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NDC 71740-0112-30 SSKI 1 g/mL Details
SSKI 1 g/mL
SSKI is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Avondale Pharmaceuticals, LLC. The primary component is POTASSIUM IODIDE.
MedlinePlus Drug Summary
Potassium iodide is used to protect the thyroid gland from taking in radioactive iodine that may be released during a nuclear radiation emergency. Radioactive iodine can damage the thyroid gland. You should only take potassium iodide if there is a nuclear radiation emergency and public officials tell you that you should take it. Potassium iodide is in a class of medications called anti-thyroid medications. It works by blocking radioactive iodine from entering the thyroid gland. Potassium iodide can protect you from the effects of radioactive iodine that may be released during a nuclear radiation emergency, but will not protect you from other dangerous substances that may be released during the emergency. Public officials may tell you to do other things to protect yourself during the emergency. Follow all of these directions carefully.
Related Packages: 71740-0112-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Potassium Iodide
Product Information
| NDC | 71740-0112 |
|---|---|
| Product ID | 71740-112_c4fa3bda-4300-446d-a12a-cd6592461e30 |
| Associated GPIs | 43202010002060 |
| GCN Sequence Number | 001676 |
| GCN Sequence Number Description | potassium iodide SOLUTION 1 G/ML ORAL |
| HIC3 | C3H |
| HIC3 Description | IODINE CONTAINING AGENTS |
| GCN | 05011 |
| HICL Sequence Number | 000748 |
| HICL Sequence Number Description | POTASSIUM IODIDE |
| Brand/Generic | Brand |
| Proprietary Name | SSKI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Potassium Iodide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/mL |
| Substance Name | POTASSIUM IODIDE |
| Labeler Name | Avondale Pharmaceuticals, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 71740-0112-30 (71740011230)
| NDC Package Code | 71740-112-30 |
|---|---|
| Billing NDC | 71740011230 |
| Package | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (71740-112-30) / 30 mL in 1 BOTTLE, WITH APPLICATOR |
| Marketing Start Date | 2017-11-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ca1d3449-ea29-49a4-8863-365ec95f1553 Details
Description
Clinical Pharmacology
Indications and Usage
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
General
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.
Drug Interactions
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.
Adverse Reactions
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.
Dosage and Administration
How 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.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed and protected from light.
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.
Notice: 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.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
INGREDIENTS AND APPEARANCE
| SSKI
potassium iodide solution |
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| Labeler - Avondale Pharmaceuticals, LLC (080843532) |