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Yodoxin® 210 mg & 650 mg Tablets (IODOQUINOL, 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.

INACTIVE INGREDIENTS:

Anhydrous Lactose, Colloidal Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Polyvinylpyrrolidone.

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 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, to be taken after meals for twenty days.

Dose should not exceed 1.95 grams in twenty-four hours.

HOW SUPPLIED:

YODOXINŽ Tablets - 210 mg. are Beige, Round Tablets; Debossed "YODOXIN/92" and are supplied as: Bottle of 100 tablets - NDC-0516-0092-01

YODOXINŽ Tablets - 650 mg. are Beige, Round Tablets; Debossed "YODOXIN/93" and are supplied as: Bottle of 100 tablets - NDC-0516-0093-01

STORAGE:

Store at controlled room temperature 20-25°C (68-77°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Rx Only
Page Last Updated: Wednesday, July 10, 2013
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