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:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible 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 establishing 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 Escherichia c

Product summary:

Cephalexin capsules, USP are available in: The 250 mg capsules are a white to off white powder filled into size 2 capsules (white opaque cap and white opaque body) that are imprinted with 801 on the cap in black. They are available as follows: The 500 mg capsules are a white to off white powder filled into size 0 capsules (white opaque cap and white opaque body) that are imprinted with 802 on the cap in black. They are available as follows: NDC: 55700-009-10  Bottles of 10 NDC: 55700-009-14  Bottles of 14 NDC: 55700-009-20  Bottles of 20 NDC: 55700-009-28  Bottles of 28 NDC: 55700-009-30  Bottles of 30 NDC: 55700-009-40  Bottles of 40 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. REFERENCES Literature revised May 2011 Manufactured By            Manufacturer For Belcher Pharmaceuticals, LLC.        Virtus Pharmaceuticals, LLC Largo, Florida 33773                       Tampa, FL 33619 May 2011                L02I-AA                      R-1105

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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, 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 anhydrous lactose, gelatin, magnesium stearate,
talc and titanium dioxide. The
capsules are imprinted with edible ink containing black iron oxide.
CLINICAL PHARMACOLOGY
HUMAN PHARMACOLOGY
Cephalexin is acid stable and may be given without regard to meals. It
is rapidly absorbed after oral
administration. Following doses of 250 mg, 500 mg, and 1 g, average
peak serum levels of
approximately 9, 18, and 32 µg/mL respectively were obtained at 1
hour. Measurable levels were
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