Clindamycin Hydrochloride

Product manufactured by Avpak

Application Nr Approved Date Route Status External Links
ANDA065442 2009-08-26 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Clindamycin Hydrochloride Capsules, Usp Are Indicated In The Treatment Of Serious Infections Caused By Susceptible Anaerobic Bacteria. Clindamycin Hydrochloride Capsules, Usp Are Also Indicated In The Treatment Of Seri­ous Infections Due To Susceptible Strains Of Streptococci, Pneumococci, And Staphylococci. Its Use Should Be Reserved For Penicillin-Allergic Patients Or Other Patients For Whom, In The Judgment Of The Physician, A Penicillin Is Inappropriate. Because Of The Risk Of Colitis, As Described In The Warning Box, Before Selecting Clindamycin, The Physician Should Consider The Nature Of The Infection And The Suitability Of Less Toxic Alternatives (e.g., Erythromycin). Anaerobes: Serious Respiratory Tract Infections Such As Empyema, Anaerobic Pneumonitis, And Lung Abscess; Serious Skin And Soft Tissue Infections; Septicemia; Intra-Abdominal Infections Such As Peritonitis And Intra-Abdominal Abscess (typically Resulting From Anaerobic Organisms Resident In The Normal Gastroin­testinal Tract); Infections Of The Female Pelvis And Geni­tal Tract Such As Endometritis, Nongonococcal Tubo-Ovarian Abscess, Pelvic Cellulitis, And Postsurgical Vaginal Cuff Infection. Streptococci: Serious Respiratory Tract Infections; Seri­ous Skin And Soft Tissue Infections. Staphylococci: Serious Respiratory Tract Infections; Serious Skin And Soft Tissue Infections. Pneumococci: Serious Respiratory Tract Infections. Bacteriologic Studies Should Be Performed To Deter­mine The Causative Organisms And Their Susceptibility To Clindamycin. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Clindamycin Hydrochloride And Other Antibacterial Drugs, Clindamycin Hydrochloride Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacte­ria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Starch, Corn STARCH, CORN Unresolved
3. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clindamycin Hydrochloride CLINDAMYCIN HYDROCHLORIDE ZINC4038341