Astrazeneca Lp

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Astrazeneca Lp Drugs

Foscavir

Foscavir

CAUTION—DO NOT ADMINISTER FOSCAVIR BY RAPID OR BOLUS INTRAVENOUS INJECTION. THE TOXICITY OF FOSCAVIR MAY BE INCREASED AS A RESULT OF EXCESSIVE PLASMA LEVELS. CARE SHOULD BE TAKEN TO AVOID UNINTENTIONAL OVERDOSE BY CAREFULLY CONTROLLING THE RATE OF INFUSION. THEREFORE, AN INFUSION PUMP MUST BE USED. IN SPITE OF THE USE OF AN INFUSION PUMP, OVERDOSES HAVE OCCURRED.

ADMINISTRATION

FOSCAVIR is administered by controlled intravenous infusion, either by using a central venous line or by using a peripheral vein. The standard 24 mg/mL solution may be used with or without dilution when using a central venous catheter for infusion. When a peripheral vein catheter is used, the 24 mg/mL solution must be diluted to 12 mg/mL with 5% dextrose in water or with a normal saline solution prior to administration to avoid local irritation of peripheral veins. Since the dose of FOSCAVIR is calculated on the basis of body weight, it may be desirable to remove and discard any unneeded quantity from the bottle before starting with the infusion to avoid overdosage. Dilutions and/or removals of excess quantities should be accomplished under aseptic conditions. Solutions thus prepared should be used within 24 hours of first entry into a sealed bottle. To reduce the risk of nephrotoxicity, creatinine clearance (mL/min/kg) should be calculated even if serum creatinine is within the normal range, and doses should be adjusted accordingly.

Hydration:

Hydration may reduce the risk of nephrotoxicity. It is recommended that 750−1000 mL of normal saline or 5% dextrose solution should be given prior to the first infusion of FOSCAVIR to establish diuresis. With subsequent infusions, 750−1000 mL of hydration fluid should be given with 90−120 mg/kg of FOSCAVIR, and 500 mL with 40−60 mg/kg of FOSCAVIR. Hydration fluid may need to be decreased if clinically warranted.

After the first dose, the hydration fluid should be administered concurrently with each infusion of FOSCAVIR.

Compatibility With Other Solutions/Drugs:

Other drugs and supplements can be administered to a patient receiving FOSCAVIR. However, care must be taken to ensure that FOSCAVIR is only administered with normal saline or 5% dextrose solution and that no other drug or supplement is administered concurrently via the same catheter. Foscarnet has been reported to be chemically incompatible with 30% dextrose, amphotericin B, and solutions containing calcium such as Ringer’s lactate and TPN. Physical incompatibility with other IV drugs has also been reported including acyclovir sodium, ganciclovir, trimetrexate glucuronate, pentamidine isethionate, vancomycin, trimethoprim/sulfamethoxazole, diazepam, midazolam, digoxin, phenytoin, leucovorin, and prochlorperazine. Because of foscarnet’s chelating properties, a precipitate can potentially occur when divalent cations are administered concurrently in the same catheter.

Parenteral drug products must be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored or contain particulate matter should not be used.

Accidental Exposure:

Accidental skin and eye contact with foscarnet sodium solution may cause local irritation and burning sensation. If accidental contact occurs, the exposed area should be flushed with water.

DOSAGE

THE RECOMMENDED DOSAGE, FREQUENCY, OR INFUSION RATES SHOULD NOT BE EXCEEDED. ALL DOSES MUST BE INDIVIDUALIZED FOR PATIENTS’ RENAL FUNCTION.

Induction Treatment:

The recommended initial dose of FOSCAVIR for patients with normal renal function is:
For CMV retinitis patients, either 90 mg/kg (1-1/2 to 2 hour infusion) every twelve hours or 60 mg/kg (minimum one hour infusion) every eight hours over 2-3 weeks depending on clinical response. For acyclovir-resistant HSV patients, 40 mg/kg (minimum one hour infusion) either every 8 or 12 hours for 2-3 weeks or until healed.

An infusion pump must be used to control the rate of infusion. Adequate hydration is recommended to establish a diuresis (see Hydration for recommendation), both prior to and during treatment to minimize renal toxicity (see WARNINGS ), provided there are no clinical contraindications.

Maintenance Treatment:

Following induction treatment the recommended maintenance dose of FOSCAVIR for CMV retinitis is 90 mg/kg/day to 120 mg/kg/day (individualized for renal function) given as an intravenous infusion over 2 hours. Because the superiority of the 120 mg/kg/day has not been established in controlled trials, and given the likely relationship of higher plasma foscarnet levels to toxicity, it is recommended that most patients be started on maintenance treatment with a dose of 90 mg/kg/day. Escalation to 120 mg/kg/day may be considered should early reinduction be required because of retinitis progression. Some patients who show excellent tolerance to FOSCAVIR may benefit from initiation of maintenance treatment at 120 mg/kg/day earlier in their treatment.

An infusion pump must be used to control the rate of infusion with all doses. Again, hydration to establish diuresis both prior to and during treatment is recommended to minimize renal toxicity, provided there are no clinical contraindications (see WARNINGS ).

Patients who experience progression of retinitis while receiving FOSCAVIR maintenance therapy may be retreated with the induction and maintenance regimens given above or with a combination of FOSCAVIR and ganciclovir (see CLINICAL STUDIESsection). Because of physical incompatibility, FOSCAVIR and ganciclovir must NOT be mixed.

Use in Patients with Abnormal Renal Function:

FOSCAVIR should be used with caution in patients with abnormal renal function because reduced plasma clearance of foscarnet will result in elevated plasma levels (see CLINICAL PHARMACOLOGY). In addition, FOSCAVIR has the potential to further impair renal function (see WARNINGS ). Safety and efficacy data for patients with baseline serum creatinine levels greater than 2.8 mg/dL or measured 24-hour creatinine clearances < 50 mL/min are limited.

Renal function must be monitored carefully at baseline and during induction and maintenance therapy with appropriate dose adjustments for FOSCAVIR as outlined below (see DOSE ADJUSTMENT and PATIENT MONITORING). During FOSCAVIR therapy if creatinine clearance falls below the limits of the dosing nomograms (0.4 mL/min/kg), FOSCAVIR should be discontinued, the patient hydrated, and monitored daily until resolution of renal impairment is ensured.

Dose Adjustment:

FOSCAVIR dosing must be individualized according to the patient’s renal function status. Refer to Table 9 below for recommended doses and adjust the dose as indicated. Even patients with serum creatinine in the normal range may require dose adjustment; therefore, the dose should be calculated at baseline and frequently thereafter.

To use this dosing guide, actual 24-hour creatinine clearance (mL/min) must be divided by body weight (kg), or the estimated creatinine clearance in mL/min/kg can be calculated from serum creatinine (mg/dL) using the following formula (modified Cockcroft and Gault equation):

For males: 140 - age (x 0.85 for females) = mL/min/kg

serum creatinine x 72
TABLE 9 FOSCAVIR DOSING GUIDE INDUCTION
HSV: Equivalent to

CMV: Equivalent to

CrCl

(mL/min/kg)

80 mg/kg/day total

(40 mg/kg Q12h)

120 mg/kg/day total (40 mg/kg Q8h)

180 mg/kg/day total

(60 mg/kg Q8h) (90 mg/kg Q12h)

>1.4

40 Q12h

40 Q8h

60 Q8h

90 Q12h

>1.0-1.4

30 Q12h

30 Q8h

45 Q8h

70 Q12h

>0.8-1.0

20 Q12h

35 Q12h

50 Q12h

50Q12h

>0.6-0.8

35 Q24h

25 Q12h

40 Q12h

80 Q24h

>0.5-0.6

25 Q24h

40 Q24h

60 Q24h

60 Q24h

≥0.4-0.5

20 Q24h

35 Q24h

50 Q24h

50 Q24h

<0.4

Not Recommended

Not Recommended

Not Recommended

Not Recommended
MAINTENANCE
CMV: Equivalent to

CrCl

(mL/min/kg)

90 mg/kg/day

(once daily)

120 mg/kg/day

(once daily)
* > means "greater than" † ≥ means "greater than or equal to" ‡ < means "less than"
>*1.4

90 Q24h

120 Q24h

>*1.0-1.4

70 Q24h

90 Q24h

>*0.8-1.0

50 Q24h

65 Q24h

>*0.6-0.8

80 Q48h

105 Q48h

>*0.5-0.6

60 Q48h

80 Q48h

≥†0.4-0.5

50 Q48h

65 Q48h

<‡0.4

Not Recommended

Not Recommended

PATIENT MONITORING

The majority of patients will experience some decrease in renal function due to FOSCAVIR administration. Therefore it is recommended that creatinine clearance, either measured or estimated using the modified Cockcroft and Gault equation based on serum creatinine, be determined at baseline, 2−3 times per week during induction therapy and at least every one to two weeks during maintenance therapy, with FOSCAVIR dose adjusted accordingly (see Dose Adjustment). More frequent monitoring may be required for some patients. It is also recommended that a 24-hour creatinine clearance be determined at baseline and periodically thereafter to ensure correct dosing (assuming verification of an adequate collection using creatinine index). FOSCAVIR should be discontinued if creatinine clearance drops below 0.4 mL/min/kg.

Due to FOSCAVIR’s propensity to chelate divalent metal ions and alter levels of serum electrolytes, patients must be monitored closely for such changes. It is recommended that a schedule similar to that recommended for serum creatinine (see above) be used to monitor serum calcium, magnesium, potassium and phosphorus. Particular caution is advised in patients with decreased total serum calcium or other electrolyte levels before treatment, as well as in patients with neurologic or cardiac abnormalities, and in patients receiving other drugs known to influence serum calcium levels. Any clinically significant metabolic changes should be corrected. Also, patients who experience mild (eg, perioral numbness or paresthesias) or severe (eg, seizures) symptoms of electrolyte abnormalities should have serum electrolyte and mineral levels assessed as close in time to the event as possible.

Careful monitoring and appropriate management of electrolytes, calcium, magnesium and creatinine are of particular importance in patients with conditions that may predispose them to seizures (see WARNINGS ).
Sensorcaine Mpf

Sensorcaine Mpf

The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. The smallest dose and concentration required to produce the desired result should be administered. Dosages of Sensorcaine should be reduced for young, elderly and/or debilitated patients and patients with cardiac and/or liver disease. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible.

For specific techniques and procedures, refer to standard textbooks.

In recommended doses, Sensorcaine (bupivacaine HCl) produces complete sensory block, but the effect on motor function differs among the three concentrations.

0.25%—when used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% or 0.75% solutions.

0.5%—provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential.

0.75%—produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia.

The duration of anesthesia with Sensorcaine is such that for most indications, a single dose is sufficient.

Maximum dosage limit must be individualized in each case after evaluating the size and physical status of the patient, as well as the usual rate of systemic absorption from a particular injection site. Most experience to date is with single doses of Sensorcaine up to 225 mg with epinephrine 1:200,000 and 175 mg without epinephrine; more or less drug may be used depending on individualization of each case.

These doses may be repeated up to once every three hours. In clinical studies to date, total daily doses up to 400 mg have been reported. Until further experience is gained, this dose should not be exceeded in 24 hours. The duration of anesthetic effect may be prolonged by the addition of epinephrine.

The dosages in Table 1 have generally proved satisfactory and are recommended as a guide for use in the average adult. These dosages should be reduced for young, elderly or debilitated patients. Until further experience is gained Sensorcaine is not recommended for children younger than 12 years. Sensorcaine is contraindicated for obstetrical paracervical blocks, and is not recommended for intravenous regional anesthesia (Bier Block).

Use in Epidural Anesthesia

During epidural administration of Sensorcaine, 0.5% and 0.75% solutions should be administered in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. In obstetrics, only the 0.5% and 0.25% concentrations should be used; incremental doses of 3 mL to 5 mL of the 0.5% solution not exceeding 50 mg to 100 mg at any dosing interval are recommended. Repeat doses should be preceded by a test dose containing epinephrine if not contraindicated. Use only the single dose ampules and single dose vials for caudal or epidural anesthesia; the multiple dose vials contain a preservative and therefore should not be used for these procedures.

Test dose for Caudal and Lumbar Epidural Blocks:

See PRECAUTIONS.

Unused portions of solutions in single dose containers should be discarded, since this product form contains no preservatives.
Table 1. DOSAGE RECOMMENDATIONS − SENSORCAINE (bupivacaine HCl) INJECTIONS
Type of Block

Conc.

Each Dose

(mL)

(mg)

Motor Block*
* With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% may produce complete motor block. Intercostal nerve block with 0.25% may also produce complete motor block for intra-abdominal surgery † Solutions with or without epinephrine ‡ For single dose use, not for intermittent epidural technique. Not for obstetric anesthesia § See PRECAUTIONS
Local Infiltration

0.25%†

up to max.

up to max.

—

Epidural

0.75%‡, †

10-20

75-150

complete

0.5%†

10-20

50-100

moderate to complete

0.25%†

10-20

25-50

partial to moderate

Caudal

0.5%†

15-30

75-150

moderate to complete

0.25%†

15-30

37.5-75

moderate

Peripheral Nerves

0.5%†

5 to max.

25 to max.

moderate to complete

0.25%†

5 to max.

12.5 to max.

moderate to complete

Retrobulbar§

0.75%†

2-4

15-30

complete

Sympathetic

0.25%

20-50

50-125

—

Epidural§

0.5%

2-3

10-15

—

Test Dose

w/epi

10-15 μg epinephrine

(See PRECAUTIONS)

NOTE:

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. The Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
Xylocaine

Xylocaine

Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required, only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated.

These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for the elderly and debilitated patients and patients with cardiac and/or liver disease.

The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (ie, total dose) of local anesthetic used. Thus, an increase in volume and concentration of Xylocaine Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Xylocaine Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine HCl is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.

For intravenous regional anesthesia, only the 50 mL single dose vial containing Xylocaine (lidocaine HCl) 0.5% Injection should be used.

Epidural Anesthesia

For epidural anesthesia, only the following dosage forms of Xylocaine Injection are recommended:

1% without epinephrine

10 mL Polyamp DuoFit™

1% without epinephrine

30 mL single dose solutions

1% with epinephrine 1:200,000

30 mL single dose solutions

1.5% without epinephrine

10 mL Polyamp DuoFit™

1.5% without epinephrine

20 mL Polyamp DuoFit™

1.5% with epinephrine

1:200,000

30 ml ampules, 30 mL single dose solutions

2% without epinephrine

10 mL Polyamp DuoFit™

2% with epinephrine

1:200,000

20 mL ampules, 20 mL single dose solutions

Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block, provided they are employed as single dose units. These solutions contain no bacteriostatic agent.

In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2-3 mL of the indicated concentration per dermatome).

Caudal and Lumbar Epidural Block: As a precaution against the adverse experience sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2-3 mL of 1.5% lidocaine HCl should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose, (10-15 µg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Xylocaine Injection through the catheter should be avoided, and, when feasible, fractional doses should be administered.

In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.
Xylocaine Mpf

Xylocaine Mpf

When 4% Xylocaine-MPF Sterile Solution is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients.

Although the incidence of adverse effects with 4% Xylocaine-MPF Sterile Solution is quite low, caution should be exercised, particularly when employing large volumes and concentrations of 4% Xylocaine-MPF Sterile Solution since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered. For specific techniques and procedures refer to standard textbooks.

The dosages below are for normal, healthy adults.

RETROBULBAR INJECTION: The suggested dose for a 70 kg person is 3−5 mL (120−200 mg of lidocaine HCl), i.e., 1.7−3 mg/kg or 0.9−1.5 mg/lb body weight. A portion of this is injected retrobulbarly and the rest may be used to block the facial nerve.

TRANSTRACHEAL INJECTION: For local anesthesia by the transtracheal route 2−3 mL should be injected through a large enough needle so that the injection can be made rapidly. By injecting during inspiration some of the drug will be carried into the bronchi and the resulting cough will distribute the rest of the drug over the vocal cords and the epiglottis.

Occasionally it may be necessary to spray the pharynx by oropharyngeal spray to achieve complete analgesia. For the combination of the injection and spray, it should rarely be necessary to utilize more than 5 mL (200 mg of lidocaine HCl), ie, 3 mg/kg or 1.5 mg/lb body weight.

TOPICAL APPLICATION: For laryngoscopy, bronchoscopy and endotracheal intubation, the pharynx may be sprayed with 1−5 mL (40−200 mg of lidocaine HCl), ie, 0.6−3 mg/kg or 0.3−1.5 mg/lb body weight.

MAXIMUM RECOMMENDED DOSAGES

Normal Healthy Adults: The maximum recommended dose of 4% Xylocaine-MPF Sterile Solution should be such that the dose of lidocaine HCl is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

Children:

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (eg, Clark’s rule). For example, in a child of five years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg when calculated according to Clark’s rule. In any case, the maximum dose of Xylocaine Solution with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Xylocaine Solution administered should be such that the dose of lidocaine is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2.0 mg/lb) of body weight.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.
Astramorph

Astramorph

Astramorph/PF is intended for intravenous, epidural or intrathecal administration.

Intravenous Administration:

Dosage:

The initial dose of morphine sulfate should be 2 mg to 10 mg/70 kg of body weight. No information is available regarding the use of Astramorph/PF in patients under the age of 18.

Geriatric Use:

Administer with extreme caution (See PRECAUTIONS .)

Epidural Administration:

ASTRAMORPH/PF SHOULD BE ADMINISTERED EPIDURALLY BY OR UNDER THE DIRECTION OF A PHYSICIAN EXPERIENCED IN THE TECHNIQUE OF EPIDURAL ADMINISTRATION AND WHO IS THOROUGHLY FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT AND A SPECIFIC ANTAGONIST (NALOXONE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH MIGHT RESULT FROM INADVERTENT INTRATHECAL OR INTRAVASCULAR INJECTION. (NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE.) PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR.

Proper placement of a needle or catheter in the epidural space should be verified before Astramorph/PF is injected. Acceptable techniques for verifying proper placement include: a) aspiration to check for absence of blood or cerebrospinal fluid, or b) administration of 5 mL (3 mL in obstetric patients) of 1.5% PRESERVATIVE-FREE Lidocaine and Epinephrine (1:200,000) Injection and then observe the patient for lack of tachycardia (this indicates that vascular injection has not been made) and lack of sudden onset of segmental anesthesia (this indicates that intrathecal injection has not been made).

Epidural Adult Dosage:

Initial injection of 5 mg in the lumbar region may provide satisfactory pain relief for up to 24 hours. If adequate pain relief is not achieved within one hour, careful administration of incremental doses of 1 to 2 mg at intervals sufficient to assess effectiveness may be given. No more than 10 mg/24 hr should be administered.

Thoracic administration has been shown to dramatically increase the incidence of early and late respiratory depression even at doses of 1 to 2 mg.

For continuous infusion an initial dose of 2 to 4 mg/24 hours is recommended. Further doses of 1 to 2 mg may be given if pain relief is not achieved initially.

Geriatric Use:

Administer with extreme caution. (See PRECAUTIONS .)

Epidural Pediatric Use:

No information on use in pediatric patients is available. (See PRECAUTIONS .)

Intrathecal Administration:

NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE .

ASTRAMORPH/PF SHOULD BE ADMINISTERED INTRATHECALLY BY OR UNDER THE DIRECTION OF A PHYSICIAN EXPERIENCED IN THE TECHNIQUE OF INTRATHECAL ADMINISTRATION AND WHO IS THOROUGHLY FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT AND A SPECIFIC ANTAGONIST (NALOXONE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH MIGHT RESULT FROM INADVERTENT INTRAVASCULAR INJECTION. PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR. RESPIRATORY DEPRESSION (BOTH EARLY AND LATE ONSET) HAS OCCURRED MORE FREQUENTLY FOLLOWING INTRATHECAL ADMINISTRATION THAN EPIDURAL ADMINISTRATION.

Intrathecal Adult Dosage:

A single injection of 0.2 to 1 mg may provide satisfactory pain relief for up to 24 hours. (CAUTION: THIS IS ONLY 0.4 TO 2 ML OF THE 5 MG/10ML AMPULE/VIAL OR 0.2 TO 1 ML OF THE 10 MG/10 ML AMPULE/VIAL OF ASTRAMORPH/PF.) DO NOT INJECT INTRATHECALLY MORE THAN 2 ML OF THE 5 MG/10 ML AMPULE/VIAL OR 1 ML OF THE 10 MG/10ML AMPULE/VIAL. USE IN THE LUMBAR AREA ONLY IS RECOMMENDED. Repeated intrathecal injections of Astramorph/PF are not recommended. A constant intravenous infusion of naloxone, 0.6 mg/hr, for 24 hours after intrathecal injection may be used to reduce the incidence of potential side effects.

Geriatric Use:

Administer with extreme caution. (See PRECAUTIONS .)

Repeat Dosage:

If pain recurs, alternative routes of administration should be considered, since experience with repeated doses of morphine by the intrathecal route is limited.

Intrathecal Pediatric Use:

No information on use in pediatric patients is available. (See PRECAUTIONS .)
Xylocaine

Xylocaine

Adults

Single Direct Intravenous Injection (bolus)

The usual dose is 50 to 100 mg of lidocaine hydrochloride (0.70 to 1.4 mg/kg; 0.32 to 0.63 mg/lb) administered intravenously under ECG monitoring. This dose may be administered at the rate of approximately 25 to 50 mg/min (0.35 to 0.70 mg/kg/min; 0.16 to 0.32 mg/lb/min). Sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action. If the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be injected after 5 minutes. NO MORE THAN 200 TO 300 mg OF LIDOCAINE HYDROCHLORIDE SHOULD BE ADMINISTERED DURING A ONE HOUR PERIOD.

Continuous Intravenous Infusion

Following bolus administration, intravenous infusions of Xylocaine may be initiated at the rate of 1 to 4 mg/min of lidocaine hydrochloride (0.014 to 0.057 mg/kg/min; 0.006 to 0.026 mg/lb/min). The rate of intravenous infusions should be reassessed 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 for lidocaine for prolonged periods.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Do not use if solution is discolored or cloudy.

Pediatric

Controlled clinical studies in the pediatric population to establish dosing schedules have not been conducted.
Vimovo

Vimovo

Carefully consider the potential benefits and risks of VIMOVO and other treatment options before deciding to use VIMOVO. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. VIMOVO does not allow for administration of a lower daily dose of esomeprazole. If a dose of esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.

Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis

The dosage is one tablet twice daily of VIMOVO 375 mg naproxen and 20 mg of esomeprazole or 500 mg naproxen and 20 mg of esomeprazole.

The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet. VIMOVO is to be taken at least 30 minutes before meals.

Geriatric Patients

Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly use the lowest effective dose [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].

Patients With Moderate to Severe Renal Impairment

Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 mL/min) [see Warnings and Precautions (5.6, 5.7) and Use in Specific Populations (8.7)].

Hepatic Insufficiency

Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen component of VIMOVO.

VIMOVO should be avoided in patients with severe hepatic impairment [see Warnings and Precautions (5.11), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Pediatric Patients

The safety and efficacy of VIMOVO in children younger than 18 years has not been established. VIMOVO is therefore not recommended for use in children.
Plendil

Plendil

The recommended starting dose is 5 mg once a day. Depending on the patient's response, the dosage can be decreased to 2.5 mg or increased to 10 mg once a day. These adjustments should occur generally at intervals of not less than 2 weeks. The recommended dosage range is 2.5−10 mg once daily. In clinical trials, doses above 10 mg daily showed an increased blood pressure response but a large increase in the rate of peripheral edema and other vasodilatory adverse events (see ADVERSE REACTIONS). Modification of the recommended dosage is usually not required in patients with renal impairment.

PLENDIL should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism). PLENDIL should be swallowed whole and not crushed or chewed.

Geriatric Use – Patients over 65 years of age are likely to develop higher plasma concentrations of felodipine (see CLINICAL PHARMACOLOGY). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (2.5 mg daily). Elderly patients should have their blood pressure closely monitored during any dosage adjustment.

Patients with Impaired Liver Function – Patients with impaired liver function may have elevated plasma concentrations of felodipine and may respond to lower doses of PLENDIL; therefore, patients should have their blood pressure monitored closely during dosage adjustment of PLENDIL (see CLINICAL PHARMACOLOGY).
Pulmicort Flexhaler

Pulmicort Flexhaler

PULMICORT FLEXHALER should be administered twice daily by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing [seePatient Counseling Information (17.1)].

Patients should be instructed to prime PULMICORT FLEXHALER prior to its initial use, and instructed to inhale deeply and forcefully each time the device is used.

The safety and efficacy of PULMICORT FLEXHALER when administered in excess of recommended doses have not been established.

After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with PULMICORT FLEXHALER, increasing the dose may provide additional asthma control.

2.1 Asthma

If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Patients 18 Years of Age and Older: For patients 18 years of age and older, the recommended starting dosage is 360 mcg twice daily. In some adult patients, a starting dose of 180 mcg twice daily may be adequate. The maximum dosage should not exceed 720 mcg twice daily.

Patients 6 to 17 Years of Age: The recommended starting dosage is 180 mcg twice daily. In some pediatric patients, a starting dose of 360 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.

For all patients, it is desirable to titrate to the lowest effective dose after adequate asthma stability is achieved.

Improvement in asthma control following inhaled administration of budesonide can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks, or longer. Individual patients will experience a variable onset and degree of symptom relief.

If a previously effective dosage regimen of PULMICORT FLEXHALER fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options (e.g. replacing the lower strength of PULMICORT FLEXHALER with the higher strength or initiating oral corticosteroids) should be considered.
Pulmicort Respules

Pulmicort Respules

The recommended starting dose and highest recommended dose of PULMICORT RESPULES, based on prior asthma therapy, are listed in the following table.
Previous Therapy Recommended Starting Dose Highest Recommended Dose
Bronchodilators alone

0.5 mg total daily dose administered either once daily or twice daily in divided doses

0.5 mg total daily dose

Inhaled Corticosteroids

0.5 mg total daily dose administered either once daily or twice daily in divided doses

1 mg total daily dose

Oral Corticosteroids

1 mg total daily dose administered either as 0.5 mg twice daily or 1 mg once daily

1 mg total daily dose

2.1 Dosing Recommendations

Dosing recommendations based on previous therapy are as follows:
• Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily • Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily • Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily
In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered. If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a divided dose. In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved.

2.2 Directions for Use

PULMICORT RESPULES should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of PULMICORT RESPULES and, therefore, are NOT recommended.

The effects of mixing PULMICORT RESPULES with other nebulizable medications have not been adequately assessed. PULMICORT RESPULES should be administered separately in the nebulizer [see Patient Counseling Information, Administration with a jet nebulizer (17.1)].

A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver PULMICORT RESPULES to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of PULMICORT RESPULES delivered by other nebulizers and compressors have not been established.
Rhinocort Aqua

Rhinocort Aqua

The recommended starting dosage for adults and children 6 years of age and older is 64 mcg per day administered as one spray per nostril of RHINOCORT AQUA Nasal Spray 32 mcg once daily. Some patients who do not achieve symptom control at the recommended starting dosage may benefit from an increased dosage. The maximum recommended dosage for adults (12 years of age and older) is 256 mcg per day administered as four sprays per nostril once daily of RHINOCORT AQUA Nasal Spray 32 mcg and the maximum recommended dose for pediatric patients (6 to <12 years of age) is 128 mcg per day administered as two sprays per nostril once daily of RHINOCORT AQUA Nasal Spray 32 mcg.

It is always desirable to titrate an individual patient to the minimum effective dosage to reduce the possibility of side effects. An improvement in nasal symptoms may be noted in patients within 10 hours of first using RHINOCORT AQUA Nasal Spray, however, clinical improvement usually takes 1-2 days with maximum benefit in approximately 2 weeks. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage may be effective in maintaining control of the allergic rhinitis symptoms in patients who were initially controlled on higher dosages.

Prior to initial use, the container must be shaken gently and the pump must be primed by actuating eight times. If used daily, the pump does not need to be reprimed. If not used for two consecutive days, reprime with one spray or until a fine spray appears. If not used for more than 14 days, rinse the applicator and reprime with two sprays or until a fine spray appears. Shake the container gently before each use.

Illustrated Patient’s Instructions for Use accompany each package of RHINOCORT AQUA Nasal Spray 32 mcg.
Entocort Ec

Entocort Ec

2.1 Mild to Moderate Active Crohn’s Disease

The recommended adult dosage for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon is 9 mg orally taken once daily in the morning for up to 8 weeks. Repeated 8 week courses of ENTOCORT EC can be given for recurring episodes of active disease.

2.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease

Following an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI less than 150), ENTOCORT EC 6 mg orally is recommended once daily for maintenance of clinical remission up to 3 months. If symptom control is still maintained at 3 months an attempt to taper to complete cessation is recommended. Continued treatment with ENTOCORT EC 6 mg for more than 3 months has not been shown to provide substantial clinical benefit.

Patients with mild to moderate active Crohn’s disease involving the ileum and/or ascending colon have been switched from oral prednisolone to ENTOCORT EC with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating ENTOCORT EC treatment.

2.3 CYP3A4 inhibitors

If concomitant administration with ketoconazole, or any other CYP3A4 inhibitor, is indicated, patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Grapefruit juice, which is known to inhibit CYP3A4, should also be avoided when taking ENTOCORT EC. In these cases, reduction in the dose of ENTOCORT EC capsules should be considered [see Drug Interactions (7)and Clinical Pharmacology (12.3)].
Symbicort

Symbicort

SYMBICORT should be administered twice daily every day by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing [see Patient Counseling Information (17.4)].

Prime SYMBICORT before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well before each spray and releasing two test sprays into the air away from the face.

More frequent administration or a higher number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of SYMBICORT is not recommended as some patients are more likely to experience adverse effects with higher doses of formoterol. Patients using SYMBICORT should not use additional long-acting beta2-agonists for any reason. [See Warnings and Precautions (5.3, 5.12)].

2.1 Asthma

If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Adult and Adolescent Patients 12 Years of Age and Older: For patients 12 years of age and older, the dosage is 2 inhalations twice daily (morning and evening, approximately 12 hours apart).

The recommended starting dosages for SYMBICORT for patients 12 years of age and older are based upon patients' asthma severity.

The maximum recommended dosage is SYMBICORT 160/4.5 mcg twice daily.

Improvement in asthma control following inhaled administration of SYMBICORT can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with SYMBICORT 80/4.5, replacement with SYMBICORT 160/4.5 may provide additional asthma control.

If a previously effective dosage regimen of SYMBICORT fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, (e.g., replacing the lower strength of SYMBICORT with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.

2.2 Chronic Obstructive Pulmonary Disease (COPD)

For patients with COPD the recommended dose is SYMBICORT 160/4.5, two inhalations twice daily.

If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
Zoledronic Acid

Zoledronic Acid

2.1 Dosing

In the management of ACS, initiate BRILINTA treatment with a 180 mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily.

Do not administer BRILINTA with another oral P2Y12 platelet inhibitor.

Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg [see Warnings (5.2) and Clinical Studies (14.1)]. A patient who misses a dose of BRILINTA should take one tablet (their next dose) at its scheduled time.

2.2 Administration

For patients who are unable to swallow tablets whole, BRILINTA tablets can be crushed, mixed with water and drunk. The mixture can also be administered via a nasogastric tube (CH8 or greater) [see Clinical Pharmacology (12.3)].
Clindamycin

Clindamycin

The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. ATACAND can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Patients requiring further reduction in blood pressure should be titrated to 32 mg. Doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.

Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.

Use in Renal Impairment: Dosing recommendations for ATACAND HCT in patients with creatinine clearance < 30 mg/min cannot be provided (see SPECIAL POPULATIONS, Renal Insufficiency).

Use in moderate to severe Hepatic Impairment: ATACAND HCT is not recommended for initiation because the appropriate starting dose, 8 mg, cannot be given (see SPECIAL POPULATIONS, Hepatic Insufficiency).

Replacement Therapy: The combination may be substituted for the titrated components.

Dose Titration by Clinical Effect: A patient whose blood pressure is not controlled on 25 mg of hydrochlorothiazide once daily can expect an incremental effect from ATACAND HCT 16-12.5 mg. A patient whose blood pressure is controlled on 25 mg of hydrochlorothiazide but is experiencing decreases in serum potassium can expect the same or incremental blood pressure effects from ATACAND HCT 16-12.5 mg and serum potassium may improve.

A patient whose blood pressure is not controlled on 32 mg of ATACAND can expect incremental blood pressure effects from ATACAND HCT 32-12.5 mg and then 32-25 mg. The maximal antihypertensive effect of any dose of ATACAND HCT can be expected within 4 weeks of initiating that dose.

ATACAND HCT may be administered with other antihypertensive agents.

ATACAND HCT may be administered with or without food.
Nexium I.v.

Nexium I.v.

General Information

NEXIUM I.V. for Injection should not be administered concomitantly with any other medications through the same intravenous site and/or tubing. The intravenous line should always be flushed with either 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP both prior to and after administration of NEXIUM I.V. for Injection.

The admixture should be stored at room temperature up to 30°C (86°F) and should be administered within the designated time period as listed in Table 1 below. No refrigeration is required.
Table 1 Storage Time for Final (diluted) Product Diluent Administer within:
0.9% Sodium Chloride Injection, USP

12 hours

Lactated Ringer’s Injection, USP

12 hours

5% Dextrose Injection, USP

6 hours

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

As soon as oral therapy is possible or appropriate, intravenous therapy with NEXIUM I.V. for Injection should be discontinued and the therapy should be continued orally.

2.1 GERD with Erosive Esophagitis

Adult Patients

The recommended adult dose is either 20 mg or 40 mg NEXIUM given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes). Safety and efficacy of NEXIUM I.V. for Injection as a treatment of GERD patients with erosive esophagitis for more than 10 days have not been demonstrated.

Dosage adjustment is not required in patients with mild to moderate liver impairment (Child Pugh Classes A and B). For patients with severe liver impairment (Child Pugh Class C), a maximum dose of 20 mg once daily of NEXIUM should not be exceeded [seeUse in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Pediatric Patients

The recommended doses for children ages 1 month to 17 years, inclusive, are provided below. Dose should be infused over 10 minutes to 30 minutes.

1 year to 17 years:
Body weight less than 55 kg: 10 mg Body weight 55 kg or greater: 20 mg
1 month to less than 1 year of age: 0.5 mg/kg

2.2 Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers following Therapeutic Endoscopy in Adults

Adult dose is 80 mg administered as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg/h for a total treatment duration of 72 hours (i.e., includes initial 30-minute dose plus 71.5 hours of continuous infusion). Intravenous therapy is aimed solely at the acute initial management of bleeding gastric or duodenal ulcers and does not constitute full treatment. Intravenous therapy should be followed by oral acid-suppressive therapy.

For patients with liver impairment, no dosage adjustment of the initial esomeprazole 80 mg infusion is necessary. For patients with mild to moderate liver impairment (Child Pugh Classes A and B), a maximum continuous infusion of esomeprazole 6 mg/h should not be exceeded. For patients with severe liver impairment (Child Pugh Class C), a maximum continuous infusion of 4 mg/h should not be exceeded [seeUse in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.3 Preparation and Administration Instructions

General Information

The reconstituted solution of Nexium I.V. should be stored at room temperature up to 30°C (86°F) and administered within 12 hours after reconstitution. (Administer within 6 hours if 5% Dextrose Injection is used after reconstitution). No refrigeration is required [seeDosage and Administration (2), Table 1].

Gastroesophageal Reflux Disease (GERD) with Erosive Esophagitis

Preparation Instructions for Adult Patients

Intravenous Injection (20 mg or 40 mg vial) over no less than 3 minutes
The freeze-dried powder should be reconstituted with 5 mL of 0.9% Sodium Chloride Injection, USP. Withdraw 5 mL of the reconstituted solution and administer as an intravenous injection over no less than 3 minutes.
Preparation Instructions for Pediatric Patients

Intravenous Infusion (20 mg or 40 mg) over 10 minutes to 30 minutes
A solution for intravenous infusion is prepared by first reconstituting the contents of one vial* with 5 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP and further diluting the resulting solution to a final volume of 50 mL. The resultant concentration after diluting to a final volume of 50 mL is 0.8 mg/mL (for 40 mg vial) and 0.4 mg/mL (for 20 mg vial). The solution (admixture) should be administered as an intravenous infusion over a period of 10 minutes to 30 minutes. *For patients 1 month to less than 1 year of age, first calculate the dose (0.5 mg/kg) to determine the vial size needed.
Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers in Adults

Preparation Instructions for Loading dose (80 mg) to be given over 30 minutes

The loading dose of 80 mg is prepared by reconstituting two 40 mg vials. Reconstitute each 40 mg vial with 5 mL of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be further diluted in 100 mL 0.9% Sodium Chloride Injection, USP for intravenous use. Administer over 30 minutes.

Preparation Instructions for Continuous Infusion to be given at 8 mg/hour for 71.5 hours

The continuous infusion is prepared by using two 40 mg vials. Reconstitute each 40 mg vial with 5 mL each of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be further diluted in 100 mL 0.9% Sodium Chloride Injection, USP for intravenous use. Administer at a rate of 8 mg/hour for 71.5 hours.
Serevent Diskus

Serevent Diskus

2.1 Adult Hypertension

Dosage must be individualized. Blood pressure response is dose related over the range of 2 to 32 mg. The usual recommended starting dose of ATACAND is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. ATACAND can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Larger doses do not appear to have a greater effect, and there is relatively little experience with such doses. Most of the antihypertensive effect is present within 2 weeks, and maximal blood pressure reduction is generally obtained within 4 to 6 weeks of treatment with ATACAND.

Use in Hepatic Impairment: Initiate with 8 mg ATACAND in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency [see CLINICAL PHARMACOLOGY (12.3)].

ATACAND may be administered with or without food.

If blood pressure is not controlled by ATACAND alone, a diuretic may be added. ATACAND may be administered with other antihypertensive agents.

2.2 Pediatric Hypertension 1 to < 17 Years of age

ATACAND may be administered once daily or divided into two equal doses. Adjust the dosage according to blood pressure response. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate ATACAND under close medical supervision and consider administration of a lower dose [see WARNINGS AND PRECAUTIONS (5.3)].

Children 1 to < 6 years of age:

The dose range is 0.05 to 0.4 mg/kg per day. The recommended starting dose is 0.20 mg/kg (oral suspension).

Children 6 to < 17 years of age:

For those less than 50 kg, the dose range is 2 to 16 mg per day. The recommended starting dose is 4 to 8 mg.

For those greater than 50 kg, the dose range is 4 to 32 mg per day. The recommended starting dose is 8 to 16 mg.

Doses above 0.4 mg/kg (1 to < 6 year olds) or 32 mg (6 to < 17 year olds) have not been studied in pediatric patients [see CLINICAL STUDIES (14.1)].

An antihypertensive effect is usually present within 2 weeks, with full effect generally obtained within 4 weeks of treatment with ATACAND.

Children < 1 year of age must not receive ATACAND for hypertension.

All pediatric patients with a glomerular filtration rate less than 30 ml/min/1.73m2 should not receive ATACAND since ATACAND has not been studied in this population [seeSPECIAL POPULATIONS (8)].

For children who cannot swallow tablets, an oral suspension may be substituted as described below:

Preparation of Oral Suspension:

ATACAND oral suspension can be prepared in concentrations within the range of 0.1 to 2.0 mg/mL. Typically, a concentration of 1 mg/mL will be suitable for the prescribed dose. Any strength of ATACAND tablets can be used in the preparation of the suspension.

Follow the steps below for preparation of the suspension. The number of tablets and volume of vehicle specified below will yield 160 mL of a 1 mg/mL suspension.
• Prepare the vehicle by adding equal volumes of 1Ora-Plus ® (80 mL) and 1Ora-Sweet SF ® (80 mL) or, alternatively, use, 1,2Ora-Blend SF ® (160 mL). • Add a small amount of vehicle to the required number of ATACAND tablets (five 32 mg tablets) and grind into a smooth paste using a mortar and pestle. • Add the paste to a preparation vessel of suitable size. • Rinse the mortar and pestle clean using the vehicle and add this to the vessel. Repeat, if necessary. • Prepare the final volume by adding the remaining vehicle. • Mix thoroughly. • Dispense into suitably sized amber PET bottles. • Label with an expiry date of 100 days and include the following instructions:
Store at room temperature (below 30°C/86°F). Use within 30 days after first opening. Do not use after the expiry date stated on the bottle.

Do not freeze.

Shake well before each use.
1 Ora-Plus®, Ora-Sweet SF®, and Ora-Blend SF® are registered trademarks of Paddock Laboratories, Inc. 2Supplied as a 50/50% pre-mix of Ora-Plus® and Ora-Sweet®
2.3 Adult Heart Failure

The recommended initial dose for treating heart failure is 4 mg once daily. The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient.
Toprol Xl

Toprol Xl

TOPROL-XL is an extended-release tablet intended for once daily administration. For treatment of hypertension and angina, when switching from immediate-release metoprolol to TOPROL-XL, use the same total daily dose of TOPROL-XL. Individualize the dosage of TOPROL-XL. Titration may be needed in some patients.

TOPROL-XL tablets are scored and can be divided; however, do not crush or chew the whole or half tablet.

2.1 Hypertension

Adults: The usual initial dosage is 25 to 100 mg daily in a single dose. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. Dosages above 400 mg per day have not been studied.

Pediatric Hypertensive Patients ≥ 6 Years of age: A pediatric clinical hypertension study in patients 6 to 16 years of age did not meet its primary endpoint (dose response for reduction in SBP); however some other endpoints demonstrated effectiveness [see Use in Specific Populations (8.4)]. If selected for treatment, the recommended starting dose of TOPROL-XL is 1 mg/kg once daily, but the maximum initial dose should not exceed 50 mg once daily. Dosage should be adjusted according to blood pressure response. Doses above 2 mg/kg (or in excess of 200 mg) once daily have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].

TOPROL-XL is not recommended in pediatric patients < 6 years of age [see Use in Specific Populations (8.4)].

2.2 Angina Pectoris

Individualize the dosage of TOPROL-XL. The usual initial dosage is 100 mg daily, given in a single dose. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, reduce the dosage gradually over a period of 1 - 2 weeks [see Warnings and Precautions (5)].

2.3 Heart Failure

Dosage must be individualized and closely monitored during up-titration. Prior to initiation of TOPROL-XL, stabilize the dose of other heart failure drug therapy. The recommended starting dose of TOPROL-XL is 25 mg once daily for two weeks in patients with NYHA Class II heart failure and 12.5 mg once daily in patients with more severe heart failure. Double the dose every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of TOPROL-XL. Initial difficulty with titration should not preclude later attempts to introduce TOPROL-XL. If patients experience symptomatic bradycardia, reduce the dose of TOPROL-XL. If transient worsening of heart failure occurs, consider treating with increased doses of diuretics, lowering the dose of TOPROL-XL or temporarily discontinuing it. The dose of TOPROL-XL should not be increased until symptoms of worsening heart failure have been stabilized.
Budesonide Spray

Budesonide Spray

The recommended starting dosage for adults and children 6 years of age and older is 64 mcg per day administered as one spray per nostril of Budesonide Nasal Spray 32 mcg once daily. Some patients who do not achieve symptom control at the recommended starting dosage may benefit from an increased dosage. The maximum recommended dosage for adults (12 years of age and older) is 256 mcg per day administered as four sprays per nostril once daily of Budesonide Nasal Spray 32 mcg and the maximum recommended dose for pediatric patients (6 to <12 years of age) is 128 mcg per day administered as two sprays per nostril once daily of Budesonide Nasal Spray 32 mcg.

It is always desirable to titrate an individual patient to the minimum effective dosage to reduce the possibility of side effects. An improvement in nasal symptoms may be noted in patients within 10 hours of first using Budesonide Nasal Spray, however, clinical improvement usually takes 1-2 days with maximum benefit in approximately 2 weeks. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage may be effective in maintaining control of the allergic rhinitis symptoms in patients who were initially controlled on higher dosages.

Prior to initial use, the container must be shaken gently and the pump must be primed by actuating eight times. If used daily, the pump does not need to be reprimed. If not used for two consecutive days, reprime with one spray or until a fine spray appears. If not used for more than 14 days, rinse the applicator and reprime with two sprays or until a fine spray appears. Shake the container gently before each use.

Illustrated Patient’s Instructions for Use accompany each package of Budesonide 32 mcg.
Nexium

Nexium

NEXIUM is supplied as delayed-release capsules for oral administration or in packets for preparation of delayed-release oral suspensions. The recommended dosages are outlined in Table 1. NEXIUM should be taken at least one hour before meals.

The duration of proton pump inhibitor administration should be based on available safety and efficacy data specific to the defined indication and dosing frequency, as described in the prescribing information, and individual patient medical needs. Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment.
Table 1: Recommended Dosage Schedule for NEXIUM * [ See Clinical Studies (14.1) ] The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4 to 8 weeks, an additional 4 to 8 weeks of treatment may be considered. † Controlled studies did not extend beyond six months. ‡ If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered. § Doses over 1 mg/kg/day have not been studied. ¶ The dosage of NEXIUM in patients with pathological hypersecretory conditions varies with the individual patient. Dosage regimens should be adjusted to individual patient needs. # Doses up to 240 mg daily have been administered [ see Drug Interactions (7)].
Indication

Dose

Frequency

Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
20 mg or 40 mg

Once Daily for 4 to 8 Weeks*
Maintenance of Healing of Erosive Esophagitis
20 mg

Once Daily†
Symptomatic Gastroesophageal Reflux Disease
20 mg

Once Daily for 4 Weeks‡

Pediatric GERD

12 to 17 Year Olds

Healing of Erosive Esophagitis

Symptomatic GERD

20 mg or 40 mg

20 mg

Once Daily for 4 to 8 Weeks

Once Daily for 4 Weeks

1 to 11 Year Olds§

Short-term Treatment of Symptomatic GERD

10 mg

Once Daily for up to 8 Weeks

Healing of Erosive Esophagitis
weight < 20 kg
10 mg

Once Daily for 8 Weeks
weight ≥ 20 kg
10 mg or 20 mg

Once Daily for 8 Weeks

1 month to < 1 year old¶

Erosive esophagitis due to acid-mediated GERD
weight 3 kg to 5 kg
2.5 mg

Once Daily for up to 6 Weeks
weight > 5 kg to 7.5 kg
5 mg

Once Daily for up to 6 Weeks
weight >7.5 kg to 12 kg
10 mg

Once Daily for up to 6 Weeks
Risk Reduction of NSAID-Associated Gastric Ulcer
20 mg or 40 mg

Once Daily for up to 6 months†

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy: NEXIUM
40 mg

Once Daily for 10 Days
Amoxicillin
1000 mg

Twice Daily for 10 Days
Clarithromycin
500 mg

Twice Daily for 10 Days

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

40 mg¶

#Twice Daily

Please refer to amoxicillin and clarithromycin prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients.

Special Populations

Hepatic Insufficiency

In patients with mild to moderate liver impairment (Child Pugh Classes A and B), no dosage adjustment is necessary. For patients with severe liver impairment (Child Pugh Class C), a dose of 20 mg of NEXIUM should not be exceeded [seeClinical Pharmacology (12.3)].

Directions for use specific to the route and available methods of administration for each of these dosage forms are presented in Table 2.
Table 2: Administration Options
Administration Options

(See text following table for additional instructions.)

Dosage Form

Route

Options

Delayed-Release Capsules

Oral

Capsule can be swallowed whole.

-or-

Capsule can be opened and mixed with applesauce.

Delayed-Release Capsules

Nasogastric Tube

Capsule can be opened and the intact granules emptied into a syringe and delivered through the nasogastric tube.

For Delayed-Release Oral Suspension

Oral

For the 2.5 mg and 5 mg strengths, mix the contents of packet with 5 mL of water, leave 2 to 3 minutes to thicken, stir and drink within 30 minutes.

For the 10 mg, 20 mg and 40 mg strengths, mix contents of packet with 15 mL of water, and follow the instructions above.

For Delayed-Release Oral Suspension

Nasogastric or Gastric Tube

For the 2.5 mg and 5 mg strengths, add 5 mL of water to a syringe and then add contents of packet. Shake the syringe; leave 2 to 3 minutes to thicken. Shake the syringe and inject through the nasogastric or gastric tube within 30 minutes.

For the 10 mg, 20 mg and 40 mg strengths, add 15 mL of water, and follow the instructions above.

NEXIUM Delayed-Release Capsules

NEXIUM Delayed-Release Capsules should be swallowed whole.

Alternatively, for patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the NEXIUM Delayed-Release Capsule can be opened, and the granules inside the capsule carefully emptied onto the applesauce. The granules should be mixed with the applesauce and then swallowed immediately: do not store for future use. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The granules should not be chewed or crushed. If the granules/applesauce mixture is not used in its entirety, the remaining mixture should be discarded immediately.

For patients who have a nasogastric tube in place, NEXIUM Delayed-Release Capsules can be opened and the intact granules emptied into a 60 mL catheter tipped syringe and mixed with 50 mL of water. It is important to only use a catheter tipped syringe when administering NEXIUM through a nasogastric tube. Replace the plunger and shake the syringe vigorously for 15 seconds. Hold the syringe with the tip up and check for granules remaining in the tip. Attach the syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach. After administering the granules, the nasogastric tube should be flushed with additional water. Do not administer the granules if they have dissolved or disintegrated.

The mixture must be used immediately after preparation.

NEXIUM For Delayed-Release Oral Suspension

NEXIUM For Delayed-Release Oral Suspension should be administered as follows:
• Empty the contents of a 2.5 mg or 5 mg packet into a container containing 5 mL of water. For the 10 mg, 20 mg, and 40 mg strengths, the contents of a packet should be emptied into a container containing 15 mL of water. • Stir. • Leave 2 to 3 minutes to thicken. • Stir and drink within 30 minutes. • If any medicine remains after drinking, add more water, stir, and drink immediately. • In cases where there is a need to use two packets, they may be mixed in a similar way by adding twice the required amount of water or follow the mixing instructions provided by your pharmacist or doctor.
For patients who have a nasogastric or gastric tube in place, NEXIUM For Delayed-Release Oral Suspension can be administered as follows:
• Add 5 mL of water to a catheter tipped syringe and then add the contents of a 2.5 mg or 5 mg NEXIUM packet. For the 10 mg, 20 mg, and 40 mg strengths, the volume of water in the syringe should be 15 mL. It is important to only use a catheter tipped syringe when administering NEXIUM through a nasogastric tube or gastric tube. • Immediately shake the syringe and leave 2 to 3 minutes to thicken. • Shake the syringe and inject through the nasogastric or gastric tube, French size 6 or larger, into the stomach within 30 minutes. • Refill the syringe with an equal amount of water (5 mL or 15 mL). • Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

Astrazeneca Lp

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