PEPCID Film-coated tablet (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health Americas Inc.

Λέξεις κλειδιά

0187-4420 0187-4440

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

PEPCID tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux ...

2. Dosage and Administration

2.1 Recommended Dosage Table 1 shows the recommended dosage of PEPCID 20 mg and 40 mg tablets in adult and pediatric patients weighing 40 kg and greater with normal renal function. The use of PEPCID 20 ...

3. Dosage Forms and Strengths

20 mg tablets: round, white to off-white film-coated tablets coded MP 973 on one side and the other side plain. 40 mg tablets: round, white to off-white film-coated tablets coded MP 974 on one side and ...

4. Contraindications

PEPCID 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

The safety and effectiveness of PEPCID have been established in pediatric patients for the treatment of peptic ulcer disease (i.e., duodenal ulcer, gastric ulcer) and GERD (i.e., symptomatic nonerosive ...

8.5. Geriatric Use

Of the 1442 PEPCID-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 PEPCID 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) tablets is a histamine-2 (H2) receptor antagonist. Famotidine is N'-3[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical ...

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

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

14.1 Active Duodenal Ulcer In a U.S. multicenter, double-blind trial in adult outpatients with endoscopically confirmed duodenal ulcer (DU), orally administered PEPCID was compared to placebo. As shown ...

16.1. How Supplied

PEPCID (famotidine) tablets are supplied as follows: NDC Strength Quantity Description 0187-4420-30 20 mg unit of use bottles of 30 round, white to off-white film-coated tablets coded with MP 973 on ...

16.2. Storage and Handling

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 USP tight, light-resistant container.

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, ...