Cimetidine

Product manufactured by Stat Rx Usa Llc

Application Nr Approved Date Route Status External Links
ANDA074246 1994-05-17 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Cimetidine Tablets Are Indicated In: (1) Short-Term Treatment Of Active Duodenal Ulcer. Most Patients Heal Within 4 Weeks And There Is Rarely Reason To Use Cimetidine At Full Dosage For Longer Than 6 To 8 Weeks (see Dosage And Administration: Duodenal Ulcer). Concomitant Antacids Should Be Given As Needed For Relief Of Pain. However, Simultaneous Administration Of Oral Cimetidine And Antacids Is Not Recommended, Since Antacids Have Been Reported To Interfere With The Absorption Of Oral Cimetidine. (2) Maintenance Therapy For Duodenal Ulcer Patients At Reduced Dosage After Healing Of Active Ulcer. Patients Have Been Maintained On Continued Treatment With Cimetidine 400 Mg H.s. For Periods Of Up To Five Years. (3) Short-Term Treatment Of Active Benign Gastric Ulcer. There Is No Information Concerning Usefulness Of Treatment Periods Of Longer Than 8 Weeks. (4) Erosive Gastroesophageal Reflux (gerd). Erosive Esophagitis Diagnosed By Endoscopy. Treatment Is Indicated For 12 Weeks For Healing Of Lesions And Control Of Symptoms. The Use Of Cimetidine Beyond 12 Weeks Has Not Been Established (see Dosage And Administration: Gerd). (5) The Treatment Of Pathological Hypersecretory Conditions (i.e., Zollinger-Ellison Syndrome, Systemic Mastocytosis, Multiple Endocrine Adenomas).

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lecithin LECITHIN Unresolved
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Povidones POVIDONES Unresolved
8. Sodium Alginate SODIUM ALGINATE Unresolved BC-Boiler compound , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
11. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
12. Vanillin VANILLIN Molecular GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cimetidine CIMETIDINE ZINC18115268

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