Adult Dosing
Contraception
- ethinyl estradiol 0.035 mg/ethynodiol diacetate 1 mg (21 tabs) + 7 inert tabs
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or first Sunday after the onset of menses x 21 days, followed by 1 inert tablet x 7 days
- After taking 28 tabs, start a new course on the day after taking the last inert tablet
- ethinyl estradiol 0.05 mg/ethynodiol diacetate 1 mg (21 tabs) + 7 inert tabs
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or first Sunday after the onset of menses x 21 days, followed by 1 inert tablet x 7 days
- After completing 28-tablet regimen, start a new course on the day after taking the last inert tablet
Notes:- Tablets should be taken at the same time each day. Tablets must be taken as recommended and at intervals not exceeding 24 hrs
- For the first cycle of a Sunday start regimen, use another nonhormonal back-up method of contraception until after the first 7 consecutive days of administration
- May be started 4-6 wks postpartum in women who elect not to breastfeed
Pediatric Dosing
Contraception (postpubertal adolescents)
- ethinyl estradiol 0.035 mg/ethynodiol diacetate 1 mg (21 tabs) + 7 inert tabs
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or first Sunday after the onset of menses x 21 days, followed by 1 inert tablet x 7 days
- After taking 28 tabs, start a new course on the day after taking the last inert tablet
- ethinyl estradiol 0.05 mg/ethynodiol diacetate 1 mg (21 tabs) + 7 inert tabs
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or first Sunday after the onset of menses x 21 days, followed by 1 inert tablet x 7 days
- After completing 28-tablet regimen, start a new course on the day after taking the last inert tablet
Note:
- Tablets should be taken at the same time each day. Tablets must be taken as recommended and at intervals not exceeding 24 hrs
- For the first cycle of a Sunday start regimen, use another nonhormonal back-up method of contraception until after the first 7 consecutive days of administration
- Not indicated before menarche
- May be started 4-6 wks postpartum in women who elect not to breastfeed
[Outline]
See Supplemental Patient Information
- Cigarette smokers are more prone to the risk of serious cardiovascular side effects from oral contraceptive use. Advise women who use contraceptives to avoid smoking [US Black Box Warning]
- Increased risk of several serious conditions such as MI, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease has been associated with the therapy. Risk of morbidity and mortality markedly increases in the presence of underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes
- Oral contraceptives may potentiate the effects of well-known risk factors such as hypertension, diabetes, hyperlipidemias, age and obesity; these risk factors have been associated with an increased risk of heart disease. Use cautiously in women with cardiovascular disease risk factors
- Increased risk of thromboembolic and thrombotic disease has been reported with the use of OCP; risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives. Discontinue use at least 4 weeks prior to and for 2 weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization; initiate use not earlier than 4-6 weeks after delivery in women electing not to breastfeed
- Oral contraceptives may increase the risk of cerebrovascular events such as thrombotic and hemorrhagic strokes; this risk is greatest among older (>35 yrs) and hypertensive women who also smoke
- Decrease in serum HDL has been associated with an increased risk of ischemic heart disease. As progestational agents decrease serum HDL and estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogen used in the contraceptives
- Individualize dosage in a way that it contains the least amount of estrogen and progestogen that is compatible with a low failure rate; new users should be started on preparations containing the lowest estrogen content producing satisfactory results
- Oral contraceptives may increase the risk of breast and cervical cancer. Discontinuation of OCP decreases this risk. Avoid use in females with known or suspected carcinoma of the breast or personal history of breast cancer
- Rarely, fatal benign hepatic adenomas have been reported with oral contraceptive use. Rupture of these benign, hepatic adenomas may cause intra-abdominal hemorrhage leading to death
- Oral contraceptives may cause retinal thrombosis leading to partial or complete loss of vision. Discontinue the drug if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions and initiate appropriate diagnostic and therapeutic measures
- Do not use oral contraceptives during pregnancy to treat threatened or habitual abortion
- Combination oral contraceptives may worsen existing gallbladder disease and may accelerate the development of this disease in previously asymptomatic women
- Estrogens at higher doses >75 mcg cause hyperinsulinism, while lower doses cause less glucose intolerance; progestogens increase insulin secretion and create insulin resistance. Hence, carefully monitor prediabetic and diabetic women while taking oral contraceptives
- Hypertension may occur during therapy. Closely monitor hypertensive women electing to use oral contraceptives; discontinue use in women with significant elevation of blood pressure
- Discontinue therapy on onset or exacerbation of migraine, development of headache with a new pattern that is recurrent, persistent or severe
- Bleeding irregularities such as breakthrough bleeding and spotting may occur, especially during the first 3 months of oral contraceptive use. Consider non-hormonal causes and initiate adequate diagnostic measures to rule out malignancy/pregnancy in the event of breakthrough bleeding or any abnormal vaginal bleeding
- Counsel patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases
- Consider physical examination and follow up in relevance to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and perform relevant laboratory tests in all the women taking OCP
- Carefully monitor women with a strong family history of breast cancer or having breast nodules
- Closely monitor women who are being treated for hyperlipidemia. Consider nonhormonal contraception in women with uncontrolled dyslipidemia
- Closely monitor women with a history of depression; discontinue use if depression recurs to a serious degree
Cautions: Use cautiously in:
Supplemental Patient Information
- Inform patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases
- Instruct patients to take pill exactly as directed and at intervals not exceeding 24 hrs
- Advise women to use an additional method of protection until after the first 7 days of administration in the initial cycle
- Instruct women to start oral contraceptives no earlier than 4-6 weeks after delivery due to its association with an increased risk of thromboembolism. On termination of pregnancy, instruct patients to start oral contraceptives immediately or within 7 days after termination
- Advise patients to promptly report their physician on spotting or persisting breakthrough bleeding
- On missing one pill, instruct patients to take it as soon as they remember and then to take the next pill at the regular time
- Educate patients that missing a pill would cause spotting or light bleeding, and they may experience gastric irritation if they take the missed pill along with their regularly scheduled pill
- In case of a missed menstrual period, inform patients to consider the possibility of pregnancy, withholding oral contraceptives until pregnancy has been ruled out. Instruct patients to rule out pregnancy before continuing the contraceptive regimen even in patients who have adhered to the prescribed regimen but missed 2 consecutive periods
Pregnancy Category:X
Breastfeeding: Combination oral contraceptives probably do not affect the composition of milk substantially in healthy, well-nourished mothers and do not adversely affect long-term infant growth and development, but can transiently affect growth negatively during the first month after introduction. Rarely, reversible breast enlargement has been reported with higher doses of estrogen. Ethinyl estradiol in doses of 30 mcg daily or greater can suppress lactation leading to earlier discontinuation of breastfeeding than nonhormonal or progestin-only contraception. The magnitude of the effect on lactation likely depends on the dose and the time of introduction postpartum. As per US expert opinion, the risks of combination contraceptive products usually outweigh the benefits before 4 weeks postpartum. Between 4 weeks and 6 months postpartum, the advantages of using the method generally outweigh the theoretical or proven risks. After 6 months postpartum, combination contraceptives can be used, but progestin-only methods are preferred if breastfeeding will be continued. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 14 July 2011). Small amounts of oral contraceptive steroids are excreted in breastmilk of nursing mothers and a few adverse effects on the child have occurred, including jaundice and breast enlargement. Combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. Manufacturer advises the nursing mother to avoid using combination oral contraceptives and to use other forms of contraception until she has completely weaned her child.
US Trade Name(s)
- Kelnor
- Zovia 1/35E
- Zovia 1/50E
US Availability
Kelnor, Zovia 1/35E (ethinyl estradiol/ethynodiol diacetate)
- TABS: 0.035 mg/1 mg (21 tabs); 7 inert tabs
Zovia 1/50E (ethinyl estradiol/ethynodiol diacetate)
- TABS: 0.05 mg/1 mg (21 tabs); 7 inert tabs
Canadian Trade Name(s)
Canadian Availability
Demulen 30 (ethinyl estradiol/ethynodiol diacetate)
- TABS: 0.03 mg/2 mg (21 tabs)
- TABS: 0.03 mg/2 mg (21 tabs); 7 inert tabs
Demulen 50 (ethinyl estradiol/ethynodiol diacetate)
- TABS: 0.05 mg/1 mg (21 tabs)
- TABS: 0.05 mg/1 mg (21 tabs); 7 inert tabs
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
15 cigarettes/day) and is quite marked in women over 35 years of age