Ranitidine

Product manufactured by Unit Dose Services

Approved Date Route External Links
2017-08-17 Oral Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ranitidine Tablets Usp Are 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 Twice Daily. Treatment Of Endoscopically Diagnosed Erosive Esophagitis. Symptomatic Relief Of Heartburn Commonly Occurs Within 24 Hours Of Therapy Initiation With Ranitidine 150 Mg 4 Times Daily. 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.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
3. Hypromelloses HYPROMELLOSES Unresolved
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
6. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 0 Total)

None

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