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

akorn operating company llc - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin 10 mg - myorisan® is indicated for the treatment of severe recalcitrant nodular acne. nodules are inflammatory lesions with a diameter of 5 mm or greater. the nodules may become suppurative or hemorrhagic. “severe,” by definition,2 means “many” as opposed to “few or several” nodules. because of significant adverse effects associated with its use, myorisan ®  should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. in addition, myorisan® is indicated only for those patients who are not pregnant, because myorisan® can cause life-threatening birth defects (see boxed contraindications and warnings ). a single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 if a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve whi

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - isotretinoin 10mg;   - soft gelatin capsule - 10 mg - active: isotretinoin 10mg   excipient: ferrous oxide gelatin glycerol soya bean oil, partially hydrogenated ferrous oxide yellow soya bean oil, hydrogenated soya oil titanium dioxide yellow beeswax - severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. isotretinoin actavis should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if isotretinoin actavis is used during pregnancy.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - isotretinoin 20mg;   - soft gelatin capsule - 20 mg - active: isotretinoin 20mg   excipient: ferrous oxide gelatin glycerol soya bean oil, partially hydrogenated ferrous oxide yellow soya bean oil, hydrogenated soya oil titanium dioxide yellow beeswax - severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. isotretinoin actavis should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if isotretinoin actavis is used during pregnancy.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - isotretinoin 5mg;   - soft gelatin capsule - 5 mg - active: isotretinoin 5mg   excipient: ferrous oxide gelatin glycerol soya bean oil, partially hydrogenated ferrous oxide yellow e172 soya bean oil, hydrogenated soya oil titanium dioxide yellow beeswax - severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. isotretinoin actavis should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if isotretinoin actavis is used during pregnancy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ennogen healthcare ltd - isotretinoin - oral capsule - 5mg

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - isotretinoin -

Australia - English - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - isotretinoin -

Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - isotretinoin, quantity: 20 mg - capsule, soft - excipient ingredients: disodium edetate; purified water; yellow beeswax; indigo carmine; butylated hydroxyanisole; brilliant scarlet 4r; dl-alpha-tocopherol; gelatin; soya oil; partially hydrogenated soya oil; glycerol; sorbitol solution (70 per cent) (non-crystallising); titanium dioxide; hydrogenated vegetable oil - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects asssociated with its use. isotretinoin should be reversed for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - isotretinoin, quantity: 10 mg - capsule, soft - excipient ingredients: soya oil; dl-alpha-tocopherol; disodium edetate; butylated hydroxyanisole; partially hydrogenated soya oil; yellow beeswax; hydrogenated vegetable oil; gelatin; glycerol; sorbitol solution (70 per cent) (non-crystallising); brilliant scarlet 4r; iron oxide black; titanium dioxide; purified water - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - isotretinoin, quantity: 40 mg - capsule, soft - excipient ingredients: purified water; titanium dioxide; dl-alpha-tocopherol; sorbitol solution (70 per cent) (non-crystallising); yellow beeswax; butylated hydroxyanisole; soya oil; partially hydrogenated soya oil; sunset yellow fcf; glycerol; disodium edetate; hydrogenated soya oil; gelatin - dermatane is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cyctic acne who are unresponsive to conventional therapy, including systemic antibiotics.