No

Contraceptive

Prevention of pregnancy

X

Thrombophlebitis, undiagnosed vaginal bleeding, hypersensitivity to ethinyl estradiol or any component, known or suspected pregnancy, carcinoma of the breast, estrogen-dependent tumor

Use of any progestin during the first 4 months of pregnancy is not recommended; use with caution in patients with asthma, seizure disorders, migraine, cardiac, renal or hepatic impairment, cerebrovascular disorders or history of breast cancer, past and present thromboembolic disease, smokers >35 years of age

Signs and symptoms: Toxicity is unlikely following single exposures of excessive doses

Treatment: Any treatment following emesis and charcoal administration should be supportive and symptomatic

Ethinyl estradiol is a CYP3A3/4 and 3A5-7 enzyme substrate; CYP1A2 enzyme inhibitor

Combination oral contraceptives inhibit ovulation via a negative feedback mechanism on the hypothalamus, which alters the normal pattern of gonadotropin secretion of a follicle-stimulating hormone (FSH) and luteinizing hormone by the anterior pituitary. The follicular phase FSH and midcycle surge of gonadotropins are inhibited. In addition, oral contraceptives produce alterations in the genital tract, including changes in the cervical mucus, rendering it unfavorable for sperm penetration even if ovulation occurs. Changes in the endometrium may also occur, producing an unfavorable environment for nidation. Oral contraceptive drugs may alter the tubal transport of the ova through the fallopian tubes. Progestational agents may also alter sperm fertility.

Ethinyl estradiol:

Protein binding: 98%

Metabolism: Inactivated by liver

Half-life: 6-20 hours

Elimination: Bile and urine, enterohepatic recycling

Oral: Adults: Female: Contraception:

For 21-tablet package: Dosage is 1 tablet daily for 21 consecutive days, followed by 7 days off of the medication; a new course begins on the 8th day after the last tablet is taken.

For 28-tablet package: Dosage is 1 tablet daily without interruption.

Schedule 2 (Day 1 starter): Dose starts on first day of menstrual cycle taking 1 tablet daily.

For 21-tablet package: Dosage is 1 tablet daily for 21 consecutive days, followed by 7 days off of the medication; a new course begins on the 8th day after the last tablet is taken.

For 28-tablet package: Dosage is 1 tablet daily without interruption.

If all doses have been taken on schedule and one menstrual period is missed, continue dosing cycle. If two consecutive menstrual periods are missed, pregnancy test is required before new dosing cycle is started.

Missed doses monophasic formulations (refer to package insert for complete information):

One dose missed: Take as soon as remembered or take 2 tablets next day

Two consecutive doses missed in the first 2 weeks: Take 2 tablets as soon as remembered or 2 tablets next 2 days. An additional method of contraception should be used for 7 days after missed dose.

Two consecutive doses missed in week 3 or three consecutive doses missed at any time: An additional method of contraception must be used for 7 days after a missed dose.

Schedule 1 (Sunday starter): Continue dose of 1 tablet daily until Sunday, then discard the rest of the pack, and a new pack should be started that same day.

Schedule 2 (Day 1 starter): Current pack should be discarded, and a new pack should be started that same day.

Missed doses biphasic/triphasic formulations (refer to package insert for complete information):

One dose missed: Take as soon as remembered or take 2 tablets next day.

Two consecutive doses missed in week 1 or week 2 of the pack: Take 2 tablets as soon as remembered and 2 tablets the next day. Resume taking 1 tablet daily until the pack is empty. An additional method of contraception should be used for 7 days after a missed dose.

Two consecutive doses missed in week 3 of the pack; An additional method of contraception must be used for 7 days after a missed dose.

Schedule 1 (Sunday Starter): Take 1 tablet every day until Sunday. Discard the remaining pack and start a new pack of pills on the same day.

Schedule 2 (Day 1 starter): Discard the remaining pack and start a new pack the same day.

Three or more consecutive doses missed; An additional method of contraception must be used for 7 days after a missed dose.

Schedule 1 (Sunday Starter): Take 1 tablet every day until Sunday; on Sunday, discard the pack and start a new pack.

Schedule 2 (Day 1 Starter): Discard the remaining pack and begin new pack of tablets starting on the same day.

Should be administered with food at same time each day

amylase (S), cholesterol (S), iron (B), sodium (S), thyroxine (S); calcium (S), protein, prothrombin time

No information available to require special precautions

When prescribing antibiotics, patient must be warned to use additional methods of birth control if on oral contraceptives

Women should inform their physicians if signs or symptoms of any of the following occur: thromboembolic or thrombotic disorders including sudden severe headache or vomiting, disturbance of vision or speech, loss of vision, numbness or weakness in an extremity, sharp or crushing chest pain, calf pain, shortness of breath, severe abdominal pain or mass, mental depression or unusual bleeding. Women should be advised that when any doses are missed, alternative contraceptive methods should be used for the next 2 days or until 2 days into the new cycle; women should discontinue taking the medication if they suspect they are pregnant or become pregnant.

Women should inform their physicians if signs or symptoms of any of the following occur: thromboembolic or thrombotic disorders including sudden severe headache or vomiting, disturbance of vision or speech, loss of vision, numbness or weakness in an extremity, sharp or crushing chest pain, calf pain, shortness of breath, severe abdominal pain or mass, mental depression or unusual bleeding. Women should be advised that when any doses are missed, alternative contraceptive methods should be used for the next 2 days or until 2 days into the new cycle; women should discontinue taking the medication if they suspect they are pregnant or become pregnant.

Tablet:

Ortho Tri-Cyclen®: Phase 1 (7 white tablets): Ethinyl estradiol 0.035 mg and norgestimate 0.18 mg; Phase 2 (5 light blue tablets): Ethinyl estradiol 0.035 mg and norgestimate 0.215 mg; Phase 3 (10 blue tablets): Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg (21s, 28s)

Ortho-Prefest®: 1 mg estradiol (#15) and 1 mg estradiol with 0.09 mg norgestimate (#15)