Advertisement

Topics

Rx OnlySelenium Sulfide2.25% Shampoo | Selenium Sulfide [Acella Pharmaceuticals, LLC] | BioPortfolio

12:24 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

​DESCRIPTION: A liquid antiseborrheic, antifungal preparation for topical application. Each mL of Selenium Sulfide 2.25% Shampoo contains 22.5 mg selenium sulfide, ammonium lauryl sulfate, caprylic/capric triglyceride, citric acid, cocamidopropyl betaine, chromium oxide green, FD&C yellow 8, distearyl phthalic acid amide, diazolidinyl urea, edetate disodium, fragrance, hydroxypropyl methylcellulose, magnesium aluminum silicate, methylparaben, panthenol, PPG-2 hydroxyethyl coco/isostearamide, propylene glycol, propylparaben, purified water, FD&C Red 40, sodium citrate, tocopherol acetate, titanium dioxide, urea, and zinc pyrithione.

CLINICAL PHARMACOLOGY: Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, reducing corneocyte production.

PHARMACOKINETICS: The mechanism of action of topically applied selenium sulfide is not yet known.

INDICATIONS & USAGE: A liquid antiseborrheic, antifungal preparation for the treatment of seborrheic dermatitis of the scalp, dandruff and tinea versicolor. Urea hydrates and is useful for conditions such as dry scalp.

CONTRAINDICATIONS: Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.

WARNINGS: For external use only. Not for ophthalmic use.

DO NOT USE ON BROKEN SKIN OR INFLAMED AREAS. If allergic reaction occurs, discontinue use. Avoid contact with eyes, genital areas and skin folds, as irritation and burning may result. If accidental contact occurs, rinse thoroughly with water. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

PRECAUTIONS: This medication is to be used as directed by a physician. Not to be used when inflammation or exudation is present as increased absorption may occur.

CARCINOGENESIS: Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects.

USE IN PREGNANCY:

CATEGORY C

Animal reproduction studies have not been conducted with this medication. It is also not known whether this product can cause fetal harm when applied to the body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances, selenium sulfide 2.25% shampoo should not be used by pregnant women.

NURSING MOTHERS: It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when this product is administered to a nursing woman.

PEDIATRIC USE: Safety and effectiveness in children have not been established.

ADVERSE REACTIONS: In decreasing order of severity: skin irritation; occasional reports of increase in normal hair loss; discoloration of hair (can be avoided or minimized by thorough rinsing of hair after treatment). As with other shampoos, oiliness or dryness of hair and scalp may occur.

OVERDOSAGE: There are no documented reports of serious toxicity in humans resulting from acute ingestion of selenium sulfide 2.25% shampoo. However, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. Evacuation of the stomach contents should be considered in cases of acute oral ingestion.

DOSAGE AND ADMINISTRATION:

SHAKE WELL BEFORE USING For seborrheic dermatitis and dandruff: Generally 2 applications each week for 2 weeks will control symptoms. Subsequently, shampoo may be used less frequently – weekly, every 2 weeks, every 3 to 4 weeks or as directed by a physician. Should not be applied more frequently than necessary to maintain control.For tinea versicolor: Wet skin and apply to affected areas. Massage gently into skin working to a full lather. Allow product to remain on skin for 10 minutes, then rinse thoroughly. Repeat procedure once a day for seven days or as directed by a physician.

HOW SUPPLIED: Selenium Sulfide 2.25% Shampoo is supplied in 6 fluid oz. (180 mL) bottles, NDC 42192-152-06. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing.

All prescription substitutions and / or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or otherequivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, inactive ingredients (excipients) and other chemical information provided herein.

Manufactured for:Acella Pharmaceuticals, LLCAlpharetta, GA 30022Rev 0417-01

NDC 42192-152-06

​Rx Only

​Selenium

Sulfide

2.25%

Shampoo

​6 fluid oz. (180 mL)

FOR TOPICAL USE ONLY

NOT FOR OPTHALMIC USE

Manufacturer

Acella Pharmaceuticals, LLC

Active Ingredients

Source

Drugs and Medications [69 Associated Drugs and Medications listed on BioPortfolio]

Selenium sulfide [a-s medication solutions]

SELENIUM SULFIDE LOTION, USP 2.5%

Selenium sulfide [central texas community health centers]

SELENIUM SULFIDE 2.5% LOTION

Selenium sulfide [morton grove pharmaceuticals, inc.]

SELENIUM SULFIDE LOTION, USP 2.5%

Selenium sulfide [rpk pharmaceuticals, inc.]

Selenium Sulfide Topical Suspension USP, 2.5% (Lotion)

Selenium sulfide [physicians total care, inc.]

SELENIUM SULFIDE TOPICAL SUSPENSION USP, 2.5% (LOTION)

Clinical Trials [87 Associated Clinical Trials listed on BioPortfolio]

Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)

Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo h...

Optimization of Selenoprotein P in Chinese Subjects

The purpose of this study is to determine the amount of selenium as selenomethionine that is required to optimize selenoprotein P in selenium-deficient Chinese subjects

Selenium Supplementation of Patients With Cirrhosis

This study is being conducted to determine if patients with cirrhosis (liver disease) are selenium deficient. The effect of supplementation with two chemical forms of selenium on plasma se...

Selenium Supplementation of Patients With Cirrhosis

The purpose of this study is to determine whether patients with liver cirrhosis can improve their selenium nutritional status by taking supplemental selenium.

Research on Association Between Selenium Deficiencies and Change of Thyroid Function

As one of the essential micronutrients, selenium has important biological functions. However, an effective and convenient method for evaluation of selenium nutritional status has not yet b...

PubMed Articles [561 Associated PubMed Articles listed on BioPortfolio]

Role of extracellular reactive sulfur metabolites on microbial Se(0) dissolution.

The dissolution of elemental selenium [Se(0)] during chemical weathering is an important step in the global selenium cycle. While microorganisms have been shown to play a key role in selenium dissolut...

Selenium-lentinan inhibits tumor progression by regulating epithelial-mesenchymal transition.

Selenium supplementation can be used to treat tumors. However, inorganic selenium is highly toxic, and natural organic selenium is extremely rare. Polysaccharides can improve drug bioavailability and ...

Amorphous nano-selenium quantum dots improve endothelial dysfunction in rats and prevent atherosclerosis in mice through Na/H exchanger 1 inhibition.

Selenium, a trace element involved in important enzymatic activities inside the body, has protective effects against cardiovascular diseases including atherosclerosis. The safe dose of selenium in the...

Evidence that thiol group modification and reactive oxygen species are involved in hydrogen sulfide-induced mitochondrial permeability transition pore opening in rat cerebellum.

We report here the effects of hydrogen sulfide (sulfide), that accumulates in ETHE1 deficiency, in rat cerebellum. Sulfide impaired electron transfer and oxidative phosphorylation. Sulfide also induce...

Kinetics of sulfide precipitation with ferrous and ferric iron in wastewater.

Traditionally, sulfide abatement has been done by adding e.g. ferrous or ferric iron salts to the start of sewer force mains. Iron dosage must hence correspond to an estimate of how much sulfide will ...

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Dermatology
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...

Dermatitis
Dermatitis means an inflammation of the skin. Contact dermatitis is a term used when this inflammation is caused by contact with something in the environment. The changes of dermatitis seen in the skin take the form of eczema; hence it may sometimes be r...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record