Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
bosentan monohydrate, Quantity: 64.54 mg (Equivalent: bosentan, Qty 62.5 mg)
Accord Healthcare Pty Ltd
bosentan monohydrate
Tablet, film coated
Excipient Ingredients: povidone; maize starch; sodium starch glycollate type A; pregelatinised maize starch; purified water; magnesium stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red
Oral
14 tablets in blister pack, 56 tablets in blister pack, 112 tablets in blister pack
(S4) Prescription Only Medicine
Bosentan Astron 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.
Visual Identification: Orange-white, round, biconvex, film-coated tablets, debossed with IB1 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-03-22
BOSENTAN ASTRON CONSUMER MEDICINE INFORMATION Version: 2.0 ‐2016‐ Page 1 of 5 BOSENTAN ASTRON (BOSENTAN FILM‐COATED TABLETS 62.5 MG AND 125 MG) _Bosentan monohydrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bosentan Astron. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Bosentan Astron against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING BOSENTAN ASTRON ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT BOSENTAN ASTRON IS USED FOR Bosentan Astron is used for the treatment of high blood pressure in the blood vessels between the heart and the lungs. This condition is called pulmonary arterial hypertension. This medicine acts to reduce abnormally high blood pressure by widening these blood vessels. It belongs to the class of medicines known as endothelin receptor antagonists. Your doctor however, may prescribe Bosentan Astron for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE BOSENTAN ASTRON _WHEN YOU MUST NOT TAKE _ _BOSENTAN ASTRON _ DO NOT TAKE THIS MEDICINE IF YOU ARE: • PREGNANT OR INTEND TO BECOME PREGNANT. YOU MUST STOP TAKING THE MEDICINE AT LEAST 3 MONTHS BEFORE TRYING TO BECOME PREGNANT. It is known that this medicine causes harm to the developing baby if you take it during pregnancy and in the three months before becoming pregnant. • BREAST‐FEEDING: Tell your doctor immediately if you are breast‐feeding. You are advised to stop breast‐ feeding if this medicine is prescribed for you because it is not known if this drug passes into the milk in women who are taking this medicine. • Being treated with cyclosporine A (a medicine used after a tr Perskaitykite visą dokumentą
Bosentan Astron (Bosentan Film-coated Tablets 62.5 mg and 125 mg) Version 2.0 -2016- Page 1 of 27 PRODUCT INFORMATION Bosentan Astron (bosentan film-coated tablets 62.5 mg and 125 mg) BOSENTAN ASTRON may cause birth defects and is contraindicated in pregnancy. See CONTRAINDICATIONS and PRECAUTIONS. Rare cases of hepatic cirrhosis and hepatic failure have been reported in patients using bosentan. See PRECAUTIONS NAME OF THE MEDICINE Bosentan Astron (bosentan film-coated tablets 62.5 mg and 125 mg). Active: bosentan (as monohydrate) The chemical name of bosentan monohydrate is benzenesulphonamide, 4-(1,1- dimethylethyl)-N-[6-(2hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2’-bipyrimidin]-4-yl]-, monohydrate. The structural formula is: The molecular formula is: C 27 H 29 N 5 O 6 S Anhydrous molecular weight: 551.62 C 27 H 29 N 5 O 6 S.H 2 O Monohydrate molecular weight: 569.63 CAS 147536-97-8 (anhydrous substance) Bosentan is the first of a new drug class, an endothelin receptor antagonist. Bosentan Astron (bosentan) belongs to a class of highly substituted pyrimidine derivatives, with no chiral centres. DESCRIPTION Bosentan monohydrate, a white to off-white powder, is practically insoluble at low pH (0.1 mg/100 mL at pH 1.1 and 4.0; 0.2 mg/100 mL at pH 5.0). Solubility increases at higher pH values (43 mg/100 mL at pH 7.5). In the solid state, bosentan monohydrate is very stable, is not hygroscopic and shows no light sensitivity. Bosentan Astron (Bosentan Film-coated Tablets 62.5 mg and 125 mg) Version 2.0 -2016- Page 2 of 27 Inactive: maize starch, pregelatinised maize starch, sodium starch glycollate type A, povidone, magnesium stearate, hypromellose, glycerol triacetate, purified talc, titanium dioxide, iron oxide yellow and iron oxide red. PHARMACOLOGY Pharmacodynamic Properties The neurohormone endothelin-1 (ET-1) is a potent vasoconstrictor. ET-1 concentrations are elevated in plasma and lung tissue of patients with pulmonary arterial hypertension, suggesting a pathogenic role for ET-1 in this disease. Bosentan is Perskaitykite visą dokumentą