Ivermectin (Soolantra)

Trade Name : SOOLANTRA

Galderma Laboratories, L.P.

CREAM

Strength 10 mg/g

IVERMECTIN Antiparasitic [EPC],Pediculicide [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ivermectin (Soolantra) which is also known as SOOLANTRA and Manufactured by Galderma Laboratories, L.P.. It is available in strength of 10 mg/g per ml. Read more

Ivermectin (Soolantra) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

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

Apply to the affected areas once daily. ()
Not for oral, ophthalmic or intravaginal use. ()

Cream, 1%.Each gram of SOOLANTRA cream contains 10 mg of ivermectin in a white to pale yellow cream base. SOOLANTRA cream is supplied in tubes of 30 g, 45 g and 60 g.
Cream, 1%, supplied in tubes of 30 g, 45 g and 60 g. ()

None.
None. ()

In controlled clinical trials with SOOLANTRA the most common adverse reactions (incidence u2264 1 %) included skin burning sensation and skin irritation. ()
To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or n

In vitro studies have shown that SOOLANTRA cream, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.

No data

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.

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.

No data

In a 2-year dermal mouse carcinogenicity study, ivermectin was administered to CD-1 mice at topical doses of 1, 3, and 10 mg/kg/day (0.1%, 0.3% and 1% ivermectin cream applied at 2 ml/kg/day). No drug-related tumors were noted in this study up to the highest dose evaluated in this study of 10 mg/kg/day (747X maximum topical human dose [MTHD]).
In a 2-year oral rat carcinogenicity study, ivermectin was administered to Wistar rats at gavage doses of 1, 3, and 9 mg/kg/day. A statistically significant increase in the incidence of hepatocellular adenoma was noted in males treated with 9 mg/kg/day (1766X MTHD) ivermectin. The clinical relevance of this finding is unknown. No drug-related tumors were noted in females up to the highest dose evaluated in this study of 9 mg/kg/day (1959X MTHD). No drug-related tumors were noted in males at doses u2264 3 mg/kg/day (599X MTHD).
Ivermectin revealed no evidence of genotoxic potential based on the results of two in vitro genotoxicity tests (the Ames test and the L5178Y/TK mouse lymphoma assay) and one in vivo genotoxicity test (rat micronucleus assay).
In a fertility study, oral doses of 0.1, 1 and 9 mg/kg/day ivermectin were administered to male and female rats. Mortality occurred at 9 mg/kg/day (1027X MTHD). The precoital period was generally prolonged at 9 mg/kg/day. No treatment-related effects on fertility or mating performance were noted at doses u2264 1 mg/kg/day (68X MTHD).

SOOLANTRA cream applied once daily at bedtime was evaluated in the treatment of inflammatory lesions of rosacea in two randomized, double-blind, vehicle controlled clinical trials, which were identical in design. The trials were conducted in 1371 subjects aged 18 years and older who were treated once daily for 12 weeks with either SOOLANTRA cream or vehicle cream.
Overall, 96% of subjects were Caucasian and 67% were female. Using the 5-point Investigator Global Assessment (IGA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe), 79% of subjects were scored as moderate (IGA=3) and 21% scored as severe (IGA= 4) at baseline.
The co-primary efficacy endpoints in both pivotal trials were the success rate based on the IGA outcome (percentage of subjects u201cclearu201d and u201calmost clearu201d) and absolute change from baseline in inflammatory lesion counts at Week 12. Table 1 presents the co-primary efficacy results at Week 12. SOOLANTRA cream was more effective than vehicle cream on the co-primary efficacy endpoints starting from 4 weeks of treatment in both studies, see Figures 1 through 4.
Figures 1 and 2: IGA Success Rates Over Time
Figures 3 and 4: Mean Absolute Change in Inflammatory Lesion Counts from Baseline Over Time

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 0299-3823-60n
Storage

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).
Patients using SOOLANTRA cream should receive the following instruction:
Keep out of reach of children.
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USA
Made in Canada.
P52476-2

SOOLANTRA (soo lan' trah) (ivermectin) cream, 1%
Important:
Read and follow the steps below so that you use SOOLANTRA cream correctly:
1. Open the tube of SOOLANTRA cream by gently pressing down on the child resistant cap and twist in the direction of the arrow (counterclockwise) as shown below. See Figures A and B. To avoid spilling, do not squeeze the tube while opening or closing.
2. To apply SOOLANTRA cream to your face, squeeze a pea-sized amount of SOOLANTRA cream from the tube onto your fingertip. See Figure C.
3. Apply SOOLANTRA to the affected areas of your face once a day. Use a pea-sized amount of SOOLANTRA cream for each area of your face (forehead, chin, nose, each cheek) that is affected. Spread the cream smoothly and evenly in a thin layer. Avoid contact with your eyes and lips.
4. To close SOOLANTRA cream, gently press down on the child resistant cap and twist to the right (clockwise). See Figure D.
How should I store SOOLANTRA cream?
Keep SOOLANTRA cream out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, TX 76177 USA
Made in Canada.
Issued: July 2018
P52476-2

NDC 0299-3823-30
soolantran
(ivermectin) cream, 1%
NET WT. 30 g
Rx only
For Topical Use Only
Keep Out of Reach of Children
GALDERMA

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Ivermectin (Soolantra)

Trade Name : SOOLANTRA

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Ivermectin (Soolantra)

Trade Name : SOOLANTRA

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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CONTACT US

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