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Drug overview for THYROSAFE (potassium iodide):
Generic name: POTASSIUM IODIDE
Drug class: Iodine
Therapeutic class: Electrolyte Balance-Nutritional Products
Potassium iodide is an antithyroid agent, antisporotrichotic agent, and expectorant.
No enhanced Uses information available for this drug.
Generic name: POTASSIUM IODIDE
Drug class: Iodine
Therapeutic class: Electrolyte Balance-Nutritional Products
Potassium iodide is an antithyroid agent, antisporotrichotic agent, and expectorant.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for THYROSAFE (potassium iodide) have been approved by the FDA:
Indications:
Thyroid gland radiation protection
Professional Synonyms:
Radiation protection of the thyroid gland
Indications:
Thyroid gland radiation protection
Professional Synonyms:
Radiation protection of the thyroid gland
The following dosing information is available for THYROSAFE (potassium iodide):
The recommended adult dosage of oral potassium iodide for a radiation emergency is 130 mg once daily (one 130-mg tablet or two 65-mg tablets once daily). If the commercially available oral solution containing 65 mg/mL is used, adults should receive 130 mg once daily (2 mL once daily). Alternatively, if an extemporaneous oral solution containing 16.25
mg/5 mL (16.25 mg/teaspoon) is used, adults should receive a dosage of 130 mg once daily (40 mL or 8 teaspoons once daily).
During a radiation emergency, the FDA recommends use of potassium iodide in adults 19 through 40 years of age if predicted thyroid exposure is 10 centigrays (cGy) or more and in pregnant or lactating women if predicted thyroid exposure is 5 cGy or more. Because of the risk of hypothyroidism, the FDA recommends potassium iodide in adults older than 40 years of age only if predicted thyroid exposure is 500 cGy or more.
For a radiation emergency, adolescents older than 12 through 18 years of age should receive oral potassium iodide in a dosage of 130 mg once daily if they weigh 70 kg (150 lbs) or more or a dosage of 65 mg once daily if they weigh less than 70 kg (150 lbs). (See Table 1and Table 2.) The FDA recommends use of potassium iodide in adolescents if predicted thyroid exposure is 5 cGy or more.
For a radiation emergency, neonates and children through 12 years of age should receive potassium iodide in a dosage based on age. (See Table 1and Table 2.) The FDA recommends use of potassium iodide in neonates and children 12 years of age or younger if predicted thyroid exposure is 5 cGy or more.
Table 1. Recommended Pediatric Dosage of Potassium Iodide for Radiation Emergency (65- or 130-mg Tablets or Oral Solution Containing 65 mg/mL)
Age and Weight Potassium Iodide Tablets Potassium Iodide Oral (Iosat(R), ThyroSafe(R)) Solution Containing 65 mg/mL (Thyroshield(R)) Birth to 1 month (See Table 2) 16.25 mg once daily (0.25 mL) >1 month to 3 years (See Table 2) 32.5 mg once daily (0.5 mL) >3 through 12 years 65 mg once daily (one 65 mg once daily (1 mL) 65-mg tablet or 1/2 of 130-mg tablet) >12 through 18 years 65 mg once daily (one 65 mg once daily (1 mL) weighing <70 kg (150 65-mg tablet or 1/2 of lbs) 130-mg tablet) >12 through 18 years 130 mg once daily (two 130 mg once daily (2 mL) weighing >=70 kg (150 65-mg tablets or one lbs) 130-mg tablet)
Table 2. Recommended Pediatric Dosage of Potassium Iodide for Radiation Emergency (Extemporaneous Oral Solutions)
Age and Weight Extemporaneous Oral Extemporaneous Oral Solution Containing Solution Containing 8.125 mg/5 mL (8.125 16.25 mg/5 mL (16.25 mg/teaspoon) mg/teaspoon) Birth to 1 month 16.25 mg once daily (10 16.25 mg once daily (5 mL or 2 teaspoons) mL or 1 teaspoon) >1 month to 3 years 32.5 mg once daily (20 32.5 mg once daily (10 mL or 4 teaspoons) mL or 2 teaspoons) >3 through 12 years 65 mg once daily (40 mL 65 mg once daily (20 mL or 8 teaspoons) or 4 teaspoons) >12 through 18 years 65 mg once daily (40 mL 65 mg once daily (20 mL weighing <70 kg (150 or 8 teaspoons) or 4 teaspoons) lbs) >12 through 18 years Use alternative 130 mg once daily (40 mL weighing >=70 kg (150 preparation or 8 teaspoons) lbs)
mg/5 mL (16.25 mg/teaspoon) is used, adults should receive a dosage of 130 mg once daily (40 mL or 8 teaspoons once daily).
During a radiation emergency, the FDA recommends use of potassium iodide in adults 19 through 40 years of age if predicted thyroid exposure is 10 centigrays (cGy) or more and in pregnant or lactating women if predicted thyroid exposure is 5 cGy or more. Because of the risk of hypothyroidism, the FDA recommends potassium iodide in adults older than 40 years of age only if predicted thyroid exposure is 500 cGy or more.
For a radiation emergency, adolescents older than 12 through 18 years of age should receive oral potassium iodide in a dosage of 130 mg once daily if they weigh 70 kg (150 lbs) or more or a dosage of 65 mg once daily if they weigh less than 70 kg (150 lbs). (See Table 1and Table 2.) The FDA recommends use of potassium iodide in adolescents if predicted thyroid exposure is 5 cGy or more.
For a radiation emergency, neonates and children through 12 years of age should receive potassium iodide in a dosage based on age. (See Table 1and Table 2.) The FDA recommends use of potassium iodide in neonates and children 12 years of age or younger if predicted thyroid exposure is 5 cGy or more.
Table 1. Recommended Pediatric Dosage of Potassium Iodide for Radiation Emergency (65- or 130-mg Tablets or Oral Solution Containing 65 mg/mL)
Age and Weight Potassium Iodide Tablets Potassium Iodide Oral (Iosat(R), ThyroSafe(R)) Solution Containing 65 mg/mL (Thyroshield(R)) Birth to 1 month (See Table 2) 16.25 mg once daily (0.25 mL) >1 month to 3 years (See Table 2) 32.5 mg once daily (0.5 mL) >3 through 12 years 65 mg once daily (one 65 mg once daily (1 mL) 65-mg tablet or 1/2 of 130-mg tablet) >12 through 18 years 65 mg once daily (one 65 mg once daily (1 mL) weighing <70 kg (150 65-mg tablet or 1/2 of lbs) 130-mg tablet) >12 through 18 years 130 mg once daily (two 130 mg once daily (2 mL) weighing >=70 kg (150 65-mg tablets or one lbs) 130-mg tablet)
Table 2. Recommended Pediatric Dosage of Potassium Iodide for Radiation Emergency (Extemporaneous Oral Solutions)
Age and Weight Extemporaneous Oral Extemporaneous Oral Solution Containing Solution Containing 8.125 mg/5 mL (8.125 16.25 mg/5 mL (16.25 mg/teaspoon) mg/teaspoon) Birth to 1 month 16.25 mg once daily (10 16.25 mg once daily (5 mL or 2 teaspoons) mL or 1 teaspoon) >1 month to 3 years 32.5 mg once daily (20 32.5 mg once daily (10 mL or 4 teaspoons) mL or 2 teaspoons) >3 through 12 years 65 mg once daily (40 mL 65 mg once daily (20 mL or 8 teaspoons) or 4 teaspoons) >12 through 18 years 65 mg once daily (40 mL 65 mg once daily (20 mL weighing <70 kg (150 or 8 teaspoons) or 4 teaspoons) lbs) >12 through 18 years Use alternative 130 mg once daily (40 mL weighing >=70 kg (150 preparation or 8 teaspoons) lbs)
Potassium iodide is administered orally. For use during a radiation emergency, potassium iodide is commercially available as tablets containing 65 or 130 mg of the drug and as an oral solution containing 65 mg/mL. If the oral solution containing 65 mg/mL is used, the dose should be administered undiluted using the calibrated dropper provided by the manufacturer.
For other indications, an oral solution of potassium iodide containing 1 g/mL (also known as saturated solution of potassium iodide (SSKI(R))) also is available. If this oral solution is used, the dose should be administered in a glassful of water, fruit juice, or milk. To minimize GI irritation, the dose should be taken with food or milk.
A calibrated dropper marked to deliver 300 mg (0.3 mL) or 600 mg (0.6 mL) of the drug is provided by the manufacturer. If a dose of the oral solution containing 1 g/mL is administered using a standard medicinal dropper, each drop (0.05 mL) contains 50 mg of potassium iodide. Potassium iodide may be available as strong iodine solution (also known as Lugol's solution), an oral solution containing 50 mg of iodine and 100 mg of potassium iodide per mL; this preparation may be commercially available but is not approved by the US Food and Drug Administration (FDA).
Doses of strong iodine solution should be diluted in water or juice. If a dose of strong iodine solution is administered using a standard medicinal dropper, each drop contains 8 mg of iodide.
For other indications, an oral solution of potassium iodide containing 1 g/mL (also known as saturated solution of potassium iodide (SSKI(R))) also is available. If this oral solution is used, the dose should be administered in a glassful of water, fruit juice, or milk. To minimize GI irritation, the dose should be taken with food or milk.
A calibrated dropper marked to deliver 300 mg (0.3 mL) or 600 mg (0.6 mL) of the drug is provided by the manufacturer. If a dose of the oral solution containing 1 g/mL is administered using a standard medicinal dropper, each drop (0.05 mL) contains 50 mg of potassium iodide. Potassium iodide may be available as strong iodine solution (also known as Lugol's solution), an oral solution containing 50 mg of iodine and 100 mg of potassium iodide per mL; this preparation may be commercially available but is not approved by the US Food and Drug Administration (FDA).
Doses of strong iodine solution should be diluted in water or juice. If a dose of strong iodine solution is administered using a standard medicinal dropper, each drop contains 8 mg of iodide.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for THYROSAFE (potassium iodide):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Radioactive Iodide/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1) PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(2) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(3) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1) |
ADREVIEW, JEANATOPE, MEGATOPE, SODIUM IODIDE I-123 |
| Sodium Iodide I 131/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1,2) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1,2) PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1,2) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(3) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(4) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1,2) |
HICON, SODIUM IODIDE I-131 |
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Lithium/Iodide Salts SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Unknown. CLINICAL EFFECTS: Concurrent administration of lithium and iodide salts may produce hypothyroidism. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If both drugs are given, monitor patient for signs and symptoms of hypothyroidism. If hypothyroidism develops, thyroid hormone may be used to treat symptoms. DISCUSSION: Hypothyroidism is a side effect that may occur with long-term lithium treatment. Thyroid gland enlargement and increased thyroid stimulating hormone may also be present. Iodide administration to patients receiving lithium may increase the risk of patients developing hypothyroidism. |
LITHIUM CARBONATE, LITHIUM CARBONATE ER, LITHIUM CITRATE, LITHIUM CITRATE TETRAHYDRATE, LITHOBID |
| Trientine/Selected Minerals, Oral SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Mineral supplements may bind to trientine and block its absorption. CLINICAL EFFECTS: The levels and clinical effects of trientine may be decreased. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of trientine states that mineral supplements should not be given with trientine. If concomitant therapy is necessary, take trientine on an empty stomach and separate administration at least one hour apart from any other drug. Monitor clinical status for decreased effectiveness and adjust the trientine dose if necessary. DISCUSSION: Multivitamins with minerals may decrease trientine absorption so ensure patient is aware of the risks. |
CUVRIOR, SYPRINE, TRIENTINE HCL |
The following contraindication information is available for THYROSAFE (potassium iodide):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Dermatitis herpetiformis |
| Pregnancy |
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Active tuberculosis |
| Hyperkalemia |
| Hypocomplementemic urticarial vasculitis |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Goiter |
| Hashimoto thyroiditis |
The following adverse reaction information is available for THYROSAFE (potassium iodide):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 9 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Angioedema Arthralgia Eosinophilia Lymphadenopathy Urticaria |
| Rare/Very Rare |
|---|
|
Iodine poisoning Polyarteritis nodosa Systemic lupus erythematosus Thrombotic thrombocytopenic purpura |
There are 3 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dysgeusia Nausea |
| Rare/Very Rare |
|---|
|
Diarrhea |
The following precautions are available for THYROSAFE (potassium iodide):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Iodides readily cross the placenta and may result in abnormal thyroid function and/or goiter in the neonate. Fetal thyroid may be most susceptible to the effects of excess iodine at the end of gestation. Some experts state that potassium iodide is contraindicated in pregnant women.
The American Academy of Pediatrics (AAP) states that use of potassium iodide as an expectorant is contraindicated during pregnancy. There is no evidence that short-term use (e.g., 10 days) of potassium iodide for preoperative management of hyperthyroidism in pregnant women with Graves' disease undergoing thyroidectomy+ is harmful to the fetus. If thyroidectomy is necessary for the treatment of hyperthyroidism during pregnancy, the American Thyroid Association (ATA) and American Association of Clinical Endocrinologists (AACE) recommend that the surgery be performed during the second trimester.
The FDA recommends that pregnant women receive potassium iodide during a radiation emergency for their own protection and that of the fetus; however, repeat administration should be avoided during pregnancy, unless other protective measures are not available. When repeat administration is indicated in a pregnant woman, consultation with a clinician is recommended and thyroid function monitoring may be indicated in the neonate. If potassium iodide is used during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential risks to the fetus.
The American Academy of Pediatrics (AAP) states that use of potassium iodide as an expectorant is contraindicated during pregnancy. There is no evidence that short-term use (e.g., 10 days) of potassium iodide for preoperative management of hyperthyroidism in pregnant women with Graves' disease undergoing thyroidectomy+ is harmful to the fetus. If thyroidectomy is necessary for the treatment of hyperthyroidism during pregnancy, the American Thyroid Association (ATA) and American Association of Clinical Endocrinologists (AACE) recommend that the surgery be performed during the second trimester.
The FDA recommends that pregnant women receive potassium iodide during a radiation emergency for their own protection and that of the fetus; however, repeat administration should be avoided during pregnancy, unless other protective measures are not available. When repeat administration is indicated in a pregnant woman, consultation with a clinician is recommended and thyroid function monitoring may be indicated in the neonate. If potassium iodide is used during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential risks to the fetus.
Potassium iodide is distributed into milk and may cause rash and thyroid suppression in nursing infants. The AAP considers potassium iodide to be compatible with breast-feeding. In a radiation emergency, the FDA recommends that lactating women receive potassium iodide for their own protection.
However, repeat administration should be avoided in lactating women unless other protective measures are not available. If repeat administration is indicated in a nursing woman, consultation with a clinician is recommended; thyroid function monitoring may be indicated in a breast-fed neonate. Because radioactive iodine is distributed into milk, some experts (including the AAP) recommend that lactating women temporarily not breast-feed after a radiation emergency, unless no alternative is available.
Breast-feeding can then be resumed when public authorities declare it safe to do so. The fact that administration of potassium iodide to lactating women potentially can reduce the radioiodine content of milk should be considered.
However, repeat administration should be avoided in lactating women unless other protective measures are not available. If repeat administration is indicated in a nursing woman, consultation with a clinician is recommended; thyroid function monitoring may be indicated in a breast-fed neonate. Because radioactive iodine is distributed into milk, some experts (including the AAP) recommend that lactating women temporarily not breast-feed after a radiation emergency, unless no alternative is available.
Breast-feeding can then be resumed when public authorities declare it safe to do so. The fact that administration of potassium iodide to lactating women potentially can reduce the radioiodine content of milk should be considered.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for THYROSAFE (potassium iodide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for THYROSAFE (potassium iodide)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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