Yodoxin

Laboratory Tests

Contains 64% organically-bound iodine.110 May interfere with certain thyroid function tests by increasing protein-bound serum iodine concentrations.110 This effect may persist for as long as 6 months after cessation of iodoquinol therapy.110

Iodoquinol belongs to the group of medicines called antiprotozoals. These medicines are used to treat infections caused by protozoa (tiny, one-celled animals). Iodoquinol is used most often in the treatment of an intestinal infection called amebiasis. However, it may be used to treat other types of infection as determined by your doctor.

Iodoquinol is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children may be more likely to develop certain side effects, especially if given high doses for a long time.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of iodoquinol in the elderly with use in other age groups.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Eye disease—Iodoquinol may cause side effects affecting the eye or make eye disease worse

• Kidney disease or
• Liver disease or
• Thyroid disease—Patients with kidney disease, liver disease, or thyroid disease may have an increased chance of side effects

This section provides information on the proper use of a number of products that contain iodoquinol. It may not be specific to Yodoxin. Please read with care.

Take this medicine after meals to lessen possible stomach upset, unless otherwise directed by your doctor.

If the tablets are too large to swallow whole, they may be crushed and mixed with a small amount of applesauce or chocolate syrup.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For amebiasis:
    • Adults—630 or 650 milligrams (mg) three times a day for twenty days.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 to 13.3 mg per kilogram (kg) (4.5 to 6 mg per pound) of body weight three times a day for twenty days.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Consult your pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

Applies to iodoquinol: oral tablet

Along with its needed effects, iodoquinol (the active ingredient contained in Yodoxin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking iodoquinol:

• Fever or chills
• skin rash, hives, or itching
• swelling of neck

• Blurred vision or any change in vision
• clumsiness or unsteadiness
• decreased vision or eye pain
• increased weakness
• muscle pain
• numbness, tingling, pain, or weakness in hands or feet

Some side effects of iodoquinol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• nausea or vomiting
• stomach pain

• Headache
• itching of the rectal area

Applies to iodoquinol: compounding powder, oral tablet

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal cramps, diarrhea, and pruritus ani.[Ref]

Nervous system

Some neuropathy may be irreversible. Seizures and encephalopathy have been reported in at least one patient. Optic atrophy has been reported, generally in children being treated for acrodermatitis enteropathica at daily dosages between 1300 to 3600 mg for up to two years. Visual deterioration is generally irreversible.

Clioquinol, another hydroxyquinoline, was associated with several thousand cases of subacute myelo-optic neuropathy in Japan, leading to its removal from the market. This syndrome consisted of peripheral weakness, spastic paraparesis, dysesthesia, and optic neuropathy.

Because of the neurotoxicity associated with iodoquinol (the active ingredient contained in Yodoxin) and its growing use in pediatric patients for the treatment of nonspecific chronic diarrhea in the 1970's, the American Academy of Pediatrics Committee on Drugs issued a statement recommending that products containing clioquinol or iodoquinol not be used in pediatric patients.[Ref]

Nervous system side effects have been reported rarely. These have included peripheral neuropathy and headache. Optic atrophy has been reported, generally in pediatric patients receiving large doses for long periods of time.[Ref]

Dermatologic

Dermatologic side effects have included acneiform papular or pustular skin eruptions, bulla, urticaria, and pruritus. These reactions are related to the iodine content of iodoquinol (the active ingredient contained in Yodoxin) [Ref]

Other

Other side effects have included fever, chills, and enlargement of the thyroid.[Ref]

Some side effects of Yodoxin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.