Search Results
| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
|---|
COMPOSITION:
Metaz Cream 0.1%
Each gram contains 1mg Mometasone Furoate.
Metaz Ointment 0.1%
Each gram contains 1mg Mometasone Furoate.
ACTIONS:
Mometasone furoate, a synthetic corticosteroid, exhibits anti-inflammatory, antipruritic, and vasoconstrictive properties.
INDICATIONS AND USAGE:
Metaz Cream and Ointment 0.1% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, such as psoriasis and atopic dermatitis.
CONTRA-INDICATIONS:
Metaz Cream and Ointment 0.1% are contraindicated in patients who are sensitive to mometasone furoate, to other corticosteroids, or to any component of these preparations.
Metaz Cream and Ointment 0.1% are also contraindicated in fungal, tubercular skin infections or viral skin infections such as herpes simplex or zoster, facial rosacea, acne vulgaris & perioral dermatitis.
PRECAUTIONS:
If irritation or sensitization develops with the use of Metaz products, treatment should be discontinued and appropriate therapy instituted.
In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection is controlled adequately.
Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. The use of topical corticosteroids in children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Since the safe use of Metaz products in pregnant women has not been established, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used on pregnant patients in large amounts or for prolonged periods of time. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Excessive, prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency. Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are virtually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of corticosteroids is advised.
Metaz products are FOR DERMATOLOGICAL USE ONLY, these are NOT FOR OPHTHALMIC USE.
DOSAGE AND ADMINISTRATION:
A thin film of Metaz Cream or Ointment 0.1% should be applied to the affected skin areas once daily.
ADVERSE REACTIONS:
Local adverse reactions rarely reported with mometasone furoate include burning, pruritus, paresthesia, tingling/stinging, acneiform reaction, folliculitis, and signs of skin atrophy.
The following local adverse reactions have been reported infrequently with the use of other topical corticosteroids; irritation, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.
Store below 30° C.
Keep out of the reach of children.
For external use only.
Metaz Cream 0.1%
Each gram contains 1mg Mometasone Furoate.
Metaz Ointment 0.1%
Each gram contains 1mg Mometasone Furoate.
SPIMACO
Al-Qassim Pharmaceutical Plant
Saudi Arabia
For: COOPER PHARMA
التركيب :
ميتاز كريم %0.1
يحتوي كل جرام على 1ملجم فيورويت موميتازون.
ميتاز مرهم %0.1
يحتوي كل جرام على 1ملجم فيورويت موميتازون.
التأثير الدوائي:
فيورويت الموميتازون هو ستيرويد قشري مخلق له خصائص مضادة للإلتهاب والحكة وقابضة للأوعية الدموية.
دواعي الإستعمال :
ميتاز كريم ومرهم %0.1 يوصى به طبيا لمداواة ظواهر الإلتهاب والحكة المصاحبة لأمراض الجلد المستجيبة للستيرويدات القشرية كالصدفية وإلتهاب الجلد التحسسي.
موانع الإستعمال :
ميتاز كريم ومرهم %0.1 يمنع إستخدامها في المرضى الذين لديهم تاريخ تحسسي لمادة فيورويت الموميتازون أو أي ستيرويدات قشرية أو ضد أي من مكونات هذه المستحضرات.
كذلك يمنع إستخدام ميتاز كريم ومرهم %0.1 في حالات عدوى الجلد الفطرية أو الدرنية أو الفيروسية مثل الهربس البسيط أو الهربس النطاقى أو حب الشباب ووردية الوجه وإلتهابات ما حول الفم.
الإحتياطات :
في حالة حدوث تهيج أو تحسس عند إستخدام أي من مستحضرات ميتاز، يجب إيقاف إستخدامه وإستبداله بعلاج آخر مناسب.
في حالة وجود إنتان يجب إستخدام مضاد للفطريات أو للبكتريا وفي حالة عدم الحصول على إستجابة حسنة وسريعة يجب إيقاف إستخدام الستيرويد القشري حتى تتم السيطرة الكافية على الإنتان. الآثار الجانبية التي سجلت عقب الإستعمال العام للستيرويدات القشرية، بما فيها تثبيط الغدة الكظرية، قد تحدث عند إستخدام الستيرويدات القشرية الموضعية وخاصة في الرضع والأطفال.
يزيد الإمتصاص العام للستيرويدات القشرية الموضعية عند علاج مساحات واسعة من الجلد أو إذا إستخدمت الضمادات المغلقة. يجب إتخاذ الإحتياطات الملائمة في تلك الحالات أو لدى توقع الإستخدام الطويل المدي، خاصة في الرضع والأطفال.
المرضى من الأطفال قد يظهرون قابلية لحدوث تثبيط محور الغدد تحت المخية ــ النخامية وكذلك تناذر كوشنج نتيجة لإستخدام الستيرويدات القشرية الموضعية وذلك أكثر من البالغين بسبب كبر نسبة مساحة الجلد إلى وزن الجسم.
إستخدام الستيرويدات القشرية الموضعية في الأطفال يجب أن يحدد إلى أقل مقدار يتناسب مع نظام علاجي فعال. العلاج المزمن بالستيرويدات القشرية قد يتداخل مع نمو الأطفال.
حيث أن سلامة إستخدام مستحضرات ميتاز في السيدات الحوامل لم تحدد بعد فإنه يجب إستخدام الستيرويدات القشرية الموضعية أثناء الحمل فقط إذا كانت الفائدة المرجوة منها تبرر إحتمال الخطر الذي قد يتعرض له الجنين. الأدوية من هذه المجموعة يجب عدم إستخدامها في المريضات الحوامل بكميات كبيرة أو لمدد طويلة. ليس معروفا إذا كان الإمتصاص العام للستيرويدات القشرية الموضعية يكفي لإفراز كميات يمكن إقتفاء أثرها في لبن الأم. الستيرويدات القشرية المستعملة جهازيا تفرز بكميات من غير المرجح أن يكون لها أثر سلبي على الرضيع. ورغم ذلك فإنه يجب إتخاذ قرار بفطام الطفل أو إيقاف العلاج وذلك وفقا لأهمية الدواء بالنسبة للأم. الإستخدام المفرط طويل المدى للستيرويدات القشرية يمكنه تثبيط وظيفة الغدد النخامية الكظرية مما ينتج عنه قصور كظري ثانوي يحتاج إلى علاج مناسب وفقا للأعراض المرضية. العلامات الحادة لزيادة نسبة القشريات يمكن عكسها. يجب أيضا إذا لزم الأمر معالجة الخلل في مستوى المنحلات الكهربية. في حالات التسمم المزمن ينصح بالسحب التدريجي للستيرويدات القشرية.
مستحضرات ميتــــاز مخصصــة للإستخـدامات الجلديــة وليس للإستخـدام في العين.
الجرعة وكيفية الإستعمال :
توضع طبقة رقيقة من ميتاز كريم أو مرهم %0.1 على منطقة الجلد المصابة مرة واحدة يوميا.
التأثيرات الجانبية :
نادرا ما سجلت تأثيرات جانبية موضعية مع ميتاز وتتضمن : حرقان، تشوش الحس، الحكة، علامات ضمور الجلد، وبثور مشابهة لحب الشباب.
التأثيرات الجانبية والمتضمنة : تهيج، فرط نمو الشعر، نقص تصبغ الجلد، إلتهاب حول الفم، إلتهاب الجلد التحسسي بالتماس، تعطن الجلد، الإنتان الثانوي، الأثلام الجلدية وخلل وظائف العرق فإنها نادرا ما تسجل عند إستخدام ستيرويدات قشرية موضعية أخرى.
يحفظ في درجة حرارة أقل من 30 درجة مئوية.
يحفظ بعيدا عن متناول الأطفال.
للاستخدام الخارجي فقط.
ميتاز كريم %0.1
يحتوي كل جرام على 1ملجم فيورويت موميتازون.
ميتاز مرهم %0.1
يحتوي كل جرام على 1ملجم فيورويت موميتازون.
العبوات المتوفرة :
ميتاز كريم في أنابيب.
ميتاز مرهم في أنابيب.
إنتاج: الدوائية
مصنع الأدوية بالقصيم
المملكة العربية السعودية
لصالح: كوبر فارما
Metaz is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.
Adults, including elderly patients and Children: A thin film of Metaz should be applied to the affected areas of skin once daily.
Use of topical corticosteroids in children or on the face should be limited to the least amount compatible with an effective therapeutic regimen and duration of treatment should be no more than 5 days
| If irritation or sensitisation develop with the use of Metaz, treatment should be withdrawn and appropriate therapy instituted. Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled. Systemic absorption of topical corticosteriods can produce reversible hypothalamic-pituitaryadrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. As the safety and efficacy of Metaz in paediatric patients below 2 years of age have not been established, its use in this age group is not recommended. Local and systemic toxicity is common especially following long continued use on large areas of damaged skin, in flexures and with polythene occlusion. If used in childhood, or on the face, occlusion should not be used. If used on the face, courses should be limited to 5 days and occlusion should not be used. Long term continuous therapy should be avoided in all patients irrespective of age. Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralized pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important. As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When long term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can develop which takes the form of a dermatitis with intense redness, stinging and burning. This can be prevented by slow reduction of the treatment, for instance continue treatment on an intermittent basis before discontinuing treatment. Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing. Metaz topical preparations are not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
|
None stated.
Pregnancy During pregnancy and lactation treatment with Metaz should be performed only on the physician's order. Then however, the application on large body surface areas or over a prolonged period should be avoided. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There are no adequate and well-controlled studies with Metaz in pregnant women and therefore the risk of such effects to the human foetus is unknown. However as with all topically applied glucocorticoids, the possibility that foetal growth may be affected by glucocorticoid passage through the placental barrier should be considered. There may therefore be a very small risk of such effects in the human foetus. Like other topically applied glucocorticoids, Metaz should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or the foetus.
Lactation It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Metaz should be administered to nursing mothers only after careful consideration of the benefit/risk relationship. If treatment with higher doses or long term application is indicated, breast-feeding should be discontinued. |
None stated.
Local adverse reactions reported infrequently with topical dermatalogic corticosteroids include: skin dryness, irritation, dermatitis, perioral dermatitis, maceration of the skin, miliaria and telangiectasiae.
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced
Hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
Chronic corticosteroids therapy may interfere with the growth and development of children.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
To report any side effect(s):
The National Pharmacovigilance and Drug Safety Centre (NPC) o Fax: +966-11-205-7662 o Call NPC at +966-11-2038222, Exts: 2317-2356-2340. o Reporting hotline: 19999. o E-mail: npc.drug@sfda.gov.sa o Website: www.sfda.gov.sa/npc
|
Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.
The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.
Pharmacotherapeutic group: Mometasone, ATC code: D07AC13
Mometasone furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic activity in standard animal predictive models.
In the croton oil assay in mice, mometasone was equipotent to betamethasone valerate after single application and about 8 times as potent after five applications.
In guinea pigs, mometasone was approximately twice as potent as betamethasone valerate in reducing m.ovalis-induced epidermal acanthosis (i.e. anti-psoriatic activity) after 14 applications.
Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate 0.1% is minimal, approximately 0.4% of the applied dose in man, the majority of which is excreted within 72 hours following application. Characterisation of metabolites was not feasible owing to the small amounts present in plasma and excreta.
| There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
|
For Metaz cream:
Hexylene Glycol NF, Chlorocresol BP, Disodium Edetate, Cetostearyl Alcohol NF, Liquid Paraffin EP, White Soft Paraffin BP, Dimethicone 100 NF, Glyceryl Monostearate NF, Sodium Citrate Anhydrous, Citric Acid Monohydrate, Emulsifying Wax BP, Purified Water
Not Known.
| Do not store above 30°C. |
Metaz pack contains 10g and 30g Aluminum tube with threaded nozzle, fitted with fully applied tapered plastic screw cap
Not applicable
