CEFACLOR capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFACLOR (UNII: 69K7K19H4L) (CEFACLOR - UNII:69K7K19H4L)

Available from:

Alvogen, Inc.

INN (International Name):

CEFACLOR

Composition:

CEFACLOR 250 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFACLOR - CEFACLOR CAPSULE
ALVOGEN, INC.
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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.
Following a