Clotrimazole And Betamethasone Dipropionate (Lotrisone)

Trade Name : Lotrisone

Merck Sharp & Dohme Corp.

CREAM

Strength 10.5 mg/gmg/g

CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE Azole Antifungal [EPC],Azoles [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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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 Clotrimazole And Betamethasone Dipropionate (Lotrisone) which is also known as Lotrisone and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 10; .5 mg/g; mg/g per ml. Read more

Clotrimazole And Betamethasone Dipropionate (Lotrisone) 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

LOTRISONE cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to , , and in patients 17 years and older.
LOTRISONE cream contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to , , and in patients 17 years and older. ()

Treatment of tinea corporis or tinea cruris:
Treatment of tinea pedis:
LOTRISONE cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Avoid contact with eyes. Wash hands after each applicationn

Tinea pedis:
Tinea cruris and tinea corporis:
Do not use with occlusive dressings unless directed by a physician. ()
Not for ophthalmic, oral or intravaginal use. ()

Cream, 1%/0.05%. Each gram of LOTRISONE cream contains 10 mg of clotrimazole and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a white to off-white cream base.
Cream, 1%/0.05% ()
Each gram of LOTRISONE cream contains 10 mg of clotrimazole and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) ()

None.
None. ()

No data

LOTRISONE cream can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of the treatment. Risk factor(s) are: use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify use should HPA axis suppression develop. (, )
Pediatric patients may be more susceptible to systemic toxicity. (, )
The use of LOTRISONE cream in the treatment of diaper dermatitis is not recommended. ()
Topical corticosteroid products may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ()

Most common adverse reactions reported for LOTRISONE cream were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients. ()
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

LOTRISONE (clotrimazole and betamethasone dipropionate) cream, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use.
Chemically, clotrimazole is 1u2013(o-chloro-u03b1,u03b1-diphenylbenzyl) imidazole, with the empirical formula CHCLN, a molecular weight of 344.84, and the following structural formula:
Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.
Betamethasone dipropionate has 9-fluoro-11u03b2,17,21-trihydroxy-16u03b2-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula CHFO, a molecular weight of 504.59, and the following structural formula:
Betamethasone dipropionate is a white to creamy-white, odorless crystalline powder, insoluble in water.
Each gram of LOTRISONE cream contains 10 mg clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a white to off-white, hydrophilic cream consisting of benzyl alcohol as a preservative, ceteareth-30, cetyl alcohol plus stearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, and white petrolatum.

No data

Long-term animal studies have not been performed to evaluate the carcinogenic potential of the combination of clotrimazole and betamethasone dipropionate or either component individually.
Betamethasone was negative in the bacterial mutagenicity assay ( and ) and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.
In a combined study of the effects of clotrimazole on fertility, embryofetal development, and postnatal development, male and female rats were dosed orally (diet admixture) with dose levels of 5, 10, 25, or 50 mg/kg/day from 10 weeks prior to mating until 4 weeks postpartum. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted.
Reproductive studies with betamethasone dipropionate conducted in rabbits at doses of 1.0 mg/kg/day by the intramuscular route and in mice up to 33 mg/kg/day by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species.

In clinical trials of tinea corporis, tinea cruris, and tinea pedis, subjects treated with LOTRISONE cream showed a better clinical response at the first return visit than subjects treated with clotrimazole cream. In tinea corporis and tinea cruris, the subject returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Mycological cure rates observed in subjects treated with LOTRISONE cream were as good as, or better than, in those subjects treated with clotrimazole cream. In these same clinical studies, patients treated with LOTRISONE cream showed better clinical responses and mycological cure rates when compared with subjects treated with betamethasone dipropionate cream.

LOTRISONE cream is white to off-white and supplied in 15-gram (NDC 0085-0924-01) and 45-gram tubes (NDC 0085-0924-02), boxes of one. Store at 20-25u00b0C (68-77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature].
Rx only

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform the patient of the following:

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of n Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 1983-2019 Merck Sharp & Dohme Corp., a subsidiary of . All rights reserved.
uspi-mk5335A-cr-1906r005

usppi-mk5335A-cr-1906r005

NDC 0085-0924-01
15 g
Lotrisone
cream,1%/0.05%
FOR TOPICAL USE ONLY,NOT FOR OPHTHALMIC,ORAL, OR INTRAVAGINALUSE, NOT RECOMMENDEDFOR PATIENTS UNDERTHE AGE OF 17 YEARS ANDNOT RECOMMENDED FORDIAPER DERMATITIS.
Rx only

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Clotrimazole And Betamethasone Dipropionate (Lotrisone)

Trade Name : Lotrisone

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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Clotrimazole And Betamethasone Dipropionate (Lotrisone)

Trade Name : Lotrisone

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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