postcoital contraception
† non-FDA-approved indication
Ethinyl Estradiol; Levonorgestrel (Triphasil) Indications and Dosage
For routine contraception:
Oral dosage (Levlen®, Levora™, Nordette®, or Portia™):
Adult and adolescent females: 1 tablet (containing 0.15 mg levonorgestrel and 30 mcg of ethinyl estradiol) PO once daily for 21 days, followed by a period of 7 days without drug. 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.
Oral dosage (Alesse™, Lessina™, Levlite™, or Lutera™):
Adult and adolescent females: 1 tablet (containing ethinyl estradiol 20 mcg and levonorgestrel 0.1 mg) PO once daily for 21 days, followed by a period of 7 days without drug. 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.
Oral dosage (Triphasic regimens, Enpresse®, Tri-Levlen®, Triphasil®, or Trivora®):
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 6 tablets as a combination of 0.05 mg of levonorgestrel and 30 mcg of ethinyl estradiol. Phase 2 contains 5 tablets as a combination of 0.075 mg of levonorgestrel and 40 mcg of ethinyl estradiol. Phase 3 contains 10 tablets as a combination of 0.125 mg of levonorgestrel and 30 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 continuous contraception:
Oral dosage (Seasonale® extended oral contraceptive):
Adult and adolescent females: 1 tablet (0.15 mg levonorgestrel/30 mcg ethinyl estradiol) PO once daily for 84 days, followed by a period of 7 days without drug to allow withdrawal bleeding to occur. Repeat dosage cycles begin on the eighth day after taking the last hormonally active tablet. Completed phase III trials indicate the regimen has comparable safety and efficacy to standard OC regimens; reduces withdrawal bleeds to 4 per year.
For use as postcoital contraception within 72 hours of unprotected intercourse, or known or suspected contraceptive failure, in females who have no known contraindications to oral contraceptives, have achieved menarche, and are not known or suspected to be pregnant:
Oral dosage (Preven™ tablets):
Adult and adolescent females: Preven™ tablets are FDA approved for emergency contraception. After the Preven™ pregnancy test is known to be negative, take 2 blue tablets (250 mcg levonorgestrel and 50 mcg ethinyl estradiol per tablet) as soon as possible after intercourse (preferably within 12 - 24 hours and no later than 72 hours after the event). The dose MUST be repeated in 12 hours. If the patient vomits within 1 hour of the initial (1st) dose, the dose should be repeated. An anti-emetic may be needed for some patients.
Oral dosage † (Levlen® tablets, Levora® tablets, Nordette®, or Portia™ tablets):
Adult and adolescent females: Patients who are using tablets from a 28-tablet package should be reminded that the last 7 tablets are inactive and should not be used for this purpose. Take 4 tablets (150 mcg levonorgestrel and 30 mcg ethinyl estradiol per tablet) as soon as possible after intercourse (preferably within 12 - 24 hours and no later than 72 hours after the event). The dose MUST be repeated in 12 hours. If the patient vomits within 1 hour of the initial (1st) dose, the dose should be repeated. An anti-emetic may be needed for some patients.
Oral dosage † (Alesse®, Lessina™, Levlite™, or Lutera™ tablets only):
Adult and adolescent females: Patients who are using tablets from a 28-tablet package should be reminded that the last 7 tablets are inactive and should not be used for this purpose. Take 5 pink tablets (100 mcg levonorgestrel and 20 mcg ethinyl estradiol per tablet) as soon as possible after intercourse (preferably within 12 - 24 hours and no later than 72 hours after the event). The dose MUST be repeated in 12 hours. If the patient vomits within 1 hour of the initial (1st) dose, the dose should be repeated. An anti-emetic may be needed for some patients.
Oral dosage † (triphasic tablets --Enpresse®, Triphasil®, Tri-Levlen®, or Trivora®):
Adult and adolescent females: Patients who are using tablets from a 28-tablet package should be reminded that the last 7 tablets are inactive and should not be used for this purpose. The only tablets effective for emergency contraception regimens will come from the 3rd phase (yellow Triphasil® or Tri-Levlen® tablets, or pink Trivora® tablets). The tablets in the other phases of these tri-phasic regimens should not be used. Take 4 tablets (125 mcg levonorgestrel and 30 mcg ethinyl estradiol per tablet) as soon as possible after intercourse (preferably within 12 - 24 hours and no later than 72 hours after the event). The dose MUST be repeated in 12 hours. If the patient vomits within 1 hour of the initial (1st) dose, the dose should be repeated. An anti-emetic may be needed for some patients.
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:
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:
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 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:
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:
Allergies
