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Tracleer

Tracleer

bosentan

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Bosentan
Indications/Uses
Pulmonary arterial HTN (PAH) in patients of WHO functional class II-IV.
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Dosage/Direction for Use
Initially 62.5 mg bd for 4 wk. Maintenance: 125 mg bd.
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Overdosage
View Tracleer overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Swallow whole, do not divide/chew/crush.
Contraindications
Hypersensitivity. Concomitant use of cyclosporin A. Moderate to severe hepatic impairment (Child-Pugh class B or C). Baseline values of liver aminotransferase (AST &/or ALT >3 x ULN). Women of childbearing potential not using reliable methods of contraception. Pregnancy.
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Warnings
For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Tracleer detailed prescribing information
Special Precautions
Liver function, measure liver aminotransferase prior to treatment initiation & subsequently at mthly intervals. Hb conc, check Hb conc prior to treatment initiation, every 1 mth during 1st 4 mth & quarterly thereafter. Pulmonary veno-occlusive disease, PAH w/ concomitant left ventricular failure, monitor signs signs for fluid retention. PAH associated w/ HIV infection. Pulmonary HTN secondary to COPD. May affect ability to drive or operate machinery. May affect fertility. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. Not recommended during lactation. Paed. Elderly.
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Adverse Reactions
Anaemia, decreased Hb, hypersensitivity reactions, headache, syncope, palpitations, flushing, hypotension, nasal congestion, GERD, diarrhoea, abnormal LFT, erythema, oedema, fluid retention.
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Drug Interactions
Increased plasma conc w/ potent CYP3A4 inhibitor (eg, ketoconazole, itraconazole, ritonavir) & CYP2C9 inhibitor (eg, voriconazole). Decreased blood conc of cyclosporine A. Reduced/decreased plasma conc of tacrolimus, sirolimus. glibenclamide, warfarin, simvastatin. Decreased plasma conc w/ potent CYP2C9 & CYP3A4 inducers eg, rifampicin. Reduced systemic exposure w/ other CYP3A4 inducers eg, carbamazepine, phenobarb, phenytoin, St. John's wort. Reduced clearance w/ lopinavir + ritonavir, other ritonavir-boosted PIs. Additive toxicity w/ nevirapine. Decreased AUC of norethisterone, ethinyl estradiol, sildenafil. Reduced tadalafil systemic exposure. Decreased AUC, Cmax & Cmin of digoxin.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Tracleer detailed prescribing information
Storage
View Tracleer storage conditions for details to ensure optimal shelf-life.
Description
View Tracleer description for details of the chemical structure and excipients (inactive components).
Action
View Tracleer mechanism of action for pharmacodynamics and pharmacokinetics details.
MIMS Class
Other Antihypertensives
ATC Classification
C02KX01 - bosentan ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.
Presentation/Packing
Form
Tracleer FC tab 125 mg
Packing/Price
60's
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