General MedicationsOralHigh Alert

Levonest

LEVONORGESTREL AND ETHINYL ESTRADIOL

Standard Dose

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 tablet. (If LEVONEST™ Tablets are first taken later than the first day of the first menstrual cycle of medication or postpartum, contraceptive reliance should not be placed on LEVONEST™ Tablets until after the first 7 consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered.) When switching from another oral contraceptive, LEVONEST™ Tablets should be started on the first day of bleeding following the last active tablet taken of the previous oral contraceptive. The patient begins her next and all subsequent 28-day courses of LEVONEST™ Tablets on the same day of the week that she began her first course, following the same schedule. She begins taking her yellow tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Any time a subsequent cycle of LEVONEST™ Tablets is started later than the next day, the patient should be protected by another means of contraception until she has taken a tablet daily for seven consecutive days. If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Although the occurrence of pregnancy is highly unlikely if LEVONEST™Tablets are taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. The risk of pregnancy increases with each active (yellow, green, or light brown) tablet missed. For additional patient instructions regarding missed pills, see the " WHAT TO DO IF YOU MISS PILLS " section in the DETAILED PATIENT LABELING below. If breakthrough bleeding occurs following missed active tablets, it will usually be transient and of no consequence. If the patient misses one or more white tablets, she is still protected against pregnancy provided she begins taking yellow tablets again on the proper day. In the nonlactating mother, LEVONEST™ may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postparturn period must be considered (see “ Contraindications ”, “ Warnings ”, and “ Precautions ” concerning thromboembolic disease). It is to be noted that early resumption of ovulation may occur if Parlodel ® (bromocriptine mesylate) has been used for the prevention of lactation.

Max Dose

See official label

Primary Use

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.

Summary

Indications and 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.

Structured Monograph

Clinical summary

Indications and 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, jellies, and vaginal suppositories) 6 26 Periodic abstinence (all methods) 1-9* 25 Withdrawal 4 19 No contraception (planned pregnancy) 85 85 NA – not available *Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology : 17 t h Revised Edition . NY, NY: Ardent Media, Inc., 1998 Dosage and 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 tablet. (If LEVONEST™ Tablets are first taken later than the first day of the first menstrual cycle of medication or postpartum, contraceptive reliance should not be placed on LEVONEST™ Tablets until after the first 7 consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered.) When switching from another oral contraceptive, LEVONEST™ Tablets should be started on the first day of bleeding following the last active tablet taken of the previous oral contraceptive. The patient begins her next and all subsequent 28-day courses of LEVONEST™ Tablets on the same day of the week that she began her first course, following the same schedule. She begins taking her yellow tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Any time a subsequent cycle of LEVONEST™ Tablets is started later than the next day, the patient should be protected by another means of contraception until she has taken a tablet daily for seven consecutive days. If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Although the occurrence of pregnancy is highly unlikely if LEVONEST™Tablets are taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. The risk of pregnancy increases with each active (yellow, green, or light brown) tablet missed. For additional patient instructions regar

Monitoring

• 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.

Interaction Notes

• Review official label interaction section.