PROCTOFOAM H.C.

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

HYDROCORTISONE ACETATE; PRAMOCAINE HYDROCHLORIDE

متاح من:

MEGAPHARM LTD

ATC رمز:

A07EA02

الشكل الصيدلاني:

FOAM

تركيب:

HYDROCORTISONE ACETATE 1 %; PRAMOCAINE HYDROCHLORIDE 1 %

طريقة التعاطي:

RECTAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

KREMERS URBAN PHARMACEUTICALS INC., USA

المجال العلاجي:

HYDROCORTISONE

الخصائص العلاجية:

Proctofoam HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses of the anal region.

تاريخ الترخيص:

2015-11-17

نشرة المعلومات

2
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied by physician’s prescription only
PROCTOFOAM HC
RECTAL FOAM
ACTIVE INGREDIENTS:
Hydrocortisone acetate 1%
Pramoxine hydrochloride 1%
For the list of inactive ingredients – see section "Additional
information"._ _
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains essential information about this medicine. If you have any
further questions, refer to
the physician or to the pharmacist.
PAY ATTENTION TO "DIRECTIONS FOR USE" UNDER THE SECTION "HOW SHOULD
YOU USE THE
MEDICINE?", IN ORDER TO USE THE PRODUCT PROPERLY AND PREVENT PROBLEMS
DURING USE.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar.
WHAT IS THIS MEDICINE INTENDED FOR?
PROCTOFOAM HC is indicated for the relief of the inflammatory and
pruritic manifestations of
corticosteroid responsive dermatoses of the anal region.
THERAPEUTIC GROUP: Hydrocortisone acetate - Corticosteroids for local
treatment.
Pramoxine hydrochloride - local anesthetic.
BEFORE USING THIS MEDICINE
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
BEFORE THE TREATMENT WITH
PROCTOFOAM HC, TELL YOUR PHYSICIAN IF:

You are pregnant or breastfeeding

Bacterial, viral or fungal infection exists in the treated area or
around it
-
Before starting treatment with this medicine, you must undergo a
rectal examination. Do
not use this medicine frequently, or for a long period, without
consulting a physician.
-
If you are sensitive to any type of food or medicine, inform your
physician before
commencing treatment with this medicine.
-
During prolonged treatment with this medicine or if there are open
wounds, there is a
possibility of systemic absorption of hydrocortisone.
-
Avoid contact of the medicine with the eyes. In case of contact, wash
immediately with
water.
-
Do not use this medicine for more than 7 consecutive day

خصائص المنتج

PROCTOFOAM
® H.C.
HYDROCORTISONE ACETATE 1% (LABEL CLAIM) [0.936%W/W INCLUDING
PROPELLANT)
PRAMOXINE HYDROCHLORIDE 1% (LABEL CLAIM) [0.936%W/W INCLUDING
PROPELLANT)
Topical aerosol, 10 gr
RX ONLY
DESCRIPTION: Proctofoam® H.C. (Hydrocortisone acetate 1% and
Pramoxine hydrochloride 1%) is a
topical aerosol foam for anal use containing Hydrocortisone acetate 1%
and Pramoxine hydrochloride
1% in a hydrophilic base containing cetyl alcohol NF, Emulsifying wax
NF, Methylparaben USP,
Polyoxyethylene-10-Stearyl Ether, Propylene glycol USP, Propylparaben
USP, Purified water USP,
Trolamine NF and Hydrocarbon Propellant A-46.
Proctofoam®-HC contains a synthetic corticosteroid used as an
anti-inflammatory/antipruritic agent and
a local anesthetic.
HYDROCORTISONE ACETATE
Molecular weight: 404.50. Solubility of Hydrocortisone acetate in
water: 1 mg/100 mL.
Chemical name: pregn-4-ene-3,20-dione,
21-(acetyloxy)-11,17-dihydroxy-, (11β)-.
PRAMOXINE HYDROCHLORIDE
Molecular weight: 329.86. Pramoxine hydrochloride is freely soluble in
water.
Chemical name: morpholine, 4-[3-(4-butoxyphenoxy) propyl]-,
hydrochloride.
CLINICAL PHARMACOLOGY: Topical corticosteroids share
anti-inflammatory, antipruritic and
vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical
corticosteroids is unclear. Various laboratory
methods, including vasoconstrictor assays, are used to compare and
predict potencies and/or clinical
efficacies of the topical corticosteroids. There is some evidence to
suggest that a recognizable
correlation exists between vasoconstrictor potency and therapeutic
efficacy in man.
Pramoxine hydrochloride is a surface or local anesthetic which is not
chemically related to the "caine"
types of local anesthetics. Its unique chemical structure is likely to
minimize the danger of cross-
sensitivity reactions in patients allergic to other local anesthetics.
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors including the vehicle, the integrity of