Iodine 5 %

Potassium iodide 10%

This product has several uses where iodine is indicated. This product may be used in the treatment of hyperthyroidism in the immediate preoperative period in preparation for thyroidectomy. It may be used alone, but more frequently is used after the hyperthyroidism is controlled by an antithyroid drug.

This product is also used in thyrotoxicosis crisis in conjunction with supportive measures to control fever and adequate fluid intake.

Preoperative to decrease thyroid blood flow, vascularity, and intraoperative blood loss during thyroidectomy for treatment of Graves' disease

Treatment of thyroid storms to rapidly decrease T₄ and T₃ levels

Preoperative given with antithyroid drug therapy and beta-blockers to control hyperthyroidism prior to thyroidectomy in pregnant patients with difficult-to-treat hyperthyroidism in their second trimester

Preoperative to decrease thyroid blood flow, vascularity, and intraoperative blood loss during thyroidectomy for treatment of Graves' disease

Treatment of thyroid storms to rapidly decrease T₄ and T₃ levels

Preoperative given with antithyroid drug therapy and beta-blockers to control hyperthyroidism prior to thyroidectomy in pregnant patients with difficult-to-treat hyperthyroidism in their second trimester

To reduce free T₄ or total T₄ and total T₃ levels to normal or subnormal range for children in whom antithyroid drugs were chosen as initial management of Graves' disease but are unable to administer methimazole

Preoperative for thyroidectomy in children with Graves' disease

Usual dose: 4.5 minims 3 times daily diluted with water or juice

Usual dose range: 1.5 to 15 minims daily

It is given during the 10 days immediately prior to the operation. Optimal control of hyperthyroidism is achieved if antithyroid drugs are first given alone. 

Preoperative to decrease thyroid blood flow, vascularity, and intraoperative blood loss during thyroidectomy for treatment of Graves' disease: 5 to 7 drops (0.25 to 0.35 mL) three times daily mixed in water or juice for 10 days before surgery

Treatment of thyroid storms to rapidly decrease T₄ and T₃ levels: N/A

Preoperative given with antithyroid drug therapy and beta-blockers to control hyperthyroidism prior to thyroidectomy in pregnant patients with difficult-to-treat hyperthyroidism in their second trimester: N/A

Preoperative to decrease thyroid blood flow, vascularity, and intraoperative blood loss during thyroidectomy for treatment of Graves' disease: 1 to 2 drops (0.05 to 0.1 mL) three times daily mixed in water or juice for 10 days before surgery

Treatment of thyroid storms to rapidly decrease T₄ and T₃ levels: N/A

Preoperative given with antithyroid drug therapy and beta-blockers to control hyperthyroidism prior to thyroidectomy in pregnant patients with difficult-to-treat hyperthyroidism in their second trimester: N/A

To reduce free T₄ or total T₄ and total T₃ levels to normal or subnormal range for children in whom antithyroid drugs were chosen as initial management of Graves' disease but are unable to administer methimazole: 3 to 7 drops (0.15 to 0.35 mL) three times daily for 10 days prior to surgery

Preoperative for thyroidectomy in children with Graves' disease: 1 to drops (0.05 to 0.1 mL) three times daily for 10 days prior to surgery

Large dosage may cause iodine poisoning.

Iodine therapy does not completely control the manifestations of hyperthyroidism in that after a variable period of time, the beneficial effects wear off. With continued administration of iodine, the hyperthyroidism may return in its initial intensity or may become even more severe than it was at first.

Measurements of the protein-bound iodine or of the uptake of radioiodine are rendered useless if iodine is given. 

Iodine readily crosses the placental barrier and may affect the fetus.

Potassium iodide can cause fetal harm, abnormal thyroid function, and goiter when administered to a pregnant woman. Because of the possible development of fetal goiter, if the drug is used during pregnancy or if the patient becomes pregnant during therapy, apprise the patient of the potential hazard.

In some patients, prolonged use of iodides can lead to hypothyroidism. Iodides should be used with caution in patients having Addison's disease, cardiac disease, hyperthyroidism, myotonia congenita, tuberculosis, acute bronchitis, or renal function impairment.

Concurrent use with lithium or antithyroid drugs may potentiate the hypothyroid and goitrogenic effects of these medications. Concurrent use with potassium-containing medications, potassium-sparing diuretics and angiotensin-converting enzyme inhibitors (ACE inhibitors) may result in hyperkalemia and cardiac arrhythmias or cardiac arrest.

Thyroid function tests may be altered by iodide.

Potassium iodide is excreted in breast milk. Use by nursing mothers may cause skin rash and thyroid suppression in the infant.

Safety and effectiveness in children have not been established.

Average dosage of iodine may cause skin rash.

Prolonged therapy may cause iodism. 

The ingestion of large quantities of iodine may cause abdominal pain, nausea, vomiting, and diarhea.

The most frequent adverse reactions to potassium iodide are stomach upset, diarrhea, nausea, vomiting, stomach pain, skin rash, and salivary gland swelling or tenderness. 

Less frequent adverse reactions include gastrointestinal bleeding, confusion, irregular heartbeat, numbness, tingling, pain or weakness in hands or feet, unusual tiredness, weakness or heaviness of legs, fever, and swelling of neck or throat. Thyroid adenoma, goiter, and myxedema are possible side effects.

Iodism or chronic iodine poisoning may occur during prolonged treatment or with the use of high doses. The symptoms of iodism include burning of mouth or throat, severe headache, metallic taste, soreness of teeth and gums, symptoms of head cold, irritation of the eyes with swelling of the eyelids, unusual increase in salivation, acneform skin lesions in the seborrheic areas, and rarely, severe skin eruptions. If symptoms of iodism appear, the drug should be withdrawn and the patient given appropriate supportive therapy.

Hypersensitivity to iodides may occur and may be manifested by angioedema, cutaneous and mucosal hemorrhage, and signs and symptoms resembling serum sickness, such as fever, arthralgia, lymph node enlargement, and eosinophilia.

1 fluid ounce (30 ml) bottles with a calibrated dropper marked to deliver 0.3 ml (300 mg) and 0.6 ml (600 mg); and 8 fluid ounce (237 ml) bottles; inactive ingredient: sodium thiosulfate as a preservative

Storage information not provided

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)

Keep tightly closed and protected from light.

When exposed to cold temperatures, crystallization may occur, but on warming and shaking, the crystals will redissolve. If the solution turns brownish-yellow in color, it should be discarded.

For the 237mL bottle, dispense in tight, light-resistant containers with child-resistant closures. For the 30mL bottle, place the child-resistant cap back on the amber glass bottle after using the clear plastic dropper for dispensing.