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Basic Drug Info
Drug Name:PEPCID
Manufacturer:Salix Pharmaceuticals, Inc
Other Info:



Clinical Trials:


Indications and Usage

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.

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.

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.

Short-term treatment of gastroesophageal reflux disease (GERD).

PEPCID is indicated for short-term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

PEPCID is also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
Duodenal Ulcer -- A PEPTIC ULCER located in the DUODENUM.

Ulcer -- A lesion on the surface of the skin or a mucous surface, produced by the sloughing of inflammatory necrotic tissue.

Gastroesophageal reflux disease -- Retrograde flow of gastric juice (GASTRIC ACID) and/or duodenal contents (BILE ACIDS; PANCREATIC JUICE) into the distal ESOPHAGUS, commonly due to incompetence of the LOWER ESOPHAGEAL SPHINCTER. Gastric regurgitation is an extension of this process with retrograde flow into the PHARYNX or MOUTH.

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Esophagitis -- INFLAMMATION, acute or chronic, of the ESOPHAGUS caused by BACTERIA, chemicals, or TRAUMA.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Zollinger-Ellison syndrome -- A syndrome that is characterized by the triad of severe PEPTIC ULCER, hypersecretion of GASTRIC ACID, and GASTRIN-producing tumors of the PANCREAS or other tissue (GASTRINOMA). This syndrome may be sporadic or be associated with MULTIPLE ENDOCRINE NEOPLASIA TYPE 1.

Multiple Endocrine Neoplasia -- group of specific, familial syndromes characterized by simultaneous neoplastic transformation of multiple endocrine tissues, typically the parathyroid glands, pancreatic islets, and anterior pituitary.

Contraindications

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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.


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