Levonest
levonorgestrel and ethinyl estradiol · KIT · A-S Medication Solutions
Levonest is a kit containing levonorgestrel and ethinyl estradiol. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Levonest
- Generic Name
- levonorgestrel and ethinyl estradiol
- NDC Code (Product)
50090-2505- Manufacturer
- A-S Medication Solutions
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA090719
- Marketing Start
- 12/29/2010
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
Indications and Usage Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD Method Perfect Use Typical Use Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Depo-Provera ® (injectable progestogen) 0.3 0.3 Oral contraceptives 5 Combined 0.1 NA Progestin only 0.5 NA IUD Progesterone 1.5 2.0 Copper T 380A 0.6 0.8 Condom (male) without spermicide 3 14 (Female) without spermicide 5 21 Cervical cap Nulliparous women 9 20 Parous women 26 40 Vaginal sponge Nulliparous women 9 20 Parous women 20 40 Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams,…
Dosage & Administration
Dosage and Administration To achieve maximum contraceptive effectiveness, LEVONEST™ Tablets (levonorgestrel and ethinyl estradiol tablets-triphasic regimen) must be taken exactly as directed and at intervals not exceeding 24 hours. LEVONEST™ Tablets (levonorgestrel and ethinyl estradiol tablets-triphasic regimen) are a three-phase preparation plus 7 inert tablets. The dosage of LEVONEST™ Tablets is one tablet daily for 28 consecutive days per menstrual cycle in the following order: 6 yellow tablets (phase 1), followed by 5 green tablets (phase 2), followed by 10 light brown tablets (phase 3), plus 7 white inert tablets, according to the prescribed schedule. It is recommended that LEVONEST™ Tablets be taken at the same time each day, preferably after the evening meal or at bedtime. During the first cycle of medication, the patient should be instructed to take one LEVONEST™ Tablet daily in the order of 6 yellow, 5 green, 10 light brown tablets, and then 7 white inert tablets for twenty-eight (28) consecutive days, beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) Withdrawal bleeding usually occurs within 3 days following the last light brown…
Warnings
WARNINGS Cigarette smoking increases the risk of serious cardiovascular side effects from oral-contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke. The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity and 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 based principally on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the …
Contraindications
CONTRAINDICATIONS Levonest™ is contraindicated in females who are known to have or develop the following conditions: Thrombophlebitis or thromboembolic disorders. A past history of deep-vein-thrombophlebitis or thromboembolic disorders. Cerebral-vascular or coronary-artery disease. Current diagnosis or history of breast cancer, which may be hormone sensitive. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior pill use. Hepatic adenomas and carcinomas. Known or suspected pregnancy. Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations (see WARNINGS , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).
Adverse Reactions
Adverse Reactions To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . An increased risk of the following serious adverse reactions has been associated with the use of oral- contraceptives (see “ Warings ” section): Thrombophlebitis. Arterial thromboembolism. Pulmonary embolism. Myocardial infarction. Cerebral hemorrhage. Cerebral thrombosis. Hypertension. Gallbladder disease. Hepatic adenomas or benign liver tumors. Postmarketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duratio…
Frequently Asked Questions
What is Levonest used for?
Levonest contains levonorgestrel and ethinyl estradiol. It is a kit taken as directed. Consult your doctor for specific uses.
Is Levonest a controlled substance?
Levonest is not classified as a controlled substance by the DEA.
What is the generic name for Levonest?
The generic name for Levonest is levonorgestrel and ethinyl estradiol. There are 12 other brand versions of levonorgestrel and ethinyl estradiol.
What is the NDC code for Levonest ?
The NDC (National Drug Code) for Levonest is 50090-2505, listed by A-S Medication Solutions.