FAMOTIDINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)

Available from:

REMEDYREPACK INC.

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of: • active duodenal ulcer. • active gastric ulcer. • symptomatic non-erosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: • treatment of pathological hypersecretory conditions (e.g., Zollinger- Ellison Syndrome, multiple endocrine neoplasias). • reduction of the risk of duodenal ulcer recurrence. Famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H2 receptor antagonists. 8.1 Pregnancy Risk Summary Available data with H2-receptor antagonists, including famotidine, in pregnant women are insufficient to

Product summary:

Famotidine 20 mg tablets are white, round, film-coated tablets engraved with CTI 121 on one side, supplied as follows: NDC: 70518-0461-00 30 in 1 BOTTLE PLASTIC NDC: 70518-0461-01 30 in 1 BLISTER PACK Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense in a tight, light-resistant container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE TABLET
REMEDYREPACK INC.
----------
FAMOTIDINE TABLETS USP
1 INDICATIONS AND USAGE
Famotidine tablets are indicated in adult and pediatric patients 40 kg
and above for the
treatment of:
• active duodenal ulcer.
• active gastric ulcer.
• symptomatic non-erosive gastroesophageal reflux disease (GERD).
• erosive esophagitis due to GERD, diagnosed by biopsy.
Famotidine tablets are indicated in adults for the:
• treatment of pathological hypersecretory conditions (e.g.,
Zollinger-
Ellison Syndrome, multiple endocrine neoplasias).
• reduction of the risk of duodenal ulcer recurrence.
2 DOSAGE AND ADMINISTRATION
2.1 RECOMMENDED DOSAGE
Table 1 shows the recommended dosage of Famotidine 20 mg and 40 mg
tablets in adults and pediatric patients weighing 40 kg or greater
with normal renal
function. The use of Famotidine 20 mg and 40 mg tablets is not
recommended for use in
pediatric patients weighing less than 40 kg because the lowest
available strength (20
mg) exceeds the recommended dose for these patients. Use another
famotidine
formulation for pediatric patients weighing less than 40 kg.
TABLE 1: RECOMMENDED DOSAGE AND DURATION OF FAMOTIDINE TABLETS IN
ADULTS
AND PEDIATRIC PATIENTS 40KG AND GREATER WITH NORMAL RENAL FUNCTION
INDICATION RECOMMENDED DOSAGE RECOMMENDED
DURATION ACTIVE DUODENAL ULCER (DU)
40mg once daily; or 20mg
twice daily
Up to 8 weeks ACTIVE GASTRIC ULCER
40mg once daily
Up to 8 weeks SYMPTOMATIC NON-EROSIVE
GERD
20mg twice daily
Up to 6 weeks EROSIVE ESOPHAGITIS DIAGNOSED
BY ENDOSCOPY
20mg tiwce daily; or 40mg
twice daily
Up to 12 weeks PATHOLOGICAL HYPERSECRETORY
CONDITIONS
Starting dosage: 20mg
every 6 hours;
adjust dosage to individual
patient needs
Maximum dosage 160mg
every 6 hours
As clinically indicated
a
b,c
c
a
D
c REDUCTION OF THE RISK OF DU
RECURRENCE
20mg once daily
1 year
 or as clinidally
indicated
aBoth dosages demonstrated effectiveness in clinical trials [see
Clinical Studies (14)].
bIn clinical trials, the majority of patients hea