Yodoxin ® Iodoquinol Tablets, U.S.P.
Prescribing Information

DESCRIPTION:

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 percent 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.

WARNINGS:

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 atter 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: (650 mg each) One tablet t.i.d. for twenty days, to be taken after meals.

Children: 10 to 13.3 mg. per kg. of body weight, 3 times per day (not to exceed 1.95 grams in 24 hours), for 20 days.

PACKAGING:

Yodoxin® 210 mg. Tablets
Iodoquinol Tablets, U.S.P.
Bottles of 100 tablets - NDC-0516-0092-01

Yodoxin® 650 mg. Tablets
Iodoquinol Tablets, U.S.P.
Bottles of 100 tablets - NDC-0516-0093-01

STORAGE:

Store at controlled room temperature 15-30°C (59-86°F).