Australien - engelska - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - bosentan monohydrate, quantity: 129.083 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; magnesium stearate; maize starch; povidone; sodium starch glycollate type a; glycerol dibehenate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; ethylcellulose - bosentan is indicated for the treatment of,? idiopathic pulmonary arterial hypertension,? familial pulmonary arterial hypertension,? pulmonary arterial hypertension associated with scleroderma or,? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger?s physiology,in patients with who functional class ii, iii or iv symptoms

Australien - engelska - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - bosentan monohydrate, quantity: 64.541 mg - tablet, film coated - excipient ingredients: maize starch; glycerol dibehenate; povidone; pregelatinised maize starch; sodium starch glycollate type a; magnesium stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; ethylcellulose - bosentan is indicated for the treatment of,? idiopathic pulmonary arterial hypertension,? familial pulmonary arterial hypertension,? pulmonary arterial hypertension associated with scleroderma or,? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger?s physiology,in patients with who functional class ii, iii or iv symptoms

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

viatris limited - bosentan monohydrate 129.082mg equivalent to bosentan anhydrous 125 mg;  ; bosentan monohydrate 129.082mg equivalent to bosentan anhydrous 125 mg - film coated tablet - 125 mg - active: bosentan monohydrate 129.082mg equivalent to bosentan anhydrous 125 mg   excipient: glyceryl behenate magnesium stearate maize starch opadry yellow 03k82318 povidone sodium laurilsulfate sodium starch glycolate starch surelease clear e-7-19040 as solid active: bosentan monohydrate 129.082mg equivalent to bosentan anhydrous 125 mg excipient: glyceryl behenate magnesium stearate maize starch opadry white 03k580000 povidone sodium laurilsulfate sodium starch glycolate starch surelease clear e-7-19040 as solid - indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

viatris limited - bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg;  ; bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg - film coated tablet - 62.5 mg - active: bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg   excipient: glyceryl behenate magnesium stearate maize starch opadry yellow 03k82318 povidone sodium laurilsulfate sodium starch glycolate starch surelease clear e-7-19040 as solid active: bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg excipient: glyceryl behenate magnesium stearate maize starch opadry white 03k580000 povidone sodium laurilsulfate sodium starch glycolate starch surelease clear e-7-19040 as solid - indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - bosentan monohydrate, quantity: 64.5 mg (equivalent: bosentan, qty 62.5 mg) - tablet, film coated - excipient ingredients: maize starch; sodium starch glycollate type b; povidone; pregelatinised maize starch; glycerol dibehenate; magnesium stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; purified water; ethylcellulose; cetyl alcohol; hydrogen peroxide; sodium lauryl sulfate; octamethylcyclotetrasiloxane; silica dimethicone silylate; dimeticone 5000; cyclomethicone - bosentan is indicated for the treatment of: - idiopathic pulmonary arterial hypertension - familial pulmonary arterial hypertension - pulmonary arterial hypertension associated with scleroderma or - pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who functional class ii, iii or iv symptoms.

Irland - engelska - HPRA (Health Products Regulatory Authority)

zentiva k.s. - bosentan monohydrate - film-coated tablet - bosentan

Irland - engelska - HPRA (Health Products Regulatory Authority)

zentiva k.s. - bosentan monohydrate - film-coated tablet - bosentan

USA - engelska - NLM (National Library of Medicine)

actavis pharma, inc. - bosentan (unii: q326023r30) (bosentan anhydrous - unii:xul93r30k2) - bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): - in adults to improve exercise ability and to decrease clinical worsening. studies establishing effectiveness included predominantly patients with who functional class ii-iv symptoms and etiologies of idiopathic or heritable pah (60%), pah associated with connective tissue diseases (21%), and pah associated with congenital heart disease with left-to-right shunts (18%) [see clinical studies (14.1)] . - in pediatric patients aged 3 years and older with idiopathic or congenital pah to improve pulmonary vascular resistance (pvr), which is expected to result in an improvement in exercise ability. use of bosentan is contraindicated in females who are or may become pregnant. to prevent pregnancy, females of reproductive potential must use two reliable forms of contraception during treatment and for one month after stopping bosentan [see boxed warning, warnings and precautions (5.2), drug interactions (7.2), use in specific populations (8.1)] . coadministration of cyclosporine a and bosentan resulted in markedly increased plasma concentrations of bosentan. therefore, concomitant use of bosentan and cyclosporine a is contraindicated [see cytochrome p450  drug interactions (7.1)] . an increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. therefore coadministration of glyburide and bosentan is contraindicated [see cytochrome p450  drug interactions (7.1)] . bosentan is contraindicated in patients who are hypersensitive to bosentan or any component of the product. observed reactions include drug reaction with eosinophilia and systemic symptoms (dress), anaphylaxis, rash, and angioedema [see adverse reactions (6.2), description (11)] . risk summary based on data from animal reproduction studies, bosentan may cause fetal harm, including birth defects and fetal death, when administered to a pregnant female and is contraindicated during pregnancy [see contraindications (4.1)] . there are limited data on bosentan use in pregnant women. in animal reproduction studies, oral administration of bosentan to pregnant rats at 2-times the maximum recommended human dose (mrhd) on a mg/m2 basis caused teratogenic effects in rats, including malformations of the head, mouth, face, and large blood vessels [see animal data] . advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data bosentan was teratogenic in rats given oral doses two times the mrhd (on a mg/m2 basis). in an embryo-fetal toxicity study in rats, bosentan showed dose-dependent teratogenic effects, including malformations of the head, mouth, face and large blood vessels. bosentan increased stillbirths and pup mortality at oral doses 2 and 10 times the mrhd (on a mg/m2 basis). although birth defects were not observed in rabbits given oral doses of up to the equivalent of 10.5 g/day in a 70 kg person, plasma concentrations of bosentan in rabbits were lower than those reached in the rat. the similarity of malformations induced by bosentan and those observed in endothelin-1 knockout mice and in animals treated with other endothelin receptor antagonists indicates that embryo-fetal toxicity is a class effect of these drugs. risk summary there are no data on the presence of bosentan in human milk, the effects on the breastfed infant, or the effect on milk production. because of the potential for serious adverse reactions, such as fluid retention and hepatotoxicity, in breastfed infants from bosentan, advise women not to breastfeed during treatment with bosentan. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating bosentan, monthly during treatment and one month after stopping treatment with bosentan. the patient should contact her physician immediately for pregnancy testing if onset of menses is delayed or pregnancy is suspected. if the pregnancy test is positive, the physician and patient must discuss the risks to her, the pregnancy, and the fetus. contraception drug interaction studies show that bosentan reduces serum levels of the estrogen and progestin in oral contraceptives. based on these findings, hormonal contraceptives (including oral, injectable, transdermal, and implantable contraceptives) may be less effective for preventing pregnancy in patients using bosentan and should not be used as a patient’s only contraceptive method [see drug interactions (7.2)] . females of reproductive potential using bosentan must use two acceptable methods of contraception during treatment and for 1 month after treatment with bosentan. patients may choose one highly effective form of contraception (intrauterine devices (iud) or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods). if a partner’s vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. counsel patients on pregnancy planning and prevention, including emergency contraception, or designate counseling by another healthcare provider trained in contraceptive counseling [see boxed warning] . infertility males decreased sperm counts have been observed in patients receiving bosentan. based on these findings and findings in animals, bosentan may impair fertility in males of reproductive potential. it is not known whether effects on fertility would be reversible [see warnings and precautions (5.6), adverse reactions (6.1), nonclinical toxicology (13.1)] . the efficacy of bosentan in patients <18 years is supported by data from an uncontrolled trial in which 19 pediatric patients were treated with bosentan. in this study, cardiopulmonary hemodynamic improvements were similar to those seen in adults treated with bosentan [see pulmonary arterial hypertension (14.1)] . safety in pediatric patients is supported by data from 100 pediatric patients treated with bosentan for a median of 17 months [see clinical studies experience (6.1), pulmonary arterial hypertension (14.1)] . juvenile animal toxicity data in a juvenile rat toxicity study, rats were treated from day 4 postpartum to adulthood (day 69 postpartum). decreased body weights, absolute weights of testes and epididymides, and reduced number of sperm in epididymides were observed after weaning. no effect on testis histology or sperm morphology and function was seen. the noael was 4 times (at day 4 postpartum) and 2 times (day 69 postpartum) the human therapeutic exposure, respectively. no effects on general development, sensory, cognitive function and reproductive performance were detected at the highest dose tested in juvenile rats, 7 times the therapeutic exposure in children with pah. clinical studies of bosentan did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. because there is in vitro and in vivo evidence that the main route of excretion of bosentan is biliary, liver impairment could be expected to increase exposure (cmax and auc) of bosentan. the pharmacokinetics of bosentan have not been evaluated in patients with severe liver impairment (child-pugh class c). in patients with moderate hepatic impairment (child-pugh class b), the systemic exposures to bosentan and its active metabolite increased significantly. bosentan should generally be avoided in patients with moderate or severe liver impairment. pharmacokinetics of bosentan were not altered in patients with mild impairment of hepatic function (child-pugh class a) [see dosage and administration (2.6), warnings and precautions (5.1), pharmacokinetics (12.3)] . the effect of renal impairment on the pharmacokinetics of bosentan is small and does not require dosing adjustment [see pharmacokinetics (12.3)] .

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - bosentan monohydrate, quantity: 129.082 mg - tablet, film coated - excipient ingredients: glycerol dibehenate; magnesium stearate; pregelatinised maize starch; sodium starch glycollate type a; maize starch; povidone; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; ethylcellulose - for the treatment of,? idiopathic pulmonary arterial hypertension,? familial pulmonary arterial hypertension,? pulmonary arterial hypertension associated with scleroderma or,? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger?s physiology,in patients with who functional class ii, iii or iv symptoms

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - bosentan monohydrate, quantity: 64.541 mg - tablet, film coated - excipient ingredients: sodium starch glycollate type a; maize starch; povidone; glycerol dibehenate; magnesium stearate; pregelatinised maize starch; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; ethylcellulose - for the treatment of,? idiopathic pulmonary arterial hypertension,? familial pulmonary arterial hypertension,? pulmonary arterial hypertension associated with scleroderma or,? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger?s physiology,in patients with who functional class ii, iii or iv symptoms