Application Nr Approved Date Route Status External Links
ANDA201821 2012-08-28 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Clindamycin Palmitate Hydrochloride For Oral Solution, Usp (pediatric) (clindamycin Palmitate Hcl) Is Indicated In The Treatment Of Serious Infections Caused By Susceptible Anaerobic Bacteria. Clindamycin Is 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. In Vitro Susceptibility Testing: A Standardized Disk Testing Procedure 2 Is Recommended For Determining Susceptibility Of Aerobic Bacteria To Clindamycin. A Description Is Contained In The Clindamycin Susceptibility Disk Insert. Using This Method, The Laboratory Can Designate Isolates As Resistant, Intermediate, Or Susceptible. Tube Or Agar Dilution Methods May Be Used For Both Anaerobic And Aerobic Bacteria. When The Directions In The Clindamycin Susceptibility Powder Insert Are Followed, An Mic (minimal Inhibitory Concentration) Of 1.6 Mcg/ml May Be Considered Susceptible; Mics Of 1.6 To 4.8 Mcg/ml May Be Considered Intermediate And Mics Greater Than 4.8 Mcg/ml May Be Considered Resistant. Clindamycin Susceptibility Disks 2 Mcg. See Package Insert For Use. Clindamycin Susceptibility Powder 20 Mg. See Package Insert For Use. For Anaerobic Bacteria The Minimal Inhibitory Concentration (mic) Of Clindamycin Can Be Determined By Agar Dilution And Broth Dilution (including Microdilution) Techniques. If Mics Are Not Determined Routinely, The Disk Broth Method Is Recommended For Routine Use. The Kirby-Bauer Disk Diffusion Method And Its Interpretive Standards Are Not Recommended For Anaerobes. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Clindamycin Palmitate Hydrochloride For Oral Solution (pediatric) And Other Antibacterial Drugs, Clindamycin Palmitate Hydrochloride For Oral Solution (pediatric) 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 (4 Total)

Name Structure Kind Function Status
1. Ethylparaben ETHYLPARABEN Molecular
2. Poloxamer 188 POLOXAMER 188 Unresolved
3. Simethicone SIMETHICONE Unresolved
4. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clindamycin Palmitate Hydrochloride