Panixine

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 C16H17N3O4S•H2O 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.

Each cephalexin tablet for oral administration contains cephalexin monohydrate equivalent to 125 mg (360 µmol) or 250 mg (720 µmol) of cephalexin.

In addition, each cephalexin tablet for oral suspension contains the following inactive ingredients: aspartame*, colloidal silicon dioxide, crospovidone, D&C yellow No. 10 aluminum lake, fruit gum flavor, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone.

* See PRECAUTIONS

BEFORE CEPHALEXIN THERAPY IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS AND PENICILLIN. CEPHALOSPORIN C DERIVATIVES SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS.

SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES

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.

Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. No exception should be made with regard to cephalexin.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cephalexin, and may range from mild to life threatening. Therefore, it is important to consider this diagnosis in patients with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis.

After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

Usage in Pregnancy Safety of this product for use during pregnancy has not been established.

Panixine

DisperDose®

(cephalexin tablets for oral suspension)

PATIENT’S DIRECTIONS FOR USE

Mix one Panixine DisperDose tablet in water before you take it.

1. Remove one tablet from the bottle, or unit dose pack.

2. Place the tablet in a small amount of water (approximately 2 teaspoonfuls).

3. Swirl or stir until thoroughly mixed.

4. Drink the mixture immediately after mixing. (The mixture is light yellow colored and has a fruity peppermint flavor.)

5. Be sure to drink the entire mixture.

6. 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 Panixine DisperDose tablets whole. The tablets will not rapidly dissolve in your mouth.

Take all of the medicine as recommended by your doctor or other health care provider.

Do not mix Panixine DisperDose with any liquid other than water.

Manufactured for:

Ranbaxy Laboratories, Inc.

Jacksonville, FL 32257 USA

by: Ranbaxy Laboratories Limited

New Delhi - 110 019, India

December 2006