Country: United States
Language: English
Source: NLM (National Library of Medicine)
DICLOXACILLIN SODIUM (UNII: 4HZT2V9KX0) (DICLOXACILLIN - UNII:COF19H7WBK)
AvKARE, Inc.
DICLOXACILLIN SODIUM
DICLOXACILLIN 500 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules USP and other antibacterial drugs, dicloxacillin sodium 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. Dicloxacillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organisms and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Plate Testing ) . Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal i
Dicloxacillin sodium capsules USP are available as follows: 250 mg: Each capsule contains dicloxacillin sodium monohydrate equivalent to 250 mg dicloxacillin (anhydrous), with green colored cap and light green colored body, imprinted "TEVA" on the cap and “3123” on the body. 500 mg: Each capsule contains dicloxacillin sodium monohydrate equivalent to 500 mg dicloxacillin (anhydrous), with green colored cap and light green colored body, imprinted "TEVA" on the cap and “3125” on the body, available in bottles of 100 (NDC 42291-216-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
DICLOXACILLIN SODIUM- DICLOXACILLIN SODIUM CAPSULE AVKARE, INC. ---------- DICLOXACILLIN SODIUM CAPSULES USP RX ONLY To reduce the development of drug resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules USP and other antibacterial drugs, dicloxacillin sodium capsules USP 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 a semisynthetic antibiotic substance which resists destruction by the enzyme penicillinase (beta - lactamase). It is monosodium (2 _S_,5 _R_,6 _R_)-6-[3-(2,6-dichlorophenyl)-5- methyl-4-isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylate monohydrate. Dicloxacillin is administered orally via capsule form or powder for reconstitution. Structurally, dicloxacillin sodium USP may be represented as follows: C H Cl N NaO S·H O MW 510.32 INACTIVE INGREDIENTS CLINICAL PHARMACOLOGY MICROBIOLOGY _Mechanism of Action_ 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. _Antibacterial Activity_ Dicloxacillin sodium has been shown to be active against most isolates of the following microorganisms, both _in vitro_ and in clinical infections as described in the INDICATIONS AND USAGE section. Gram-positive Bacteria _Staphylococcus_ spp. _Susceptibility Test Methods_ 19 16 2 3 5 2 Susceptibility of staphylococcal isolates to dicloxacillin may be inferred by testing penicillin and either oxacillin or cefoxitin . For staphylococcal isolates, penicillin susceptibility implies susceptibility to other β-lactam agents, and penicillin resistance implies resistance to penicillinase-labile penicillins. Resistance to oxacillin (or cefoxitin) implies resistance to all other β-lactam agents, except newer agents with activity against methicillin-resistant _Staphylococcus aureus_. Routine Read the complete document