Famotidine (Page 5 of 5)

Pediatric Patients

In a clinical study in 35 pediatric patients <1 year of age with GERD symptoms [e.g., vomiting (spitting up), irritability (fussing)], agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued.

OVERDOSAGE

The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience (see ADVERSE REACTIONS). Oral doses of up to 640 mg/day have been given to adult patients with pathological hypersecretory conditions with no serious adverse effects. In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.

The intravenous LD50 of famotidine for mice and rats ranged from 254-563 mg/kg and the minimum lethal single I.V. dose in dogs was approximately 300 mg/kg. Signs of acute intoxication in I.V. treated dogs were emesis, restlessness, pallor of mucous membranes or redness of mouth and ears, hypotension, tachycardia and collapse. The oral LD50 of famotidine in male and female rats and mice was greater than 3000 mg/kg and the minimum lethal acute oral dose in dogs exceeded 2000 mg/kg. Famotidine did not produce overt effects at high oral doses in mice, rats, cats and dogs, but induced significant anorexia and growth depression in rabbits starting with 200 mg/kg/day orally.

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 <1 year of age Gastroesophageal Reflux Disease (GERD)

See PRECAUTIONS, Pediatric Patients <1 year of age.

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 famotidine 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 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 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 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.

Famotidine Injection

Famotidine Injection, 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. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path 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 protector from outlet port at bottom of container.
3.
Attach administration set. Refer to complete directions accompanying set.

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.

Famotidine Injection, 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.)

HOW SUPPLIED

FOR INTRAVENOUS USE ONLY

Famotidine Injection containing 20 mg of famotidine per 50 mL is a clear, non-preserved, sterile solution premixed in a vehicle made iso-osmotic with sodium chloride. Famotidine Injection is supplied in a carton of 12 x 50 mL single dose GALAXY plastic containers as follows:

2G3424

50 mL container

NDC 0338-5197-41

Storage

Store Famotidine Injection 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.

Baxter Healthcare Corporation Deerfield, IL 60015 USA

Printed in USA

Baxter and Galaxy are registered trademarks of Baxter International Inc.

07-19-00-719

Rev. May 2018

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL

Famotidine Representative Container Label  NDC 0338-5197-41
(click image for full-size original)

Container Label

Baxter
Famotidine
Injection

20 mg

Rx only

GALAXY
Single Dose
Container

50 mL
Iso-osmotic

NDC 0338-5197-41
Code 2G3424
Sterile Nonpyrogenic

Each 50 mL contains: 20 mg famotidine, USP, 450 mg sodium chloride, USP, and
6.8 mg L-aspartic acid. pH may have been adjusted with additional L-aspartic acid
and/or sodium hydroxide. pH 5.7 to 6.4

Usual Dosage: Intravenously as directed by a physician. See package insert.

Cautions: Do not add supplementary medication. Must not be used in series
connections.

Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as
sterility may be impaired. Do not use unless solution is clear.

Recommended storage: Room temperature (25°C/77°F). Avoid excessive heat.
Brief exposure up to 35°C/95°F does not adversely affect the product.

______________________________________________________________________

Baxter and Galaxy are registered trademarks of
Baxter International Inc.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

PL 2501 Plastic

07-34-63-666

Famotidine Representative Carton Label  NDC 0338-5197-41
(click image for full-size original)
Famotidine Representative Carton Label  NDC 0338-5197-41
(click image for full-size original)
Famotidine Representative Carton Label  NDC 0338-5197-41
(click image for full-size original)

Carton Label

Recommended storage: Room temperature (25°C/77°F). Avoid excessive heat.
Brief exposure up to 35°C/95°F does not adversely affect the product.
Baxter and GALAXY are trademarks of Baxter International Inc. 07-04-47-201
07-04-47-201
PL 2501 Plastic
Recommended storage: Room temperature (25°C/77°F). Avoid excessive heat.
Brief exposure up to 35°C/95°F does not adversely affect the product.
Baxter and GALAXY are trademarks of Baxter International Inc. 07-04-47-201
07-04-47-201
PL 2501 Plastic

Baxter NDC 0338-5197-41
Famotidine Injection Rx only 20 mg Code 2G3424

12 x 50 mL Single Dose Containers Iso-osmotic
Recommended storage: Room temperature (25°C/77°F)

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

*FOR BAR CODE POSITION ONLY
(01) 20303385197414

Baxter NDC 0338-5197-41
Famotidine Injection Rx only 20 mg Code 2G3424

12 x 50 mL Single Dose Containers Iso-osmotic
Recommended storage: Room temperature (25°C/77°F)

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

*FOR BAR CODE POSITION ONLY(01) 20303385197414

GALAXY Container Sterile Nonpyrogenic

Each 50 mL contains: 20 mg famotidine, USP, 450 mg sodium chloride, USP, and 6.8 mg L-aspartic acid. pH may have been adjusted with additional L-aspartic acid and/or sodium hydroxide. pH 5.7 to 6.4

Usual Dosage: Intravenously as directed by physician. See package insert.

Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.

GALAXY Container Sterile Nonpyrogenic

Each 50 mL contains: 20 mg famotidine, USP, 450 mg sodium chloride, USP, and 6.8 mg L-aspartic acid. pH may have been adjusted with additional L-aspartic acid and/or sodium hydroxide. pH 5.7 to 6.4

Usual Dosage: Intravenously as directed by physician. See package insert.

Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.

FAMOTIDINE famotidine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-5197
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 450 mg in 50 mL
ASPARTIC ACID 6.8 mg in 50 mL
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-5197-41 12 BAG in 1 CARTON contains a BAG
1 50 mL in 1 BAG This package is contained within the CARTON (0338-5197-41)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075591 05/10/2001
Labeler — Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 194684502 MANUFACTURE (0338-5197), LABEL (0338-5197), ANALYSIS (0338-5197), PACK (0338-5197), STERILIZE (0338-5197)

Revised: 05/2018 Baxter Healthcare Corporation

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