Panixine Disperdose (Cephalexin) - Indications and Dosage

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Panixine DisperDose and other antibacterial drugs, Panixine DisperDose 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.

Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

Respiratory tract infections caused by S. pneumoniae and S. 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 S. pneumoniae, H. influenzae, staphylococci, streptococci and M. catarrhalis

Skin and skin structure infections caused by staphylococci and/or streptococci

Bone infections caused by staphylococci and/or P. mirabilis

Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae

Note — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.

DOSAGE AND ADMINISTRATION

Panixine DisperDose is administered orally after complete mixing in water.

Directions for Panixine DisperDose: Mix one tablet in a small amount of water [approximately 2 teaspoonfuls]. Drink the entire mixture. Rinse the container with an additional small amount of water and drink the contents to assure the whole dose is taken. Do not chew or swallow the tablets. The tablets will not rapidly dissolve in your mouth.

Adults — The adult dosage ranges from 1 to 4 g daily in divided doses. 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 greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

Pediatric Patients — The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

*CERTAIN DOSES FOR PEDIATRIC PATIENTS MAY NOT BE OBTAINABLE BY TAKING A WHOLE OR HALF TABLET. THEREFORE, CEPHALEXIN ORAL SUSPENSION MAY BE BETTER SUITED FOR DOSES IN THE PEDIATRIC POPULATION.
Child’s Weight	Cephalexin Suspension 125 mg/5 mL	Cephalexin Suspension 250 mg/5 mL	Cephalexin Tablets for Oral Suspension 125 mg*	Cephalexin Tablets for Oral Suspension 250 mg*
10 kg (22 lb)	½ to 1 tsp q.i.d.	¼ to ½ tsp q.i.d.	* ½ to 1 tablet q.i.d.	---
20 kg (44 lb)	1 to 2 tsp q.i.d.	½ to 1 tsp q.i.d	1 to 2 tablets q.i.d.	*½ to 1 tablet q.i.d.
40 kg (88 lb)	2 to 4 tsp q.i.d.	1 to 2 tsp q.i.d.	2 to 4 tablets q.i.d.	1 to 2 tablets q.i.d.
		or
Child’s Weight	Cephalexin Suspension 125 mg/5 mL	Cephalexin Suspension 250 mg/5 mL	Cephalexin Tablets for Oral Suspension 125 mg*	Cephalexin Tablets for Oral Suspension 250 mg*
10 kg (22 lb)	1 to 2 tsp b.i.d.	½ to 1 tsp b.i.d.	1 to 2 tablets b.i.d.	* ½ to 1 tablet b.i.d.
20 kg (44 lb)	2 to 4 tsp b.i.d.	1 to 2 tsp b.i.d.	2 to 4 tablets b.i.d.	1 to 2 tablets b.i.d.
40 kg (88 lb)	4 to 8 tsp b.i.d.	2 to 4 tsp b.i.d.	4 to 8 tablets b.i.d.	2 to 4 tablets 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 β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.

HOW SUPPLIED

Panixine DisperDose (Cephalexin Tablets for Oral Suspension):

Each tablet for oral suspension contains 125 mg or 250 mg cephalexin as the monohydrate.

125 mg Tablet For Oral Suspension

The 125 mg is a light yellow colored, capsule shaped tablets with a deep break line on one side and a score line on the other side, with a fruity peppermint flavor. Tablets are debossed with "RC” on one side of the score line and “80” on the other side of the score line.

NDC 10631-573-20 Bottles of 20

NDC 10631-573-40 Bottles of 40

NDC 10631-573-01 Bottles of 100

NDC 10631-573-41 Blister unit-dose pack of 40 (5 x 8)

NDC 10631-573-80 Strip unit-dose pack of 100 (10 x 10)

NDC 10631-573-42 Strip unit-dose pack of 40 (5 x 8)

NDC 10631-573-77 Blister unit-dose pack of 100 (10 x 10)

250 mg Tablet For Oral Suspension

The 250 mg is a light yellow colored, capsule shaped tablets with a deep break line on one side and a score line on the other side, with a fruity peppermint flavor. Tablets are debossed with "RC” on one side of the score line and “81” on the other side of the score line.

NDC 10631-574-20 Bottles of 20

NDC 10631-574-40 Bottles of 40

NDC 10631-574-01 Bottles of 100

NDC 10631-574-41 Blister unit-dose pack of 40 (5 x 8)

NDC 10631-574-80 Strip unit-dose pack of 100 (10 x 10)

NDC 10631-574-42 Strip unit-dose pack of 40 (5 x 8)

NDC 10631-574-77 Blister unit-dose pack of 100 (10 x 10)

The bottle packages contain desiccant.

Dispense in tight, light-resistant container.

Store at 20 – 25° C (68 – 77° F). [see USP Controlled Room Temperature].

This product is also available as:

Cephalexin for Oral Suspension:

125 mg/5 mL

NDC 63304-958-01 - 100 mL bottles

NDC 63304-958-02 - 200 mL bottles

250 mg/5 mL

NDC 63304-959-01 - 100 mL bottles

NDC 63304-959-02 - 200 mL bottles

See the package insert for Cephalexin for Oral Suspension for complete prescribing information.