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

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: 100-mL Bottles                        200-mL Bottles                        The 250 mg per 5 mL oral suspension* is available as follows: 100-mL Bottles                       NDC 55700-656-00 200-mL Bottles                        * 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 giv