Usual Adult Dose for Abnormal Uterine Bleeding

2.5 to 10 mg orally once a day
Duration of therapy: 5 to 10 days

Comments:

• This drug should be used when the endometrium is adequately primed with endogenous/exogenous estrogen.
• Withdrawal bleeding typically occurs within 3 to 7 days of treatment discontinuation.

Use: Treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance without organic pathology (e.g., submucous fibroids, uterine cancer)

Usual Adult Dose for Amenorrhea

2.5 to 10 mg orally once a day
Duration of therapy: 5 to 10 days

Comments:

• This drug should be used when the endometrium is adequately primed with endogenous/exogenous estrogen.
• Withdrawal bleeding typically occurs within 3 to 7 days of treatment discontinuation.

Use: Treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance without organic pathology (e.g., submucous fibroids, uterine cancer)

Usual Adult Dose for Contraception

0.35 mg orally once a day

Comment:

• This drug should be taken at the same time each day.

Use: Prevention of pregnancy

Usual Adult Dose for Endometriosis

Initial dose: 5 mg orally once a day for 2 weeks

• Maximum dose: 15 mg/day

Comments:

• The dose should be increased by 2.5 mg/day every 2 weeks until 15 mg is reached.
• Treatment may continue for 6 to 9 months OR until annoying breakthrough bleeding demands temporary termination.

Uses: Treatment of endometriosis

Usual Pediatric Dose for Contraception

Postpubertal adolescents (under 16 years): 0.35 mg orally once a day

Comments:

• This drug should be used after menarche occurs.
• The dose should be taken at the same time each day.

Use: Prevention of pregnancy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction: Data not available
Severe liver dysfunction or disease: Contraindicated

Dose Adjustments

Oral Contraceptives:

• Switching from combined oral contraceptives (COC): This drug should be started the day after the last active COC pill is taken.
• Switching to a COC: Patients should take the first active pill on the first day of the menstrual period (even if this drug is not finished).

Precautions

Safety and efficacy have not been established in patients before menarche.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Starting treatment: Patients should begin treatment on the first day of the menstrual period OR the next day after a miscarriage or abortion. Patients who begin treatment on another day should use backup birth control methods for 2 to 7 days.
• Breastfeeding: Patients who are fully breastfeeding should begin treatment 6 weeks after delivery; patients who are partially breastfeeding may begin 3 weeks after delivery.
• Contraceptive missed dose(s): Patients should take the missed dose as soon as possible, then continue taking the same dose at the regular time PLUS a backup birth control method for 2 to 7 days.
• IM injection: The injection should be administered extremely slowly, deep into the gluteal muscles with at least a medium bore needle. The ampoule may be immersed in warm water to facilitate injection.

Storage requirements:

• IM injection: Protect from light.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

Monitoring:

• Liver function tests
• Unusual bleeding
• Abdominal pain

Patient advice:

• Patients should be told that this drug does not protect against HIV/AIDS infection and other sexually-transmitted diseases.
• If this drug is taken 3 or more hours late, patients should be instructed to use a backup birth control method for the next 48 hours (e.g., condom and spermicide).
• Patients should be counseled to take this drug at the same time each day, and to avoid interruption of treatment between pill pack use.