Pfizer Labs, Division Of Pfizer Inc.
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Pfizer Labs, Division Of Pfizer Inc. Drugs
DOSAGE AND ADMINISTRATION – ADULTS
Ciprofloxacin Injection, USP should be administered to adults by intravenous infusion over a period of 60 minutes at dosages described in the Dosage Guidelines table. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation.. (See Preparation of Ciprofloxacin Injection, USP for Administration section.)
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.ADULT DOSAGE GUIDELINES * DUE TO THE DESIGNATED PATHOGENS (See INDICATIONS AND USAGE.) † used in conjunction with metronidazole. (See product labeling for prescribing information.) ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION. Total duration of ciprofloxacin administration (IV or oral) for inhalational anthrax (post-exposure) is 60 days. Infection* Severity Dose Frequency Usual Duration Urinary Tract Mild/Moderate Severe/Complicated 200 mg 400 mg q12h q12h 7-14 Days 7-14 Days Lower Respiratory Tract Mild/Moderate Severe/Complicated 400 mg 400 mg q12h q8h 7-14 Days 7-14 Days Nosocomial Pneumonia Mild/Moderate/Severe 400 mg q8h 10-14 Days Skin and Skin Structure Mild/Moderate Severe/Complicated 400 mg 400 mg q12h q8h 7-14 Days 7-14 Days Bone and Joint Mild/Moderate Severe/Complicated 400 mg 400 mg q12h q8h ≥ 4-6 Weeks ≥ 4-6 Weeks Intra-Abdominal † Acute Sinusitis Complicated Mild/Moderate 400 mg 400 mg q12h q12h 7-14 Days 10 Days Chronic Bacterial Prostatitis Mild/Moderate 400 mg q12h 28 Days Empirical Therapy inFebrileNeutropenicPatients SevereCiprofloxacin+Piperacillin 400 mg 50 mg/kgNot to exceed24 g/day q8h q4h 7-14 Days Inhalational anthrax (post- exposure)‡ 400 mg q12h 60 Days
Ciprofloxacin Injection, USP should be administered by intravenous infusion over a period of 60 minutes.
Conversion of I.V. to Oral Dosing in Adults: Ciprofloxacin tablets and oral suspension for oral administration are available. Parenteral therapy may be switched to oral ciprofloxacin when the condition warrants, at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin Injection, USP Dosage 250 mg Tablet q 12 h 200mg I.V.q 12 h 500 mg Tablet q 12 h 400mg I.V.q 12 h 750 mg Tablet q 12 h 400mg I.V.q 8h
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dosage >30 See usual dosage. 5-29 200-400 mg q 18-24 hr
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance:
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age) 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function. For patients with changing renal function or for patients with renal impairment and hepatic insufficiency, careful monitoring is suggested.
DOSAGE AND ADMINISTRATION – PEDIATRICS
Ciprofloxacin injection should be administered by intravenous infusion as described in the Dosage Guidelines table.
An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.PEDIATRIC DOSAGE GUIDELINES * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION. Infection Route of Administration Dose>(mg/kg) Frequency TotalDuration Complicated Urinary Tract or Pyelonephritis(patients from1 to 17 years of age) Intravenous 6 to 10 mg/kg(maximum 400mg per dose; not to be exceeded even in patientsweighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to beexceeded even inpatients weighing > 51 kg) Every 12 hours Inhalational Anthrax(Post-Exposure)† Intravenous 10 mg/kg(maximum 400mg per dose) Every 12 hours 60 days Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of 50 mL/min/1.73m2).
Preparation of Ciprofloxacin Injection, USP for Administration
Vials (Injection Concentrate): THIS PREPARATION MUST BE DILUTED BEFORE USE. The intravenous dose should be prepared by aseptically withdrawing the concentrate from the vial of Ciprofloxacin Injection, USP. This should be diluted with a suitable intravenous solution to a final concentration of l-2mg/mL. (See COMPATIBILITY AND STABILITY .) The resulting solution should be infused over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.
If the Y-type or “piggyback” method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of ciprofloxacin injection. If the concomitant use of ciprofloxacin injection and another drug is necessary each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.
Flexible Containers:Ciprofloxacin Injection, USP is also available as a 0.2% premixed solution in 5% dextrose in flexible containers of 100 mL or 200 mL. The solutions in flexible containers do not need to be diluted and may be infused as described above.
COMPATIBILITY AND STABILITY
Ciprofloxacin injection 1% (10 mg/mL), when diluted with the following intravenous solutions to concentrations of 0.5 to 2.0 mg/mL, is stable for up to 14 days at refrigerated or room temperature storage.0.9% Sodium Chloride Injection 5% Dextrose Injection Sterile Water for Injection 10% Dextrose for Injection 5% Dextrose and 0.225% Sodium Chloride for Injection 5% Dextrose and 0.45% Sodium Chloride for Injection Lactated Ringer’s for Injection
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:
15 mg/kg infused over one hour (approximately 1 g for a 70-kg adult).
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.
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 Metronidazole Injection, USP treatment. 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.
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 levels2 and toxicity is recommended.
In patients receiving Metronidazole Injection, USP 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.
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.
Caution: Metronidazole Injection, USP is to be administered by slow intravenous drip infusion only, either as a continuous or intermittent infusion. Additives should not be introduced into Metronidazole Injection, USP. 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.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Ondansetron Hydrochloride And Dextrose
Prevention of Chemotherapy-Induced Nausea and Vomiting:
The recommended I.V. dosage of ondansetron injection for adults is a single 32-mg dose or three 0.15-mg/kg doses. A single 32-mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. The recommended infusion rate should not be exceeded (see OVERDOSAGE). With the three-dose (0.15-mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron injection.
Ondansetron injection should not be mixed with solutions for which physical and chemical compatibility has not been established. In particular, this applies to alkaline solutions as a precipitate may form.
Flexible Plastic Container:
REQUIRES NO DILUTION. Ondansetron in 5 % Dextrose Injection, 32 mg in 50 mL.
On the basis of the available information (see CLINICAL TRIALS: Pediatric Studies and CLINICAL PHARMACOLOGY: Pharmacokinetics), the dosage in pediatric cancer patients 4 to 18 years of age should be three 0.15-mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Ondansetron in 5 % Dextrose Injection. The drug should be infused intravenously over 15 minutes. Little information is available about dosage in pediatric cancer patients younger than 6 months of age.
Dosing information for pediatric cancer patients 6 months to 48 months of age is approved for GlaxoSmithKline Corporation's ondansetron injection. However, due to GlaxoSmithKline's marketing exclusivity rights, this drug product is not labeled for use in this subpopulation of pediatric patients.
Flexible Plastic Container:
REQUIRES NO DILUTION. Ondansetron in 5 % Dextrose Injection, 32 mg in 50 mL.
The dosage recommendation is the same as for the general population.
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