The active ingredient in PEPCID* (famotidine) Injection Premixed and PEPCID (famotidine) Injection is a histamine H2-receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4- thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C₈H₁₅N₇O₂S₃ and its molecular weight is 337.43. Its structural formula is:

Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.

PEPCID Injection (famotidine injection) Premixed is supplied as a sterile solution, for intravenous use only, in plastic single dose containers. Each 50 mL of the premixed, iso-osmotic intravenous injection contains 20 mg famotidine, USP, and the following inactive ingredients: L-aspartic acid 6.8 mg, sodium chloride, USP, 450 mg, and Water for Injection. The pH ranges from 5.7 to 6.4 and may have been adjusted with additional L-aspartic acid or with sodium hydroxide.

The plastic container is fabricated from a specially designed multilayer plastic (PL 2501). Solutions are in contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

PEPCID (famotidine) Injection is supplied as a sterile concentrated solution for intravenous injection. Each mL of the solution contains 10 mg of famotidine and the following inactive ingredients: L-aspartic acid 4 mg, mannitol 20 mg, and Water for Injection q.s. 1 mL. The multidose injection also contains benzyl alcohol 0.9% added as preservative.

Last reviewed on RxList: 11/30/2007
This monograph has been modified to include the generic and brand name in many instances.