Medically reviewed by Drugs.com. Last updated on Aug 4, 2021.
Applies to the following strengths: 150 mg; 200 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Endometriosis
150 mg orally once a day for 24 months
For Women with Dyspareunia:
-Consider 200 mg orally twice a day for 6 months
-Exclude pregnancy before starting or start therapy within 7 days from onset of menses.
-Use lowest effective dose, considering the severity of symptoms and treatment objectives.
-Limit the duration of use because of bone loss; for women with dyspareunia or moderate hepatic impairment, duration of use is limited to 6 months.
Use: For the management of moderate to severe pain associated with endometriosis.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
Mild hepatic impairment (Child-Pugh A): No adjustment recommended
Moderate hepatic impairment (Child-Pugh B): 150 mg orally once a day for up to 6 months
Severe hepatic impairment (Child-Pugh C): Contraindicated
-Hypersensitivity to the active substance or any product ingredients
-Severe hepatic impairment
-Concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions
No adjustment recommended
-Take orally at approximately the same time each day, with or without food
Missed dose: Take on same day as soon as remembered; Do not exceed daily dose
-Store at 36F to 86F (2C to 30C)
-The effect of supplementation with calcium and vitamin D has not been studied, but supplementation is suggested due to the potential for bone loss.
-Patients should be instructed to read the US FDA-approved medication guide
-Patients should understand effective non-hormonal contraceptives should be used during therapy and for 28 days after stopping therapy; pregnancy is contraindicated during use.
-Patients should understand that menstrual changes are expected during therapy.
-Patients should understand there is a risk of bone loss and adequate calcium and vitamin D intake should be encouraged.
-Patients should seek immediate medical attention for suicidal ideation and behavior; patients with new or worsening depression, anxiety, or other mood changes should seek prompt medical advice.
-Patients should be instructed to promptly report signs or symptoms of liver injury.
-Patients should be advised to dispose of unused medication via a take-back option if possible. Otherwise, follow FDA instructions for disposing of in household trash (www.fda.gov/drugdisposal); do not flush down the toilet.
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