polycystic ovary syndrome †
† non-FDA-approved indication
Ethinyl Estradiol; Desogestrel (Mircette) Indications and Dosage
For routine contraception:
Oral dosage (all monophasic formulations except Mircette™):
Adult and adolescent females: 1 tablet (containing 0.15 mg desogestrel and 30 mcg of ethinyl estradiol) PO once daily for 21 days, followed by 7 days without drug. Repeat dosage cycles begin on the eighth day after taking the last hormonally active tablet. Administration of most monophasic fixed-combination OCs begins on day 5 of the menstrual cycle or on the first Sunday after or on which bleeding has started. However, some clinicians suggest that administration begin on day 1 of the menstrual cycle to decrease the risk of early ovulation. If administration begins on day 1, spotting and breakthrough bleeding may be more common during the initial dosage cycle.
Oral dosage (Mircette™ or Kariva™ only):
Adult and adolescent females: 1 tablet PO once daily for 28 days; first as white tablets (containing 0.15 mg desogestrel and 20 mcg of ethinyl estradiol) for 21 days, then 2 green inert tablets, and then followed by 5 yellow tablets (containing 10 mcg ethinyl estradiol only). Administration should begin on the first Sunday after or on which bleeding has started, or on day 1 of menstruation. For all subsequent cycles, begin a new 28-day regimen on the next day after taking the last yellow tablet from the previous cycle.
Oral dosage (Triphasic regimen, e.g., Cyclessa®, Velivet™):
Adult and adolescent females: 1 tablet PO once daily for 21 days in the order indicated in the pack, followed by a period of 7 days without drug. Phase 1 contains 7 tablets as a combination of 0.1 mg of desogestrel and 25 mcg of ethinyl estradiol. Phase 2 contains 7 tablets as a combination of 0.125 mg of desogestrel and 25 mcg of ethinyl estradiol. Phase 3 contains 7 tablets as a combination of 0.15 mg of desogestrel and 25 mcg of ethinyl estradiol. Repeat dosage cycles begin on the eighth day after taking the last hormonally active tablet. Administration of most combination OCs begins on the first Sunday after or on which bleeding has started. However, some clinicians suggest that administration begin on day 1 of the menstrual cycle to decrease the risk of early ovulation. If administration begins on day 1, spotting and breakthrough bleeding may be more common during the initial dosage cycle.
For the treatment of severe acne vulgaris † related to sebum overproduction in females who have no known contraindications to oral contraceptives, desire contraception, have achieved menarche, and are unresponsive to topical anti-acne medications:
Oral dosage (all formulations except Mircette™ or Kariva™):
Adult and adolescent females: Follow dose as for routine contraception. Improvement may not be noticeable for 2 - 4 months. Prolonged treatment may be needed to control condition.
For the treatment or adjuvant treatment of amenorrhea † , dysfunctional uterine bleeding † , hirsutism † , hypermenorrhea † , or polycystic ovary syndrome † related to hypoestrogenic or hyperandrogenic conditions in females who have no known contraindications to oral contraceptives, desire contraception, have achieved menarche, and have been evaluated for causes of the condition:
Oral dosage (all formulations except Mircette™ or Kariva™):
Adult and adolescent females: Follow dose as for routine contraception. Treatment for 6 - 12 months may be required; OCs have limited utility when the underlying cause of the condition is not related to a hypoestrogenic or hyperandrogenic state.
For the treatment of endometriosis † to induce endometrial involution to a ‘resting’ phase and reduce the size and growth of endometrial tissue in females with no contraindications to oral contraceptives, have achieved menarche and who desire contraception:
Oral dosage (all formulations except Mircette™ or Kariva™):
Adult and adolescent females: Follow dose as for routine contraception; alternatively, the active tablets can be given continuously. Treatment for 6 - 9 months may be needed to induce endometrial atrophy and reduce symptoms.
Maximum Dosage Limits: