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Properties:
Lidocaine hydrochloride is an active ingredient of xylophil gel, it is used mainly as local anesthetic and could also be described as local analgesic because it produces loss of pain without loss of nervous control. The gel form of xylophil is suitable for application on mucous membranes
Indications:
Xylophil gel is used topically for temporary relief of the pain associated with minor burns , abraisons of the skin and mucous membranes of the oropharynx, also for relief of the pain associated with hemmorrhoidal and anal fissures .
Warning:
When topical anesthetics are used in the mouth, the patient should be warned that; the local anesthetic may impair swallowing and thus enhance the danger of aspiration, therefore food should not be ingested for 60 minutes after the use of the local anesthetics in the mouth or throat area, this of particular importance in children.
throat area, this of particular importance in children.
The topical use of local anesthetics should be used with caution in patients with severe traumatized mucosa and/ or sepsis in the region of the proposed application
- Do not leave on large body areas for more than 2 hours. - Not for ophthalmic use.
Dosage and administration:
Apply a thin layer of xylophil gel once a day without rubbing ,the treatment may be repeated when it required, or as directed by the physician.
Side Effects:
As with any local anesthetic, adverse reactions may result from high plasma level due to excessive dosage or rapid absorption, or may result from hypersensitivity, idiosyncrasy or diminished tolerance.
Excitatory reactions may be very brief or may not occur at all, if it is occurred ; the reactions are characterized by dizziness, blurred vision, followed by drowsiness.
Keep at room temperature not exceeding 30 C
Composition:
Each gram contains: Lidocaine Hydrochloride B.P. 20mg. in a gel base.
Philadelphia Pharmaceuticals
10. St. King Abdullah II Industrial City / Amman – Jordan
P.O.Box : 276 – Amman 11512 Jordan
Tel : + 962 6 402 9181
Fax : + 962 6 402 9182
الخواص:
الليدوكايين هايدروكلوريد هي المادة الفعالة لمستحضر زايلوفيل جل وهو بالدرجة الأولى يستعمل كمخدر موضعي ويمكن اعتباره ايضا مسكن الم موضعيحيث أنه يزيل الشعور بالألم بدون أن يؤثر على السيطرة الارادية
الزايلوفيل بشكله الهلامي مناسب لاستعماله علة الأنسجة المخاطية
الاستعمالات:
يستعمل زايلوفيل جل موضعيا كمسكن مؤقت للآلام المصاحبة للحروق البسيطة وكشط الجلد والأغشية المخاطية في تجويف الحلق وكذلك لتسكين الألم المصاحب للبواسير وتشققات الشرج
التحذيرات
عند الاستعمال الخارجي للمخدرات الموضعية في الفم فيجب اخذ الحذر من قدرة المخدرات الموضعية على اضعاف عملية البلع مما يؤدي الى خطورة بعملية التنفس لذلك يجب عدم تناول الطعام الا بعد ساعة من استخدام هذا المستحضر وتكمن أهمية ذلك خصوصا عند الأطفال ويجب أخذ الحيطة والحذر من الاستعمال الموضعي لليدوكيين هيدروكلوريد للمرضى المصابين بجروح غميقة في الأغشية المخاطية أو تقيح المنطقة المراد استعمال العلاج عليها
لا يترك على مساحات واسعة من الجلد لاكثر من ساعتين
غير مخصص لاستخدامه على العينيين
توضع طبقة رقيقة من الزايلوفيل فوق المنطقة المراد علاجها مرة واحدة باليوم دون فرك وقد يحتاج الى تكرار العلاج متى دعت الحاجة أو حسب ارشادات الطبيب
كما في كل المخدارات الموضعية فان الثار الجانبية قد تنشأ من ارتفاع تركيز في البلازما نتيجة الفرط في الجرعة او الامتصاص السريع للمادة الدوائية ويمكن ان تنشأ من التحسس الشديد من العلاج والاستعداد الذاتي للمريض او فقدان القدرة على التحمل للعلاج.
يحفظ زايلوفيل بدرجة حرارة الغرفة دون 30 م
كل غرام من زايلوفيل جل يحتوي على ليدوكيين هيدروكلوريد 20 ملغم ف . ب. في قاعدة هلامية
أنبوب 30 غم
شركة فیلادلفیا لصناعة الأدویة
شارع ۱۰ مدینة الملك عبدلله الثاني الصناعیة - عمان / الاردن
ص.ب ۲۷٦ – عمان ( ۱۱٥۱۲ ) الأردن
الھاتف : 96264029181+
فاكس : 96264029182+
Xylophil gel is used topically for temporary relief of the pain associated with abrasions of the skin and mucous membranes of the oropharynx, also for relief of the pain associated with haemorrhoidal and anal fissures.
For topical administration.
Apply a thin layer of Xylophil gel once a day without rubbing ,the treatment may be repeated when it required, or as directed by the physician.
When topical anesthetics are used in the mouth, the patient should be warned that; the local anesthetic may impair swallowing and thus enhance the danger of aspiration, therefore food should not be ingested for 60 minutes after the use of the local anesthetics in the mouth or throat area, this of particular importance in children.
The topical use of local anesthetics should be used with caution in patients with severe traumatized mucosa and/ or sepsis in the region of the proposed application.
None Known.
During the first 3 months of pregnancy, lidocaine should be used only if absolutely necessary. The amount of lidocaine excreted in breast milk is too small to be harmful.
Not relevant
As with any local anesthetic, adverse reactions may result from high plasma level due to excessive dosage or rapid absorption, or may result from hypersensitivity, idiosyncrasy or diminished tolerance.
Excitatory reactions may be very brief or may not occur at all, if it is occurred ; the reactions are characterized by dizziness, blurred vision, followed by drowsiness.
Symptoms
In the event of excessive absorption of lidocaine into the bloodstream, symptoms may include CNS effects (such as convulsions, unconsciousness and possibly respiratory arrest) and cardiovascular reactions (such as hypotension, myocardial depression, bradycardia and possibly cardiac arrest).
Treatment
Treatment of a patient suffering from systemic toxicity of lidocaine consists of arresting the convulsions and ensuring adequate ventilation with oxygen, if necessary by assisted or controlled ventilation (respiration).
Pharmacotherapeutic (ATC) Classification:
D01A C08
The anesthetic ingredient of Xylophil® is lidocaine, which stabilizes neuronal membranes and prevents initiation and conduction of nerve impulses, thus effecting local anesthetic action
After the product´s application to mucous membranes, lidocaine is absorbed, but its blood concentrations after the instillation of doses of up to 800mg into the urethra remain in the low range, below toxic levels. The metabolism of Lidocaine takes place in the liver and unchanged drug is excreted renally.
There is no relevant information additional to that contained elsewhere in the Summary of Product Characteristics.
Glycerin
Benzyl Alcohol
Hydroxyethyl Cellulose
Purified water
Sodium Hydroxide
Not applicable.
Store below 30° C
Aluminum tube 25 mm in diameter with membrane screw capped with HDPE cap, with leaflet & box. Pack sizes: 30 gm.
Not applicable.
