Elagox 200mg Tablet

✔️ Elagox is indicated for the management of:

• Moderate to severe pain associated with endometriosis

✔️ Elagox should not be used in patients with:

• Pregnancy
• Known osteoporosis
• Severe hepatic impairment
• Concurrent use of strong OATP1B1 inhibitors such as:
  • Cyclosporine
  • Gemfibrozil

✔️ Dosage and Administration

Before starting treatment, pregnancy should be ruled out. Therapy should ideally begin within seven days of the start of menstruation.

✔️ Recommended Dosing

Elagox 150 mg

• 150 mg once daily
• May be used for up to 24 months
• In patients with moderate liver impairment, treatment should not exceed 6 months

Elagox 200 mg

• 200 mg twice daily
• Recommended for up to 6 months, particularly in women experiencing painful intercourse (dyspareunia)
• Treatment beyond 6 months is not recommended due to the risk of bone mineral density loss

Renal Impairment

• No dose adjustment is required, including for patients with end-stage renal disease or those receiving dialysis.

Hepatic Impairment

• Mild impairment: No dosage adjustment needed.
• Moderate impairment: Only the 150 mg once-daily regimen is recommended, limited to 6 months.
• Severe impairment: Use is contraindicated.

Children and Adolescents

• Safety and effectiveness in patients under 18 years of age have not been established.

✔️ Drug Interactions

Interactions with Medicines

Elagox may affect the activity of several medications, including:

• P-glycoprotein (P-gp) substrates such as digoxin
• CYP2C19 substrates such as omeprazole (daily doses above 40 mg may require adjustment)
• CYP3A substrate medications
• Midazolam
• Rosuvastatin

Strong CYP3A inducers may reduce the effectiveness of Elagox.

Contraceptive Interactions

Estrogen-containing contraceptives may become less effective during Elagox treatment. Non-hormonal contraception is recommended.

✔️ Side Effects:

• Hot flashes
• Night sweats
• Headache
• Nausea
• Absence of menstrual periods (amenorrhea)
• Joint pain (arthralgia)
• Mood changes
• Bone mineral density loss

✔️ Safety Information:

1. Elagox may cause a decrease in bone mineral density that may not be fully reversible. Women with additional risk factors for osteoporosis should undergo appropriate bone health assessments.
2. The medication may alter menstrual bleeding patterns, making pregnancy harder to detect. Pregnancy testing should be performed if pregnancy is suspected.
3. Elagox has been associated with:

• Depression
• Anxiety
• Mood disorders
• Suicidal thoughts or behavior

Patients experiencing new or worsening mood symptoms should seek medical attention promptly

4. Dose-related increases in liver enzymes may occur. Patients should be advised to watch for symptoms of liver injury, including:

• Yellowing of the skin or eyes
• Dark urine
• Persistent nausea
• Unusual fatigue
• Upper abdominal pain

5. Women should use effective non-hormonal contraception during treatment and continue for at least one week after stopping Elagox.

✔️ Storage:

Store in a cool, dry place away from direct sunlight, heat, and moisture. Keep out of reach of children.