CEPHALEXIN capsule CEPHALEXIN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN - UNII:OBN7UDS42Y)

Available from:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

cephalexin

Composition:

250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules and cephalexin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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 eradicati

Product summary:

Cephalexin For Oral Suspension, USP is available in: The 125 mg per 5 mL oral suspension* is pink in color with a strawberry flavor and is available as follows: 100 mL Bottles NDC 63304-958-01 200 mL Bottles NDC 63304-958-02 The 250 mg per 5 mL oral suspension* is pink in color with a strawberry flavor and is available as follows: 100 mL Bottles NDC 63304-959-01 200 mL Bottles NDC 63304-959-02 * After mixing, store in a refrigerator. May be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed. Cephalexin Capsules, USP are available in: 250 mg dark green and white, size 2, printed “RX656” on both cap and body. (28s) NDC 63304-656-27 (100s) NDC 63304-656-01 (500s) NDC 63304-656-05 500 mg, dark green and light green, size 0, printed “RX657” on both cap and body. (28s) NDC 63304-657-27 (100s) NDC 63304-657-01 (500s) NDC 63304-657-05 The bottle packages contain desiccant. Dispense in tight, light-resistant container. Store at 20 – 25° C (68 – 77° F). (See USP Controlled Room Temperature).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN CAPSULE
CEPHALEXIN- CEPHALEXIN SUSPENSION
RANBAXY PHARMACEUTICALS INC.
----------
CEPHALEXIN CAPSULES, USP AND CEPHALEXIN FOR ORAL SUSPENSION, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cephalexin
capsules and cephalexin for oral suspension and other antibacterial
drugs, cephalexin capsules
and 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.
Each capsule for oral administration, contains cephalexin monohydrate
equivalent to 250 mg (720 µmol)
or 500 mg (1,439 µmol) of cephalexin.
In addition, each capsule contains the following inactive ingredients:
D&C Yellow No. 10, edible
printing ink with black iron oxide, FD&C Green No. 3, FD&C Yellow No.
6, gelatin, lactose
monohydrate, magnesium stearate and titanium dioxide.
Also, the 500 mg strength capsule contains FD&C Blue No.1.
Aft