SOOLANTRA™ (ivermectin) cream, 1%
SOOLANTRA™ (ivermectin) cream, 1% is a topical prescription medication used to treat the inflammatory lesions of rosacea. It contains the active ingredient ivermectin, which has both anti-inflammatory and anti-parasitic properties. The cream is applied once a day to the affected areas of the face and has been shown to reduce the number of papules and pustules associated with rosacea.
SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of SOOLANTRA cream contains 10 mg of ivermectin.
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 A1a plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A1a, generally referred to as22,23dihydroavermectin B1a and B1b or H2B1a and H2B1b, respectively; and the ratio (calculated by area percentage) of component H2B1a/(H2B1a + H2B1b)) is not less than 90.0 %.
The respective empirical formulas of H2B1a and H2B1b are C48H74O14 and C47H72O14 with molecular weights of 875.10 and 861.07 respectively.
Component H2B1a: R = C2H5, Component H2B1b: R = CH3.
SOOLANTRA cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citricacid 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.
INDICATIONS AND USAGE
SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.
Mechanism of Action
The mechanism of action of SOOLANTRA cream in treating rosacea lesions is unknown.
DOSAGE AND ADMINISTRATION
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.
CONTRAINDICATIONS
None.
ADVERSE REACTIONS
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Local adverse reactions: contact dermatitis and allergic dermatitis.
DRUG INTERACTIONS
In vitro studies have shown that SOOLANTRA cream, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.
USE IN SPECIFIC POPULATIONS
Pregnancy: The available data on the use of ivermectin, including SOOLANTRA cream, in pregnant women are insufficient to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Lactation: The presence of ivermectin in human milk following topical administration of ivermectin has not been evaluated. There are no data available regarding the effects of ivermectin on milk production. Published literature suggests that ivermectin was detectable in human milk in 4 lactating women after a single 150 mcg/kg oral dose of ivermectin. However, there is insufficient information from this report to determine the effects of ivermectin on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Soolantra cream and any potential adverse effects on the breastfed infant from Soolantra cream or from the underlying maternal conditions.
Pediatric Use: Safety and effectiveness of SOOLANTRA cream in pediatric patients have not been established.
OVERDOSAGE
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.
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LINKS
- https://www.soolantra.com/#:~:text=Indication%3A%20SOOLANTRA%C2%AE%20(ivermectin),burning%20sensation%20and%20skin%20irritation.
- https://www.rxlist.com/soolantra-drug.htm
- https://www.soolantra.com/what-is-soolantra-made-of
- https://www.pbm.va.gov/PBM/clinicalguidance/drugmonographs/Ivermectin_Cream_SOOLANTRA_Monograph.pdf
- https://www.drugs.com/soolantra.html
- https://thedrugs.store/drug/5937/soolantra-ivermectin-cream-1
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1d5b166-ab06-4ab5-b0c6-31126238118a
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