PEPCID for oral suspension for GERD

PEPCID for oral suspension for GERD

Pepcid - (Famotidine) for Oral Suspension

PEPCID is indicated in short-term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use PEPCID at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.

PEPCID is also indicated in maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year.

PEPCID is also indicated in short-term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.

PEPCID is also indicated in short-term treatment of gastroesophageal reflux disease (GERD). PEPCID is indicated for short-term treatment of patients with symptoms of GERD. PEPCID is also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy.

PEPCID is also indicated in treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas).

Important Safety Information for PEPCID® (Famotidine) for Oral Suspension

PEPCID® (Famotidine) for Oral Suspension is contraindicated in patients with a hypersensitivity to any component of these products. Cross sensitivity in this class of compounds has been observed. Therefore PEPCID should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.

It should be noted that symptomatic response to therapy with PEPCID does not preclude the presence of gastric malignancy.

Since CNS adverse events have been reported in patients with moderate or severe renal insufficiency, longer intervals between doses and lower doses of PEPCID may need to be used to adjust for the longer elimination half-life of famotidine.

The most common adverse events (>1% of patients) reported in clinical trials were headache, dizziness, constipation, and diarrhea.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for PEPCID.pdf

The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.

SAL-US-0057

Thank you for signing up. You will receive a confirmation email shortly./p>