
Prescription Drug Name:
Cephalexin for Oral Suspension USP, Rx Only, Rev. 09/09
ID:
bf7ebcb2-b720-4c58-8dde-a7f5e7eb2374
Code:
34391-3
DESCRIPTION
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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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
After mixing, each 5 mL of Cephalexin for Oral Suspension, USP, will contain cephalexin monohydrate equivalent to 125 mg (360 µcmol) or 250 mg (720 µcmol) of cephalexin. The suspensions also contain citric acid
INDICATIONS AND USAGE
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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Respiratory tract infections caused by
Skin and skin structure infections caused by
Bone infections caused by
Genitourinary tract infections, including acute prostatitis, caused by
Note— Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
CONTRAINDICATIONS
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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
WARNINGS
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displayName: WARNINGS SECTION
FDA Article Code: 34071-1
There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.
DOSAGE AND ADMINISTRATION
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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Cephalexin for Oral Suspension greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Cephalexin for Oral Suspension
20 kg (44 lb) 1 to 2 tsp q.i.d.
40 kg (88 lb) 2 to 4 tsp q.i.d.
20 kg (44 lb) 1/2 to 1 tsp q.i.d.
40 kg (88 lb) 1 to 2 tsp q.i.d.
or
20 kg (44 lb) 2 to 4 tsp b.i.d.
40 kg (88 lb) 4 to 8 tsp b.i.d.
20 kg (44 lb) 1 to 2 tsp b.i.d.
40 kg (88 lb) 2 to 4 tsp b.i.d.
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of ß-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
HOW SUPPLIED
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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
The 125 mg per 5 mL oral suspension is available as follows:
100-mL Bottles
200-mL Bottles
The 250 mg per 5 mL oral suspension is available as follows:
100-mL Bottles
200-mL Bottles
REFERENCES
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displayName: REFERENCES SECTION
FDA Article Code: 34093-5
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests — Sixth Edition. Approved Standard NCCLS Document M2-A6, Vol. 17, No. 1, NCCLS, Wayne, PA, January, 1997.
3. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing — Eighth Informational Supplement. Approved Standard NCCLS Document M100-S8, Vol. 18, No. 1, NCCLS, Wayne, PA, January, 1998.
P.O Box 106229
Riyadh 11666
Saudi Arabia
Amman 11118
Jordan
PRINCIPAL DISPLAY PANEL
id: 9f7bcd0a-164d-4827-9c51-4fef0cca1318
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
125 mg per 5 mL
NDC 0143-9769-01
PRINCIPAL DISPLAY PANEL
id: 8a6704c4-cdb2-4a63-99c1-d7a711198649
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
250 mg per 5 mL
NDC 0143-9770-01