Singapore - English - HSA (Health Sciences Authority)

teva pharmaceutical investments singapore pte. ltd. - acitretin - capsule - 25 mg - acitretin 25 mg

Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - acitretin - capsule - acitretin 25 mg - antipsoriatics

Singapore - English - HSA (Health Sciences Authority)

teva pharmaceutical investments singapore pte. ltd. - acitretin - capsule - 10 mg - acitretin 10 mg

United States - English - NLM (National Library of Medicine)

avkare - acitretin (unii: lch760e9t7) (acitretin - unii:lch760e9t7) - acitretin 10 mg - acitretin capsules, usp are indicated for the treatment of severe psoriasis in adults. because of significant adverse effects associated with its use, acitretin capsules, usp should be prescribed only by those knowledgeable in the systemic use of retinoids. in females of reproductive potential, acitretin capsules, usp should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed contraindications and warnings — acitretin capsules, usp can cause severe birth defects). most patients experience relapse of psoriasis after discontinuing therapy. subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy. pregnancy category x: ( see boxed contraindications and warnings. ) acitretin is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed warnings: hepatotoxicity, warnings: lipids and possible cardiovascular effects, and precautions). an increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. consequently, the combination of methotrexate with acitretin is also contraindicated (see precautions: drug interactions). since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see warnings: pseudotumor cerebri). acitretin is contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria) to the preparation (acitretin or excipients) or to other retinoids .

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - acitretin (unii: lch760e9t7) (acitretin - unii:lch760e9t7) - acitretin 10 mg - acitretin capsules are indicated for the treatment of severe psoriasis in adults. because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. in females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed contraindications and warnings — acitretin capsules can cause severe birth defects). most patients experience relapse of psoriasis after discontinuing therapy. subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy. pregnancy category x ( see boxed contraindications and warnings) acitretin is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed warnings: hepatotoxicity, warnings: lipids and possible cardiovascular effects , and precautions ). an increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. consequently, the combination of methotrexate with acitretin is also contraindicated (see precautions: drug interactions ). since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see warnings: pseudotumor cerebri ). acitretin is contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria) to the preparation (acitretin or excipients) or to other retinoids.

United States - English - NLM (National Library of Medicine)

sigmapharm laboratories, llc - acitretin (unii: lch760e9t7) (acitretin - unii:lch760e9t7) - acitretin 10 mg - acitretin capsules, usp are indicated for the treatment of severe psoriasis in adults. because of significant adverse effects associated with its use, acitretin capsules, usp should be prescribed only by those knowledgeable in the systemic use of retinoids. in females of reproductive potential, acitretin capsules, usp should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed contraindications and warnings — acitretin capsules, usp can cause severe birth defects). most patients experience relapse of psoriasis after discontinuing therapy. subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy. pregnancy category x:  ( see boxed contraindications and warnings. ) acitretin is con

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - acitretin (unii: lch760e9t7) (acitretin - unii:lch760e9t7) - acitretin 10 mg - acitretin capsules are indicated for the treatment of severe psoriasis in adults. because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. in females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed contraindications and warnings  — acitretin capsules can cause severe birth defects). most patients experience relapse of psoriasis after discontinuing therapy. subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy. (see boxed contraindications and warnings.) acitretin is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed warnings ,hepatotoxicity ; warnings ,lipids and possibl

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - acitretin (unii: lch760e9t7) (acitretin - unii:lch760e9t7) - acitretin 10 mg - pregnancy: acitretin capsules must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. acitretin capsules also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. acitretin is a metabolite of etretinate (tegison), and major human fetal abnormalities have been reported with the administration of acitretin and etretinate. potentially, any fetus exposed can be affected. clinical evidence has shown that concurrent ingestion of acitretin and ethanol has been associated with the formation of etretinate, which has a significantly longer elimination half-life than acitretin. because the longer elimination half-life of etretinate would increase the duration of teratogenic potential for female patients, ethanol must not be ingested by female patients of childbearing potential either during treatment with acitretin capsules or for 2 months after cessation of therapy. this allows for elimination of acitretin, thus removing the substrate for transesterification to etretinate. the mechanism of the metabolic process for conversion of acitretin to etretinate has not been fully defined. it is not known whether substances other than ethanol are associated with transesterification. acitretin has been shown to be embryotoxic and/or teratogenic in rabbits, mice, and rats at oral doses of 0.6, 3, and 15 mg per kg, respectively. these doses are approximately 0.2, 0.3, and 3 times the maximum recommended therapeutic dose, respectively, based on a mg-per-m2 comparison. major human fetal abnormalities associated with acitretin and/or etretinate administration have been reported including meningomyelocele; meningoencephalocele; multiple synostoses; facial dysmorphia; syndactyly; absence of terminal phalanges; malformations of hip, ankle, and forearm; low-set ears; high palate; decreased cranial volume; cardiovascular malformation; and alterations of the skull and cervical vertebrae. acitretin capsules should be prescribed only by those who have special competence in the diagnosis and treatment of severe psoriasis, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity. because of the teratogenicity of acitretin, a program called the mymac program, my m ylan a citretin c ommitment, has been developed to educate women of childbearing potential and their healthcare providers about the serious risks associated with acitretin and to help prevent pregnancies from occurring with the use of this drug and for 3 years after its discontinuation. the mymac program requirements are described below and program materials are available at www.acitretincommitment.com or may be requested by calling 1-877-446-3679 (1-877-4-info-rx) (see also precautions section). important information for women of childbearing potential: acitretin capsules should be considered only for women with severe psoriasis unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments. females of reproductive potential must not be given a prescription for acitretin capsules until pregnancy is excluded. acitretin capsules are contraindicated in females of reproductive potential unless the patient meets all of the following conditions: there have been 25 cases of reported conception when the male partner was taking acitretin. the pregnancy outcome is known in 13 of these 25 cases. of these, 9 reports were retrospective and 4 were prospective (meaning the pregnancy was reported prior to knowledge of the outcome).3 timing of paternal acitretin treatment relative to conception delivery of healthy neonate spontaneous abortion induced abortion total at time of conception 5a 5 1 11 discontinued ~ 4 weeks prior 1b 1 discontinued ~ 6 to 8 months prior 1 1 a four of 5 cases were prospective. b with malformation pattern not typical of retinoid embryopathy (bilateral cystic hygromas of neck,    hypoplasia of lungs bilateral, pulmonary atresia, vsd with overriding truncus arteriosus). for all patients: an acitretin capsules medication guide must be given to the patient each time acitretin capsules are dispensed, as required by law. acitretin capsules are indicated for the treatment of severe psoriasis in adults. because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. in females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed contraindications and warnings - acitretin capsules can cause severe birth defects). most patients experience relapse of psoriasis after discontinuing therapy. subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy. see boxed contraindications and warnings. acitretin capsules are contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed warnings: hepatotoxicity , warnings: lipids and possible cardiovascular effects, and precautions). an increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. consequently, the combination of methotrexate with acitretin capsules is also contraindicated (see precautions: drug interactions). since both acitretin capsules and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see warnings: pseudotumor cerebri). acitretin capsules are contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria) to the preparation (acitretin or excipients) or to other retinoids .