CEFACLOR capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Hikma Pharmaceuticals USA Inc.

INN (Διεθνής Όνομα):

CEFACLOR

Σύνθεση:

CEFACLOR ANHYDROUS 250 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 Lower respiratory tract infections , including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes 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 ski

Περίληψη προϊόντος:

Cefaclor Capsules, USP 250 mg: opaque purple and white hard gelatin capsules imprinted with “West-ward 985” in bottles of 15 and bottles of 100. Cefaclor Capsules, USP 500 mg: opaque purple and gray hard gelatin capsules imprinted with “West-ward 986” in bottles of 15 and bottles of 100. Cefaclor Capsules, USP 250 mg and 500 mg (Pack of 15’s and Pack of 100’s) are supplied with child-resistant closures. Store bottles at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP using a child-resistant closure. Distributed by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 USA Manufactured by: Jazeera Pharmaceutical Industries (JPI) Al- Kharj Road P. O. Box 106229 Riyadh 11666 Saudi Arabia An Affiliate of: HIKMA Pharmaceuticals P.O. Box 182400 Amman 11118 – Jordan Revised November 2020

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CEFACLOR- CEFACLOR CAPSULE
HIKMA PHARMACEUTICALS USA INC.
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CEFACLOR CAPSULES, USP
REV. 11/2020
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefaclor and
other antibacterial drugs, cefaclor should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Cefaclor Capsules, USP are 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 molecular formula for cefaclor is C
H ClN O S•H O and the molecular weight is
385.82.
Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68
mmol) or 500 mg (1.36 mmol)
anhydrous cefaclor. The capsules also contain black iron oxide,
croscarmellose sodium, FD & C Red
No.3, FD & C Blue No.2, gelatin, magnesium stearate, corn starch, and
titanium dioxide.
The color of the capsule powder is white to off white.
Cefaclor Capsules, USP are 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 molecular formula for cefaclor is C15H14ClN3O4S•H2O
and the molecular weight
is 385.82.
Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68
mmol) or 500 mg (1.36 mmol)
anhydrous cefaclor. The capsules also contain black iron oxide,
croscarmellose sodium, FD & C Red
No.3, FD & C Blue No.2, gelatin, magnesium stearate, corn starch, and
titanium dioxide.
The color of the capsule powder is white to off white.
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 administration of 25