Zyvodol

Generic name: diclofenac sodium, amitriptyline hydrochloride, prilocaine hydrochloride and lidocaine
Dosage form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Zyvodol Description

Zyvodol® is comprised of 3 g of Diclofenac Sodium USP, 4 g of Amitriptyline HCl USP, 2.5 g of Prilocaine HCl USP, and 2.5 g of Lidocaine HCl USP for topical use.1 Zyvodol® also contains a Cream Base containing purified water, white petrolatum, sorbitol solution, cetearyl alcohol, propylene glycol, ceteareth-20, simethicone, glyceryl monostearate, polyethylene glycol monostearate, sorbic acid and BHT. When mixed as instructed, the final product provides a homogeneous cream mixture containing Diclofenac Sodium, Amitriptyline HCl, Prilocaine HCl, and Lidocaine HCl comparable to the active ingredients (Voltaren Gel® 1%, Elavil®, and Emla® 2.5%/2.5%) contained in Zyvodol®, as dispensed. 2

1

Certificate of analysis on file

2

This product is not manufactured by Novartis, manufacturer of Voltaren Gel®, AstraZeneca Pharmaceuticals, manufacturer of Elavil® and Emla®.

Zyvodol Dosage and Administration

The pharmacist must mix contents of each container with appropriate amount of Cream Base yielding a final volume of 100 grams at the time of dispensing. Pharmacist may utilize diluent(s) if needed from the respective active component Material Safety Data Sheet only. For topical use only. This product should not be administered orally.

Contraindications

Zyvodol® Topical Cream, as dispensed, is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

USES

Consult your pharmacist.

HOW TO USE

Consult your pharmacist.

Precautions

Consult your pharmacist.

Drug Interactions

Consult your pharmacist. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

SIDE EFFECTS

Consult your pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

MISSED DOSE

Consult your pharmacist.

NOTES

No Monograph available at this time.

How is Zyvodol Supplied

Zyvodol® Cream, as dispensed, is supplied as six component package: four containers which contain the activ...