ABRIDGED PRESCRIBING INFORMATION

Composition: Betadine® 5% Ointment: Each gram ointment contains Povidone-Iodine USP 50 mg. Betadine® 10% Standardised Microbicidal Solution 100 ml: Each 100 ml solution contains Povidone-Iodine USP 10 gm. Betadine® 10% Standardised Microbicidal Solution 500 ml: Each 500 ml solution contains Povidone-Iodine USP 50 gm. Betadine® 10% Standardised Microbicidal Solution 1000 ml: Each 1000 ml solution contains Povidone-Iodine USP 100 gm. Betadine® 5% Standardised Microbicidal Solution 100 ml: Each 100 ml solution contains Povidone-Iodine USP 5 gm. Betadine® 7.5% Surgical Scrub 500 ml: Each 500 ml solution contains Povidone-Iodine USP 37.5 gm with nonionic surfactants. Betadine® 7.5% Surgical Scrub 100 ml: Each 100 ml solution contains Povidone-Iodine USP 7.5 gm with nonionic surfactants. Betadine® 5% Microbicidal Sprinkling Powder: Each gram powder contains Povidone-Iodine USP 50 mg. Betadine® 1% Germicide Gargle & Mouthwash 100 ml: Each 100 ml gargle & mouthwash contains Povidone-Iodine USP 1 gm.

Pharmacology: Betadine® a preparation of povidone-iodine USP (Polyvinylpyrrolidone-Iodine) is a complex of iodine and an organic polymer Povidone.This polymerization makes Betadine® superior to ordinary elemental iodine. It prolongs the germicidal activity of iodine by liberating elemental iodine slowly.

Indications: Betadine® 5% Ointment : Treatment of skin infections and prevention of infection in burns, cuts, scratches and abrasions. Betadine® 10% & 5% Standardised Microbicidal Solution: Cuts, bruises, wounds and burns; skin infections. For preparation of skin prior to surgery-helps reduce bacteria that potentially can cause skin infection. Betadine® 7.5% Surgical Scrub: For preparation of the skin prior to surgery. For hand washing to reduce bacteria on the skin. Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. Betadine® 5% Microbicidal Sprinkling Powder: Treatment of skin infections. Prevention of infections in wounds, burns, cuts, scratches and abrasions. Betadine® 1% Germicide Gargle & Mouthwash: For the treatment of acute mucosal infections of the mouth and pharynx e.g. gingivitis, mouth ulcers, for oral hygiene prior to, during, and after dental and oral surgery. Contra-indication: Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient. History of abnormal thyroid function or goitre. Regular use should be avoided in patients on concurrent lithium therapy. Do not use in children six years and under.  Warnings: Use of this preparation may interfere with tests of thyroid function. In patients with impaired renal function, blood levels of iodine should be monitored. If local irritation and hypersensitivity develop, then discontinue treatment. Side Effects: Betadine® 5% Ointment & Cream: Very rarely, hypersensitive skin reactions may occur. Betadine® 10% & 5% Standardised Microbicidal Solution: Local irritation may be experienced. Betadine® 7.5% Surgical Scrub: Skin reactions may occur but these are very rare. Betadine® 5% Microbicidal Sprinkling Powder: Rarely, allergic skin reaction. Very rarely, acute generalized allergic reactions. Betadine® 1% Germicide Gargle & Mouthwash: Local irritation may be experienced. May produce mucous irritation of the mouth as well as hypersensitivity reaction.

Pregnancy and Lactation: Iodine freely crosses the placenta and is secreted in breast milk. Povidone iodine should not be used regularly during pregnancy unless there is no alternative treatment available.

Storage:  Store protected from light at temperature not exceeding 300 C. Keep out of the reach of children.

Presentation:

Betadine® 5% Ointment: Tubes of 15gm and 125gm.

Betadine® 5% Standardised Microbicidal Solution: Amber color PET bottle of 100 ml. Betadine® 10% Standardised Microbicidal Solution: Amber color PET bottles of 100 ml, 500ml & 1000ml.

Betadine®  Surgical Scrub 7.5%: Amber color PET bottle of 100ml with dispensing pump & 500 ml.

Betadine® 5% Microbicidal Sprinkling Powder: White color PET bottle of 10gm.

Betadine® 1% Germicide Gargle & Mouthwash : Amber color PET bottle of 100ml with measuring cup.