CEPHALEXIN- cephalexin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cephalexin capsules USP are indicated for the treatment of the following infections when caused by susceptibile strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus 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 estabilishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes , and Moraxella catarrhalis Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis Genitourinary tract infections, including acute prostatitis, caused by Escher

Product summary:

Cephalexin Capsules USP are available in: The 250 mg capsules are white opaque body imprinted with “KLX” in black ink and green opaque cap imprinted with “140” in black ink. They are available as follows: Bottles of 14 NDC 63187-699-14 Bottles of 20 NDC 63187-699-20 Bottles of 21 NDC 63187-699-21 Bottles of 28 NDC 63187-699-28 Bottles of 30 NDC 63187-699-30 Bottles of 40 NDC 63187-699-40 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 CAPSULE
PROFICIENT RX LP
----------
CEPHALEXIN CAPSULES, USP
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
CEPHALEXIN AND OTHER ANTIBACTERIAL DRUGS, CEPHALEXIN SHOULD BE USED
ONLY TO TREAT OR PREVENT
INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY
BACTERIA.
DESCRIPTION
Cephalexin capsules 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 contains cephalexin monohydrate equivalent to 250 mg or
500 mg of cephalexin. The
capsules also contain the
following inactive ingredients: croscarmellose sodium, D&C Yellow No.
10, FD&C Blue No.1,
FD&C Yellow No. 6, gelatin, magnesium stearate, microcrystalline
cellulose, titanium dioxide. Ink
constituents are: black iron oxide, butyl alcohol, dehydrated alcohol,
isopropyl alcohol, potassium
hydroxide, propylene glycol, shellac and strong ammonia solution.
CLINICAL PHARMACOLOGY
HUMAN PHARMACOLOGY
Cephalexin is acid stable and may be given without regard to meals. It
is rapidly absorbed after oral
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