Pulmoten 62.50mg tablet 7's pack

Name: Pulmoten 62.50mg tablet 7's pack
Brand: Square Pharmaceuticals
Price: 1050.00 BDT
Availability: InStock

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Stock: In Stock
Model: MEDI-00137
Generic: Bosentan Monohydrate
Pack Size: Each pack contains 7 pcs. of Pulmoten 62.5mg tablet

Square Pharmaceuticals

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THERAPEUTIC USES
Reviews

Prescribing Information (Research Brand)

Indications

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

Therapeutic Class

Anti-hypertensive, Endothelin receptor antagonist

Pharmacology

Bosentan, an endothelium-receptor antagonist blocks endothelin receptors on vascular endothelium and smooth muscle promoting vasodilation. It improves exercise capacity and clinical worsening in patients with pulmonary arterial HTN.

Dosage & Administration

Adult/Geriatric:

<40 kg: Initial and maintenance: 62.5 mg twice daily
≥40 kg: Initial: 62.5 mg twice daily for 4 weeks; increase to maintenance dose of 125 mg twice daily. Doses more than 125 mg twice daily do not appear to confer additional clinical benefit but may increase risk of liver toxicity.

Pediatric:

Infants ≥7 months and Children: Limited data available (Barst 2003; Ivy 2004; Maiya 2006; Rosenzweig 2005):
5 to <10 kg: Initial: 15.6 mg daily for 4 weeks; increase to maintenance dose of 15.6 mg twice daily.
10 to 20 kg: Initial: 31.25 mg daily for 4 weeks; increase to maintenance dose of 31.25 mg twice daily.
>20 to 40 kg: Initial: 31.25 mg twice daily for 4 weeks; increase to maintenance dose of 62.5 mg twice daily.
>40 kg: Initial: 62.5 mg twice daily for 4 weeks; increase to maintenance dose of 125 mg twice daily.
Children >12 years and Adolescents: Refer to adult dosing.

Interaction

Increased bosentan levels with CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, diltiazem), CYP2C9 inhibitors (e.g. amiodarone, fluconazole), tacrolimus. Rifampicin initially increases but subsequently decreases bosentan concentration. May decrease plasma levels of warfarin, statins (e.g. simvastatin, lovastatin), hormonal contraceptives, sildenafil, tadalafil.

Contraindications

Acute porphyria; moderate and severe hepatic impairment. Coadministration with ciclosporin or glibenclamide. Pregnancy (use 2 forms of contraception during treatment and 1 mth after stopping).

Side Effects

Headache, nasopharyngitis, flushing, fluid retention (e.g. peripheral oedema), hypotension, palpitations, dyspepsia, fatigue, pruritus, rash, anaemia (dose-related), reduced sperm count (reversible).

Pregnancy & Lactation

Pregnancy Category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Precautions

Consider discontinuation of therapy if pulmonary oedema occurs. Avoid abrupt withdrawal and consider dose reduction (e.g. half the dose for 3-7 days) to minimise risk of clinical deterioration. Lactation.

Overdose Effects

Symptoms: Nausea, vomiting, hypotension, dizziness, sweating and blurred vision.

Management: Symptomatic and supportive treatment.

Use in Special Population

Renal Impairment: No dosage adjustment necessary. Bosentan is unlikely to be removed by dialysis (due to high molecular weight and extensive plasma protein binding).

Hepatic Impairment: Hepatic impairment at treatment initiation:

Mild impairment: No dosage adjustment necessary.
Moderate to severe impairment: Use should be avoided; systemic exposure is significantly increased in patients with moderate impairment (not studied in patients with severe impairment).