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:

Rebel Distributors Corp

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 125 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cephalexin for Oral Suspension, USP 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 for Oral Suspension, USP 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

Product summary:

Cephalexin for Oral Suspension, USP is a white to off white granular powder with characteristic flavor, and gives orange colored viscous suspension after reconstitution with water. Cephalexin for Oral Suspension, USP, is available in: The 125 mg/5 mL oral suspension is available as follows             100 - mL Bottles                   NDC 42254-338-10 After mixing store in a refrigerator. May be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed. Prior to mixing, store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN POWDER, FOR SUSPENSION
REBEL DISTRIBUTORS CORP
----------
CEPHALEXIN FOR ORAL SUSPENSION, USP
RX ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
CEPHALEXIN FOR ORAL SUSPENSION, USP AND OTHER ANTIBACTERIAL DRUGS,
CEPHALEXIN FOR ORAL
SUSPENSION, USP 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.
Cephalexin for Oral Suspension, USP is a white to off white granular
powder with characteristic
flavor, and gives orange colored viscous suspension after
reconstitution with water.
After mixing, each 5 mL of Cephalexin for Oral Suspension, USP, will
contain cephalexin monohydrate
equivalent to 125 mg (360 micro mol) or 250 mg (720 micro mol) of
anhydrous cephalexin. The
suspensions also contains the following inactive ingredients:
colloidal silicon dioxide, FD&C Yellow
No.6, tutti-frutti flavor, orange flavor, sodium lauryl sulpha