CEFACLOR capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Carlsbad Technology, Inc.

INN (International Name):

CEFACLOR

Composition:

CEFACLOR ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Cefaclor Capsule USP 250 mg (blue cap and pink body hard gelatin capsule containing white to slightly yellowish powder imprinted with ”KRC” on both capsule cap and capsule body) contains cefaclor USP (monohydrate) equivalent to 250 mg anhydrous cefaclor. Bottle of 30     NDC 61442-171-30 Bottle of 100   NDC 61442-171-01 Bottle of 500   NDC 61442-171-05 Cefaclor Capsule USP 500 mg (blue cap and orange body hard gelatin capsule containing white to slightly yellowish powder imprinted with “KRC500” on both capsule cap and capsule body) contains cefaclor USP (monohydrate) equivalent to 500 mg anhydrous cefaclor. Bottle of 30     NDC 61442-172-30 Bottle of 100   NDC 61442-172-01 Bottle of 500   NDC 61442-172-05 Store at 20℃ - 25℃ (68℃ to 77℉) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFACLOR- CEFACLOR CAPSULE
CARLSBAD TECHNOLOGY, INC.
----------
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 late