CEPHALEXIN capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

DIRECT RX

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 Escherichia

Περίληψη προϊόντος:

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 100 NDC 42043-140-01 Bottles of 500 NDC 42043-140-05 The 500 mg capsules are light green opaque body imprinted with “KLX” in black ink and green opaque cap imprinted with “141” in black ink. They are available as follows: Bottles of 100 NDC 42043-141-01 Bottles of 500 NDC 42043-141-05 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CEPHALEXIN- CEPHALEXIN CAPSULE
DIRECT RX
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CEPHALEXIN
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 C16H17N3O4S•H2O and the molecular weight
is 365.41.
Cephalexin has the following structural formula:
[mklw]
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.
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 mcg/mL respectively were obtained at 1
hour. Measurable levels were
present 6 hours after administration. Cephalexin is excreted in the
urine by glomerular filtration and
tubular secretion