Sski
Potassium Iodide
Avondale Pharmaceuticals, Llc
Human Prescription Drug
NDC 71740-112Sski also known as Potassium Iodide is a human prescription drug labeled by 'Avondale Pharmaceuticals, Llc'. National Drug Code (NDC) number for Sski is 71740-112. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Sski drug includes Potassium Iodide - 1 g/mL . The currest status of Sski drug is Active.
Drug Information:
| Drug NDC: | 71740-112 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sski |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Potassium Iodide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Avondale Pharmaceuticals, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | POTASSIUM IODIDE - 1 g/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 13 Nov, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Avondale Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312541
544597
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0371740112309
|
| UPC stands for Universal Product Code. |
| UNII: | 1C4QK22F9J
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 71740-112-30 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (71740-112-30) / 30 mL in 1 BOTTLE, WITH APPLICATOR | 13 Nov, 2017 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Sski potassium iodide potassium iodide iodide ion sodium thiosulfate
Drug Interactions:
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.
Indications and Usage:
Indications and usage 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.
Warnings:
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.
General 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.
Dosage and Administration:
Dosage and 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.
Contraindications:
Contraindications contraindicated in patients with a known sensitivity to iodides.
Adverse Reactions:
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 appropria
Read more...te 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 Interactions:
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.
Use in Pregnancy:
Pregnancy see " warnings " section.
Pediatric Use:
Pediatric use safety and effectiveness in children have not been established.
Overdosage:
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.
Description:
Description sski ® (potassium iodide oral solution, usp) is a saturated solution of potassium iodide containing 1 gram of potassium iodide per ml.
Clinical Pharmacology:
Clinical pharmacology potassium iodide is thought to act as an expectorant by increasing respiratory tract secretions and thereby decreasing the viscosity of mucus.
How Supplied:
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.
Package Label Principal Display Panel:
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 principal display panel - 30 ml bottle label