Safebo Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Special Precautions Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Bosentan monohydrate

Indications/Uses

Pulmonary arterial HTN to improve exercise ability & to decrease clinical worsening.

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Dosage/Direction for Use

Pulmonary HTN, systemic sclerosis w/ ongoing digital ulcer disease Childn >12 yr Initially 62.5 mg bid, increased after 4 wk to maintenance dose of 125 mg bid. Patient w/ low body wt (<40 kg) Initial & maintenance dose: 62.5 mg bid.

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Administration

May be taken with or without food.

Contraindications

Moderate to severe hepatic impairment (Child-Pugh class B or C).

Special Precautions

Should not be started in patients w/ conc >3x ULN. Monitor conc every 2 wk & may be continued or reintroduced & aminotransferases be checked after 3 days, after further 2 wk then mthly. Childn <18 yr.

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Adverse Reactions

Headache, nasopharyngitis, flushing, oedema, hypotension, dizziness, palpitations, GI disturbances, pruritus, skin rashes, fatigue, muscle cramps & anaemia. Anaphylaxis & angioedema (rare). Dose-related increases in liver aminotransferases, hepatic cirrhosis & liver failure.

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Drug Interactions

Drug metabolized or inhibited by CYP3A4 & CYP2C19. Increased conc w/ ciclosporin. Increased risk of hepatotoxicity & reduced hypoglycemic effect w/ glibenclamide. May reduce plasma conc of some hormonal contraceptives.

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Storage

View Safebo storage conditions for details to ensure optimal shelf-life.

Description

View Safebo description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Other Antihypertensives

ATC Classification

C02KX01 - bosentan ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.

Regulatory Classification

Presentation/Packing

Form

Safebo FC tab 125 mg

Packing/Price

30's (P625/film-coated tab)

Form

Safebo FC tab 62.5 mg

Packing/Price

30's (P415/film-coated tab)

Safebo

bosentan

Manufacturer:

MSN Lab

Distributor:

Stangen Pharmaceuticals

Marketer:

Mc Graw Pharma