Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
bosentan monohydrate, Quantity: 129.082 mg
Dr Reddys Laboratories Australia Pty Ltd
bosentan monohydrate
Tablet, film coated
Excipient Ingredients: maize starch; pregelatinised maize starch; sodium starch glycollate type A; povidone; glycerol dibehenate; magnesium stearate; hypromellose; titanium dioxide; triacetin; purified talc; iron oxide yellow; iron oxide red; ethylcellulose; cetyl alcohol; sodium lauryl sulfate
Oral
60
(S4) Prescription Only Medicine
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: Light orange, film-coated, oval biconvex tablet debossed with '125' on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-12-21
Bosentan‐DRLA CMI Page 1 of 3 BOSENTAN- DRLA _Bosentan (BOZ-en-tan) 62.5 mg/125 _ _mg film- coated tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bosentan-DRLA. 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 using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT BOSENTAN-DRLA IS USED FOR Bosentan-DRLA 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-DRLA for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor’s prescription. BEFORE YOU TAKE BOSENTAN- DRLA _WHEN YOU MUST NOT TAKE BOSENTAN-_ _DRLA_ _ _ 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. I t is known that this medicine causes harm to the developing baby if you take it during pregnancy and in the three months before b ecoming pregnant. • BREASTFEEDING: Tell your doctor immediately if you are breastfeeding. You are advised to stop breastfeeding 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. • B eing treated with cyclosporine A (a medicine used after a transplant or to treat psoriasis) Being treated with glibenclamide (a medicine used for diabete Read the complete document
1/29 PRODUCT INFORMATION BOSENTAN-DRLA BOSENTAN (AS MONOHYDRATE) 62.5 MG & 125 MG TABLETS NAME OF THE MEDICINE 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 MW: 551.62 C 27 H 29 N 5 O 6 S.H 2 O Monohydrate MW: 569.64 CAS 147536-97-8 (anhydrous substance) CAS 157212-55-0 (monohydrate) Bosentan is the first of a new drug class, an endothelin receptor antagonist. 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. Inactive: maize starch, pregelatinised maize starch, sodium starch glycollate, povidone, glyceryl behenate, magnesium stearate, hypromellose, triacetin, talc, titanium dioxide, iron oxide yellow, iron oxide red, ethylcellulose, cetyl alcohol, sodium lauryl sulfate. BOSENTAN-DRLA 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 2/29 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 a specific and competitive antagonist at endothelin receptor types ETA and ETB. Bosentan has a slightly higher affinity for ETA receptors than for ETB receptors. PHARMACOKINETICS _General_ After oral administration, maximum pla Read the complete document