PRODUCT OVERVIEW

KEY FACTS

Yodoxin (Iodoquinol) is amebicidal against the cyst and trophozoite forms of Entamoeba histolytica. Yodoxin® contains 64% organically bound iodine.

MAJOR USES

Yodoxin® is used in the treatment of intestinal amebiasis.

SAFETY INFORMATION

Contraindicated in patients with hepatic damage and in patients with known hypersensitivity to iodine and 8-hydroxyquinolines. Long term use of this drug should be avoided as optic neuritis, optic atrophy and peripheral neuropathy have been reported following prolonged high dosage with halogenated 8-hydroxyquinolines.

PRESCRIBING INFORMATION

YODOXIN®                               Rx

210 mg. & 650 mg. Tablets
(IODOQUINOL TABLETS U.S.P.)

Iodoquinol is a light yellowish to tan color, nearly odorless and stable in air. The compound is practically insoluble in water, and sparingly soluble in most other solvents. It contains 64 per cent organically bound iodine.

ACTION

Iodoquinol is amebicidal against Entamoeba histolytica and is considered effective against the trophozoite and cyst forms.

INDICATIONS

Iodoquinol is used in the treatment of intestinal amebiasis. Iodoquinol is not recommended for the treatment of non-specific diarrhea.

CONTRAINDICATIONS

Known hypersensitivity to iodine and 8-hydroxyquinolines. Contraindicated in patients with hepatic damage.

Optic neuritis, optic atrophy, and peripheral neuropathy have been reported following prolonged high dosage therapy with halogenated 8-hydroxyquinolines. Long term use of this drug should be avoided.

USE IN PREGNANCY

Safety for use in pregnancy or during lactation has not been established.

PRECAUTIONS

Iodoquinol should be used with caution in patients with thyroid disease.

Protein-bound serum iodine levels may be increased during treatment with iodoquinol and therefore interfere with certain thyroid function tests. These effects may persist for as long as six months after discontinuation of therapy. Discontinue the drug if hypersensitivity reactions occur.

ADVERSE REACTIONS

Skin: various forms of skin eruptions (acneiform papular and pustular; bullae; vegetating or tuberous iododerma), urticaria and pruritus. Gastrointestinal: nausea, vomiting, abdominal cramps, diarrhea, and pruritus ani.

Fever, chills, headache, vertigo and enlargement of thyroid have been reported. Optic neuritis, optic atrophy and peripheral neuropathy have been reported in association with prolonged high-dosage 8-hydroxyquinoline therapy.

DOSAGE AND ADMINISTRATION

Usual adult dose: (210 mg tablet) 3 tablets three times a day, to be taken after meals for twenty days. Usual adult dose: (650 mg tablet) 1 tablet three times a day, to be taken after meals for twenty days. Usual pediatric dose: 10 to 13.3 mg per kg of body weight, three times a day for 20 days. Dose should not exceed 1.95 grams in twenty-four hours.

HOW SUPPLIED

YODOXIN Tablets--210 mg.

NDC-0516-0092-01 Bottle of 100

YODOXIN Tablets--650 mg.

NDC-0516-0093-01 Bottle of 100

STORAGE

Store at Controlled Room Temperature 15-30°C. (59-86°F.)

Rx only