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Rx Item-Mentax 1% Cream 30Gm By Mylan Pharma

NDC 00378-6151-49 UPC/GTIN No.3-03786-15149-3 Mfg.Part No.615149BRAND: MENTAX NDC: 00378-6151-49,378615149 UPC: 3-03786-15149-3,303786151493 Mylan PharmaOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Mentax 1% Cream 30Gm By Mylan Pharma

$225.33$213.82

Item No.:RX503334 NDC No.378615149 UPC No.:303786151493 NDC No. 00378-6151-49 UPC/GTIN No. 3-03786-15149-3 MPN 615149 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx503334 Mentax 1% Cream 30gm by Mylan Pharma Item No. 3503334 NDC No. 00378615149 UPC No. 303786151493 Other Name Mentax, butena

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MENTAX- butenafine hydrochloride cream
Mylan Pharmaceuticals Inc.

DESCRIPTION

Mentax� Cream, 1%, contains the synthetic antifungal agent, butenafine hydrochloride. Butenafine is a member of the class of antifungal compounds known as benzylamines which are structurally related to the allylamines.

Butenafine HCl is designated chemically as N-4-tert -butylbenzyl-N-methyl-1-naphthalenemethylamine hydrochloride. The compound has the molecular formula C23 H27 N�HCl, a molecular weight of 353.93. Butenafine HCl is a white, odorless, crystalline powder. It is freely soluble in methanol, ethanol, and chloroform, and slightly soluble in water. Each gram of Mentax� Cream, 1%, contains 10 mg of butenafine HCl in a white cream base of purified water USP, propylene glycol dicaprylate, glycerin USP, cetyl alcohol NF, glyceryl monostearate SE, white petrolatum USP, stearic acid NF, polyoxyethylene (23) cetyl ether, benzyl alcohol NF, diethanolamine NF, and sodium benzoate NF.

CLINICAL PHARMACOLOGY

Pharmacokinetics
In one study conducted in healthy subjects for 14 days, 6 grams of Mentax� Cream, 1%, was applied once daily to the dorsal skin (3,000 cm2) of 7 subjects, and 20 grams of the cream was applied once daily to the arms, trunk and groin areas (10,000 cm2) of another 12 subjects. After 14 days of topical applications, the 6-gram dose group yielded a mean peak plasma butenafine HCl concentration, Cmax of 1.4 � 0.8 ng/mL, occurring at a mean time to the peak plasma concentration, Tmax, of 15 � 8 hours, and a mean area under the plasma concentration-time curve, AUC0-24 hrs of 23.9 � 11.3 ng-hr/mL. For the 20-gram dose group, the mean Cmax was 5.0 � 2.0 ng/mL, occurring at a mean Tmax of 6 � 6 hours, and the mean AUC0-24 hrs was 87.8 � 45.3 ng-hr/mL. A biphasic decline of plasma butenafine HCl concentrations was observed with the half-lives estimated to be 35 hours and > 150 hours, respectively.

At 72 hours after the last dose application, the mean plasma concentrations decreased to 0.3 � 0.2 ng/mL for the 6-gram dose group and 1.1 � 0.9 ng/mL for the 20-gram dose group. Low levels of butenafine HCl remained in the plasma 7 days after the last dose application (mean: 0.1 � 0.2 ng/mL for the 6-gram dose group, and 0.7 � 0.5 ng/mL for the 20-gram dose group). The total amount (or % dose) of butenafine HCl absorbed through the skin into the systemic circulation has not been quantitated. It was determined that the primary metabolite in urine was formed through hydroxylation at the terminal t -butyl side-chain.

In 11 patients with tinea pedis, butenafine HCl cream, 1%, was applied by the patients to cover the affected and immediately surrounding skin area once daily for 4 weeks, and a single blood sample was collected between 10 and 20 hours following dosing at 1, 2 and 4 weeks after treatment. The plasma butenafine HCl concentration ranged from undetectable to 0.3 ng/mL.

In 24 patients with tinea cruris, butenafine HCl cream, 1%, was applied by the patients to cover the affected and immediately surrounding skin area once daily for 2 weeks (mean average daily dose: 1.3 � 0.2 g). A single blood sample was collected between 0.5 and 65 hours after the last dose, and the plasma butenafine HCl concentration ranged from undetectable to 2.52 ng/mL (mean � SD: 0.91 � 0.15 ng/mL). Four weeks after cessation of treatment, the plasma butenafine HCl concentration ranged from undetectable to 0.28 ng/mL.

Microbiology
Butenafine HCl is a benzylamine derivative with a mode of action similar to that of the allylamine class of antifungal drugs. Butenafine HCl is hypothesized to act by inhibiting the epoxidation of squalene, thus blocking the biosynthesis of ergosterol, an essential component of fungal cell membranes. The benzylamine derivatives, like the allylamines, act at an earlier step in the ergosterol biosynthesis pathway than the azole class of antifungal drugs. Depending on the concentration of the drug and the fungal species tested, butenafine HCl may be fungicidal or fungistatic in vitro. However, the clinical significance of these in vitro data are unknown.

NDC 00378-6151-49 UPC/GTIN No.3-03786-15149-3 Mfg.Part No.615149
RX ITEM-Mentax 1% Cream 30Gm By Mylan Ph
NDC 00378-6151-49 UPC/GTIN No.3-03786-15149-3 Mfg.Part No.615149

BRAND: MENTAX NDC: 00378-6151-49,378615149 UPC: 3-03786-15149-3,303786151493 Mylan Pharma
Mentax 1% Cream 30Gm By Mylan Pharma
BRAND: MENTAX NDC: 00378-6151-49,378615149 UPC: 3-03786-15149-3,303786151493 Mylan Pharma

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
BUTENAFINE HCL TOPICAL CR
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.