Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol
FDA Drug Information • Also known as: Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol, Simliya, Viorele
- Brand Names
- Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol, Simliya, Viorele
- Dosage Form
- KIT
- Product Type
- HUMAN PRESCRIPTION DRUG
⚠ Boxed Warning (Black Box)
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including VIORELE, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS ).
Description
Description VIORELE ® (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) provides an oral contraceptive regimen of 21 white to off-white, round tablets each containing 0.15 mg desogestrel, USP (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include vitamin E, potato starch, povidone, isopropyl alcohol, colloidal silicon dioxide, magnesium stearate, lactose, hypromellose, titanium dioxide, macrogol, talc, followed by 2 inert pale green to yellowish green, round tablets with following inactive ingredients: lactose, starch, magnesium stearate, hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow, FD&C blue No. 2 indigo carmine aluminum lake. VIORELE ® also contains 5 light yellow to yellow, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3, 17-diol) and inactive ingredients which include vitamin E, lactose, potato starch, povidone, isopropyl alcohol, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow. The molecular weights for desogestrel, USP and ethinyl estradiol, USP are 310.48 g/mol and 296.40 g/mol respectively. The structural formulas are as follows: figure
Dosage and Administration
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, VIORELE ® (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) must be taken exactly as directed and at intervals not exceeding 24 hours. VIORELE ® may be initiated using either a Sunday start or a Day 1 start. NOTE: Each cycle pack blister is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen. Six different “day label strips” are provided with each cycle pack blister in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive “day label strip” that corresponds to her starting day over the preprinted days. IMPORTANT: The possibility of ovulation and conception prior to initiation of use of VIORELE ® should be considered. The use of VIORELE ® for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for “Nursing Mothers”). If the patient starts on VIORELE ® postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white to off-white tablet has been taken daily for 7 days. SUNDAY START When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration. Using a Sunday start, tablets are taken daily without interruption as follows: The first white to off-white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white to off-white tablet is taken on that day). One white to off-white tablet is taken daily for 21 days, followed by 1 pale green to yellowish green (inert) tablet daily for 2 days and 1 light yellow to yellow (active) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last light yellow to yellow tablet. [If switching from a Sunday start oral contraceptive, the first VIORELE ® tablet should be taken on the second Sunday after the last tablet of a 21-day regimen or should be taken on the first Sunday after the last inactive tablet of a 28 day regimen.] If a patient misses 1 white to off-white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white to off-white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive...
Side Effects (Adverse Reactions)
ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):
Warnings and Precautions
WARNINGS The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with formulations of higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with formulations of lower doses of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiologic studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among non-users. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and non-users. The attributable risk does provide information about the actual occurrence of a disease in the population (Adapted from refs. 2 and 3 with the authors' permission). For further information, the reader is referred to a text on epidemiologic methods. 1. Thromboembolic disorders and other vascular problems a. Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to nonusers to be 3 for the first episode of superficial venous thromboembolic disease, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease (2,3,19-24). Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization (25). The risk of thromboembolic disease associated with oral contraceptives is not related to length of use and disappears after pill use is stopped (2). Several epidemiologic studies indicate that third generation oral contraceptives, including those containing desogestrel, are associated with a higher risk of venous thromboembolism than certain second generation oral contraceptives (102-104). In general, these studies indicate an approximate two-fold increased risk, which corresponds to an additional 1 to 2 cases of...
Drug Interactions
7. Drug interactions Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, carbamazepine and possibly with griseofulvin, ampicillin, and tetracyclines (72). Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Concomitant Use with Hepatitis C Virus (HCV) Combination Therapy - Liver Enzyme Elevation Co-administration of VIORELE ® with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir is contraindicated, due to potential for ALT elevations (see WARNINGS , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT). Co-administration of VIORELE ® and glecaprevir/pibrentasvir is not recommended due to potential for ALT elevations. Consult the labeling of the concurrently-used drug to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Contraindications
CONTRAINDICATIONS Oral contraceptives should not be used in women who currently have the following conditions:
Pregnancy and Breastfeeding
10. Pregnancy Discontinue VIORELE if pregnancy occurs because there is no reason to use COCs in pregnancy. See WARNINGS section.
11. Lactation Small amounts of oral contraceptive steroids have been identified in human milk, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.
Overdosage
OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.
How Supplied
HOW SUPPLIED VIORELE ® (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) contains 21 round white to off-white tablets, 2 round pale green to yellowish green tablets and 5 round light yellow to yellow tablets in a blister. Each white to off-white, biconvex, film-coated tablet (debossed with ‘C1’ on one side and ‘G’ on the other side) contains 0.15 mg desogestrel, USP and 0.02 mg ethinyl estradiol, USP. Each pale green to yellowish green, biconvex, film-coated tablet (debossed with ‘C3’ on one side and ‘G’ on the other side) contains inert ingredients. Each light yellow to yellow colored, biconvex, film-coated tablet (debossed with ‘C2’ on one side and ‘G’ on the other side) contains 0.01 mg ethinyl estradiol, USP. Boxes of 3 NDC 68462-318-29 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.