Adult Dosing
Contraception
- ethinyl estradiol 0.02 mg/levonorgestrel 0.09 mg
- 1 tab PO qd without any tablet-free interval
- Start on the day one of menstrual cycle
- ethinyl estradiol 0.02 mg/levonorgestrel 0.1 mg
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x 21 days, then the inert tablets are taken x 7 days
- Start subsequent courses of tablets on the day after taking last inert tablet
- ethinyl estradiol 0.03 mg/levonorgestrel 0.15 mg
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x 21 days, then the inert tablets are taken x 7 days
- Start subsequent courses of tablets on the day after taking last inert tablet
Notes:- Tablets to be taken at the same time each day
- During the first cycle of medication ask patient to use nonhormonal back-up method of birth control for 7 consecutive days of starting the tablet
Pediatric Dosing
Contraception (Post pubertal adolescents)
- ethinyl estradiol 0.02 mg/levonorgestrel 0.09 mg
- 1 tab PO qd without any tablet-free interval
- Start on the day one of menstrual cycle
- ethinyl estradiol 0.02 mg/levonorgestrel 0.1 mg
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x 21 days, then the inert tablets are taken x 7 days
- Start subsequent courses of tablets on the day after taking last inert tablet
- ethinyl estradiol 0.03 mg/levonorgestrel 0.15 mg
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x 21 days, then the inert tablets are taken x 7 days
- Start subsequent courses of tablets on the day after taking last inert tablet
Note:
- Tablets to be taken at the same time each day
- During the first cycle of medication, or if tablet is started later than the first day ask patient to use nonhormonal back-up method of birth control for 7 consecutive days of starting the tablet
- Not indicated before menarche
[Outline]
See Supplemental Patient Information
- Cigarette smokers are more prone to risk of serious cardiovascular side effects due to oral contraceptives. Advise women who use contraceptives to avoid smoking [US Black Box Warning]
- Oral contraceptives can contribute to risk factors such as hypertension, diabetes, hyperlipidemias, 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 use of OCP; risk of post-operative thromboembolic complications increases on use of use of oral contraceptives. Discontinue use at least 4 weeks prior to and for 2 weeks after elective surgery and during and following prolonged immobilization; initiate use not earlier than 4 to 6 weeks after delivery in women electing not to breast feed
- Increases risk of cerebrovascular events (thrombotic and hemorrhagic strokes). Age >35 yrs and hypertension are the risk factor for hemorrhagic strokes
- Decrease in serum HDL is associated with an increased risk of ischemic heart disease. As progestational agents decreases 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 contraceptive
- Individualized dosage in a way that it contains the least amount of estrogen and progestogen that is compatible with a low failure rate; start on preparations containing the lowest estrogen content producing satisfactory results
- Oral contraceptives increase the risk of breast and cervical cancer. Discontinuation of OCP decreases the risk. Do not 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. Rapture of this benign hepatic adenomas can cause intra-abdominal hemorrhage leading to death
- Oral contraceptives can 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 provide appropriate measures
- Do not use 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 dose >75 mcg causes hyperinsulinism, while lower doses cause less glucose intolerance and progestogens increase insulin secretion and create insulin resistance. Hence use cautiously in prediabetic and diabetic women with careful monitoring
- Hypertension may occur; 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 new pattern headache that is recurrent, persistent or severe
- Bleeding irregularities especially during the first 3 months may occur. Consider non-hormonal and adequate diagnostic measures to rule out malignancy/pregnancy in the event of breakthrough bleeding or any abnormal vaginal bleeding
- Counsel the 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 hyperlipidemias. Consider nonhormonal contraception in women with uncontrolled dyslipidemias
- Closely monitor the Women with a history of depression, discontinue use if depression recurs to a serious degree
Cautions: Use cautiously in:
- Renal impairment
- Hepatic impairment
- Breastfeeding 6wk-6mo postpartum
- Hypertension
- Hyperlipidemia
- Cardiovascular disease risk factors
- Diabetes mellitus
- Hypercholesterolemia
- Sensitive to fluid retention
- History of depression
- Vomiting
- Diarrhea
- Obesity
- Headaches without neurologic symptoms
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
- Inform patients to start oral contraceptives no earlier than 4 to 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 report 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 during the first month after introduction. Rarely reversible breast enlargement has been reported with higher dose of estrogen. Ethinyl estradiol in doses of 30 mcg daily or greater suppresses lactation leading to earlier discontinuation of breastfeeding, than nonhormonal or progestin-only contraception. The magnitude of the effect on lactation 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 13 April 2011).Small amounts of oral contraceptive steroids are excreted in milk of nursing mothers and a few adverse effects on the child have occurred, including jaundice and breast enlargement. 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 use of oral contraceptives and the use other forms of contraception until she has completely weaned her child.
US Trade Name(s)
- Altavera
- Amethyst
- Aviane-28
- Falmina
- Kurvelo
- Levora
- Lessina
- Lutera
- Lybrel
- Marlissa
- Nordette-28
- Orsythia
- Portia-28
- Sronyx
US Availability
ethinyl estradiol/levonorgestrel (generic)
- TABS: 0.02 mg/0.1 mg (21 tabs), 7 inert tabs
- TABS: 0.03 mg/0.15 mg (21 tabs), 7 inert tabs
Orsythia (ethinyl estradiol/levonorgestrel)
- TABS: 0.02 mg/0.1 mg (21 tabs), 7 inert tabs
Altavera, Levora, Nordette-28, Portia-28, Kurvelo, Marlissa (ethinyl estradiol/levonorgestrel)
- TABS: 0.03 mg/0.15 mg (21 tabs), 7 inert tabs
Aviane-28, Falmina, Lessina, Lutera, Sronyx (ethinyl estradiol/levonorgestrel)
- TABS: 0.02 mg/0.1 mg (21 tabs), 7 inert tabs
Lybrel, Amethyst (ethinyl estradiol/levonorgestrel)
- TABS: 0.02 mg/0.09 mg (28 tabs)
Canadian Trade Name(s)
- Alesse 21
- Alesse 28
- Aviane 21
- Aviane 28
- Min-Ovral 21
- Min-Ovral 28
- Portia 21
- Portia 28
Canadian Availability
Alesse 21, Aviane 21 (ethinyl estradiol/levonorgestrel)
- TABS: 0.02 mg/0.1 mg (21 tabs)
Min-Ovral 21, Portia 21 (ethinyl estradiol/levonorgestrel)
- TABS: 0.03 mg/0.15 mg (21 tabs)
Alesse 28, Aviane 28 (ethinyl estradiol/levonorgestrel)
- TABS: 0.02 mg/0.1 mg (21 tabs), 7 inert tabs
Min-Ovral 28, Portia 28 (ethinyl estradiol/levonorgestrel)
- TABS: 0.03 mg/0.15 mg (21 tabs), 7 inert tabs
UK Trade Name(s)
- Microgynon
- Microgynon ED
- Ovranette
- Rigevidon
UK Availability
Microgynon, Ovranette, Rigevidon (ethinyl estradiol/levonorgestrel)
- TABS: 0.03 mg/0.15 mg (21 tabs)
Microgynon ED (ethinyl estradiol/levonorgestrel)
- TABS: 0.03 mg/0.15 mg (21 tabs), 7 inert tabs
Australian Trade Name(s)
- Levelen ED
- Loette
- Microgynon
- Microgynon 20 ED
- Microgynon 30 ED
- Microgynon 50 ED
- Monofeme
- Nordett
Australian Availability
Levelen ED, Microgynon 30 ED, Monofeme, Nordette
- TABS: 0.03 mg/0.15 mg (21 tabs), 7 inert tabs
Microgynon
- TABS: 0.03 mg/0.15 mg (21 tabs)
Loette, Microgynon 20 ED
- TABS: 0.02 mg/0.1 mg (21 tabs), 7 inert tabs
Microgynon 50 ED
- TABS: 0.05 mg/0.125 mg (21 tabs), 7 inert tabs
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Lessina-28 0.1-20 MG-MCG TABS [Disp Pack] (TEVA PHARMACEUTICALS USA)
28 mg-mcg = $33.99
84 mg-mcg = $85.97 - Amethyst 90-20 MCG TABS [Disp Pack] (WATSON LABS)
28 mcg = $57.99
84 mcg = $159.97 - Lybrel 90-20 MCG TABS [Disp Pack] (WYETH)
28 mcg = $73.99
84 mcg = $211.98 - Levora 0.15/30 (28) 0.15-30 MG-MCG TABS [Disp Pack] (WATSON LABS)
28 mg-mcg = $32.99
84 mg-mcg = $75.98 - Sronyx 0.1-20 MG-MCG TABS [Disp Pack] (WATSON LABS)
28 mg-mcg = $43.26
84 mg-mcg = $105.06 - Portia-28 0.15-0.03 MG TABS [Disp Pack] (TEVA PHARMACEUTICALS USA)
28 mg = $29.99
84 mg = $82.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Lybrel 28 Day Pack
Ingredient(s): Ethinyl Estradiol mixture with Levonorgestrel
Imprint: W;1117
Color(s): Yellow
Shape: Round
Size (mm): 6.00
Score: 1
Inactive Ingredient(s): cellulose, microcrystalline / lactose monohydrate / magnesium stearate / polacrilin potassium / hypromellose 2910 (6 cps) / titanium dioxide / polyethylene glycol 400 / polyethylene glycol 1450 / ferric oxide yellow / ferric oxide red
Drug Label Author:
Wyeth Pharmaceuticals Company
DEA Schedule:
Non-Scheduled
Drug Name: Sronyx 28 Day Pack
Ingredient(s): Ethinyl Estradiol mixture with Inert Ingredients and Levonorgestrel
Imprint: WATSON;P1
Color(s): Orange
Shape: Round
Size (mm): 6.00
Score: 1
Inactive Ingredient(s): fd&c yellow #6 lake / lactose anhydrous / magnesium stearate / microcrystalline cellulose / lactose monohydrate
Drug Label Author:
Watson Laboratories, Inc.
DEA Schedule:
Non-Scheduled
15 cigarettes/day) and is quite marked in women over 35 years of age