CEPHALEXIN- cephalexin for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 250 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by S. pneumoniae and S. pyogenes . (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to S. pneumoniae, H. influenzae , staphylococci, streptococci, and M. catarrhalis . Skin and skin structure infections caused by staphylococci and/or streptococci. Bone infections caused by staphylococci and/or P. mirabilis . Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and

Product summary:

Cephalexin for Oral Suspension, USP, is available in: The 125 mg per 5 mL oral suspension* is available as follows: The 250 mg per 5 mL oral suspension* is available as follows: 55700-149-00 ———————————————————————————————————— * After mixing, store in a refrigerator. May be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed. Prior to mixing, store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN FOR SUSPENSION
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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CEPHALEXIN FOR ORAL SUSPENSION USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cephalexin for
oral suspension and other antibacterial drugs, cephalexin for oral
suspension should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by bacteria.
DESCRIPTION
Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended
for oral administration. It is 7- (D-
α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid
monohydrate. Cephalexin has the
molecular formula C
H N O S • H O and the molecular weight is 365.41.
Cephalexin has the following structural formula:
The nucleus of cephalexin is related to that of other cephalosporin
antibiotics. The compound is a
zwitterion; i.e., the molecule contains both a basic and an acidic
group. The isoelectric point of
cephalexin in water is approximately 4.5 to 5.
The crystalline form of cephalexin which is available is a
monohydrate. It is a white crystalline solid
having a bitter taste. Solubility in water is low at room temperature;
1 or 2 mg/mL may be dissolved
readily, but higher concentrations are obtained with increasing
difficulty.
The cephalosporins differ from penicillins in the structure of the
bicyclic ring system.
Cephalexin has a D-phenylglycyl group as substituent at the 7-amino
position and an unsubstituted
methyl group at the 3-position.
Cephalexin for Oral Suspension, USP, is a pink colored powder forming
pink colored suspension on
constitution. After mixing, each 5 mL of cephalexin for oral
suspension, will contain cephalexin USP
equivalent to 125 mg (360 µmol) or 250 mg (720 µmol) of anhydrous
cephalexin. The suspension also
contains the following inactive ingredients: colloidal silicon
dioxide, FD&C Red No. 40, sodium
benzoate, strawberry flavor, sucrose, xanthan gum.
CLINICAL PHARMACOLOGY
_Human Pharmacology _– Cephalexin is acid stable and may be gi