CEPHALEXIN capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

STAT Rx USA LLC

INN (Διεθνής Όνομα):

CEPHALEXIN

Σύνθεση:

CEPHALEXIN ANHYDROUS 500 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Cephalexin is 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 coli,

Περίληψη προϊόντος:

Cephalexin capsules USP 500 mg.  Capsule identification number and color: “TEVA” - “3147”, swedish orange cap and body. Available as follows: In bottles of  4 - NDC # 42549-565-04 In bottles of 10 - NDC # 42549-565-10 In bottles of 28 - NDC # 42549-565-28 In bottles of 30 - NDC # 42549-565-30 In bottles of 40 - NDC # 42549-565-40 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
STAT RX USA LLC
----------
CEPHALEXIN - 500 MG - CAPSULES
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cephalexin
capsules, cephalexin for oral suspension, cephalexin tablets, and
other antibacterial drugs, cephalexin
capsules, cephalexin for oral suspension, and cephalexin tablets
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 following structural formula:
C
H N O S•H O M.W. 365.41
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 (720
μmol) or 500 mg (1,439
μmol) of cephalexin.
INACTIVE INGREDIENTS: CAPSULES: magnesium stearate, silicon dioxide,
and sodium starch glycolate.
_Capsule Shell and Print Constituents: _black iron oxide, D&C Yellow
#10 Aluminum Lake, FD&C Blue
#1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum
Lake, gelatin,
pharmaceutical glaze modified in SD-45, silicon dioxide or
carboxymethylcellulose sodium, sodium
lauryl sulfate, titanium dioxide and may contain propylene gl