DICLOXACILLIN SODIUM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DICLOXACILLIN SODIUM (UNII: 4HZT2V9KX0) (DICLOXACILLIN - UNII:COF19H7WBK)

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

DICLOXACILLIN SODIUM

Composition:

DICLOXACILLIN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Dicloxacillin sodium capsules USP are available as follows: 250 mg: Each capsule contains dicloxacillin sodium monohydrate equivalent to 250 mg dicloxacillin, with green colored cap and light green colored body, imprinted "TEVA" on the cap and “3123” on the body, available in bottles of 100. 500 mg: Each capsule contains dicloxacillin sodium monohydrate equivalent to 500 mg dicloxacillin, with green colored cap and light green colored body, imprinted "TEVA" on the cap and “3125” on the body, available in bottles of 100. 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). References Available Upon Request. Manufactured In Canada By: TEVA CANADA LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. E 10/2010 Repacked by: H.J. Harkins Company, Inc. 513 Sandydale Drive Nipomo, CA 93444

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICLOXACILLIN SODIUM - DICLOXACILLIN SODIUM CAPSULE
H.J. HARKINS COMPANY, INC.
----------
DICLOXACILLIN SODIUM CAPSULES USP
3123
3125
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 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 may be represented as follows:
C
H Cl
N NaO S·H O MW 510.32
INACTIVE INGREDIENTS
Capsules
Magnesium Stearate.
Capsule Shell and Print Constituents
D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2
Aluminum Lake,
FD&C Red #40 Aluminum Lake, Gelatin, Pharmaceutical Glaze, Silicon
Dioxide, Sodium Lauryl
Sulfate, Synthetic Black Iron Oxide, Titanium Dioxide and may contain
Carboxymethylcellulose Sodium
and/or Propylene Glycol.
CLINICAL PHARMACOLOGY
MICROBIOLOGY
Dicloxacillin exerts a bactericidal action against
penicillin-susceptible microorganisms during the state
of active multiplication. All penicillins inhibit the biosynthesis of
the bacterial cell wall.
The drugs in this class are highly resistant to inactivation by
staphylococcal penicillinase and are active
19
16
2
3
5
2
against penicillinase-producing and nonpenicillinase-producing strains
of _Staphylococcus aureus. _The
penicillinase- resistant penicillins are active _in vitro _against a
variety of other bacteria.
SUSCEPTIBILITY PLATE TESTING
Quantitative methods of susceptibility testing that require
measurements of zone diameters or minimal
inhibitory concentrations (