Usual Adult Dose for Contraception

0.15 mg desogestrel/0.03 mg ethinyl estradiol tablet regimen:

• Days 1 to 21: 1 tablet orally once a day
• Days 22 to 28: 1 inert tablet orally once a day

Biphasic regimen:

• Days 1 to 21: 0.15 mg desogestrel/0.02 mg ethinyl estradiol tablet orally once a day
• Days 22 to 23: 1 inert tablet orally once a day
• Days 24 to 28: 0.01 mg ethinyl estradiol tablet orally once a day

Triphasic regimen:

• Days 1 to 7: 0.1 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day
• Days 8 to 14: 0.125 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day
• Days 15 to 21: 0.15 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day
• Days 22 to 28: 1 inert tablet orally once a day

Comments:

• This drug should be taken at the same time each day.
• Patients may begin on the first day of the menstrual period or on the first Sunday after the onset of the menstrual period.
• Additional forms of contraception should be used if patients begin on Sunday.

Use: Prevention of pregnancy

Usual Pediatric Dose for Contraception

Postpubertal adolescents:
0.15 mg desogestrel/0.03 mg ethinyl estradiol tablet regimen:

• Days 1 to 21: 1 tablet orally once a day
• Days 22 to 28: 1 inert tablet orally once a day

Biphasic regimen:

• Days 1 to 21: 0.15 mg desogestrel/0.02 mg ethinyl estradiol tablet orally once a day
• Days 22 to 23: 1 inert tablet orally once a day
• Days 24 to 28: 0.01 mg ethinyl estradiol tablet orally once a day

Triphasic regimen:

• Days 1 to 7: 0.1 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day
• Days 8 to 14: 0.125 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day
• Days 15 to 21: 0.15 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day
• Days 22 to 28: 1 inert tablet orally once a day

Comments:

• This drug should be taken at the same time each day.
• Patients may begin on the first day of the menstrual period or on the first Sunday after the onset of the menstrual period.
• Additional forms of contraception should be used if patients begin on Sunday.

Use: Prevention of pregnancy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Patients with liver dysfunction and normal liver function tests: Data not available.
Patients with hepatic tumors OR acute/chronic active liver disease with abnormal liver function tests: Contraindicated.
Jaundice occurring during treatment: Discontinue use.

Dose Adjustments

Postpartum use: Patients who do not elect to breastfeed may begin after 4 to 6 weeks. Patients who do not have a period before beginning treatment should use another contraceptive method for the first 7 days of treatment.

Spotting/breakthrough bleeding: If continued breakthrough bleeding/spotting occur and
pregnancy and malignancy are ruled out, switching to another contraceptive should be considered.

Missed tablets:

• Missed 1 active tablet: Patients should take the tablet as soon as it is remembered.
• Missed 2 consecutive active tablets in weeks 1 or 2: Patients should take 2 tablets when remembered and 2 tablets the next day.
• Missed 2 or more consecutive active tablets in week 3: Patients should take 1 active tablet daily until the following Sunday. The pack should be discarded and a new pack should be started on Sunday.

Local protocol and/or the manufacturer product information should be consulted for further guidance.

Precautions

US BOXED WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING: Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including this drug, should not be used by women who are over 35 years of age and smoke.

Safety and efficacy have not been established in patients before menarche and in patients over 65 years of age.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be taken at the same time each day.
• Tablets may be taken with or without liquid.

Storage requirements: Protect from light.

General: Oral contraceptives with doses over 0.035 mg of ethinyl estradiol may provide non-contraceptive health benefits (e.g., increased cycle regularity and decreased blood loss, dysmenorrhea, iron-deficient anemia, functional ovarian cysts, ectopic pregnancy, fibroadenomas/fibrocystic breast disease, acute pelvic inflammatory disease, endometrial and ovarian cancer).

Monitoring:

• Cardiovascular: Blood pressure, edema/fluid retention
• Genitourinary: Breast exams (monthly), cervical cytology (yearly)
• Hepatic: Jaundice
• Metabolic: Blood glucose, lipid levels (HDL, LDL, triglycerides)
• Ocular: Vision exam
• Psychiatric: Depression screenings

Patient advice:

• Patients should be told to use back-up contraception for 7 days after restarting this drug (e.g., missed doses or starting within days 2 to 5 of a menstrual period).
• Patients should be informed that this drug does not prevent HIV/AIDS and other sexually-transmitted diseases.
• Patients should be instructed to seek immediate medical attention if the signs/symptoms of thromboembolism, liver dysfunction (e.g., jaundice), or changes in depression occur.