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Basic Drug Info
Drug Name:Ranitidine Hydrochloride
Manufacturer:Sandoz Inc.
Other Info:06-2007M7292Sandoz Inc.Princeton, NJ 08540



Clinical Trials:


Indications and Usage

Ranitidine is indicated in:Short-term treatment of active duodenal ulcer.

Most patients heal within 4 weeks.

Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).Short-term treatment of active, benign gastric ulcer.

Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated.

Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers.

Placebo-controlled studies have been carried out for 1 year.Treatment of GERD.

Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg b.i.d.Treatment of endoscopically diagnosed erosive esophagitis.

Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg q.i.d.Maintenance of healing of erosive esophagitis.

Placebo-controlled trials have been carried out for 48 weeks.Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
Duodenal Ulcer -- A PEPTIC ULCER located in the DUODENUM.

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.

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.

Erosive esophagitis --

Heartburn -- Substernal pain or burning sensation, usually associated with regurgitation of gastric juice into the esophagus.

Contraindications
Ranitidine is contraindicated in patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS).
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Branded Drugs
The following US Branded drugs contain Ranitidine Hydrochloride


ZANTAC 150 -- GLAXOSMITHKLINE

ZANTAC 300 -- GLAXOSMITHKLINE

ZANTAC -- GLAXOSMITHKLINE

ZANTAC IN PLASTIC CONTAINER -- GLAXOSMITHKLINE

ZANTAC 25 -- GLAXOSMITHKLINE

ZANTAC 75 -- BOEHRINGER INGELHEIM PHARMACEUTICALS INC

RANITIDINE -- DR REDDYS LABORATORIES LTD

RANITIDINE -- GENPHARM INC

RANITIDINE -- IVAX PHARMACEUTICALS INC

RANITIDINE -- LEINER HEALTH PRODUCTS INC

RANITIDINE -- L PERRIGO CO

RANITIDINE -- RANBAXY LABORATORIES LTD

RANITIDINE -- RANBAXY PHARMACEUTICALS INC

RANITIDINE -- SANDOZ INC

RANITIDINE -- TORPHARM INC

RANITIDINE -- WATSON LABORATORIES INC

RANITIDINE -- WOCKHARDT LTD

ZANTAC 150 -- BOEHRINGER INGELHEIM

ZANTAC 75 -- BOEHRINGER INGELHEIM


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