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Ambrisentan oral tablets
LETAIRIS™ |
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FDA Approval: |
June 2007 |
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Indication: |
Pulmonary hypertension |
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Pharmacology: |
Endothelin receptor antagonist |
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Usual Dose: |
Initial: 5 mg once a day |
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Contraindications: |
Pregnancy (teratogenic) |
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Warnings: |
Women must use at least 2 reliable methods of contraception or have had a tubal
sterilization Not recommended in moderate or severe hepatic impairment or
ALT/AST >3xULN; use caution in mild impairment
May cause hepatotoxicity; monitor liver function tests at baseline and
monthly;
Monitor hemoglobin at baseline, after 1 month, and periodically; consider
discontinuation if significant decrease occurs
Monitor for peripheral edema and weight gain
Use caution with concomitant cyclosporine, potent CYP450 3A inhibitors, and
potent CYP450 2C19 inhibitors
Prescribers and pharmacies must register with the LETAIRIS Education and
Access Program; patients must be enrolled and meet all criteria
Safety and efficacy have not been established in pediatric patients
Breastfeeding is not recommended
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Pregnancy Category: |
X |
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Side Effects: |
Peripheral edema Nasal congestion
Sinusitis
Flushing
Palpitations
Nasopharyngitis
Abdominal pain
Constipation
Dyspnea
Headache |
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Drug Interactions: |
Potent CYP450 3A4 inhibitors
Potent CYP450 2C19 inhibitors
Potent P-gp inhibitors
Potent OATP inhibitors
Potent CYP450, UGT, and P-gp inducers |
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