MENTAX CREAM

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

BUTENAFINE HYDROCHLORIDE

可用日期:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC代码:

D01AE23

药物剂型:

CREAM

组成:

BUTENAFINE HYDROCHLORIDE 1 %

给药途径:

DERMAL

处方类型:

Required

厂商:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

治疗组:

BUTENAFINE

治疗领域:

BUTENAFINE

疗效迹象:

Interdigital tinea pedis, tinea coporis, tinea cruris . (Treatment in tinea coporis and tinea cruris is limited to up to 4 weeks).

授权日期:

2023-04-30

资料单张

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
MENTAX CREAM
The cream contains Butenafine Hydrochloride at a concentration of 1%.
Inactive ingredients: see section 6 in this leaflet.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
THIS
LEAFLET CONTAINS CONCISE INFORMATION ABOUT THE MEDICINE. Keep this
leaflet.
You may want to read it again. If you have further questions, refer to
the
doctor or pharmacist.
This medicine has been prescribed for you only, to treat your ailment.
Do
not pass it on to others. It may harm them even if it seems to you
that their
medical condition is similar.
THIS MEDICINE IS NOT INTENDED FOR INFANTS AND CHILDREN BELOW THE AGE
OF 12.
1.
WHAT IS THE MEDICINE INTENDED FOR?
An antifungal preparation for interdigital tinea pedis (athlete's
foot), tinea
corporis (ringworm) and tinea cruris (jock itch).
Use of this preparation for ringworm and jock itch is for a period of
up to 4
weeks.
THERAPEUTIC GROUP: Antifungal.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
You are sensitive (allergic) to butenafine hydrochloride or to any of
the other
ingredients in Mentax Cream (see section 6 in this leaflet).
Special attention and caution are required if you are sensitive to
allylamine
antifungals, as you may also be sensitive to Mentax Cream. DRUG INTERACTIONS
IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER MEDICINES, INCLUDING
NON-PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, tell the
doctor
or pharmacist. IF YOU ARE PREGNANT OR BREASTFEEDING, consult the doctor before using
Mentax Cream.
In any case, breastfeeding women must abstain from applying the
preparation
to the breast area.
3.
HOW SHOULD YOU USE THE MEDICINE?
• Always use according to the doctor's instructions.
• Check with the doctor or pharmacist if you are uncertain.
• The dosage and treatment regimen will be determined by the doctor
only.
The usual dosage is generally:
For treatment o

产品特点

1
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Mentax
®
Cream
Butenafine hydrochloride 1% w/w
Rx Only
2.THERAPUETIC INDICATIONS
Interdigital tinea pedis, tinea
corporis
, tinea cruris . (Treatment in tinea corporis and tinea
cruris is limited to up to 4 weeks).
3.DESCRIPTION
Mentax
Cream, contains the synthetic antifungal agent, butenafine
hydrochloride 1%.
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 empirical
formula
C
23
H
27
N•HCl, a molecular weight of 353.93, and the following structural
formula:
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, contains 10 mg of butenafine HCl in a white cream base
of purified
water, propylene glycol dicaprilate, glycerin, cetyl alcohol, glyceryl
monostearate,
white soft parafin, stearic acid, polyoxyethylene cetyl ether,
diethanolamine, and
sodium benzoate.
4. CLINICAL PHARMACOLOGY
Pharmacokinetics
In one study conducted in healthy subjects for 14 days, 6 grams of
Mentax Cream,
was applied once daily to the dorsal skin (3,000 cm
2
) of 7 subjects, and 20 grams of
the cream was applied once daily to the arms, trunk and groin areas
(10,000 cm
2
) 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, AUC
0-24 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,
2
occurring at a mean Tmax of 6 ± 6 hours, and the mean AUC
0-24 hrs
was 87.8 ± 45.3
ng-hr/mL. A biphasic decline of plasma butenafine HCl concen