pms-Bosentan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Bosentan monohydrate 62.5mg;  

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Bosentan monohydrate 62.5 mg

Dosage:

62.5 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Bosentan monohydrate 62.5mg   Excipient: Magnesium stearate Opadry orange 03K93638 Povidone Pregelatinised maize starch Sodium starch glycolate

Units in package:

Blister pack, Aluminium foil and PVC/PCTFE film, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

MSN Laboratories Private Limited

Therapeutic indications:

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.

Product summary:

Package - Contents - Shelf Life: Blister pack, Tekniflex VA/ aluminium foil - 60 tablets - 36 months from date of manufacture stored at or below 25°C. manufactured at Genvion Corporation - Bottle, plastic, HDPE, PP cap - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2012-07-27

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1. PMS-BOSENTAN
Bosentan monohydrate 62.5 mg and 125 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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.
The chemical name of bosentan monohydrate is benzenesulphonamide,
4-(1,1-dimethylethyl)-N-[6-
(2hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]-,
monohydrate.
3. PHARMACEUTICAL FORM
pms-Bosentan 62.5 mg are orange coated, white round tablets debossed B
on one side and 62.5 on the
other. Each tablet contains 62.5 mg bosentan monohydrate.
pms-Bosentan 125 mg are orange coated white oval tablets debossed B on
one side and 125 on the
other. Each tablet contains 125 mg bosentan monohydrate.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 DOSE AND METHOD OF ADMINISTRATION
_GENERAL _
Bosentan should be administered under the supervision of a physician
experienced in the management
of pulmonary arterial hypertension. pms-Bosentan treatment should be
started at a dose of 62.5 mg,
BOSENTAN 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
twice daily for 4 weeks. Efficacy was demonstrated in cl