国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
DICLOXACILLIN SODIUM (UNII: 4HZT2V9KX0) (DICLOXACILLIN - UNII:COF19H7WBK)
Sandoz Inc
DICLOXACILLIN SODIUM
DICLOXACILLIN 250 mg
ORAL
PRESCRIPTION DRUG
The penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. Cultures and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Testing ). The penicillinase-resistant penicillins may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus , therapy should not be continued with a penicillinase-resistant penicillin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, d
Dicloxacillin sodium capsules, USP 250 mg Light blue opaque cap/body capsule printed with GG854 containing dicloxacillin sodium, USP equivalent to 250 mg dicloxacillin. Bottle of 100 capsules NDC 0781-2248-01 500 mg Light blue opaque cap/body capsule printed with GG855 containing dicloxacillin sodium, USP equivalent to 500 mg dicloxacillin. Bottle of 100 capsules NDC 0781-2258-01 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN Revised: November 2020 46276383 Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540
Abbreviated New Drug Application
DICLOXACILLIN SODIUM- DICLOXACILLIN SODIUM CAPSULE SANDOZ INC ---------- DICLOXACILLIN SODIUM CAPSULES, USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase-resistant, acid resistant semisynthetic penicillin suitable for oral administration. Dicloxacillin sodium, USP is chemically designated as 4-Thia-1-azabicyclo [3.2.0]heptane-2- carboxylic acid, 6-[[[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolyl]-carbonyl]-amino]-3,3-dimethyl-7- oxo-, monosodium salt, monohydrate, [2S-(2α5α,6β)] and has the following structural formula: MOLECULAR FORMULA: C H CL N NAO S ·H O MOLECULAR WEIGHT: 510.32 Each capsule for oral administration contains dicloxacillin sodium, USP equivalent to 250 or 500 mg of dicloxacillin. The inactive ingredient is magnesium stearate. The capsule shells contain FD&C Blue 1, titanium dioxide, and gelatin. The capsule ink contains shellac, propylene glycol, black iron oxide, ammonium hydroxide and potassium hydroxide CLINICAL PHARMACOLOGY MICROBIOLOGY Penicillinase-resistant penicillins exert a bactericidal action against penicillin-susceptible microorganisms during the state of active multiplication. All penicillins inhibit the biosynthesis of the bacterial cell wall. Dicloxacillin sodium has been shown to be active against most isolates of the following CAS – 13412 64-1 19 16 2 3 5 2 microorganisms, both _in vitro_ and in clinical infections as described in the INDICATIONS AND USAGE section. _AEROBIC GRAM-POSITIVE MICROORGANISMS:_ _Staphylococcus_ spp. SUSCEPTIBILITY TESTING For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA fo 阅读完整的文件