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Potassium Iodide

Class: Antithyroid Agents
Note: This monograph also contains information on Strong Iodine Solution
ATC Class: R05CA02
VA Class: RE302
CAS Number: 7681-11-0
Brands: Iosat, SSKI, ThyroSafe, ThyroShield

Introduction

Antithyroid agent,b antisporotrichotic agent,b and expectorant.a b

Uses for Potassium Iodide

Hyperthyroidism

Preoperatively to reduce vascularity of thyroid gland prior to thyroidectomy;b c d f usually used in conjunction with other antithyroid agents (e.g., propylthiouracil) and/or propranolol.b f For preparation of patients with Graves’ disease for surgery, potassium iodide and propranolol may be preferred regimen.b

Management of thyrotoxic crisis (by preventing intrathyroid iodine accumulation); usually used in conjunction with other antithyroid agents (e.g., propylthiouracil) and/or propranolol.b f

May be useful for treatment of persistent or recurrent hyperthyroidism in patients with Graves’ disease after surgery or treatment with radioactive iodine.b

Radiation Emergency

Blockage of thyroidal uptake of radioactive isotopes of iodine (e.g.,131I) that may be accidentally released into the environment (e.g., from a nuclear power plant), thus minimizing the risk of radiation-induced thyroid neoplasms.100 101 102 103 104 105 138 139 149 Has no impact on uptake of other radioactive materials and does not provide protection against external irradiation of any kind.138 h

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Used as an adjunct to other protective measures (e.g., evacuation, sheltering, assurance of uncontaminated milk and food).138 139 Neonates, children, pregnant or lactating women, and individuals who are unable to tolerate potassium iodide should be given priority with regard to these other protective measures.138

The US government stockpiles potassium iodide tablets for emergency use,140 and the decision to distribute and use the drug resides with state and/or local public health authorities.101 102 103 104 138 139 (See Advice to Patients.)

Sporotrichosis

Has been used with good results in the treatment of cutaneous sporotrichosis (localized to the skin; also known as fixed cutaneous or plaque sporotrichosis) and lymphocutaneous sporotrichosis (involves skin, subcutaneous tissues, regional lymphatics) caused by Sporothrix schenckii.107 108 109 112 113 114 118 119 120 121 122 123 124 143 144 145 146 Oral itraconazole generally considered drug of choice for treatment of these conditions;109 143 144 145 potassium iodide considered alternative therapy109 143 144 145 because of problems with long-term compliance (i.e., numerous adverse effects, lack of solid oral dosage form).124 143 144 145 146

Not effective in the treatment of extracutaneous (pulmonary, osteoarticular, meningeal) sporotrichosis or disseminated sporotrichosis; IV amphotericin B or oral itraconazole considered drugs of choice for these forms of sporotrichosis.109 124 144 145

Cough

Has been used as an expectorant in the symptomatic management of conditions such as chronic bronchitis, bronchiectasis, bronchial asthma, and pulmonary emphysema;a b however, efficacy not established, and the drug generally has been replaced by more effective and safer expectorants.b

Potassium Iodide Dosage and Administration

Administration

Oral Administration

Administer orally.b To minimize GI irritation, administer after meals and at bedtime with food or milk.a b

Administer saturated (1-g/mL) oral solution in a large quantity (240 mL) of water, fruit juice, milk, formula, or broth.a b Administer 65-mg/mL oral solution undiluted using the dropper provided by the manufacturer.b Dilute strong iodine solution with water or juice.f

For administration in infants and small children during a radiation emergency, tablets may be pulverized, mixed with water and a drink, and administered as an oral solution; the best beverages to disguise the salty taste of potassium iodide are raspberry syrup (best), low-fat chocolate milk, orange juice, and flat soda (i.e., cola).140 To prepare an oral solution, place one tablet (containing 130 or 65 mg of potassium iodide) in a small bowl and pulverize tablet using a metal spoon.140 e Then add 4 teaspoonsful (20 mL) of water to the powder and mix until powder dissolves.140 e Next, add 4 teaspoonsful (20 mL) of the selected drink and mix.140 e Using a 130-mg tablet results in a solution that contains 16.25 mg of potassium iodide per teaspoonful (5 mL).140 e Using a 65-mg tablet results in a solution that contains 8.125 mg of potassium iodide per teaspoonful (5 mL).140

During a radiation emergency, administer potassium iodide before or immediately coincident with passage of the radioactive cloud for optimal protection against inhaled radioiodines; administration 3–4 hours after exposure may still provide substantial protection.138 c

Dosage

Available as potassium iodide; dosage expressed in terms of the salt.a Potassium iodide also is available in fixed combination with iodine (i.e., strong iodine solution).b

Pediatric Patients

Hyperthyroidism
Graves’ Disease
Oral

Neonates: 1 drop of strong iodine solution every 8 hours suggested by some clinicians.b

Reduction of Thyroid Gland Vascularity in Preparation for Thyroidectomy

Administer only after achieving euthyroidism with other antithyroid agents (e.g., propylthiouracil).b f

Oral

Children: Usually, 50–250 mg (approximately 1–5 drops of a 1-g/mL solution) 3 times daily for 10–14 days before surgery.b

Radiation Emergency
Oral

Recommended dosages vary by age and/or weight (see Table 1).b

In neonates (birth to 1 month of age), avoid repeat administration to minimize risk of hypothyroidism during period of critical brain development.138 c e g Monitor for hypothyroidism by measuring TSH and, if indicated, free thyroxine (T4) concentrations; institute thyroid replacement therapy if hypothyroidism occurs.138 e

In other pediatric patients (infants, children, and adolescents), administer once daily (every 24 hours)e g until risk of substantial exposure to radioiodines (either by inhalation or ingestion) no longer exists.138 140 c h

Table 1. Recommended Dosages of Potassium Iodide (i.e., Iosat, ThyroSafe, ThyroShield) for Self-medication Before, During, or Immediately Following a Radiation Emergency in Pediatric Patients138149begh

Age

Predicted Thyroid Exposure

Potassium Iodide Dosage

Birth to 1 month

≥5 centigrays (cGy)

One 16-mg dose

>1 month to 3 years

≥5 cGy

32 mg once daily

>3–12 years

≥5 cGy

65 mg once daily

>12–18 years weighing <68.2 kg (150 lbs)

≥5 cGy

65 mg once daily

>12–18 years weighing ≥68.2 kg (150 lbs)

≥5 cGy

130 mg once daily

Sporotrichosis
Cutaneous or Lymphocutaneous Sporotrichosis
Oral

Initially, 250 mg (approximately 5 drops of a 1-g/mL solution) 3 times daily.124 144 145 Gradually increase dosage as tolerated to a maximum of 1.25–2 g (approximately 25–40 drops of a 1-g/mL solution) 3 times daily.124 (See Pediatric Use under Cautions.)

Usual duration of therapy is 3–6 months.124 144 145

Cough
Oral

Children: Usually, 60–250 mg 4 times daily.b (See Pediatric Use under Cautions.)

Adults

Hyperthyroidism
Reduction of Thyroid Gland Vascularity in Preparation for Thyroidectomy

Administer only after achieving euthyroidism with other antithyroid agents (e.g., propylthiouracil).b f

Oral

Usually, 50–250 mg (approximately 1–5 drops of a 1-g/mL solution) 3 times daily for 10–14 days before surgery.b Alternatively, 0.1–0.3 mL (approximately 3–5 drops) of strong iodine solution 3 times daily for 10–14 days before surgery.b f

Thyrotoxic Crisis

Administer initial dose ≥1 hour after initial dose of propylthiouracil or methimazole.b c

Oral

Dosage used preoperatively usually is adequate.b (See Adults: Reduction of Thyroid Gland Vascularity in Preparation for Thyroidectomy under Dosage and Administration.)

Some clinicians recommend 500 mg every 4 hours (approximately 10 drops of a 1-g/mL solution).b Alternatively, 1 mL of strong iodine solution 3 times daily has been suggested.b

Radiation Emergency
Oral

Recommended dosages vary by age, predicted thyroid exposure, and pregnancy and lactation status (see Table 2).138

In pregnant women, generally avoid repeat administration because of risk of blocking fetal thyroid function;138 c e the risks versus benefits of repeat administration in pregnant women depend on the probability of continued radioiodine exposure.149 In lactating women, avoid repeat administration except during continuing severe contamination.138 c e

In patients >18 years of age, administer once daily (every 24 hours)e g until risk of substantial exposure to radioiodines (either by inhalation or ingestion) no longer exists.138 140 c h

Table 2. Recommended Dosages of Potassium Iodide (i.e., Iosat, ThyroSafe, ThyroShield) for Self-medication Before, During, or Immediately Following a Radiation Emergency in Adults138149eg

Patient Group

Predicted Thyroid Exposure

Potassium Iodide Dosage

Pregnant or lactating women

≥5 cGy

One 130-mg dose

>18–40 years of age

≥10 cGy

130 mg once daily

>40 years of age

≥500 cGy

130 mg once daily

Sporotrichosis
Cutaneous or Lymphocutaneous Sporotrichosis
Oral

Initially, 250 mg (approximately 5 drops of a 1-g/mL solution) 3 times daily.124 144 145 Gradually increase dosage as tolerated to a maximum of 2–2.5 g (approximately 40–50 drops of a 1-g/mL solution) 3 times daily.124 144 145

Usual duration of therapy is 3–6 months.124 144 145

Cough
Oral

Usually, 300–650 mg 3 or 4 times daily.a b

Prescribing Limits

Pediatric Patients

Radiation Emergency
Oral

Neonates (birth to 1 month of age): Maximum one dose.138 (See Pediatric Patients: Radiation Emergency under Dosage and Administration.)

Pediatric patients >1 month to 18 years of age: Maximum one dose every 24 hours.b g (See Pediatric Patients: Radiation Emergency under Dosage and Administration.)

Sporotrichosis
Cutaneous or Lymphocutaneous Sporotrichosis
Oral

Children: Maximum 1.25–2 g (approximately 25–40 drops of a 1-g/mL solution) 3 times daily.124 (See Pediatric Use under Cautions.)

Adults

Radiation Emergency
Oral

Pregnant and lactating women: Maximum one dose except during continuing severe contamination.138 c (See Adults: Radiation Emergency under Dosage and Administration.)

Adults >18 years of age: Maximum 1 dose every 24 hours.138 140 c (See Adults: Radiation Emergency under Dosage and Administration.)

Sporotrichosis
Cutaneous or Lymphocutaneous Sporotrichosis
Oral

Maximum 2–2.5 g (approximately 40–50 drops of a 1-g/mL solution) 3 times daily.124 144 145

Cautions for Potassium Iodide

Contraindications

  • Known hypersensitivity to iodides or any ingredient in the formulation.a b e f g h j

  • Hypocomplementemic vasculitis.e g h j

  • Dermatitis herpetiformis.e g h j

  • Nodular thyroid disease (e.g., multinodular goiter) with heart disease.e g h

  • Active tuberculosis.f

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity

May cause fetal harm (i.e., abnormal thyroid function, fetal goiter).a b c i If used during pregnancy or if pregnancy occurs during therapy, apprise of potential fetal hazard.a

Use during Radiation Emergency

Use with cautionh and as directed in patients with preexisting thyroid diseases; however, consult clinician if therapy must be administered for more than a few days.e g

Eye or Skin Exposure

Possible vesication and desquamation if strong iodine solution is allowed to pool in contact with skin.f Remove excess iodine with alcohol to prevent “iodine burns”.f

If accidental contact with the skin or eyes occurs, flush with copious amounts of water for 15 minutes.f

Sensitivity Reactions

Hypersensitivity Reactions

Angioedema, cutaneous and mucosal hemorrhage, and signs and symptoms resembling serum sickness (e.g., fever, arthralgia, lymph node enlargement, eosinophilia) may occur.a b Urticaria, thrombotic thrombocytopenic purpura, and fatal periarteritis also may occur.b

Patients with hypocomplementemic vasculitis associated with chronic urticaria or systemic lupus erythematosus are at increased risk of developing severe systemic illness;b avoid use in patients with hypocomplementemic vasculitis.e g h (See Contraindications under Cautions.)

Avoid use in patients with dermatitis herpetiformis.e g h (See Contraindications under Cautions.)

If hypersensitivity reaction occurs, discontinue therapy.f

Major Toxicities

Iodism (Chronic Iodine Poisoning)

Iodism (chronic iodine poisoning) may occur following long-term therapy or with use of high dosages.a b f Manifestations include burning in mouth or throat, severe headache, metallic taste, soreness of teeth and gums, head cold symptoms, coryza, sneezing, eye irritation with eyelid swelling, unusual increase in salivation, acneiform lesions in seborrheic areas, and, rarely, severe and sometimes fatal skin eruptions (ioderma).a b d Productive cough, pulmonary edema, and swelling/tenderness of parotid and submaxillary glands, inflammation of the pharynx/larynx/tonsils, gastric irritation, and diarrhea (sometimes bloody) also may occur.b

If manifestations of iodism occur, discontinue potassium iodide and initiate appropriate supportive therapy.a Symptoms usually resolve soon after discontinuance of drug;a b abundant fluid and salt intake may help eliminate iodide.a

General Precautions

Alterations in Thyroid Function

Long-term use may induce hyperthyroidism, particularly in older individuals, in patients with preexisting nontoxic nodular goiter, and in areas with endemic iodine deficiency.a j k

Long-term use of excessive dosages may result in goiter and severe hypothyroidism.a b c d j

Use with caution in patients with preexisting thyroid disease (multinodular goiter, Graves’ disease, autoimmune thyroiditis).j

Concomitant Illnesses

Use with caution in patients with Addison’s disease, cardiac disease, myotonia congenita, or renal impairment.a b

Specific Populations

Pregnancy

Category D.a i (See Fetal/Neonatal Morbidity under Cautions.)

Short-term therapy (e.g., for management of thyrotoxic crisis, 10-day course in preparation for thyroidectomy) used by some clinicians without evidence of adverse fetal effects.b i

FDA recommends that pregnant women receive potassium iodide during a radiation emergency for their own protection and that of the fetus.138 (See Adults: Radiation Emergency under Dosage and Administration.)

Use as expectorants during pregnancy considered by AAP to be contraindicated.i Long-term therapy considered by most clinicians to be contraindicated.b

Lactation

Distributed into milk;a possible rash and thyroid suppression in infant.a AAP considers potassium iodide to be compatible with breast-feeding.i

FDA recommends that lactating women receive potassium iodide during a radiation emergency for their own protection.138 Because radioactive iodine is distributed into milk, experts (including AAP) recommend that lactating women temporarily not breast-feed after the release of radioiodines, unless no alternative is available;149 breast-feeding can resume when public health authorities declare it safe to do so.149 However, because administration of potassium iodide to lactating women potentially can reduce the radioiodine content of milk, FDA suggests that infants whose mothers receive potassium iodide after radioiodine exposure may breast-feed.138 149 Avoid repeat administration of potassium iodide in nursing women, except during continuing severe contamination;138 however, if repeat doses are required, monitor nursing neonate for potential development of hypothyroidism.138

Pediatric Use

Safety and efficacy not established according to manufacturer.a

Because benefits exceed potential risks, FDA recommends that all pediatric patients receive potassium iodide during a radiation emergency.140 (See Pediatric Patients: Radiation Emergency under Dosage and Administration.) In neonates (birth to 1 month of age) receiving potassium iodide, monitor for development of hypothyroidism (by measuring TSH concentrations and, if indicated, free T4) and initiate thyroid replacement therapy if hypothyroidism occurs.138

Common Adverse Effects

Stomach upset,a diarrhea,a e g nausea,a e g vomiting,a e g stomach pain,a e g skin rash,a e g salivary gland swellinga e g or tenderness.a

Interactions for Potassium Iodide

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

ACE inhibitors (e.g., captopril, enalapril)

Possible hyperkalemia, cardiac arrhythmias, or cardiac arresta

Antithyroid agents (e.g., methimazole, propylthiouracil)

Possible potentiation of hypothyroid and goitrogenic effects of antithyroid agents127 a

Diuretics, potassium-sparing

Possible hyperkalemia, cardiac arrhythmias, or cardiac arresta b

Lithium

Possible additive or synergistic hypothyroid effect126 127 128 129 132 133 134 135 136 137 a

Hypothyroidism reported128 131 134 135 136

Generally avoid concomitant use; if used concomitantly, monitor closely for signs and symptoms of hypothyroidism127 128 129 131 135 136

Potassium-containing drugs

Possible hyperkalemia, cardiac arrhythmias, or cardiac arrest137 a

Test for thyroid function

Possible altered thyroid function test resultsa

Potassium Iodide Pharmacokinetics

Absorption

Bioavailability

Dietary iodine is well (>90%) absorbed under normal conditions.142

Onset

Effects on thyroid function usually observed within 24 hours and are maximal after 10–15 days of continuous therapy.b

Duration

When administered during a radiation emergency, protective effect lasts 24 hours.138 c

Distribution

Extent

Distributes selectively into thyroid gland in amounts required for adequate thyroid hormone synthesis.142 Also distributes to a minor extent into salivary glands, breast, choroid plexus, and gastric mucosa.142

Readily crosses the placenta and is distributed into milk.138 a b f i

Elimination

Elimination Route

Iodide not concentrated in thyroid gland is excreted principally in urine.142

Stability

Storage

Oral

Tablets

20–25°C; keep dry and foil intact.e

Oral Solution

65-mg/mL solution: Tight containers at 25°C (may be exposed to 15–30°C); protect from light.g

Saturated (1-g/mL) solution: Tight, light resistant containers at 15–30°C; protect from light.a Crystallization may occur following exposure to cold temperatures; crystals will dissolve with warming and shaking of solution.a Discard if solution turns brownish-yellow.a

Extemporaneously prepared solution (potassium iodide in water and raspberry syrup, low-fat chocolate milk, orange juice, or soda): Store in refrigerator and use within 7 days.140 e

Strong iodine solution: Tight containers, preferably at temperatures ≤35°C.b

Actions

  • Iodine participates in a complex series of reactions in the thyroid gland to produce the thyroid hormones T4 and triiodothyronine (T3).142 Thyroid hormones are essential for human life as they regulate many key biochemical reactions (e.g., protein synthesis, enzymatic activity) and target the developing brain, muscle, heart, pituitary, and kidneys.142

  • In patients with hyperthyroidism, iodide rapidly inhibits release of thyroid hormones via direct effect on the thyroid gland and inhibits synthesis of thyroid hormones.b d Also attenuates effects of TSH mediated via cAMPb and decreases vascularity of thyroid gland.c

  • When administered before or promptly after radioactive iodine exposure, potassium iodide blocks or reduces accumulation of radioactive iodine in the thyroid gland.100 138 141

  • Mechanism of antifungal activity against S. schenckii not determined.143 144 145 147 Does not appear to increase monocyte or neutrophil killing of S. schenckii;143 147 however, exposure of yeast form of S. schenckii to various concentrations of iodine (iodine and potassium iodide solution) has resulted in rapid cell destruction.143 148

  • Mechanism of expectorant activity not clearly established; however, drug thought to increase respiratory tract secretions and thereby decrease mucus viscosity.a b

Advice to Patients

  • During a radiation emergency, importance of understanding the nature of the radiation hazard and the potential benefits and adverse effects of potassium iodide.102 Importance of administering potassium iodide only as directed by public health authorities.e g Necessity of adhering to other emergency measures recommended by public health authorities.e g

  • If hypersensitivity reaction (e.g., difficulty breathing/speaking/swallowing, wheezing, shortness of breath, swelling of mouth//tongue/throat), irregular heart beat, or chest pain occurs, discontinue potassium iodide and seek medical care immediately.e g

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a Necessity for clinicians to advise pregnant women of risk to the fetus.a

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a

  • Importance of informing patients of other important precautionary information.a (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Potassium Iodide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

65 mg/mL

ThyroShield (with parabens and propylene glycol)

Fleming

1 g/mL*

SSKI

Upsher-Smith

Tablets

65 mg

ThyroSafe (scored)

Recip US

130 mg

Iosat (scored)

Anbex

Strong Iodine Solution

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

Iodine 50 mg/mL and Potassium Iodide 100 mg/mL

Iodine Strong Solution

Marlex

Lugol’s Solution

Humco

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

SSKI 1GM/ML Solution (UPSHER-SMITH): 237/$163.41 or 474/$308.64

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions February 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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101. Federal Emergency Management Agency. Federal policy on distribution of potassium iodide around nuclear power sites for use as a thyroidal blocking agent. Fed Regist. 1985; 50:25624-5.

102. Food and Drug Administration. Potassium iodide as a thyroid-blocking agent in a radiation emergency: final recommendations on use. Fed Regist. 1982; 47:28158-9.

103. Food and Drug Administration. Potassium iodide as a thyroid-blocking agent in a radiation emergency: changes to labeling guideline. Fed Regist. 1979; 44:48347-8.

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142. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary reference intakes for vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. Washington, DC: National Academy Press; 2001. (Prepublication copy uncorrected proofs.)

143. Sterling JB, Heymann WR. Potassium iodide in dermatology: a 19th century drug for the 21st century—uses, pharmacology, adverse effects, and contraindications. J Am Acad Dermatol. 2000; 43:691-7. [IDIS 454006] [PubMed 11004629]

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a. Upsher-Smith Laboratories. SSKI (potassium iodide) oral solution, USP (saturated) 1 g/mL prescribing information. Minneapolis, MN; 2001 Sept.

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e. Anbex Inc. Iosat (potassium iodide tablets, 130 mg) consumer package insert. New York, NY. From Anbex website. Accessed 2007 Nov 11.

f. Humco. Strong iodine (Lugol’s) solution, USP prescribing information. Texarkana, TX; undated.

g. Fleming Pharmaceuticals. ThyroShield (potassium iodide oral solution, 65 mg/mL) consumer package insert. St. Louis, MO; 2005 Jan.

h. Food and Drug Administration. Frequently asked questions on potassium iodide (KI). From FDA website. 2006 Mar 6.

i. Potassium iodide. In: Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:1326-7.

j. Food and Drug Administration. Guidance: Potassium iodide as a thyroid blocking agent in radation emergencies. From FDA website.

k. American Association of Clinical Endocrinologists. Medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism, 2006 amended version. Endocr Pract. 2002; 8:457-69. [PubMed 15260011]

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