CEFACLOR capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

CEFACLOR (UNII: 69K7K19H4L) (CEFACLOR ANHYDROUS - UNII:3Z6FS3IK0K)

Предлага се от:

A-S Medication Solutions

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsule and other antibacterial drugs, Cefaclor Capsule 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.

Каталог на резюме:

Product: 50090-1602 NDC: 50090-1602-2 21 CAPSULE in a BOTTLE NDC: 50090-1602-0 30 CAPSULE in a BOTTLE

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CEFACLOR- CEFACLOR CAPSULE
A-S MEDICATION SOLUTIONS
----------
CEFACLOR CAPSULES USP
Rx Only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Cefaclor Capsule and other antibacterial drugs, Cefaclor Capsules USP
should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused
by bacteria.
DESCRIPTION
Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral
administration. It is
chemically designated as
3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic
acid monohydrate. The chemical formula for cefaclor is C
H
ClN O S•H O and the
molecular weight is 385.82.
Each 250-mg capsule contains cefaclor monohydrate equivalent to 250 mg
(0.68 mmol)
of anhydrous cefaclor and inactive ingredients: magnesium stearate,
sodium starch
glycolate, lactose monohydrate, talc. The 250 mg capsule shell
contains gelatin, titanium
dioxide, FD & C Blue No. 1, FD & C Red No. 3, and imprinting ink
components: shellac,
strong ammonia solution, potassium hydroxide, black iron oxide,
.dehydrated alcohol,
isopropyl alcohol, butyl alcohol and propylene glycol.
Each 500-mg capsule contains cefaclor monohydrate equivalent to 500 mg
(1.36 mmol)
of anhydrous cefaclor and inactive ingredients: magnesium stearate,
sodium starch
glycolate, lactose monohydrate, talc. The 500 mg capsule shell
contains gelatin, titanium
dioxide, FD & C Blue No. 1, FD & C Red No. 3, FD & C Yellow No. 6, FD
& C Red No. 40,
and imprinting ink components: shellac, strong ammonia solution,
titanium dioxide, FD &
C Blue No. 1 aluminum lake, dehydrated alcohol, isopropyl alcohol,
butyl alcohol and
propylene glycol.
CLINICAL PHARMACOLOGY
Cefaclor is well absorbed after oral administration to fasting
subjects. Total absorption is
the same whether the drug is given with or without food; however, when
it is taken with
food, the peak concentration achieved is 50% to 75% of that observed
when the drug is
administered to fasting subjects and generally appears from three
fourths to 1 hour
later