Recommended Topic Related To:

Pepcid Injection

"The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).

GE"...

Pepcid Injection

Indications
Dosage
How Supplied

INDICATIONS

PEPCID Injection (famotidine injection) Premixed, supplied as a premixed solution in plastic containers (PL 2501 Plastic), and PEPCID Injection (famotidine injection) , supplied as a concentrated solution for intravenous injection, are intended for intravenous use only. PEPCID Injection (famotidine injection) Premixed and PEPCID Injection (famotidine injection) are 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 PEPCID at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight 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). PEPCID is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
    PEPCID 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, PEPCID Injection (famotidine injection) Premixed or PEPCID Injection (famotidine injection) may be administered until oral therapy can be instituted.

The recommended dosage for PEPCID Injection (famotidine injection) Premixed and PEPCID Injection (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 < 1 year of age Gastroesophageal Reflux Disease (GERD)

See PRECAUTIONS, Pediatric Patients < 1 year of age.

The studies described in PRECAUTIONS, Pediatric Patients < 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients < 1 year of age with GERD has not been adequately studied.

Dosage for Pediatric Patients 1-16 years of age

See PRECAUTIONS, Pediatric Patients 1-16 years of age.

The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age 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 1-16 years of age have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

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 PEPCID is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours 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 PEPCID Injection (famotidine injection) Premixed or PEPCID Injection (famotidine injection) may be reduced to half the dose, or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

Based on the comparison of pharmacokinetic parameters for PEPCID 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 PEPCID in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20 mg 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.

PEPCID Injection (famotidine injection) Premixed

PEPCID Injection (famotidine injection) Premixed, supplied in Galaxy§ containers (PL 2501 Plastic), is a 50 mL iso-osmotic solution premixed with 0.9% sodium chloride for administration as an infusion over a 15-30 minute period. This premixed solution is for intravenous use only using sterile equipment.

Directions for Use of Galaxy® Containers

Check the container for minute leaks prior to use by squeezing the bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not add supplementary medication. Do not use unless solution is clear and seal is intact.

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.

Preparation for administration:

  1. Suspend container from eyelet support.
  2. Remove plastic protector from outlet port at bottom of container.
  3. Attach administration set. Refer to complete directions accompanying set. To prepare PEPCID intravenous solutions, aseptically dilute 2 mL of PEPCID Injection (solution containing 10 mg/mL) with 0.9% Sodium Chloride Injection or other compatible intravenous solution (see Stability, PEPCID Injection (famotidine injection) ) to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.

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

PEPCID Injection (famotidine injection) Premixed

PEPCID Injection (famotidine injection) Premixed, as supplied premixed in 0.9% sodium chloride in Galaxy® containers (PL 2501 Plastic), is stable through the labeled expiration date when stored under the recommended conditions. (See HOW SUPPLIED, Storage.)

PEPCID Injection (famotidine injection)

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

HOW SUPPLIED

FOR INTRAVENOUS USE ONLY

No. 3537 - PEPCID Injection (famotidine injection) Premixed 20 mg per 50 mL is a clear, non-preserved, sterile solution premixed in a vehicle made iso-osmotic with Sodium Chloride, and is supplied as follows:

NDC 0006-3537-50, 50 mL single dose Galaxy® containers (PL 2501 Plastic).

No. 3539 - PEPCID Injection (famotidine injection) 10 mg per 1 mL, is a non-preserved, clear, colorless solution and is supplied as follows:

NDC 0006-3539-04, 10 x 2 mL single dose vials.

No. 3541 - PEPCID Injection (famotidine injection) 10 mg per 1 mL, is a clear, colorless solution and is supplied as follows:

NDC 0006-3541-14, 4 mL vials
NDC
0006-3541-20, 20 mL vials
NDC
0006-3541-49, 10 x 20 mL vials.

Storage

Store PEPCID Injection (famotidine injection) Premixed in Galaxy® containers (PL 2501 Plastic) at room temperature (25°C, 77°F). Exposure of the premixed product to excessive heat should be avoided. Brief exposure to temperatures up to 35°C (95°F) does not adversely affect the product.

Store PEPCID Injection (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 PEPCID Injection (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 PEPCID Injection (famotidine injection) should be refrigerated and used within 48 hours (See DOSAGE AND ADMINISTRATION).

PEPCID (famotidine) Injection Premixed is manufactured for: MERCK & CO., INC/Whitehouse Station, NJ 08889, USA, By: BAXTER HEALTHCARE CORPORATION., Deerfield, Illinois 60015 USA. PEPCID (famotidine) Injection is manufactured by: MERCK & CO., INC/Whitehouse Station, NJ 08889, USA. Issued October 2006. FDA rev date: 11/5/2007

Last reviewed on RxList: 11/30/2007
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Pepcid Injection - User Reviews

Pepcid Injection User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Pepcid Injection sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


GI Disorders

Get the latest treatment options.


NIH talks about Ebola on WebMD