SSKI Oral Solution: Package Insert / Prescribing Info

SSKI Oral Solution Description

SSKI® (potassium iodide oral solution, USP) is a saturated solution of potassium iodide containing 1 gram of potassium iodide per mL.

SSKI Oral Solution - Clinical Pharmacology

Potassium iodide is thought to act as an expectorant by increasing respiratory tract secretions and thereby decreasing the viscosity of mucus.

Indications and Usage for SSKI Oral Solution

SSKI® (potassium iodide oral solution, USP) is for use as an expectorant in the symptomatic treatment of chronic pulmonary diseases where tenacious mucus complicates the problem, including bronchial asthma, bronchitis and pulmonary emphysema.

Contraindications

Contraindicated in patients with a known sensitivity to iodides.

Warnings

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.

Precautions

Adverse Reactions/Side Effects

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 If symptoms of iodism appear, the drug should be withdrawn and the patient given appropriate supportive therapy.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.

Overdosage

Acute toxicity from potassium iodide is relatively rare. An occasional individual may show marked sensitivity and the onset of acute poisoning can occur immediately or hours after administration. Angioedema, laryngeal edema and cutaneous hemorrhages may occur.

Iodism or chronic iodine poisoning may occur during prolonged treatment or with the use of high doses. Symptoms of iodism typically disappear soon after discontinuation of the drug. Abundant fluid and salt intake aids in iodide elimination.

SSKI Oral Solution Dosage and Administration

How is SSKI Oral Solution supplied

SSKI® (potassium iodide oral solution, USP) is supplied in 1 fluid ounce (30 ml) bottles (NDC 71740-112-30) 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 (NDC 71740-112-08). Inactive ingredient: Sodium thiosulfate as a preservative.

Manufactured for
Avondale Pharmaceuticals, LLC
Birmingham, AL 35209

112886-02

Revised 0420

© 2020 Avondale Pharmaceuticals, LLC

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC 71740-112-30

SSKI®

Potassium Iodide
Oral Solution, USP
(saturated)

1 g/mL

1 Fluid Oz.
(30 mL)
Rx only

AVONDALE