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Famotidine Injection

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Famotidine Injection

INDICATIONS

Famotidine injection, supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions:

  1. Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than 8 weeks.
  2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year.
  3. Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
  4. Short term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
    Famotidine is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
  5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

DOSAGE AND ADMINISTRATION

In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, famotidine injection may be administered until oral therapy can be instituted.

The recommended dosage for famotidine injection in adult patients is 20 mg intravenously q 12 h.

The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients

See PRECAUTIONS, Pediatric Use.

The studies described in PRECAUTIONS, Pediatric Use suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15 minute infusion) q 12 h up to 40 mg/day.

While published uncontrolled clinical studies suggest effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1year of age.

Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency

In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine injection may be reduced to half the dose, or the dosing interval may be prolonged to 36 to 48 hours as indicated by the patient's clinical response. .

Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. In some patients, a higher starting dose may be required. Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

Preparation of Intravenous Solutions

To prepare famotidine intravenous solutions, aseptically dilute 2 mL of famotidine injection (solution containing 10 mg/mL) with 0.9% Sodium Chloride Injection or other compatible intravenous solution (see Stability), to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.

To prepare famotidine intravenous infusion solutions, aseptically dilute 2 mL of famotidine injection with 100 mL of 5% dextrose or other compatible solution (see Stability), and infuse over a 15 to 30 minute period.

Concomitant Use of Antacids

Antacids may be given concomitantly if needed.

Stability

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

When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, or Lactated Ringer's Injection, diluted famotidine injection is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature – see HOW SUPPLIED, Storage.

When added to or diluted with Sodium Bicarbonate Injection, 5%, famotidine injection at a concentration of 0.2 mg/mL (the recommended concentration of famotidine intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initialpotency) for 7 days at room temperature – see HOW SUPPLIED, Storage. However, a precipitate may form at higher concentrations of famotidine injection ( > 0.2mg/mL) in Sodium Bicarbonate Injection, 5%.

HOW SUPPLIED

FOR INTRAVENOUS USE ONLY AFTER DILUTION

Famotidine Injection 10 mg per 1mL is a clear, colorless solution and is supplied as:

Product No. NDC No.  
730804 63323-738-04 Famotidine Injection, 10 mg/mL, 4 mL multiple dose vial, packaged individually.
730820 63323-738-20 Famotidine Injection, 10 mg/mL, 20 mL multiple dose vial, 10 vials per tray.

Storage

Store famotidine injection at 2°-8°C (36°-46°F). If solution freezes, bring to room temperature; allow sufficient time to solubilize all the components.

Although diluted famotidine injection has been shown to be physically and chemically stable for 7 days at room temperature, there are no data on the maintenance of sterility after dilution. Therefore, it is recommended that if not used immediately after preparation, diluted solutions of famotidine injection should be refrigerated and used within 48 hours (see DOSAGE AND ADMINISTRATION).

Vial stoppers do not contain natural rubber latex.

Abraxis Pharmaceuticals Products. Schaumburg, IL 60173. Revised: December 2006. FDA revision date: 6/25/2008

Last reviewed on RxList: 1/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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