CEFACLOR suspension

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

Cefaclor (UNII: 69K7K19H4L) (Cefaclor - UNII:69K7K19H4L)

Disponibbli minn:

Rebel Distributors Corp

INN (Isem Internazzjonali):

Cefaclor

Kompożizzjoni:

Cefaclor 250 mg in 5 mL

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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. 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 gene

Sommarju tal-prodott:

For Oral Suspension: 250 mg/5 mL, strawberry flavor † - (150-mL size) NDC 21695-782-15 †After mixing, store in a refrigerator. Shake well before using. Keep tightly closed. The mixture may be kept for 14 days without significant loss of potency. Discard unused portion after 14 days. Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from moisture.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

CEFACLOR- CEFACLOR SUSPENSION
REBEL DISTRIBUTORS CORP
----------
CEFACLOR CAPSULES USP AND CEFACLOR FOR ORAL SUSPENSION USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefaclor
Capsules and Cefaclor for Oral Suspension and other antibacterial
drugs, Cefaclor Capsules and
Cefaclor for Oral Suspension 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 capsule contains cefaclor monohydrate equivalent to 250 mg (0.68
mmol) or 500 mg (1.36 mmol)
anhydrous cefaclor. The capsules also contain colloidal silicon
dioxide, croscarmellose sodium, D&C
Yellow No. 10, D&C Red No. 28, edible printing ink, FD&C Blue No. 1,
FD&C Red No. 40, gelatin,
magnesium stearate, pregelatinized starch, sicomet black oxide and
titanium dioxide.
After mixing, each 5 mL of Cefaclor for Oral Suspension will contain
cefaclor monohydrate equivalent
to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375
mg (1.0 mmol) anhydrous
cefaclor. The suspensions also contain citric acid, colloidal silicon
dioxide, FD&C Red No. 40,
flavor, simethicone emulsion, sodium benzoate, sodium citrate,
sucrose, and xanthan gum.
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. It
has been reported that following
administration of 250 mg, 500 mg, and 1 g doses to fasting subjects,
average peak serum levels of
approximately 7,