CEPHALEXIN capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Bi-Coastal Pharma International LLC

INN（国際名）:

CEPHALEXIN

構図:

CEPHALEXIN ANHYDROUS 250 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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: Bottles of 100                                                    NDC 42582-211-10 Bottles of 500                                                    NDC 42582-211-18 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: Bottles of 100                                                    NDC 42582-212-10 Bottles of 500                                                    NDC 42582-212-18 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

認証ステータス:

Abbreviated New Drug Application

製品の特徴

CEPHALEXIN- CEPHALEXIN CAPSULE
BI-COASTAL PHARMA INTERNATIONAL LLC
----------
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.
16
17
3
4
2
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 present