CEFACLOR capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Bryant Ranch Prepack

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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. Cefaclo

Огляд продуктів:

NDC: 63629-1007-3: 30 Capsules in a BOTTLE

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

CEFACLOR- CEFACLOR CAPSULE
BRYANT RANCH PREPACK
----------
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. Fo