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TRACLEER (BOSENTAN)
- Pulmonary arterial hypertension
32 mg tablet for oral suspension
- Dosage information is not available
125 mg tablet
- 1 tablet (125 mg) by oral route 2 times per day in the morning and evening
62.5 mg tablet
- 2 tablets (125 mg) by oral route 2 times per day in the morning and evening
125 mg tablet
- 1 tablet (125 mg) by oral route 2 times per day in the morning and evening
62.5 mg tablet
- 2 tablets (125 mg) by oral route 2 times per day in the morning and evening
Pulmonary arterial hypertension
- 2 tablets (125 mg) by oral route 2 times per day in the morning and evening
- 1 tablet (125 mg) by oral route 2 times per day in the morning and evening
- cyclosporine
- cyclosporine modified
- Diabeta
- Gengraf
- Glucovance
- glyburide
- glyburide micronized
- glyburide-metformin
- Glynase
- Neoral
- Sandimmune
Contraindicated
- Altavera (28)
- Alyacen 1/35 (28)
- Alyacen 7/7/7 (28)
- Amethia
- Amethia Lo
- Amethyst
- Apri
- Aranelle (28)
- atazanavir
- Aubra
- Aviane
- axitinib
- Azurette (28)
- Balziva (28)
- bedaquiline
- Beyaz
- Bosulif
- bosutinib
- Brevicon (28)
- Briellyn
- Camila
- Camrese
- Camrese Lo
- Caziant (28)
- Chateal
- Crixivan
- Cryselle (28)
- Cyclafem 1/35 (28)
- Cyclafem 7/7/7 (28)
- Cyclessa (28)
- Dasetta 1/35 (28)
- Dasetta 7/7/7 (28)
- Daysee
- Depo-provera
- Depo-subq Provera 104
- desog-e.estradiol/e.estradiol
- Desogen
- desogestrel-ethinyl estradiol
- drospirenone-e.estradiol-lm.FA
- drospirenone-ethinyl estradiol
- Elinest
- elvitegr-cobicist-emtric-tenof
- Emoquette
- Enpresse
- Enskyce
- enzalutamide
- Errin
- Estarylla
- estradiol valerate-dienogest
- Estrostep Fe-28
- ethynodiol diac-eth estradiol
- etonogestrel
- etonogestrel-ethinyl estradiol
- Falmina (28)
- Femcon Fe
- fosamprenavir
- Generess Fe
- Gianvi (28)
- Gildagia
- Gildess
- Gildess Fe
- guanfacine
- Heather
- indinavir
- Inlyta
- Introvale
- Intuniv Er
- Jencycla
- Jolessa
- Jolivette
- Junel 1.5/30 (21)
- Junel 1/20 (21)
- Junel Fe 1.5/30 (28)
- Junel Fe 1/20 (28)
- Kaletra
- Kariva (28)
- Kelnor 1/35 (28)
- Kurvelo
- L norgest&E estradiol-E estrad
- Larin 1/20 (21)
- Larin Fe
- Leena 28
- Lessina
- Levonest (28)
- levonorg-eth estrad triphasic
- levonorgestrel
- levonorgestrel-ethinyl estrad
- Levora 0.15/30 (28)
- Levora-28
- Lexiva
- Lo Loestrin Fe
- Loestrin 1.5/30 (21)
- Loestrin 1/20 (21)
- Loestrin Fe 1.5/30 (28)
- Loestrin Fe 1/20 (28)
- Lomedia 24 Fe
- lopinavir-ritonavir
- Loryna (28)
- Loseasonique
- Low-ogestrel (28)
- Lutera (28)
- Lyza
- Marlissa
- medroxyprogesterone
- Microgestin 1.5/30 (21)
- Microgestin 1/20 (21)
- Microgestin Fe 1.5/30 (28)
- Microgestin Fe 1/20 (28)
- Minastrin 24 Fe
- Mircette (28)
- Mirena
- Modicon (28)
- Mono-linyah
- Mononessa (28)
- My Way
- Myzilra
- Natazia
- Necon 0.5/35 (28)
- Necon 1/35 (28)
- Necon 1/50 (28)
- Necon 10/11 (28)
- Necon 7/7/7 (28)
- nelfinavir
- Nexplanon
- Next Choice One Dose
- Nor-qd
- Nora-be
- norelgestrom-ethinyl estradiol
- noreth-ethinyl estradiol-iron
- norethin-e.estradiol triphasic
- norethin-eth estrad biphasic
- norethindrone (contraceptive)
- norethindrone ac-eth estradiol
- norethindrone-e.estradiol-iron
- norethindrone-ethin estradiol
- norethindrone-mestranol
- norgestimate-ethinyl estradiol
- norgestrel-ethinyl estradiol
- Norinyl 1+35 (28)
- Norinyl 1+50 (28)
- Nortrel 0.5/35 (28)
- Nortrel 1/35 (21)
- Nortrel 1/35 (28)
- Nortrel 7/7/7 (28)
- Norvir
- Norvir Soft Gelatin
- Nuvaring
- Ocella
- Ogestrel (28)
- Olysio
- Orsythia
- Ortho Evra
- Ortho Micronor
- Ortho Tri-cyclen (28)
- Ortho Tri-cyclen Lo (28)
- Ortho-cept (28)
- Ortho-cyclen (28)
- Ortho-novum 1/35 (28)
- Ortho-novum 7/7/7 (28)
- Ovcon-35 (28)
- Philith
- Pimtrea (28)
- Pirmella
- Plan B One-step
- Portia
- Previfem
- Quartette
- Quasense
- Reclipsen (28)
- Reyataz
- ritonavir
- Safyral
- Seasonique
- simeprevir
- Sirturo
- Skyla
- Sprintec (28)
- Sronyx
- Stribild
- Syeda
- Tenex
- Tilia Fe
- Tri-estarylla
- Tri-legest Fe
- Tri-linyah
- Tri-norinyl (28)
- Tri-previfem (28)
- Tri-sprintec (28)
- Trinessa (28)
- Trivora (28)
- Velivet Triphasic Regimen (28)
- Vestura (28)
- Viorele (28)
- Viracept
- Vyfemla (28)
- Wera (28)
- Wymzya Fe
- Xtandi
- Yasmin (28)
- Yaz 28
- Zarah
- Zenchent (28)
- Zenchent Fe
- Zeosa
- Zovia 1/35E (28)
- Zovia 1/50E (28)
Severe
Moderate
- Advicor
- Altoprev
- amlodipine-atorvastatin
- atorvastatin
- Caduet
- ezetimibe-atorvastatin
- ezetimibe-simvastatin
- isoniazid-rifamp-pyrazinamide
- ketoconazole
- Lipitor
- Liptruzet
- lovastatin
- Mevacor
- niacin-lovastatin
- niacin-simvastatin
- Rifadin
- Rifamate
- rifampin
- rifampin-isoniazid
- Rifater
- Simcor
- simvastatin
- Vytorin 10-10
- Vytorin 10-20
- Vytorin 10-40
- Vytorin 10-80
- Zocor
- Lactating mother
- Pregnancy
- Pulmonary veno-occlusive disease
- Severe hepatic disease
Contraindicated
- Abnormal hepatic function tests
- Acute decompensated heart failure
- Disease of liver
- Hyperbilirubinemia
- Pulmonary edema
Severe
Moderate
- Anemia
- Edema
- Thrombocytopenic disorder
TRACLEER (BOSENTAN)
- Pulmonary arterial hypertension
- Anemia
- Disease of liver
- Fever
- Flushing
- Headache disorder
- Upper respiratory infection
More Frequent
Severe
Less Severe
- Abnormal hepatic function tests
- Edema
- Increased alanine transaminase
- Increased aspartate transaminase
- Palpitations
- Worsening of chronic heart failure
- Arthralgias
- Body fluid retention
- Chest pain
- Hypotension
- Peripheral edema
- Sinusitis
- Syncope
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Angioedema
- DRESS syndrome
- Eosinophilia
- Hepatic cirrhosis
- Hepatic failure
- Hyperbilirubinemia
- Hypersensitivity drug reaction
- Jaundice
- Leukopenia
- Neutropenic disorder
- Skin rash
- Thrombocytopenic disorder
Less Severe
- Nasal congestion
- Oligospermia
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Bosentan
Efficacy unknown in pediatrics age < 3 years.
- 1 Day – 3 Years
- Efficacy unknown in pediatrics age < 3 years.
Bosentan
- Severity Level:
1
- Additional Notes: Based on drug pharmacology developmental toxicity is possible.
Contraindicated
Bosentan
Potential serious adv eff on infant;Moleculr wt low enough for poss excretion
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Potential serious adv eff on infant;Moleculr wt low enough for poss excretion |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- Talk with your doctor about the benefits and risks of taking this medication. Because bosentan can have serious side effects, you must be enrolled in a special program (Tracleer REMS Program) to receive it. This requirement applies in the United States.<br /><br />If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations. Bosentan may rarely cause serious (possibly fatal) liver damage. Rarely, liver problems have happened in people after stopping treatment with bosentan.<br /><br />Your doctor will perform liver function tests before you start treatment and once a month during treatment. Tell your doctor right away if you notice dark urine, loss of appetite, persistent nausea/vomiting, stomach/abdominal pain, or yellowing eyes/skin. Bosentan must not be used during pregnancy because it may cause serious harm (such as birth defects) in an unborn baby.<br /><br /> Women of childbearing age must have a negative pregnancy test before starting this medication and monthly during treatment. Use at least two reliable forms of birth control while taking bosentan and for at least one month after stopping bosentan as directed by your doctor to prevent pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. (See also Precautions section.)
| Pulmonary arterial hypertension | |
| I27.0 | Primary pulmonary hypertension |
| I27.21 | Secondary pulmonary arterial hypertension |
| 0-9 | A-Z |
|---|---|
| I27.0 | Primary pulmonary hypertension |
| I27.21 | Secondary pulmonary arterial hypertension |
Formulary Reference Tool