دواعي استعمال رواكيوتين 20مجم 30 كبسولة

معلومات من نشرات دوائية ومراجع موثقة، مع مصدر كل معلومة. السعر الحالي: 533ج.م.

دواعي الاستعمال

Severe forms of acne (such as nodular or conglobate acne, or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy.الفئة: Adults and adolescents 12 years and olderelectronic medicines compendium (emc)

الآثار الجانبية

Very common: dry skin, cheilitis, dermatitis, pruritus, conjunctivitis, dry eyes, raised transaminases, raised triglycerides and cholesterol, back pain, arthralgia, myalgia, anaemia and thrombocytosis/thrombocytopenia.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

موانع الاستعمال

Pregnancy and breast-feeding; women of childbearing potential unless all conditions of the Pregnancy Prevention Programme are met.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Hepatic insufficiency, excessively elevated blood lipid values, hypervitaminosis A.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Concomitant treatment with tetracyclines; hypersensitivity to isotretinoin or excipients (contains soya oil: allergy to peanut or soya).نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

تحذيرات واحتياطات

Depression, anxiety, mood changes and rarely suicidal ideation, suicide attempts and suicide reported; monitor for signs of depression and refer as needed.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Benign intracranial hypertension reported, some with tetracyclines; serious skin reactions (erythema multiforme, SJS, TEN) reported.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Decreased night vision, dry eyes and corneal opacities may occur; persistent sexual dysfunction has been reported.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Patients must not donate blood during therapy and for one month after discontinuation.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

التداخلات الدوائية

Vitamin AAvoid concomitant use: risk of hypervitaminosis A.electronic medicines compendium (emc)
TetracyclinesContraindicated: cases of benign intracranial hypertension reported.electronic medicines compendium (emc)
Topical keratolytic or exfoliative anti-acne agentsShould be avoided because of increased local irritation.electronic medicines compendium (emc)

الحمل والرضاعة

Pregnancy is an absolute contraindication; isotretinoin is highly teratogenic. Foetal malformations include CNS abnormalities (hydrocephalus, microcephaly), external ear abnormalities, eye abnormalities, facial dysmorphia, cleft palate, thymus and cardiovascular abnormalities and parathyroid deficiency.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Women of childbearing potential may only be treated if all conditions of the Pregnancy Prevention Programme are fulfilled, including effective contraception before, during and for one month after treatment and medically supervised pregnancy testing.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Contraindicated during breast-feeding; isotretinoin is highly lipophilic and likely to pass into milk.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

المتابعة أثناء العلاج

Check liver function and serum lipids (fasting) before treatment, one month after starting and then at 3-monthly intervals unless more frequent monitoring is indicated; monthly pregnancy testing under the Pregnancy Prevention Programme.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

كيف يعمل الدواء

Stereoisomer of all-trans retinoic acid; suppresses sebaceous gland activity and reduces sebaceous gland size (Roaccutane SmPC section 5.1).

المصادر