CEPHALEXIN powder, for suspension

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

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 250 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, Pr

Product summary:

Cephalexin for oral suspension* USP (a cherry mixed fruit flavored formula)— 250 mg/5 mL: bottles of 100 mL (NDC 63187-205-00) 250 mg/5 mL: bottles of 200 mL (NDC 63187-205-20) Directions for mixing are included on the label. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Shake well before using. Keep tightly closed. * After mixing, store in refrigerator. May be kept for 14 days without significant loss of potency.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN POWDER, FOR SUSPENSION
PROFICIENT RX LP
----------
CEPHALEXIN FOR ORAL SUSPENSION USP, 250 MG/5 ML
RX ONLY
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
16
17
3
4
2
Lake, gelatin, pharmaceutical glaze modified in SD-45, silicon dioxide
or
carboxymethylcellulose sodium, sodium lauryl sulf