Search Results
| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
|---|
Clanlzole cream is a synlhetic broad spectrum aoti-fungal. Indicated fur
ADVERSE EFFECTS:
Severe iD:itation, pruriti11, s~ painful alleiW.c reactions.
PRECAUTIONS:
Sulfite Sensitivity: The cream conlains sulfite& that may cause allergictype
reactions including anaphylactic symptoms and life threatening or
less asthmal:ic episodes in susceptible persons.
Chnzole =am CBIIIlOt be used fur ophthalmic inti:ctions.
STORAGE: Store at room tc:mpen11un: not exceeding 2S"C (should not
fu:ezc).
the treatmcDt of dennatophyte inti:ctioos of the skin such as: tinea
corpori11, tinea cruris and tinea pedis due to Trichophyton nJbrum,
Trichophyton mentagrophyta, Microspo...m canis, Epidermophyton
floccosum, as w.:U as in the treatmcDt of cutaocous caodidosi11, pityriasis + To be dispensed by mediesl prescription.
venricolor and sebonhoeic demlatitis
DOSAGE & ADMINISmATION:
Apply Clamzole cream to cover the affi:cted area
oompl.etcly, 1 - 2 timl:s daily, depCDding on the severity of
infection.
Treatment sbould be continued for fuw days after
disappearance of all signs and symptoms.
CoDsult physician if no clinic:al improvement is noted after 4
weeks.
GencnJI. measures in regard to hygiene should be observed to
control sources of infecticm or reinfection.
+ The used treatmcDt duralioo is as follows:
Tinea corporis 3 - 4 weeks
Tinea pedis 4 - 6 weeks
Tinea cruris 2 - 4 weeks
Pityriasis wnioolor 2- 3 w.:eb
Sebonboeic dennatitis 4 weeks
Mamtcnance therapy is applied once or twice weekly in
seborrlloeic dermatitis.
In case of potent topical corticosteroids bas been used
previously in treatment of sebonhoeic dermatitis, a reCOYeJY
period of 2 weeks should be allow.:d be:lbre using Clanlzole
cream due to ))OS8l"bility of skin sensitizatioo if no reoovery
period bas been allowed.
CONTRA-INDICATIONS:
Clanlzole cream is contrBindicated with hypetsensitivity to my of its
i.ogrOOi.ents.
USE DURING PREGNANCY AND LACTATION:
Should cmly be used if its use is coosidered esseotial as it is not
systematically ab8orbed after topical application.
Pl"tgnancy: Category C - There are no adequate and -n controlled
studies in pregnancy. Use during pregnancy cmly if the potential benefits
outweigh the potential hazanls to the fetus.
LKtatlon: Sail:ty bas not been establis.IK:d.
Chilcb"tn: Sail:ty and eflialcy in clrildren have not been establisbed.
DOSAGE & ADMINISmATION:
Apply Clamzole cream to cover the affi:cted area
oompl.etcly, 1 - 2 timl:s daily, depCDding on the severity of
infection.
Treatment sbould be continued for fuw days after
disappearance of all signs and symptoms.
CoDsult physician if no clinic:al improvement is noted after 4
weeks.
GencnJI. measures in regard to hygiene should be observed to
control sources of infecticm or reinfection.
+ The used treatmcDt duralioo is as follows:
Tinea corporis 3 - 4 weeks
Tinea pedis 4 - 6 weeks
Tinea cruris 2 - 4 weeks
Pityriasis wnioolor 2- 3 w.:eb
Sebonboeic dennatitis 4 weeks
Mamtcnance therapy is applied once or twice weekly in
seborrlloeic dermatitis.
In case of potent topical corticosteroids bas been used
previously in treatment of sebonhoeic dermatitis, a reCOYeJY
period of 2 weeks should be allow.:d be:lbre using Clanlzole
cream due to ))OS8l"bility of skin sensitizatioo if no reoovery
period bas been allowed.
ADVERSE EFFECTS:
Severe iD:itation, pruriti11, s~ painful alleiW.c reactions.
Store at room tc:mpen11un: not exceeding 2S"C (should not
fu:ezc).
Aluminum oollapsible tube of 30gm.
MEDPHARMA
PHARMA & CHEM. IND'S (L.L.C.)
SHARJAH-U.A E
na
na
na
na
na
na
na
na
CLARAZOLE cream contains a medicine called Ketoconazole. This belongs to a group of
medicines called 'antifungals'. CLARAZOLE cream is used for fungal and yeast infections
of the skin in adults. Infections may appear on the:
• Trunk, chest or back
• Hands or feet
• Scalp or face
• Groin or genitals
CLARAZOLE cream works by killing the fungus that causes the infection.
Always use CLARAZOLE cream exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
How often you should use CLARAZOLE cream
This will depend on the type of infection and how serious it is. Your doctor will tell you
how often to use CLARAZOLE cream and for how long.
The recommended dose is:
Once or twice each day for l to 6 weeks
Do not use the cream more often than your doctor has told you.
Preparing your skin
• Wash the infected skin and dry it well
Using CLARAZOLE cream
• Each tube of CLARAZOLE cream is sealed. You will need to use the cap to pierce
the seal
• Rub the cream gently into the affected area and surrounding skin with clean fingers
• Do not put CLARAZOLE cream in the eyes
Personal hygiene
• Unless the affected skin is on your hands, wash your hands with soap and water
after using the cream
• Washing your hands after using the cream will stop you spreading the infection to
other parts of your body or to other people
• Do not allow other people to use your flannel or towel. This will stop them from
getting your infection
• Clothing that touches infected skin should be washed and changed often.
CLARAZOLE cream is non- greasy and should not stain clothes
If you stop using CLARAZOLE cream
Keep using the cream for several days after all the symptoms have gone away. This will
stop the symptoms from coming back.
If your symptoms do not improve after 4 weeks, talk to your doctor.
If you swallow CLARAZOLE cream
If you swallow any cream, tell your doctor straight away.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Talk to your doctor or pharmacist before using this medicine:
• If you have recently used a cream, ointment or lotion on your skin infection that
contains a steroid
You should continue to apply a mild steroid (such as hydrocortisone) cream,
ointment or lotion in the morning whilst applying CLARAZOLE cream in the
evening. The mild steroid treatment can then be gradually stopped over a period of
2-3 weeks.
If you have any questions about stopping your steroid cream, ointment or lotion, ask your
doctor or pharmacist.
CLARAZO LE Cream is not recommended for use in children under 18 years of age.
Taking other medicines
Clarazole cream does not normally react with other medicines. However, tell your doctor
or pharmacist if you are taking or have recently taken any other medicines. This includes
medicines that you buy without a prescription or herbal medicines.
CLARAZOLE cream can be used if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before takiun~g;a::n~~~:=r~==o~u;a;r_::e~pregnant
or breast-feeding.
CLARAZOLE cream is not likely to affect you being able to drive or use any tools or
machines.
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Stop using CLARAZOLE cream and tell your doctor straight away if you notice or
suspect any of the following. You may need urgent medical treatment.
• Severe irritation or reddening of the skin where the cream has been used or other signs of
allergy during the first few days of treatment. This can affect fewer than 1 in 10 people
• Peeling or blistering of the skin. This can affect fewer than 1 in 100 people
• Problems where the cream has been used such as:
Bleeding
- Discomfort
- Dryness
. - Inflammation ( contact dermatitis)
- Tingling
• Rash, hives (also known as nettle rash or urticaria)
• Sticky skin
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
Not known
Pharmacotherapeutic group: Antifungal.
ATC code: DOlACO
Azoles are predominantly fungistatic. They inhibit C-14 a-demethylase (a cytochrome
P450 [CYP450] enzyme), thereby blocking the demethylation of lanosterol to ergosterol,
the principal sterol of fungal membranes. This inhibition disrupts membrane structure and
function, which, in turn, inhibits fungal cell growth. [Unfortunately, the selectivity of
ketoconazof e toward its target is not as precise as those of later azoles, in addition to
blocking fungal ergosterol synthesis, the drug also inhibits human gonadal and adrenal
steroid synthesis, leading to decreased testosterone and cortisol production. In addition,
ketoconazole inhibits CYP450-dependent hepatic drug metabolizing enzymes.]
Topical ketoconazole is used to treat tinea corporis, tinea cruris, and tinea pedis caused by
Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Also, topical ketoconazofe is used to treat tinea versicolor caused by Malassezia furfur,
cutaneous candidiasis caused by Candida species. It is also used topically in the treatment
of seborrheic dermatitis and dandruff.
Drug resistance:
Drug resistance is becoming a significant clinical problem, particularly in the protracted
therapy required for those with advanced HIV infection. Identified mechanisms of resistance include:
Mutations in the C- l 4 a-demethylase gene, which cause decreased azole binding
Some strains of fungi have developed the ability to pump the azole out of the cell.
Clinical efficacy and safety
A study in 250 patients has shown that application twice daily for 7 days of ketoconazole
2% cream vs clotrimazole 1 % cream for 4 weeks on both feet demonstrated efficacy in
patients with tinea pedis (athlete's foot) presenting lesions between the toes. The primary
efficacy endpoint was negative microscopic KOH examination at 4 weeks. Ketoconazole
2% treatment showed equivalent efficacy to 4 weeks clotrimazole 1 % treatment. There
was no evidence of relapse following treatment with ketoconazole cream at 8 weeks.
Plasma concentrations of ketoconazole were not detectable after topical adminstration of
Clarazole Cream in adults on the skin. In one study in infants with seborrhoeic dermatitis
(n = 19), where approximately 40 g of ketoconazole 2% cream was applied daily on 40%
of the body surface area, plasma levels of ketoconazole were detected in 5 infants,
ranging from 32 to 133 ng/mL.
NA
Purified Water
Isopropyle Myristate
Sodium Sulphite Anhydrous
Propylene Glycol
Tween 80 (Polysorbate 80)
Tween 60 ( POLYSORBATE 60)
Sorbitan Monostrearate
Stearyl Alcohol
Cetyl Alcohol
None known
Store below 25°C.
CLARAZOLE Cream is white, homogeneous, smooth cream. 30gm cream is packed in
annealed aluminum tubes coated internally with an epoxide resin lacquer which is packed in a box along with a leaflet.
No special instructions.
