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TARO-BOSENTAN is a brand name for Bosentan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics 02/2025 1 INDICATIONS, 1.2 Geriatrics 02/2025 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 02/2025 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 02/2025 7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding 02/2025 TABLE OF CONTENTS Sections or subsections that are not…
Verbatim from this product's HC label. Tap a section to expand.
2 Breast-feeding 02/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS .................................................................................................................... 4 1. 1 Pediatrics .......................................................................................................................................
4 1. 2 Geriatrics ....................................................................................................................................... 4 2 CONTRAINDICATIONS .......................................................................................................
4 4 DOSAGE AND ADMINISTRATION ...................................................................................... 5 4. 1 Dosing Considerations ..................................................................................................................
5 4. 2 Recommended Dose and Dosage Adjustment ............................................................................. 5 4. 4 Administration ..............................................................................................................................
6 4. 5 Missed Dose .................................................................................................................................. 6 5 OVERDOSAGE ...................................................................................................................
6
) associated with the use of bosentan could potentially occur in the breastfed infant, breast- feeding is not recommended during treatment with Taro-Bosentan. 7. 1. 3 Pediatrics Pediatrics (3-18 years of age): The safety and efficacy of bosentan in children was studied in a group of 19 patients ages 3-15 years with PAH either primary or secondary to various congenital heart defects, in WHO functional class II or III.
Of the 19 patients, 10 were receiving concomitant epoprostenol. After 12 weeks of treatment with bosentan, efficacy could not be demonstrated based on increased exercise capacity. However, statistically significant improvements in certain hemodynamic indices were noted (mean pulmonary artery pressure, mean systemic artery pressure, pulmonary vascular resistance and pulmonary vascular resistance index, systemic vascular resistance and systemic vascular resistance index, cardiac output and stroke index).
No statistically significant improvement in respiratory parameters (oxygen and CO2) or cardiac index was present. By treatment end, five patients had improved by one functional class and one deteriorated. No new safety concerns arose during the study, though one patient was withdrawn from treatment due to increased liver transaminases.
The dosing regimen used in the study was based on body-weight with a recommended target dose of 2 mg/kg, morning and evening. There is extremely limited clinical experience in Taro-Bosentan Product Monograph Page 12 of 52 children below 1 year of age.
d. d. d. d. d. d. 7. 1. 4 Geriatrics Geriatrics (> 65 years of age): Limited clinical experience with bosentan in patients aged 65 years or older has not identified any difference in response between elderly and younger patients, but the possibility of decreased hepatic function in the elderly should be considered (see 4.
2 Recommended Dose and Dosage Adjustment). 8 ADVERSE REACTIONS 8. 1 Adverse Reaction Overview Safety data on bosentan were obtained from placebo-controlled and open-label studies in 677 patients with pulmonary arterial hypertension or other conditions.
2 Breast-feeding 02/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS .................................................................................................................... 4 1. 1 Pediatrics .......................................................................................................................................
4 1. 2 Geriatrics ....................................................................................................................................... 4 2 CONTRAINDICATIONS .......................................................................................................
4 4 DOSAGE AND ADMINISTRATION ...................................................................................... 5 4. 1 Dosing Considerations ..................................................................................................................
5 4. 2 Recommended Dose and Dosage Adjustment ............................................................................. 5 4. 4 Administration ..............................................................................................................................
6 4. 5 Missed Dose .................................................................................................................................. 6 5 OVERDOSAGE ...................................................................................................................
Taro-Bosentan is contraindicated in patients: • who are hypersensitive to bosentan or to any excipient in the formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • who are pregnant, or of childbearing potential unless adequate contraceptive measures are taken.
1 Pregnant Women). , aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), greater than 3 times the upper limit of normal (ULN), particularly when the total bilirubin is increased to greater than 2 times the ULN (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
• concomitant use of cyclosporine A • concomitant use of glyburide. Taro-Bosentan Product Monograph Page 5 of 52
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bosentan in Canada.
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Doses up to 8 times the currently recommended maintenance dose for pulmonary arterial hypertension were administered. 1 years. In the placebo- controlled studies, the adverse events that occurred more frequently in patients treated with bosentan than those treated with placebo were flushing, leg edema, abnormal hepatic function, headache and anemia.
Treatment with bosentan has been associated with dose- dependent elevations in liver aminotransferases and decreases in hemoglobin concentration. 8. 2 Clinical Trial Adverse Drug Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
In placebo-controlled studies 258 were patients with pulmonary arterial hypertension. They received bosentan at doses of 250 mg (n=188) or 500 mg (n=70) per day. ) in placebo-controlled studies in pulmonary arterial hypertension System Organ Class / Adverse Events (AEs) Bosentan n=188 Placebo n=172 n (%) N (%) All system Organ Classes Total patients with at least one AE 155 (82) 135 (79) Total number of AEs 504 548 Infections and infestations Nasopharyngitis 16 (9) 14 (8) Upper respiratory tract infection 15 (8) 11 (6) Sinusitis 7 (4) 4 (2) Bronchitis 6 (3) 12 (7) Urinary tract infection 5 (3) 6 (4) Respiratory tract infection 5 (3) 5 (3) Influenza 4 (2) 8 (5) Lower respiratory tract infection 3 (2) 4 (2) Pharyngitis 3 (2) 1 (1) Ear infection 3 (2) Gastrointestinal disorders Nausea 15 (8) 19 (11) Diarrhea 8 (4) 13 (8) Abdominal pain 5 (3) 7 (4) Vomiting 4 (2) 10 (6) Dyspepsia 4 (2) 4 (2) Abdominal distension 4 (2) 3 (2) Rectal hemorrhage 4 (2) Constipation 3 (2) 4 (2) Dry mouth 3 (2) 2 (1) Mouth ulceration 3 (2) Nervous system disorders Headache 24 (13) 25 (15) Dizziness 18 (10) 23 (13) Syncope 8 (4) 7 (4) General disorders and administration site conditions Edema peripheral 15 (8) 13 (8) Chest pain 10 (5) 8 (5) Edema 5 (3) 4 (2) Influenza like illness 4 (2) 2 (1) Respiratory, thoracic and mediastinal disorders Cough 9 (5) 14 (8) Taro-Bosentan Product Monograph Page 14 of 52 Pulmonary hypertension 8 (4) 23 (13) Dyspnea 6 (3) 7 (4) Epistaxis 6 (3) 7 (4) Hemoptysis 4 (2) 4 (2) Dyspnea exacerbated 3 (2) 6 (4) Dyspnea exertional 3 (2) 1 (1) Musculoskeletal and connective tissue disorders Back pain 7 (4) 6 (4) Arthralgia 6 (3) 3 (2) Muscle spasms 5 (3) 6 (4) Shoulder pain 4 (2) 4 (2) Investigations Liver function test abnormal 8 (4) 3 (2) Hepatic enzyme increased 3 (2) Vascular disorders Flushing 8 (4) 5 (3) Hypotension 6 (3) 3 (2) Cardiac disorders Palpitations 6 (3) 3 (2) Eye disorders Vision blurred 3 (2) 2 (1) Blood and lymphatic system disorders Anemia 6 (3) Injury, poisoning and procedural complications Contusion 4 (2) 1 (1) In placebo-controlled studies of bosentan in the treatment of pulmonary arterial hypertension and other diseases, a total of 677 patients were treated with bosentan and 288 patients were treated with placebo, with doses ranging from 100 mg to 2,000 mg per day.
The duration of treatment ranged from […]
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................... 7 7 WARNINGS AND PRECAUTIONS ........................................................................................ 7 7. 1 Special Populations .....................................................................................................................
10 7. 1. 1 Pregnant Women ................................................................................................................ 10 7. 1. 2 Breast-feeding .....................................................................................................................
11 7. 1. 3 Pediatrics ............................................................................................................................. 11 7. 1. 4 Geriatrics .............................................................................................................................
12 8 ADVERSE REACTIONS ...................................................................................................... 12 8. 1 Adverse Reaction Overview ........................................................................................................
12 Taro-Bosentan Product Monograph Page 3 of 52 8. 2 Clinical Trial Adverse Drug Reactions .......................................................................................... 12 8. 2. 1 Clinical Trial Adverse Reactions – Pediatrics .......................................................................
17 8. 3 Less Common Clinical Trial Adverse Reactions ........................................................................... 17 8. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data 19 8. 5 Post-Market Adverse Reactions ..................................................................................................
20 9 DRUG INTERACTIONS ..................................................................................................... 20 9. 1 Serious Drug Interactions ............................................................................................................
20 9. 2 Drug Interactions Overview ........................................................................................................ 21 9. 4 Drug-Drug Interactions ...............................................................................................................
21 9. 5 Drug-Food Interactions ............................................................................................................... 27 9. 6 Drug-Herb Interactions ...............................................................................................................
27 9. 7 Drug-Laboratory Test Interactions .............................................................................................. 27 10 CLINICAL PHARMACOLOGY .............................................................................................
27 10. 1 Mechanism of Action .................................................................................................................. 27 10. 2 Pharmacodynamics .................................................................................................................
28 10. 3 Pharmacokinetics .................................................................................................................... 29 11 STORAGE AND STABILITY ................................................................................................
31 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................ 31 PART II: SCIENTIFIC INFORMATION ........................................................................................
32 13 PHARMACEUTICAL INFORMATION ................................................................................. 32 14 CLINICAL TRIALS..............................................................................................................
33 14. 3 COMPARATIVE BIOAVAILABILITY STUDY […]