Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 75834-280 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Potassium iodide |
||||||
| Type | Generic | ||||||
| Active Ingredients |
|
||||||
| Route | ORAL | ||||||
| Dosage Form | SOLUTION | ||||||
| RxCUI drug identifier | 312541 | ||||||
| Labeler Name | Nivagen Pharmaceuticals, Inc. | ||||||
| Packages |
|
||||||
| Check if available Online | Get Medication Prices online with Discount |
Overdosage of POTASSIUM IODIDE
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Drug and or laboratory test interactions
Information about any known interference by the drug with laboratory tests.DRUG & OR LABORATORY TEST INTERACTIONS Thyroid function tests may be altered by iodide.
POTASSIUM IODIDE Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Potassium iodide is thought to act as an expectorant by increasing respiratory tract secretions and thereby decreasing the viscosity of mucus.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Contraindicated in patients with a known sensitivity to iodides.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Potassium iodide oral solution, USP is a saturated solution of potassium iodide containing 1 gram of potassium iodide per mL.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE & ADMINISTRATION Adults 0.3 ml (300 mg) or 0.6 ml (600 mg) diluted in one glassful of water, fruit juice or milk 3 to 4 times daily. To minimize gastric irritation, take with food or milk. This medication should be used no longer than necessary to produce the desired effect.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS & USAGE 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.
Spl product data elements
Usually a list of ingredients in a drug product.POTASSIUM IODIDE POTASSIUM IODIDE POTASSIUM IODIDE IODIDE ION SODIUM THIOSULFATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 75834-280-30 Potassium Iodide Oral Solution, USP (saturated) 1 g/mL 1 Fluid Oz. (30 mL) Rx only NIVAGEN NDC 75834-280-08 Potassium Iodide Oral Solution, USP (saturated) 1 g/mL 8 Fluid Oz. (237 mL) Rx only NIVAGEN 30_bottle.jpg 237_bottle.jpg
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.NURSING MOTHERS Potassium iodide is excreted in breast milk. Use by nursing mothers may cause skin rash and thyroid suppression in the infant.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.PEDIATRIC USE Safety and effectiveness in children have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)PREGNANCY see " Warnings " section.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Potassium iodide oral solution, USP is supplied in 1 fluid ounce (30 ml) bottles (NDC 75834-280-30) 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 75834-280-08). 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. Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA Toll free number: 1-877-977-0687 Revised: 01/2022
General precautions
Information about any special care to be exercised for safe and effective use of the drug.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.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.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. DRUG & OR LABORATORY TEST INTERACTIONS Thyroid function tests may be altered by iodide. PREGNANCY see " Warnings " section. NURSING MOTHERS Potassium iodide is excreted in breast milk. Use by nursing mothers may cause skin rash and thyroid suppression in the infant. PEDIATRIC USE Safety and effectiveness in children have not been established.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API