Products

Pulmiprove

Pulmiprove 62.5 mg Tablets
Pulmiprove 125 mg Tablets

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Active ingredient

Qualitative and quantitative composition
Each film-coated tablet contains:
Bosentan Monohydrate 129.082( eq. to 125 mg bosentan anhydrous )
Bosentan Monohydrate 64.541( eq. to 62.5 mg bosentan anhydrous)
For the full list of excipients, see insert leaflet.

Indications

Therapeutic indications
Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.

Efficacy has been shown in:
• Primary (idiopathic and heritable) PAH
• PAH secondary to scleroderma without significant interstitial pulmonary disease
• PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology
Some improvements have also been shown in patients with PAH WHO functional class II.
Pulmiprove is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.

Dosage and Administration

Posology and method of administration
The film-coated tablets are to be swallowed with water orally, morning and evening, with or without food.
Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.
In adult patients, Pulmiprove treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
For paediatric patients aged 2 years or older, the optimal maintenance dose has not been defined in well-controlled studies. However, paediatric pharmacokinetic data have shown that bosentan plasma concentrations in children were on average lower than in adult patients and were not increased by increasing the dose of Pulmiprove above 2 mg/kg body weight twice daily. Based on these pharmacokinetic results, higher doses are unlikely to be more effective, and greater adverse event rates cannot formally be excluded in young children if the dose is increased. No clinical study has been conducted to compare
the efficacy/safety ratio of 2 mg/kg to 4 mg/kg body weight twice daily in children.
There is only limited clinical experience in paediatric patients under 2 years of age.
For more info please refer to the insert leaflet.

Contraindication

• Hypersensitivity to the active substance or to any of the excipients.

• Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C.

• Baseline values of liver aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT), greater than 3 times the upper limit of normal.

For more info please refer to the insert leaflet.

Side effects

Very common Headache

Common Anaemia, Haemoglobin decrease, Palpitations, Syncope, Hypersensitivity                  reactions (including dermatitis, pruritus and rash)

Uncommon Thrombocytopenia, Neutropenia, Leukopenia

Rare Anaphylaxis and/or Angioedema

For more info please refer to the insert leaflet.

Drug Interaction

Interaction with other medicinal products and other forms of interaction
Bosentan is an inducer of the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4. In vitro data also suggest an
induction of CYP2C19. Consequently, plasma concentrations of substances metabolised by these isoenzymes will be
decreased when Pulmiprove is co-administered.

For more info please refer to the insert leaflet.

Pregnancy and Lactation

Pregnancy and lactation

There are no reliable data on the use of Pulmiprove in pregnant women

It is not known whether bosentan is excreted into human breast milk. Breast-feeding is not recommended during treatment with Pulmiprove

Warning and Precaution

Pulmiprove should only be initiated if the systemic systolic blood pressure is higher than 85 mmHg.

Liver function:

Elevations in liver aminotransferases, i.e., aspartate and alanine aminotransferases (AST and/or ALT), associated with bosentan are dose dependent. Liver enzyme changes typically occur within the first 26 weeks of treatment. Liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals for the duration of treatment with Pulmiprove. In addition, liver aminotransferase levels must be measured 2 weeks after any dose increase.

Haemoglobin concentration:

Treatment with bosentan has been associated with dose-related decreases in haemoglobin concentration. It is recommended that haemoglobin concentrations be checked prior to initiation of treatment, every month during the first 4 months, and quarterly thereafter.

Women of child-bearing potential:

Pulmiprove treatment must not be initiated in women of child-bearing potential unless they practise reliable contraception and the result of the pre-treatment pregnancy test is negative.

Pulmonary veno-occlusive disease:

Should signs of pulmonary oedema occur when Pulmiprove is administered in patients with PAH, the possibility of associated veno-occlusive disease should be considered.

Pulmonary arterial hypertension patients with concomitant left ventricular failure:

Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with Pulmiprove.

Pulmonary arterial hypertension associated with HIV infection:

When treatment with Pulmiprove is initiated in patients who require ritonavir-boosted protease inhibitors, the patient's tolerability of Pulmiprove should be closely monitored. These patients should also be monitored carefully regarding their HIV infection.

Package and Storage

Precautions for storage: Store at temperature not exceeding 30 °C in a dry place  Package: Carton box containing 3 (AL/transparent PVC/PVDC) each of 10 F.C.T & insert leaflet

Mother Company

Manufactured by Marcyrl