Mestranol / Norethindrone Dosage

Applies to the following strengths: 0.05 mg-1 mg

Usual Adult Dose for:

Contraception

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Contraception

1 tablet orally once a day at intervals not exceeding 24 hours

Start date:

For Day 1 Start: Take first tablet on first day of menstrual flow
For Sunday Start: Take first tablet on the Sunday on or after menstrual flow has begun

Comments:

One table is taken each day at the same time of day; the first 21 tablets contain active drug (white tablets); the last 7 tablets are inert (orange tablets).
After taking all 28 tablets, a new pack is started whether bleeding has stopped or not.
During the initial cycle, an additional method of contraception will be needed for the first 7 days until efficacy is established.

Use: To prevent pregnancy.

Renal Dose Adjustments

Use with caution

Liver Dose Adjustments

Use with caution

If jaundice develops, this drug should be discontinued

Precautions

US BOXED WARNING:

CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS: Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age and with heavy smoking (15 or more cigarettes per day). Women who use oral contraceptives are strongly advised not to smoke.

CONTRAINDICATIONS:

Thrombophlebitis or thromboembolic disorders
History of deep vein thrombophlebitis or thromboembolic disorders
Cerebral vascular or coronary artery disease
Known or suspected carcinoma of the breast
Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
Undiagnosed abnormal genital bleeding
Cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use
Hepatic adenomas, carcinomas or benign liver tumors
Known or suspected pregnancy

Safety and efficacy have been established in female patients of reproductive age; use prior to menarche is not indicated.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:

For maximum effectiveness, this drug must be taken exactly as directed at intervals not exceeding 24 hours

SUNDAY-START:

Take the first active pill on the Sunday after the onset of menstruation, even if still bleeding; if menstruation begins on a Sunday, start the pack the same day.
A backup form of birth control will be needed with intercourse in the first 7-days of the first cycle
Take all subsequent pills once a day at the same time each day and begin all subsequent packs on the same day of the week (i.e., Sunday).

DAY 1 START:

Take first active pill during the first 24 hours of starting period
Take all subsequent pills once a day at the same time each day
A backup method of birth control will not be necessary with a Day 1 start

Missed ACTIVE Doses:
ONE-Day Missed: If 1 dose is missed, take as soon as remembered, take next dose at regular time; a back-up birth control method will not be needed
TWO-Days Missed during Week 1 or Week 2: if 2 doses are missed on 2 consecutive days in week 1 or 2, take 2 tablets on the day remembered and 2 tablets on the following day, then resume regular dosing; a back-up birth control method will be necessary in the 7 days after these missed doses
TWO-Days Missed during Week 3 OR THREE-Days Missed or MORE:

Day 1 Starters should throw out the rest of the pill pack and start a new pack that same day; a back-up birth control method will be necessary in the 7 days after these missed doses
Sunday Starters should keep taking 1 tablet once a day until Sunday, then throw out the rest of the pill pack and start a new pack of pills that day; a back-up birth control method will be necessary in the 7 days after these missed doses
For patients who throw out their pills during week 3 or after missing 3-doses, it is expected that a period will not occur; however, if a period is missed 2 months in a row, pregnancy should be ruled out.

Missed INERT Doses: For any doses missed in week 4, throw away the doses missed, keep taking tablets as directed until the pack is empty

If severe vomiting or diarrhea occurs, absorption may not be complete; additional contraceptive measures may be needed
If there is any doubt about missed doses, a back-up contraceptive method should be used.

General:

When starting after pregnancy, it is advisable to wait 4 to 6 weeks after delivery; if a pregnancy is terminated in the first 12 weeks, oral contraceptives can start immediately or within 7 days; if pregnancy is terminated after 12 weeks, the patient should be instructed to wait 2 weeks before starting oral contraceptives.
Pregnancy should be ruled out if 2 consecutive periods are missed; for patients who have been nonadherent, pregnancy should be considered at the time of the first missed period.
When the pill is taken correctly, the expected pregnancy rate is approximately 1%.
Noncontraceptive health benefits related to oral contraceptives include: increased menstrual cycle regularity, decreased blood loss, decreased incidence of iron-deficiency anemia, decreased incidence of dysmenorrhea, decreased incidence of functional ovarian cysts, decreased incidence of ectopic pregnancies, decreased incidence of fibroadenomas and fibrocystic disease of the breast, decreased incidence of acute pelvic inflammatory disease, decreased incidence of endometrial cancer, and decreased incidence of ovarian cancer.

Monitoring:

General: A complete medical history and physical examination should occur prior to initiation or reinstitution of this drug; an annual physical exam should be performed to asses risks and include blood pressure monitoring
Pregnancy should be ruled out if 2 consecutive periods are missed; for patients who have been nonadherent, pregnancy should be ruled out at the time of the first missed period.
Women with hyperlipidemias should be closely followed
Appropriate measures should be conducted to rule out malignancy in the case of undiagnosed, persistent or recurrent abnormal vaginal bleeding

Patient Advice:

Patients should be instructed to read the US FDA-approved patient labeling.
Patients should understand that this drug does not protect against HIV infection, AIDS, and other sexually transmitted diseases.
Patients should understand the efficacy of this drug is dependent on taking the drug exactly as prescribed; patients should understand what to do about missed doses and when back-up methods of contraception will be needed.
Patients should be instructed on the warning signs of serious adverse reactions and when to seek immediate medical assistance.