Drug Catalog - Product Detail
CLINDAMYCIN HCL 300MG CAPS 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 42571-0252-01 | MICRO LABORATORIES | 100 | 300MG | CAPSULE |
PACKAGE FILES
Generic Name
CLINDAMYCIN HYDROCHLORIDE
Substance Name
CLINDAMYCIN HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207402
Description
DESCRIPTION Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP contain clindamycin hydrochloride USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water. For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint ™ SW-0012 White Ink. Composition of imprinting ink [TekPrint ™ SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo - α -D- galacto -octopyranoside monohydrochloride.
How Supplied
HOW SUPPLIED Clindamycin hydrochloride capsules USP is available in the following strengths, colors and sizes: 75 mg- Green transparent (body)/ Green transparent (cap), size 3 hard gelatin capsule printed with “M” on cap and “40” on body filled with white to off white granular powder. Bottles of 100 NDC 42571-250-01 Carton of 90(9×10's) Unit-dose Capsules NDC 42571-250-67 150 mg- Green transparent (body)/ light blue opaque (cap), size 2 hard gelatin capsule printed with “M” on cap and “41” on body filled with white to off white granular powder. Bottles of 100 NDC 42571-251-01 Bottles of 500 � NDC 42571-251-05 Bottles of 1000 NDC 42571-251-10 Carton of 80(8×10's) Unit-dose Capsules NDC 42571-251-23 300 mg- Light blue opaque (body)/ light blue opaque (cap), size 0 hard gelatin capsule printed with “M” on cap and “42” on body filled with white to off white granular powder. Bottles of 100 NDC 42571-252-01 Bottles of 500 NDC 42571-252-05 Bottles of 1000 NDC 42571-252-10 Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP]. Rx only
Indications & Usage
INDICATIONS AND USAGE Clindamycin 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 BOXED WARNING , 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 capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION If significant diarrhea occurs during therapy, this antibacterial drug should be discontinued (See BOXED WARNING ). Administer clindamycin hydrochloride capsules, USP with a full glass of water (6 to 8 ounces, approximately 200 to 250 mL) and at least 30 minutes before lying down to reduce the potential for esophageal irritation (See ADVERSE REACTIONS ). Adults: Serious infections - 150 to 300 mg every 6 hours. More severe infections - 300 to 450 mg every 6 hours. Pediatric Patients (who are able to swallow capsules): Serious infections - 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections - 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses. Clindamycin should be dosed based on total body weight regardless of obesity. Clindamycin hydrochloride Capsules are not suitable for pediatric patients who are unable to swallow them whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use the clindamycin palmitate oral solution in some cases. Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE ® Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules. In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.