Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)
Zydus Lifesciences Limited
ORAL
PRESCRIPTION DRUG
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,
Clindamycin hydrochloride capsules, USP are available in the following strengths, colors and sizes: Clindamycin hydrochloride capsules, USP equivalent to 75 mg of clindamycin are white to off white granular powder filled in size '2' hard gelatin capsules with blue colored cap printed with "Z-89" in black ink and blue colored body printed with "75 mg" in black ink and are supplied as follows. NDC 70771-1136-8 in bottles of 16 capsules NDC 70771-1136-1 in bottles of 100 capsules NDC 70771-1136-5 in bottles of 500 capsules Clindamycin hydrochloride capsules, USP equivalent to 150 mg of clindamycin are white to off white granular powder filled in size '1' hard gelatin capsules with blue colored cap printed with "Z-90" in black ink and blue colored body printed with "150 mg" in black ink and are supplied as follows. NDC 70771-1137-8 in bottles of 16 capsules NDC 70771-1137-1 in bottles of 100 capsules NDC 70771-1137-5 in bottles of 500 capsules Clindamycin hydrochloride capsules, USP equivalent to 300 mg of clindamycin are white to off white granular powder filled in size '0' hard gelatin capsules with blue colored cap printed with "Z-91" in black ink and blue colored body printed with "300 mg" in black ink and are supplied as follows. NDC 70771-1183-8 in bottles of 16 capsules NDC 70771-1183-1 in bottles of 100 capsules NDC 70771-1183-5 in bottles of 500 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
CLINDAMYCIN HYDROCHLORIDE - CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED ZYDUS LIFESCIENCES LIMITED ---------- CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1136-1 in bottle of 100 Capsules Clindamycin Hydrochloride Capsules USP, 75 mg Rx only 100 Capsules NDC 70771-1137-1 in bottle of 100 Capsules Clindamycin Hydrochloride Capsules USP, 150 mg Rx only 100 Capsules NDC 70771-1183-1 in bottle of 100 Capsules Clindamycin Hydrochloride Capsules USP, 300 mg Rx only 100 Capsules CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride capsule, gelatin coated PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1136 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN 75 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PRODUCT CHARACTERISTICS COLOR BLUE (BLUE (CAP)) , BLUE (BLUE (BODY)) SCORE no score SHAPE CAPSULE (CAPSULE) SIZE 18mm FLAVOR IMPRINT CODE Z ;89 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70771- 1136-8 16 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2017 2 NDC:70771- 1136-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2017 3 NDC:70771- 1136-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2017 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA065217 11/17/2017 CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride capsule, gelatin coated PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1137 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT Прочитать полный документ