PEPCID Oral suspension (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Salix Pharmaceuticals, Inc

Λέξεις κλειδιά

65649-211

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1. Indications and Usage

PEPCID for oral suspension is indicated in adults for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis ...

2. Dosage and Administration

2.1 Recommended Dosage in Adults The recommended dosage and duration of PEPCID for oral suspension in adults with normal renal function is shown in Table 1. Table 1. Recommended Dosage and Duration ...

3. Dosage Forms and Strengths

For Oral Suspension: 400 mg as a white to off-white powder. When constituted as directed, PEPCID suspension is a smooth, mobile, off-white, homogeneous suspension with a cherry-banana-mint flavor, containing ...

4. Contraindications

PEPCID for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H2) receptor antagonists.

5. Warnings and Precautions

5.1 Central Nervous System Adverse Reactions Central nervous system (CNS) adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy, have been ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of famotidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Drugs Dependent on Gastric pH for Absorption Famotidine can reduce the absorption of other drugs, due to its effect on reducing intragastric acidity, leading to loss of efficacy of the concomitant ...

8.1. Pregnancy

Risk Summary Available data with H2-receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal ...

8.2. Lactation

Risk Summary There are limited data available on the presence of famotidine in human breast milk. There were no effects on the breastfed infant. There are no data on famotidine effects on milk production. ...

8.4. Pediatric Use

Peptic Ulcer Disease and GERD With or Without Esophagitis and Ulcerations Pediatric Patients One Year to Less than 17 Years of Age The safety and effectiveness of PEPCID for oral suspension have been established ...

8.5. Geriatric Use

Of the 1442 famotidine-treated patients in clinical studies, approximately 10% were 65 and older. In these studies, no overall differences in safety or effectiveness were observed between elderly and younger ...

8.6. Renal Impairment

CNS adverse reactions and prolonged QT intervals have been reported in patients with moderate and severe renal impairment [see Warnings and Precautions (5.1)]. The clearance of famotidine is reduced ...

10. Overdosage

The types of adverse reactions in overdosage of famotidine are similar to the adverse reactions encountered with use of recommended dosages [see Adverse Reactions (6.1)]. In the event of overdosage, ...

11. Description

The active ingredient in PEPCID (famotidine) for oral suspension is a histamine-2 (H2) receptor antagonist. Famotidine is N'-3[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. ...

12.1. Mechanism of Action

Famotidine is a competitive inhibitor of histamine-2 (H2) receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration ...

12.2. Pharmacodynamics

Adults Famotidine inhibited both basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration of famotidine, the onset of the antisecretory ...

12.3. Pharmacokinetics

Absorption Famotidine is incompletely absorbed. The bioavailability of oral doses is 40 to 45%. Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenic potential of famotidine was assessed in a 106-week oral carcinogenicity study in rats and a 92-week oral carcinogenicity study in mice. In the 106-week study in rats and the 92-week study ...

14. Clinical Studies

The safety and effectiveness of PEPCID for oral suspension have been established based on adequate and well-controlled studies of another oral famotidine product. The following is a summary of the efficacy ...

16.1. How Supplied

PEPCID (famotidine) for oral suspension is supplied as follows: NDC Strength Quantity Description 0006-3538-92 40 mg Bottle white to off-white powder. When constituted as directed, PEPCID suspension ...

16.2. Storage and Handling

Store PEPCID for oral suspension dry powder and constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing. Discard ...

17. Patient Counseling Information

Central Nervous System (CNS) Adverse Reactions Advise elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions, including confusion, delirium, hallucinations, ...