Strong Iodine Solution

Class: Antithyroid Agents
Note: This monograph also contains information on Potassium Iodide
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 Strong Iodine Solution

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}

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 therapy^{109 143 144 145} 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

Strong Iodine Solution 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 Strong Iodine Solution

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 caution^h 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 swelling^{a e g} or tenderness.^a

Interactions for Strong Iodine Solution

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

Strong Iodine Solution 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

ActionsActions

• 
  

  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 cAMP^b 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

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 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.

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