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 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. 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.

DOSAGE AND ADMINISTRATION

Duodenal Ulcer

Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

Benign Gastric Ulcer

Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

Gastroesophageal Reflux Disease (GERD)

The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

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 the following starting doses in pediatric patients 1-16 years of age:

Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and 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 pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

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 oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

Concomitant Use of Antacids

Antacids may be given concomitantly if needed.

Dosage Adjustment 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 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.

HOW SUPPLIED

Famotidine Tablets, USP
Strength	Quantity	NDC Number	Description
20 mg	30’s bottle 100’s bottle 1000’s bottle	NDC 64679-936-01 NDC 64679-936-02 NDC 64679-936-03	20 mg Tablets are beige colored, barrel shaped, biconvex, film coated tablets, debossed with W on one side and other side plain. 936
40 mg	30’s bottle 100’s bottle 1000’s bottle	NDC 64679-937-01 NDC 64679-937-02 NDC 64679-937-03	40 mg Tablets are white colored, barrel shaped, biconvex, film coated tablets, debossed with W on one side and other side plain. 937

Storage: Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature) in a well-closed light resistant container.

Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Rev.060412

20 mg

30’s bottle

NDC 64679-936-01

Debossed with W;936

40 mg

30’s bottle

NDC 64679-937-01

Debossed with W;937

FAMOTIDINE famotidine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-936 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSES MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400

Product Characteristics Color BROWN (beige) Score no score Shape ROUND (barrel shape) Size 9mm Flavor Imprint Code W;936 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64679-936-01 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:64679-936-02 100 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:64679-936-03 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075786 04/16/2001

FAMOTIDINE famotidine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-937 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 40 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSES MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400

Product Characteristics Color WHITE Score no score Shape ROUND (barrel shape) Size 9mm Flavor Imprint Code W;937 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64679-937-01 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:64679-937-02 100 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:64679-937-03 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075786 04/16/2001

Labeler — Wockhardt USA LLC. (170508365)

Registrant — Wockhardt Limited (650069115)

Establishment
Name	Address	ID/FEI	Operations
Wockhardt Limited		916489953	ANALYSIS (64679-936), ANALYSIS (64679-937), LABEL (64679-936), LABEL (64679-937), MANUFACTURE (64679-936), MANUFACTURE (64679-937), PACK (64679-936), PACK (64679-937)

Revised: 12/2017 Wockhardt USA LLC.