to compensate for insensible, urinary and other losses, and electrolytes for replacement and maintenance. These requirements should be determined frequently and appropriately administered. Additional electrolytes should be administered evenly throughout the day, and irritating medications should be injected at an alternate infusion site.
Pediatric Use

ProcalAmine® is intended for use in adults. Use of ProcalAmine® in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).
Venous irritation at an infusion site can be minimized by the selection of a large peripheral vein as well as by slowing the rate of infusion. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L). Parenteral drug products should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution and container permit.
Mannitol Irrigant

Mannitol Irrigant

As required for urologic irrigation.

5% Mannitol Irrigation should be administered only by the appropriate transurethraI urologic instrumentation.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
Dextrose

Dextrose

This solution is for intravenous use only.

As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations.

Do not use plastic container in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information of the drug to be used.

Addition of medication should be accomplished using aseptic technique in order to assure sterility.

Physicochemical studies have shown that the container and solution can withstand freezing.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Pediatric Use

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. See WARNINGS and PRECAUTIONS.
Ringers

Ringers

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer's recommendations should be followed.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits. See PRECAUTIONS.
Lactated Ringers

Lactated Ringers

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer's recommendations should be followed.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.
Potassium Chloride

Potassium Chloride

Not for direct patient injection. Potassium Chloride for Injection Concentrate USP, Pharmacy Bulk Package is for preparation of intravenous admixtures only and must be diluted before administration. Care must be taken to ensure there is complete mixing of the potassium chloride with the large volume fluid, particularly if soft or bag type containers are used.

Dosage and rate of administration are to be directed by the physician and are dependent upon the specific conditions of each patient (e.g., age, weight, clinical condition of the patient and laboratory determinations). Frequent laboratory determinations and clinical evaluation are essential to monitor changes in electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

If the serum potassium level is greater than 2.5 mEq/liter, potassium can be given at a rate not to exceed 10 mEq/hour and in a concentration of up to 40 mEq/liter. The 24 hour total dose should not exceed 200 mEq.

If urgent treatment is indicated (serum potassium level less than 2.0 mEq/liter and electrocardiographic changes and/or muscle paralysis), potassium chloride may be infused very cautiously at a rate of up to 40 mEq/hour. In such cases, continuous cardiac monitoring is essential. As much as 400 mEq may be administered in a 24 hour period. In critical conditions, potassium chloride may be administered in saline (unless contraindicated) rather than in dextrose containing fluids, as dextrose may lower serum potassium levels.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Directions for Use of Pharmacy Bulk Package in B. Braun Glass Containers with Solid Stoppers

Warning: Not for direct infusion. For preparation of admixtures for intravenous infusion.

The pharmacy bulk package is for use in a Pharmacy Admixture Service only. Use of this product is restricted to a suitable work area, such as a laminar flow hood (or an equivalent clean air compounding area).

Additives should not be made to Pharmacy Bulk Packages.

Designed for use with a vented sterile dispensing set.

Before use, perform the following checks:
Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Verify that closure is black and is printed with the words "MUST BE DILUTED". Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter; check the bottle for cracks or other damage. In checking for cracks, do not be confused by normal surface marks and seams on bottom and sides of bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle. To remove the outer closure, lift the tear tab and pull up, over, and down until it is below the stopper (See Figure 1). Use a circular pulling motion on the tab until it breaks away. Grasp and remove the metal disk, exercising caution not to touch the exposed sterile stopper surface. Check for vacuum at first puncture of the stopper. Insert the spike fully into the target area of the rubber stopper (See Figure 2 and promptly invert the bottle. Verify vacuum by observing rising air bubbles. Do not use the bottle if vacuum is not present. Refer to Directions for Use of set to be used. If set insertion is not performed immediately following removal of protective metal disk, swab stopper with a suitable disinfectant.
The container closure may be penetrated only one time, utilizing a suitable sterile dispensing set which allows measured dispensing of the contents.

Transfer individual dose(s) to appropriate intravenous infusion solutions. Use of a syringe with needle is not recommended. Multiple entries increase the potential of the microbial and particulate contamination.

The withdrawal of container contents should be accomplished without delay using aseptic technique. Discard container no later than 4 hours after initial closure puncture.

The bottle may be stored under laminar flow hood at room temperature (25°C) after the closure has been entered. Date and time of container entry should be noted in the area designated on the container label.
Amino Acids

Amino Acids

The appropriate daily dose of amino acids to be used with dextrose or with dextrose and intravenous fat emulsion will depend upon the metabolic status and clinical response of the patient as therapy proceeds. Doses which achieve nitrogen equilibrium or positive balance are the most desirable. The dosage on the first day should be approximately half the anticipated optimal dosage and should be increased gradually to minimize glycosuria; similarly, withdrawal should be accomplished gradually to avoid rebound hypoglycemia.

Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat free TPN.

The amount administered is dosed on the basis of amino acids/kg of body weight/day. In general, two to three g/kg of body weight for neonates and infants with adequate calories are sufficient to satisfy protein needs and promote positive nitrogen balance. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE

Plenamine™ 15% in a Pharmacy Bulk Package is not intended for direct infusion. The container closure may be penetrated only once using a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Once the closure is penetrated, the contents should be dispensed as soon as possible; the transfer of contents must be completed within 4 hours of closure entry. The bottle may be stored at room temperature (25°C) after the closure has been entered. Date and time of container entry should be noted in the area designated on the container label.

When using Plenamine™ 15% in patients with a need for fluid volume restriction, it can be diluted as follows:
Volume Amount Final Concentration Plenamine™ 15% 500 mL 75 g 7.5% Dextrose 70% 250 mL 175 g 17.5% Intralipid® 20% 250 mL 50 g 5.0%
This will provide 1395 kilocalories (kcal) per 1000 mL of admixture with a ratio of 118 non-protein calories per gram of nitrogen and an osmolarity of 1561 mOsmol/L.

In patients where the need for fluid restriction is not so marked, either of the following regimens may be used dependent upon the energy needs of the patient.
Volume Amount Final Concentration Plenamine™ 15% 500 mL 75 g 3.75% Dextrose 50% 1000 mL 500 g 25% Intralipid® 20% 500 mL 100 g 5%
This will provide 1500 kcal per 1000 mL of admixture with a ratio of 228 non-protein calories per gram of nitrogen and an osmolarity of 1633 mOsmol/L.
Volume Amount Final Concentration Plenamine™ 15% 500 mL 75 g 3.75% Dextrose 30% 1000 mL 300 g 15% Intralipid® 10% 500 mL 50 g 2.5%
This will provide 935 kcal per 1000 mL of admixture with a ratio of 158 non-protein calories per gram of nitrogen and an osmolarity of 1128.5 mOsmol/L.

A. Total Parenteral Nutrition (Central Infusion)

In unstressed adult patients with no unusual nitrogen losses, a minimum dosage of 0.1 gram nitrogen (4.2 mL of Plenamine™ 15%) plus 4.4 grams (15 calories) of dextrose per kilogram of body weight per day are required to achieve nitrogen balance and weight stability. Intravenous fat emulsion may be used as a partial substitute for dextrose. This regimen provides a ratio of 150 non-protein calories per gram of nitrogen.

For patients stressed by surgery, trauma or sepsis, and those with unusual nitrogen losses, the dosage required for maintenance may be as high as 0.3 to 0.4 grams of nitrogen (13 to 17 mL Plenamine™ 15%) per kilogram of body weight per day, with proportionate increases in non-protein calories. Periodic assessment of nitrogen balance of the individual patient is the best indicator of proper dosage. Volume overload and glycosuria may be encountered at high dosage, and nitrogen balance may not be achieved in extremely hypermetabolic patients under these constraints. Concomitant insulin administration may be required to minimize glycosuria. Daily laboratory monitoring is essential.

Use of an infusion pump is advisable to maintain a steady infusion rate during central venous infusion.

B. Peripheral Nutrition

In patients for whom central venous catheterization is not advisable, protein catabolism can be reduced by peripheral use of diluted Plenamine™ 15% plus non-protein calorie sources. Dilution of 250 mL Plenamine™ 15% in 750 mL of 10% dextrose will reduce the osmolarity to a level (724 mOsmol/L) which is more favorable to the maintenance of the integrity of the walls of the veins. Intravenous fat emulsion can be infused separately or simultaneously; if infused simultaneously the fat emulsion will provide a dilution effect upon the osmolarity while increasing the energy supply.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

To reduce the risk of bacterial contamination, all intravenous administration sets should be replaced at least every 24 hours. Usage of admixtures must be initiated within 24 hours after mixing. If storage is necessary during this 24 hour period, admixtures must be refrigerated and completely used within 24 hours of beginning administration.
Levetiracetam Solution

Levetiracetam Solution

2.1 Dosage for Treatment of Indicated Infections in Adults

Cefazolin for Injection USP and Dextrose Injection USP in the DUPLEX® Container should be used only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. The recommended adult dosages are outlined in Table 1. Cefazolin for Injection USP and Dextrose Injection USP should be administered intravenously (IV) over approximately 30 minutes.
* In rare instances, doses of up to 12 grams of cefazolin per day have been used. Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min. Site and Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours
2.2 Dosage for Perioperative Prophylactic Use in Adults

To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:
1 to 2 gram IV administered 1/2 hour to 1 hour prior to the start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.
It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

2.3 Dosage in Pediatric Patients

The 2 grams dose of Cefazolin for Injection USP and Dextrose Injection USP is not recommended for use in pediatric patients.

Only administer 1 gram Cefazolin for Injection USP and Dextrose Injection USP to pediatric patients where the individual dose is the entire contents of the 1g DUPLEX® container and not any fraction of it.

Recommended doses for pediatric patients are as follows:
For most mild to moderately severe infections: a total daily dosage of 25 to 50 mg per kg of body weight, divided into 3 or 4 equal doses. For severe infections, the total daily dosage may be increased to 100 mg per kg of body weight.
There are no dosage recommendations for pediatric patients for perioperative prophylaxis or for pediatric patients with renal impairment.

2.4 Dosage in Adult Patients with Renal Impairment

Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.
Table 2: Dosage Adjustment for Patients with Renal Impairment Creatinine Clearance Dose Frequency 55 mL/min. or greater full dose normal frequency 35 to 54 mL/min. full dose every 8 hours or longer 11 to 34 mL/min. 1/2 usual dose every 12 hours 10 mL/min. or less 1/2 usual dose every 18 to 24 hours
2.5 Preparation for Use of Cefazolin for Injection USP and Dextrose Injection USP in DUPLEX® Container

This reconstituted solution is for intravenous use only.

Do not use plastic containers in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use only if solution is clear and container and seals are intact.

DUPLEX® Container Storage
To avoid inadvertent activation, the DUPLEX® Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
Apply patient-specific label on foil side of container. Use care to avoid activation. Do not cover any portion of foil strip with patient label. Unlatch side tab and unfold DUPLEX® Container (see Diagram 1). Visually inspect diluent chamber for particulate matter. Use only if container and seals are intact. To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber (see Diagram 2). Protect from light after removal of foil strip.
Note: If foil strip is removed, the container should be re-folded and the side tab latched until ready to activate. The product must then be used within 7 days, but not beyond the labeled expiration date.

Reconstitution (Activation)
Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use. Unfold the DUPLEX® container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber (see Diagram 3). Agitate the liquid-powder mixture until the drug powder is completely dissolved.
Note: Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 days if stored under refrigeration.

Administration
Visually inspect the reconstituted solution for particulate matter. Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port (see Diagram 4). Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be compromised. Using aseptic technique, peel foil cover from the set port and attach sterile administration set (see Diagram 5). Refer to directions for use accompanying the administration set.
Important Administration Instructions
Do not use in series connections. Do not introduce additives into the DUPLEX® Container. Administer Cefazolin for Injection USP and Dextrose Injection USP intravenously over approximately 30 minutes.
Freamine Hbc

Freamine Hbc

The total daily dose of 6.9% FreAmine HBC® (Amino Acid Injection) depends on daily protein requirements and on the patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements.

While Recommended Dietary Allowances of protein are approximately 0.8 g/kg of body weight for a healthy adult, it must be recognized that protein as well as caloric requirements in traumatized or malnourished patients may be substantially increased. Daily amino acid doses of approximately 1.5 g/kg of body weight for adults with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Higher doses may be required in severely catabolic states. Such higher doses must be accompanied by frequent laboratory evaluation. Fat emulsion may be supplied to help meet energy requirements.

Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat free TPN.

The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is also required for optimum utilization of amino acids. Approximately 60 – 180 mEq of potassium, 10 – 30 mEq of magnesium, and 20 – 80 mEq of phosphate per day appear necessary to achieve optimum metabolic response. In addition, sufficient quantities of the major extracellular electrolytes (sodium, calcium, and chloride) must be given. In patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate or lactate salts to provide bicarbonate precursor. The electrolyte content of 6.9% FreAmine HBC® must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.

If a patient's nutritional intake is primarily parenteral, vitamins, especially the water soluble vitamins, and trace elements should also be provided.

Central Venous Nutrition

For severely catabolic, depleted patients or those requiring long-term total parenteral nutrition, central venous nutrition should be considered. Total parenteral nutrition may be started with infusates containing lower concentrations of dextrose; dextrose content may be gradually increased to estimated caloric needs as the patient's glucose tolerance increases.

In adults, strongly hypertonic mixtures of amino acids and dextrose may be safely administered only by continuous infusion through a central venous catheter with the tip located in the vena cava. A mixture of 750 mL 6.9% FreAmine HBC® (Amino Acid Injection) solution, and 250 mL 70% Dextrose, supplemented with electrolytes, and vitamins may be administered over an 8-hour period. If administration rate should fall behind schedule, no attempt to "catch up" to planned intake should be made. In addition to meeting protein needs, the administration rate is also governed, especially during the first few days of therapy by the patient's glucose tolerance. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determination of urine and blood sugar levels. In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% Dextrose should be administered when hypertonic dextrose infusions are abruptly discontinued.

Peripheral Parenteral Nutrition

For moderately catabolic, depleted patients requiring parenteral nutrition in whom the central venous route is not indicated, diluted 6.9% FreAmine HBC® with minimal caloric supplementation may be infused by peripheral vein, supplemented, if desired, with fat emulsion. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

Fat provides approximately 9 kcal per gram and parenteral fat emulsion may be administered along with amino acid-dextrose solutions through a Y-type administration set to supplement caloric intake. Fat, however, should not provide more than 60% of the total caloric intake.

Pediatric Use

Use of 6.9% FreAmine HBC® in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L). See WARNINGS and PRECAUTIONS, Pediatric Use.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

6.9% FreAmine HBC® may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium and magnesium ions in an additive solution should be considered when phosphate is also present, in order to avoid precipitation.

Care must be taken to avoid incompatible admixtures. Consult with pharmacist.
Trophamine

Trophamine

The objective of nutritional management of infants and young pediatric patients is the provision of sufficient amino acid and caloric support for protein synthesis and growth.

The total daily dose of TrophAmine® (Amino Acid Injections) depends on daily protein requirements and on the patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements. Dosage should also be guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response.

Recommendations for allowances of protein in infant nutrition have ranged from 2 to 4 grams of protein per kilogram of body weight per day (2.0 to 4.0 g/kg/day).1 The recommended dosage of TrophAmine® is 2.0 to 2.5 grams of amino acids per kilogram of body weight per day (2.0 to 2.5 g/kg/day) for infants up to 10 kilograms. For infants and young pediatric patients larger than 10 kilograms, the total dosage of amino acids should include the 20 to 25 grams/day for the first 10 kg of body weight plus 1.0 to 1.25 g/day for each kg of body weight over 10 kilograms.

Typically, TrophAmine® is admixed with B. Braun's 50% or 70% Dextrose Injection USP supplemented with electrolytes and vitamins and administered continuously over a 24 hour period.

Total daily fluid intake should be appropriate for the patient's age and size. A fluid dose of 125 mL per kilogram body weight per day is appropriate for most infants on TPN. Although nitrogen requirements may be higher in severely hypercatabolic or depleted patients, provision of additional nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance.

Cysteine is considered to be an essential amino acid in infants and young pediatric patients. An admixture of cysteine hydrochloride to the TPN solution is therefore recommended. Based on clinical studies, the recommended dosage is 1.0 mmole of L-cysteine hydrochloride monohydrate per kilogram of body weight per day.

In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose solutions are abruptly discontinued.

Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat free TPN.

The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is required for optimum utilization of amino acids. In addition, sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given. In patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate salts to provide bicarbonate precursor. The electrolyte content of TrophAmine® must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.

Appropriate vitamins, minerals and trace elements should also be provided.

Central Venous Nutrition. Hypertonic mixtures of amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, and gradually increased to the recommended 60–125 mL per kilogram body weight per day. If administration rate should fall behind schedule, no attempt to "catch up" to planned intake should be made. In addition to meeting protein needs, the rate of administration, particularly during the first few days of therapy, is governed by the patient's glucose tolerance. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of glucose levels in blood and urine.

Peripheral Parenteral Nutrition. For patients in whom the central venous route is not indicated and who can consume adequate calories enterally, TrophAmine® (Amino Acid Injections) may be administered by peripheral vein with or without parenteral carbohydrate calories. Such infusates can be prepared by dilution with B. Braun's Sterile Water for Injection or 5%–10% Dextrose Injection to prepare isotonic or slightly hypertonic solutions for peripheral infusion. It is essential that peripheral infusion be accompanied by adequate caloric intake. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

TrophAmine® may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium and magnesium ions in an additive solution should be considered when phosphate is also present, in order to avoid precipitation.

Care must be taken to avoid incompatible admixtures. Consult with pharmacist.
1 Suskind RM: Textbook of Pediatric Nutrition, Raven Press, New York, 1981.
Phenytoin Suspension

Phenytoin Suspension

2.1 Adult Patients

Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container should be used only in patients who require the entire 500 mg or 1 gram dose and not any fraction thereof. The recommended dose of Meropenem for Injection USP and Sodium Chloride Injection USP is 500 mg given every 8 hours for skin and skin structure infections and 1 gram given every 8 hours for intra-abdominal infections. When treating complicated skin and skin structure infections caused by P. aeruginosa, a dose of 1 gram every 8 hours is recommended.

Meropenem for Injection USP and Sodium Chloride Injection USP should be administered by intravenous infusion over approximately 15 to 30 minutes.

2.2 Use in Adult Patients with Renal Impairment

Dosage should be reduced in patients with creatinine clearance of 50 mL/min or less. (See dosing table below.)

Dosage should be reduced in renal failure if less than a full dose (1 gram or 500 mg) is required and an alternative formulation should be used to avoid risk of overdose.

When only serum creatinine is available, the following formula (Cockcroft and Gault equation)5 may be used to estimate creatinine clearance.

Males: Creatinine Clearance (mL/min) =
Weight (kg) x (140 - age) 72 x serum creatinine (mg/dL)
Females: 0.85 x above value

Table 1: Recommended Meropenem for Injection Dosage Schedule for Adult Patients With Renal Impairment
Creatinine Clearance (mL/min) Dose (dependent on type of infection) Dosing Interval greater than 50 Recommended dose (500 mg cSSSI and 1 gram Intra-abdominal infection) Every 8 hours greater than 25-50 Recommended dose Every 12 hours 10-25 One-half recommended dose Every 12 hours less than 10 One-half recommended dose Every 24 hours
There is inadequate information regarding the use of meropenem for injection in patients on hemodialysis or peritoneal dialysis.

2.3 Use in Pediatric Patients (3 Months of age and older only)

Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of meropenem. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of meropenem. Meropenem is not to be used in pediatric patients aged less than three months. There is no experience in pediatric patients with renal impairment. (See dosing table below.) [see Use in Specific Populations (8.4)].

Pediatric patients weighing over 50 kg should be administered Meropenem for Injection USP and Sodium Chloride Injection USP at a dose of 500 mg every 8 hours for complicated skin and skin structure infections, 1 gram every 8 hours for intra-abdominal infections and 2 grams every 8 hours for meningitis. Meropenem for Injection USP and Sodium Chloride Injection USP should be given as intravenous infusion over approximately 15 to 30 minutes.

Table 2: Recommended Meropenem for Injection Dosage Schedule for Pediatric Patients With Normal Renal Function
Type of Infection Dose (mg/kg) Up to a Maximum Dose Dosing Interval Complicated skin and skin structure 10 500 mg Every 8 hours Intra-abdominal 20 1 gram Every 8 hours Meningitis 40 2 grams Every 8 hours
When treating complicated skin and skin structure infections caused by P. aeruginosa, a dose of 20 mg/kg (or 1 gram for pediatric patients weighing over 50 kg) every 8 hours is recommended.

There is no experience in pediatric patients with renal impairment.

2.4 Preparation and Administration of Meropenem for Injection USP and Sodium Chloride Injection USP in DUPLEX® Container

This reconstituted solution is for intravenous use only.

Do not use plastic containers in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use only if solution is clear and container and seals are intact.

DUPLEX® Container Storage
To avoid inadvertent activation, the DUPLEX® Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
Apply patient-specific label on foil side of container. Use care to avoid activation. Do not cover any portion of foil strip with patient label. Unlatch side tab and unfold DUPLEX® Container (see Diagram 1). Visually inspect diluent chamber for particulate matter. Use only if container and seals are intact. To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber (see Diagram 2). Protect from light after removal of foil strip.
Note: If foil strip is removed, the container should be re-folded and the side tab latched until ready to activate. The product must then be used within 7 days at room temperature, but not beyond the labeled expiration date.

Reconstitution (Activation)
Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use. Unfold the DUPLEX® Container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber (see Diagram 3). Agitate the liquid-powder mixture until the drug powder is completely dissolved.
Note: Following reconstitution (activation), product must be used within 1 hour if stored at room temperature or within 15 hours if stored under refrigeration.

Administration
Visually inspect the reconstituted solution for particulate matter. Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port (see Diagram 4). Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be compromised. Using aseptic technique, peel foil cover from the set port and attach sterile administration set (see Diagram 5). Refer to directions for use accompanying the administration set.
Important Administration Instructions
Do not use in series connections. Do not introduce additives into the DUPLEX® Container. Administer Meropenem for Injection USP and Sodium Chloride Injection USP intravenously over approximately 15 to 30 minutes.
2.5 Compatibility

Compatibility of Meropenem for Injection USP and Sodium Chloride Injection USP with other drugs has not been established. Meropenem for Injection USP and Sodium Chloride Injection USP should not be mixed with or physically added to solutions containing other drugs.

2.6 Stability and Storage

Freshly prepared solutions of Meropenem for Injection USP and Sodium Chloride Injection USP should be used. Following reconstitution (activation) in the DUPLEX® Container, the product maintains satisfactory potency for 1 hour at up to 25ºC (77ºF) or for 15 hours at up to 5ºC (41ºF). Solutions of intravenous Meropenem for Injection USP and Sodium Chloride Injection USP should not be frozen.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Cefepime Hydrochloride ...

Cefepime Hydrochloride And Dextrose

2.1 Adult and Pediatric Population

Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container should be used only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. The recommended adult and pediatric dosages and routes of administration are outlined in Table 1. Cefepime for Injection USP and Dextrose Injection USP should be administered intravenously (IV) over approximately 30 minutes.
Table 1: Recommended Dosing Schedule for Cefepime for Injection USP and Dextrose Injection USP in Patients with CrCL Greater Than 60 mL/min* Site and Type of Infection Dose Frequency Duration (days) Adults *
Adjust dose in patients with CrCL less than or equal to 60 mL/min (2.2)
† Including cases associated with concurrent bacteremia ‡
ForPseudomonas aeruginosa, use 2 g IV every 8 hours (50 mg per kg per dose in pediatric patients 2 months up to 16 years).
§ Or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently. Moderate to Severe Pneumonia due to S. pneumoniae†, P. aeruginosa‡, K. pneumoniae, or Enterobacter species 1-2 g IV Every 8-12 hours 10 Empiric therapy for febrile neutropenic patients [see Indications and Usage (1) and Clinical Studies (14)] 2 g IV Every 8 hours 7§ Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis† 0.5-1 g IV Every 12 hours 7–10 Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae† 2 g IV Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes 2 g IV Every 12 hours 10 Complicated intra-abdominal infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa‡, K. pneumoniae, Enterobacter species, or B. fragilis. [see Clinical Studies (14)] 2 g IV Every 8-12 hours 7–10 Pediatric Patients (2 months up to 16 years) The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg per kg per dose, administered every 12 hours (50 mg per kg per dose, every 8 hours for febrile neutropenic patients), for durations as given above. Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of cefepime. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of cefepime.
2.2 Patients with Renal Impairment

In patients with creatinine clearance less than or equal to 60 mL/min, the dose of Cefepime for Injection USP and Dextrose Injection USP should be adjusted to compensate for the slower rate of renal elimination. The recommended initial dose of Cefepime for Injection USP and Dextrose Injection USP should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended maintenance doses of Cefepime for Injection USP and Dextrose Injection USP in patients with renal impairment are presented in Table 2. Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container should be used only in patients who require the entire 1 or 2 gram dose and not any fraction thereof.

When only serum creatinine is available, the following formula (Cockcroft and Gault equation)1 may be used to estimate creatinine clearance [see References (15)]. The serum creatinine should represent a steady state of renal function:
Males: Creatinine Clearance (mL/min) = Weight (kg) × (140-age) 72 × serum creatinine (mg/dL) Females: 0.85 × above value Table 2: Recommended Dosing Schedule for Cefepime for Injection USP and Dextrose Injection USP in Adult Patients (Normal Renal Function, Renal Impairment, and Hemodialysis) Creatinine Clearance(mL/min) Recommended Maintenance Schedule * On hemodialysis days, Cefepime for Injection USP and Dextrose Injection USP should be administered following hemodialysis. Whenever possible, Cefepime for Injection USP and Dextrose Injection USP should be administered at the same time each day. Greater than 60 (Normal recommended dosing schedule) 500 mg every 12 hours 1 g every 12 hours 2 g every 12 hours 2 g every 8 hours 30–60 500 mg every 24 hours 1 g every 24 hours 2 g every 24 hours 2 g every 12 hours 11–29 500 mg every 24 hours 500 mg every 24 hours 1 g every 24 hours 2 g every 24 hours Less than 11 250 mg every 24 hours 250 mg every 24 hours 500 mg every 24 hours 1 g every 24 hours CAPD 500 mg every 48 hours 1 g every 48 hours 2 g every 48 hours 2 g every 48 hours Hemodialysis* 1 g on day 1, then 500 mg every 24 hours thereafter 1 g every 24 hours
In patients undergoing continuous ambulatory peritoneal dialysis, Cefepime for Injection USP and Dextrose Injection USP may be administered at normally recommended doses at a dosage interval of every 48 hours (see Table 2).

In patients undergoing hemodialysis, approximately 68% of the total amount of cefepime present in the body at the start of dialysis will be removed during a 3-hour dialysis period. The dosage of Cefepime for Injection USP and Dextrose Injection USP for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours. Cefepime for Injection USP and Dextrose Injection USP should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 2).

2.3 Preparation for Use of Cefepime for Injection USP and Dextrose Injection USP in DUPLEX® Container

This reconstituted solution is for intravenous use only.

Do not use plastic containers in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use only if solution is clear and container and seals are intact.

DUPLEX® Drug Delivery System Storage
To avoid inadvertent activation, the DUPLEX® Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
Apply patient-specific label on foil side of container. Use care to avoid activation. Do not cover any portion of foil strip with patient label. Unlatch side tab and unfold DUPLEX® Container (see Diagram 1). Visually inspect diluent chamber for particulate matter. Use only if container and seals are intact. To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber (see Diagram 2). Protect from light after removal of foil strip.Note: If foil strip is removed, the container should be re-folded and the side tab latched until ready to activate. The product must then be used within 7 days, but not beyond the labeled expiration date.
Reconstitution (Activation)
Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use. Unfold the DUPLEX® container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber (see Diagram 3). Agitate the liquid-powder mixture until the drug powder is completely dissolved.Note: Following reconstitution (activation), product must be used within 12 hours if stored at room temperature or within 5 days if stored under refrigeration.
Administration
Visually inspect the reconstituted solution for particulate matter. Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port (see Diagram 4). Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be compromised. Using aseptic technique, peel foil cover from the set port and attach sterile administration set (see Diagram 5). Refer to directions for use accompanying the administration set.
Important Administration Instructions
Do not use in series connections. Do not introduce additives into the DUPLEX® Container. Administer Cefepime for Injection USP and Dextrose Injection USP intravenously over approximately 30 minutes. Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of Cefepime for Injection USP and Dextrose Injection USP, it is advisable to discontinue the other solution. Solutions of cefepime should not be added to solutions of ampicillin at a concentration greater than 40 mg/mL, and should not be added to metronidazole, vancomycin, gentamicin, tobramycin, netilimicin sulfate or aminophylline because of potential interaction. However, if concurrent therapy with cefepime is indicated, each of these antibiotics can be administered separately.
Dextrose

Dextrose

This solution is for intravenous use only. Hypertonic, administer only after dilution via central venous catheter.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Dextrose may be administered to normal individuals at a rate of 0.5 g/kg/hour without producing glycosuria. At the maximum infusion rate of 0.8 g/kg/hour, approximately 95% of the dextrose is retained.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Sterile Water Irrigant

Sterile Water Irrigant

Irrigation

Use as directed by physician.

This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Nutrient Mixtures

Sterile Water for Irrigation USP may be used to prepare non-intravenously administered nutrient mixtures. It contains no electrolytes or other added substances. Refer to preparation instructions of particular mixture to be used. The plastic container may be used for administration of non-intravenous nutrient mixture to the patient as appropriate.
Sodium Chloride For Irr...

Sodium Chloride For Irrigation Solution

As required for irrigation.

When used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
Nutrilipid I.v. Fat Emu...

Nutrilipid I.v. Fat Emulsion

2.1 Administration Instructions
Nutrilipid® 20% Pharmacy Bulk Package is not intended for direct intravenous administration. Nutrilipid® 20% is for intravenous infusion only through a peripheral or central line. When administered with dextrose and amino acids, the choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Use a non-vented infusion set or close the air vent on a vented set. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Use a dedicated line without any connections. Multiple connections could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Use a 1.2 micron in-line filter. Nutrilipid® 20% can be infused concurrently into the same vein as carbohydrate-amino acid solutions by means of a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps. Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Conventional administration sets contain polyvinyl chloride (PVC) components that have DEHP as a plasticizer.
2.2 Preparation Instructions for Nutrilipid® 20% Bags for Direct Infusion

Caution: Nutrilipid® 20% Pharmacy Bulk Package is not intended for direct intravenous administration.

Step 1: Inspect infusion bag overwrap and primary bag and do not use if damaged. Inspect oxygen indicator and do not use if oxygen indicator is pink or dark pink. Use only if container and seals are intact.

Step 2: To open, tear overwrap starting from the tear notches (Figure 1). Remove Nutrilipid® 20% bag from overwrap and discard oxygen indicator, oxygen absorber and overwrap.

Step 3: Inspect Nutrilipid® 20% bag visually (Figure 2). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect Nutrilipid® 20% to ensure that the emulsion has not separated. Discard the bag if any particulates or discoloration are observed.

Step 4: Remove aluminum foil of outlet port at the bottom of the bag (Figure 3a) and attach administration set (Figure 3b).

Step 5: Hang bag on IV Pole (Figure 4). If infusion pumps are used, flow rates of each parenteral fluid should be controlled with a separate pump.

Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag.

Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates.

If administration is controlled by a pumping device, discontinue pumping action before the bag runs dry to avoid air embolism.

Use of Admixtures in Nutrilipid® Infusion Bags for Direct Infusion
Some additives may be incompatible and should not be used. If it is deemed advisable to introduce additives, prepare the admixture using strict aseptic techniques to avoid microbial contamination. Compatible supplemental medication (e.g., fat-soluble vitamins) may be added with a 19 to 22 gauge needle through the medication port. Additions to the bag should be evaluated by a pharmacist for compatibility. Questions about compatibility may be directed to B. Braun Medical Inc., Medical Affairs. The prime destabilizers of emulsions are excessive acidity (such as pH below 5) and inappropriate electrolyte content. Give careful consideration to additions of divalent cations (Ca++ and Mg++), which have been shown to cause emulsion instability. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect Nutrilipid® 20% to ensure that: precipitates have not formed during the addition of additives and the emulsion has not separated during the addition of additives.
Discard the admixture if precipitates or discoloration are observed.

Step 1: Prepare the medication port by removal of aluminum foil (Figure 5a).

Step 2: Puncture the resealable medication port by using a 19 to 22 gauge needle and inject additive(s) (Figure 5b).

Step 3: Mix thoroughly when additives have been introduced (Figure 6).

Step 4: The medication port may be swabbed with disinfection agent (e.g., iso-propanol or chlorhexidine) before re-puncturing.

Step 5: Inspect emulsion bag visually for particulates or separation of the emulsion. Discard the bag if any particulates or discoloration are observed.

Do not store solutions containing additives.

2.3 Preparation Instructions for Admixing Using Total Parenteral Nutrition Pooling Bags
Prepare the admixture into pooling bags using strict aseptic techniques to avoid microbial contamination. Do not add additives directly to Nutrilipid® 20% Pharmacy Bulk Package. Some additives may be incompatible and should not be used. If it is deemed advisable to introduce additives, prepare the admixture using strict aseptic techniques to avoid microbial contamination. Additions to the pooling bag should be evaluated by a pharmacist for compatibility. Questions about compatibility may be directed to B. Braun Medical Inc., Medical Affairs. Do not add Nutrilipid® 20% to the pooling bag first; destabilization of the lipid may occur from such an admixture. The following proper mixing sequence must be followed to minimize pH related problems by ensuring that typically acidic Dextrose Injections are not mixed with lipid emulsions alone: Transfer Dextrose Injection to the Total Parental Nutrition Pooling Bag Transfer Amino Acid Injection Transfer Nutrilipid® 20%
Use gentle agitation during admixing to minimize localized concentration effects; shake bags gently after each addition.
Alternatively, simultaneous transfer to the pooling bag of Amino Acid Injection, Dextrose Injection and Nutrilipid® 20% is also permitted. The prime destabilizers of emulsions are excessive acidity (such as pH below 5) and inappropriate electrolyte content. Give careful consideration to additions of divalent cations (Ca++ and Mg++), which have been shown to cause emulsion instability. Amino acid solutions exert buffering effects that protect the emulsion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect Nutrilipid® 20% to ensure that: precipitates have not formed during the mixing or addition of additives and the emulsion has not separated. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion.
Discard the admixture if any of the above are observed.
Use of the Pharmacy Bulk Package for admixing should be limited to up to four hours after opening. Admixtures should be used promptly with storage under refrigeration (2-8°C) not to exceed 24 hours and must be completely used within 24 hours after removal from refrigeration. Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag. Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates. If administration is controlled by a pumping device, discontinue pumping action before the bag runs dry to avoid air embolism.
2.4 Dosing Considerations

The dosing of Nutrilipid® 20% depends on the patient’s individual energy requirements, influenced by body weight, tolerance, clinical status, age-related growth rate in pediatric patients, and the ability to eliminate and metabolize fat.

For partial parenteral nutrition, energy supplied by oral or enteral nutrition has to be taken into account. For complete parenteral nutrition, concomitant supplementation with amino acids, carbohydrates, electrolytes, vitamins, and trace elements is necessary.

Prior to administration of Nutrilipid® 20%, correct severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders. Before starting the infusion, obtain serum triglyceride levels to establish the baseline value.

Recommended Adult and Pediatric Dosing

The recommended nutritional requirements of fat and recommended dosages of Nutrilipid® 20% to be administered to meet those requirements for adults and pediatric patients are provided in Table 1, along with recommendations for the initial and maximum infusion rates. The recommended duration of infusion for Nutrilipid® 20% is between 12 and 24 hours, depending on the clinical situation. Adjust the administration flow rate by taking into account the dose being administered, the daily volume/intake, and the duration of the infusion [see Overdosage (10)].

Treatment with parenteral nutrition may be continued for as long as is required by the patient’s condition.

In patients with elevated triglyceride levels, initiate Nutrilipid® 20% at a lower dosage, and advance in smaller increments, monitoring the triglyceride levels with each adjustment [see Warnings and Precautions (5.6) and (5.10)].

When Nutrilipid® 20% is administered to correct essential fatty acid deficiency, 8% to 10% of the caloric input should be supplied by Nutrilipid® 20% in order to provide adequate amounts of linoleic and linolenic acids.

Table 1: Adult and Pediatric Nutritional Requirements1,2 as Provided by Nutrilipid® 20% and Infusion Rate for Direct Infusion Only
*
Nutrilipid® 20% Pharmacy Bulk Package is not intended for direct intravenous administration.
†
Daily dose should also not exceed a maximum of 60% of total energy requirements [see Overdosage (10)].
Age Nutritional Requirements Direct Infusion Rate* Recommended Initial Dosage and Maximum Dosage Initial Maximum
Preterm and term infants (less than 1 year of age)

[see Warnings and Precautions (5.1)]

Initial 1 to 2 g/kg/day

not to exceed 3 g/kg/day†
0.05 mL/min for the first 10 to 15 minutes; gradually increase to the required rate after 15 minutes 0.75 mL/kg/hour Pediatric patients 1 to 10 years of age
Initial 1 to 2 g/kg/day

not to exceed 3 g/kg/day†
0.75 mL/kg/hour Pediatric patients 11 to <17 years of age
Initial 1 g/kg/day

not to exceed 2.5 g/kg/day†
0.5 mL/kg/hour Adults
1 to 1.5 g/kg/day

not to exceed 2.5 g/kg/day†
0.5 mL/min for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes 0.5 mL/kg/hour
Sterile Water

Sterile Water

This solution is for intravenous use only after admixture or dilution. Do not inject until made approximately isotonic by addition of appropriate solute.

Following suitable admixture of prescribed drugs, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. See directions accompanying drugs.

The dosage and administration of Sterile Water for Injection USP is dependent upon the recommended dosage and administration of the solute used. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When performing admixture or dilution, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Lactated Ringers Irriga...

Lactated Ringers Irrigation

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer’s recommendations should be followed.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. (See PRECAUTIONS.)
Glycine Irrigant

Glycine Irrigant

As required for irrigation.

1.5% Glycine Irrigation USP should be administered only by the appropriate transurethraI urologic instrumentation.

It has been reported that absorption is significantly increased if the container is higher than 60 cm (24") above the patient.

This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

B. Braun Medical Inc.

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