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IVERMECTIN

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Overview

What is SOOLANTRA?

SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. It is intended for topical use.

Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones.

Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A, generally referred to as 22,23-dihydroavermectin B and B or HB and HB, respectively; and the ratio (calculated by area percentage) of component HB/(HB + HB) is not less than 90.0%. The respective empirical formulas of HB and HB are CHO and CHO with molecular weights of 875.10 and 861.07 respectively.

The structural formulas are:

Component HB: R = CH, Component HB: R = CH.

SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.



What does SOOLANTRA look like?



What are the available doses of SOOLANTRA?

Cream, 1%, supplied in tubes of 30 g, 45 g and 60 g. ()

What should I talk to my health care provider before I take SOOLANTRA?

How should I use SOOLANTRA?

SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.

Apply to the affected areas of the face once daily. Use a pea-size amount for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer, avoiding the eyes and lips. SOOLANTRA cream is not for oral, ophthalmic, or intravaginal use.


What interacts with SOOLANTRA?

Sorry No Records found


What are the warnings of SOOLANTRA?

Sorry No Records found


What are the precautions of SOOLANTRA?

Sorry No Records found


What are the side effects of SOOLANTRA?

Sorry No records found


What should I look out for while using SOOLANTRA?

None.


What might happen if I take too much SOOLANTRA?

In accidental or significant exposure to unknown quantities of veterinary formulations of ivermectin in humans, either by ingestion, inhalation, injection, or exposure to body surfaces, the following adverse effects have been reported most frequently: rash, edema, headache, dizziness, asthenia, nausea, vomiting, and diarrhea. Other adverse effects that have been reported include: seizure, ataxia, dyspnea, abdominal pain, paresthesia, urticaria, and contact dermatitis.

In case of accidental ingestion, supportive therapy, if indicated, should include parenteral fluids and electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if clinically significant hypotension is present. Induction of emesis and/or gastric lavage as soon as possible, followed by purgatives and other routine anti-poison measures, may be indicated if needed to prevent absorption of ingested material.


How should I store and handle SOOLANTRA?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow cream, supplied in a laminated tube with a child resistant cap in the following sizes:30 gram 0299-3823-3045 gram 0299-3823-4560 gram 0299-3823-60 StorageSOOLANTRA (ivermectin) cream, 1% is a white to pale yellow cream, supplied in a laminated tube with a child resistant cap in the following sizes:30 gram 0299-3823-3045 gram 0299-3823-4560 gram 0299-3823-60 Storage


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism of action of SOOLANTRA cream in treating rosacea lesions is unknown.

Non-Clinical Toxicology
None.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical trials, 2047 subjects with inflammatory lesions of rosacea received SOOLANTRA cream once daily. A total of 1555 subjects were treated once daily for more than 12 weeks, and 519 for approximately one year. Adverse reactions, reported in ≤ 1% of subjects treated with SOOLANTRA cream for at least 3 months in vehicle-controlled clinical trials, included skin burning sensation and skin irritation.In postmarketing use with Soolantra, occurrences of contact dermatitis and allergic dermatitis have been reported.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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