Origolix Tablet 200 mg

Origolix Tablet 200 mg Uses, Dosage, Side Effects, Food Interaction and all others data.

Origolix Tablet 200 mg
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Origolix Tablet 200 mg
Generic	Elagolix Sodium
Weight	200 mg
Type	Tablet
Therapeutic Class	Gonadotropin-releasing hormone (GnRH) antagonist
Manufacturer	Incepta Pharmaceuticals Ltd.
Available Country	Bangladesh
Last Updated:	October 19, 2023 at 6:27 am

Uses

Elagolix is indicated for the management of moderate to severe pain associated with endometriosis.

Dosage

Origolix Tablet 200 mg dosage

Pregnancy should be excluded before starting treatment with Elagolix and start Elagolix within 7 days from the onset of menses.Initial treatment with Elagolix 150 mg: 150 mg once daily up to 24 months. But in case of moderate hepatic impairment up to 6 months.Initial treatment with Elagolix 200 mg: 200 mg twice daily up to 6 months (with coexisting dyspareunia). Treatment with Elagolix 200 mg should not exist more than 6 months as it may decrease bone mineral density (BMD). In moderate to severe hepatic impairment: Elagolix 200 mg is not recommended.Use in children and adolescents: <18 years not established.

Side Effects

Common: The most common side effects include hot flushes, night sweats, headache, nausea, amenorrhea, , arthralgia, mood changes & bone loss. Rare: Insomnia, anxiety & elevated hepatic transaminase.

Precaution

Bone Loss: Dose and duration-dependent decreases in bone mineral density (BMD) that may not be completely reversible. Assess BMD in women with additional risk factors for bone loss.Reduced Ability to Recognize Pregnancy: Elagolix may alter menstrual bleeding, which may reduce the ability to recognize pregnancy. Perform testing if pregnancy is suspected. Discontinue if pregnancy is confirmed.Suicidal Ideation and Mood Disorders: Advise patients to seek medical attention for suicidal ideation, suicidal behavior, new onset or worsening depression, anxiety, or other mood changes.Hepatic Transaminase Elevations: Dose-dependent elevations in serum alanine aminotransferase (ALT). Counsel patients on signs and symptoms of liver injury.Potential for Reduced Efficacy with Estrogen-Containing Contraceptives: Use non-hormonal contraception during treatment and for one week after discontinuing Elagolix.

Interaction

With medicine: May potentiate P-gp substrates (e.g. digoxin), CYP2C19 substrates (e.g. omeprazole; limit doses to <40 mg daily). May antagonize CYP3A substrates. Antagonizes oral midazolam, rosuvastatin; consider increasing their doses. May be antagonized by CYP3A inducers. Reduced efficacy with estrogen-containing contraceptives.With food and others: No known food interaction.

Pregnancy & Breastfeeding use

The limited human data with the use of Elagolix in pregnant women are insufficient to determine whether there is a risk for major birth defects or miscarriage. Exposure to Elagolix early in pregnancy may increase the risk of early pregnancy loss. Use of it is contraindicated in pregnant women. Elagolix has to be discontinued if pregnancy occurs during treatment. There is no information on the presence of elagolix or its metabolites in human milk, the effects on the breastfed child or the effects on milk production.

Contraindication

It is contraindicated in pregnant women because exposure to Elagolix early in pregnancy may increase the risk of early pregnancy loss. With known osteoporosis, it can increase the risk of further bone loss. It is also contraindicated for severe hepatic impairment and also with concomitant use of strong organic anion transporting polypeptide OATP1B1 inhibitors (e.g. cyclosporine and gemfibrozil).

Special Warning

No dose adjustment of Elagolix is required in women with any degree of renal impairment or end-stage renal disease (including women on dialysis) No dosage adjustment of Elagolix is required in women with mild hepatic impairment. Safety and effectiveness of Elagolix in patients less than 18 years of age have not been established.

Acute Overdose

In case of overdose, patients should be monitored for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment, as needed.