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Levlite (Levonorgestrel / Ethinyl Estradiol) - Indications and Dosage

 
 



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 III 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

TABLE III. Percentage of women experiencing an unintended pregnancy
during the first year of typical use and first year of perfect use of
contraception and the percentage continuing use at the end of
the first year. United States.
% of Women Experiencing
an Accidental Pregnancy
within the First Year of Use
% of Women
Continuing Use
at One Year 3
Method
(1)
Typical Use 1
(2)
Perfect Use 2
(3)
(4)
Chance 4 85 85
Spermicides 5 26 6 40
Periodic abstinence 25 63
Calendar 9
Ovulation method 3
Sympto-thermal 6 2
Post Ovulation 1
Withdrawal 19 4
Cap 7
Parous women 40 26 42
Nulliparous women 20 9 56
Sponge
Parous women 40 20 42
Nulliparous women 20 9 56
Diaphragm 7 20 6 56
Condom 8
Female (Reality) 21 5 56
Male 14 3 61
Pill 5 71
progestin only 0.5
combined 0.1
IUD
Progesterone T 2 1.5 81
Copper T 380A 0.8 0.6 78
Lng 20 0.1 0.1 81
Depo Provera 0.3 0.3 70
Norplant and Norplant-2 0.05 0.05 88
Female sterilization 0.5 0.5 100
Male sterilization 0.15 0.10 100
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998, in press.
1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4 The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5 Foams, creams, gels, vaginal suppositories, vaginal film.
6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7 With spermicidal cream or jelly.
8 Without spermicides.

DOSAGE AND ADMINISTRATION

LEVLITE® 28 TABLETS

To achieve maximum contraceptive effectiveness, LEVLITE® 28 Tablets (levonorgestrel and ethinyl estradiol tablets, USP) must be taken exactly as directed at intervals not exceeding 24-hours.

LEVLITE® 28 Tablets are a monophasic preparation plus 7 inert tablets. The dosage of LEVLITE® 28 Tablets is one tablet daily for 21 consecutive days per menstrual cycle plus 7 white inert tablets according to the prescribed schedule. It is recommended that LEVLITE® 28 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 pink LEVLITE® 28 Tablet daily 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 pink tablet. (If LEVLITE® 28 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 LEVLITE® 28 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, LEVLITE® 28 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 LEVLITE® 28 Tablets on the same day of the week that she began her first course, following the same schedule. She begins taking her pink 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. Anytime a subsequent cycle of LEVLITE® 28 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 LEVLITE® 28 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 active 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 (pink) 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 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 pink tablets again on the proper day.

In the nonlactating mother, LEVLITE® 28 Tablets may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum 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 bromocriptine mesylate has been used for the prevention of lactation.

TRI-LEVLEN® 21 TABLETS

To achieve maximum contraceptive effectiveness, TRI-LEVLEN® 21 Tablets (levonorgestrel and ethinyl estradiol tablets--triphasic regimen) should be taken exactly as directed and at intervals not exceeding 24-hours.

TRI-LEVLEN® 21 Tablets are a three-phase preparation. The dosage of TRI-LEVLEN® 21 Tablets is one tablet daily for 21 consecutive days per menstrual cycle in the following order: 6 brown tablets (phase 1), followed by 5 white tablets (phase 2), and then followed by the last 10 light-yellow tablets (phase 3), according to the prescribed schedule. Tablets are then discontinued for 7 days (three weeks on, one week off).

It is recommended that TRI-LEVLEN® 21 Tablets be taken at the same time each day. During the first cycle of medication, the patient should be instructed to take one TRI-LEVLEN® 21 Tablet daily in the order of 6 brown, 5 white and, finally, 10 light-yellow tablets for twenty-one (21) consecutive days, beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) The tablets are then discontinued for one week (7 days). Withdrawal bleeding usually occurs within 3 days following discontinuation of TRI-LEVLEN® 21 Tablets. (If an alternate starting regimen is used [Sunday Start or postpartum], contraceptive reliance should not be placed on TRI-LEVLEN® 21 Tablets until after the first 7 consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered.)

The patient begins her next and all subsequent 21-day courses of TRI-LEVLEN® 21 Tablets on the same day of the week that she began her first course, following the same schedule: 21 days on--7 days off. She begins taking her brown tablets on the 8th day after discontinuance, regardless of whether or not a menstrual period has occurred or is still in progress. Any time the next cycle of TRI-LEVLEN® 21 Tablets is started later than the 8th 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 TRI-LEVLEN® 21 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 (brown, white, or light-yellow) 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 light-green tablets, she is still protected against pregnancy provided she begins taking brown tablets again on the proper day.

In the nonlactating mother, TRI-LEVLEN® 21 Tablets may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum 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.

TRI-LEVLEN® 28 TABLETS

To achieve maximum contraceptive effectiveness, TRI-LEVLEN® 28 Tablets (levonorgestrel and ethinyl estradiol tablets--triphasic regimen) should be taken exactly as directed and at intervals not exceeding 24-hours.

TRI-LEVLEN® 28 Tablets are a three-phase preparation plus 7 inert tablets. The dosage of TRI-LEVLEN® 28 Tablets is one tablet daily for 28 consecutive days per menstrual cycle in the following order: 6 brown tablets (phase 1), followed by 5 white tablets (phase 2), followed by 10 light-yellow tablets (phase 3), plus 7 light-green inert tablets according to the prescribed schedule.

It is recommended that TRI-LEVLEN® 28 Tablets be taken at the same time each day. During the first cycle of medication, the patient should be instructed to take one TRI-LEVLEN® 28 Tablet daily in the order of 6 brown, 5 white, 10 light-yellow tablets and then 7 light-green 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-yellow tablets. (If an alternate starting regimen is used [Sunday Start or postpartum], contraceptive reliance should not be placed on TRI-LEVLEN® 28 Tablets until after the first 7 consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered.)

The patient begins her next and all subsequent 28-day courses of TRI-LEVLEN® 28 Tablets on the same day of the week that she began her first course, following the same schedule: She begins taking her brown tablets on the next day after ingestion of the last light-green tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Any time a subsequent cycle of TRI-LEVLEN® 28 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 TRI-LEVLEN® 28 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 active 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 (brown, white, or light-yellow) 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 light-green tablets, she is still protected against pregnancy provided she begins taking brown tablets again on the proper day.

In the nonlactating mother, TRI-LEVLEN® 28 Tablets may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum 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.

LEVLEN® 21 TABLETS

To achieve maximum contraceptive effectiveness, LEVLEN® 21 Tablets (levonorgestrel and ethinyl estradiol tablets) should be taken exactly as directed and at intervals not exceeding 24-hours.

The dosage of LEVLEN® 21 Tablets is one tablet daily for 21 consecutive days per menstrual cycle according to the prescribed schedule. Tablets are then discontinued for 7 days (three weeks on, one week off).

It is recommended that LEVLEN® 21 Tablets be taken at the same time each day. During the first cycle of medication, the patient should be instructed to take one LEVLEN® 21 Tablet daily for twenty-one (21) consecutive days, beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) The tablets are then discontinued for one week (7 days). Withdrawal bleeding usually occurs within 3 days following discontinuation of LEVLEN® 21 Tablets. (If an alternate starting regimen is used [Sunday Start or postpartum], contraceptive reliance should not be placed on LEVLEN® 21 Tablets until after the first 7 consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered.)

The patient begins her next and all subsequent 21-day courses of LEVLEN® 21 Tablets on the same day of the week that she began her first course, following the same schedule: 21 days on--7 days off. She begins taking her light-orange tablets on the 8th day after discontinuance, regardless of whether or not a menstrual period has occurred or is still in progress. Any time the next cycle of LEVLEN® 21 Tablets is started later than the 8th 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 LEVLEN® 21 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.

In the nonlactating mother, LEVLEN® 21 Tablets may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See " CONTRAINDICATIONS ", " WARNINGS ", and " PRECAUTIONS " concerning thromboembolic disease.)

LEVLEN® 28 TABLETS

To achieve maximum contraceptive effectiveness, LEVLEN® 28 Tablets (levonorgestrel and ethinyl estradiol tablets) should be taken exactly as directed at intervals not exceeding 24-hours.

The dosage of LEVLEN® 28 Tablets is one light-orange tablet daily for 21 consecutive days per menstrual cycle, followed by 7 pink insert tablets according to the prescribed schedule.

It is recommended that LEVLEN® 28 Tablets be taken at the same time each day. During the first cycle of medication, the patient should be instructed to take one TRI-LEVLEN® 28 Tablet daily in the order of 21 light orange and then 7 pink 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-orange tablet. (If an alternate starting regimen is used [Sunday Start or postpartum], contraceptive reliance should not be placed on LEVLEN® 28 Tablets until after the first 7 consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered.)

The patient begins her next and all subsequent 28-day courses of LEVLEN® 28 Tablets on the same day of the week that she began her first course, following the same schedule. She begins taking her light-orange tablets on the next day after ingestion of the last pink tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Any time a subsequent cycle of LEVLEN® 28 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 LEVLEN® 28 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 active 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.

Any time the patient misses two or more tablets, she should also use another method of contraception until she has taken a tablet daily for seven consecutive days. If breakthrough bleeding occurs following missed active tablets, it usually will be transient and of no consequence. If the patient misses one or more pink tablets, she is still protected against pregnancy provided she begins taking the light-orange tablets again on the proper day.

In the nonlactating mother, LEVLEN® 28 Tablets may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See " CONTRAINDICATIONS ", " WARNINGS ", and " PRECAUTIONS " concerning thromboembolic disease.)

HOW SUPPLIED

LEVLITE® 28 Tablets (levonorgestrel and ethinyl estradiol tablets, USP), are available in packages of 3 SLIDECASE® dispensers. Each cycle contains 28 round, unscored coated tablets as follows:

ln packages of 3 SLIDECASE® dispensers, NDC 50419-408-03

Keep at room temperature, approximately 25° C (77° F).

TRI-LEVLEN® 21 tablets (Levonorgestrel and Ethinyl Estradiol Tablets--Triphasic Regimen), are available in packages of 3 and 6 SLIDECASE® dispensers. Each cycle contains 21 round, film-coated tablets as follows:

NDC 50419-195, six brown tablets marked "B" on one side and "95" on the other side, each containing 0.050 mg levonorgestrel and 0.030 mg ethinyl estradiol;

NDC 50419-196, five white to off-white tablets marked "B" on one side and "96" on the other side, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and

NDC 50419-197, ten light-yellow tablets marked "B" on one side and "97" on the other side, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol.

In packages of:

3 SLIDECASE® dispensers.................... NDC 50419-432-03

6 SLIDECASE® dispensers.................... NDC 50419-432-06

TRI-LEVLEN® 28 tablets (Levonorgestrel and Ethinyl Estradiol Tablets--Triphasic Regimen), are available in packages of 3 and 6 SLIDECASE® dispensers. Each cycle contains 28 round, film-coated tablets as follows:

NDC 50419-195, six brown tablets marked "B" on one side and "95" on the other side, each containing 0.050 mg levonorgestrel and 0.030 mg ethinyl estradiol;

NDC 50419-196, five white to off-white tablets marked "B" on one side and "96" on the other side, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol;

NDC 50419-197, ten light-yellow tablets marked "B" on one side and "97" on the other side, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; and

NDC 50419-111, seven light-green inert tablets marked "B" on one side and "11" on the other side.

In packages of:

3 SLIDECASE® dispensers.................... NDC 50419-433-03

6 SLIDECASE® dispensers.................... NDC 50419-433-06

LEVLEN® 21 tablets (Levonorgestrel and Ethinyl Estradiol Tablets), are available in packages of 3 SLIDECASE® dispensers. Each cycle contains 21 round, tablets as follows:

NDC 50419-021, 21 active light-orange tablets marked "B" on one side and "21" on the other side, each containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol;

In packages of:

3 SLIDECASE® dispensers.................... NDC 50419-410-21

LEVLEN® 28 tablets (Levonorgestrel and Ethinyl Estradiol Tablets), are available in packages of 3 SLIDECASE® dispensers. Each cycle contains 28 round tablets as follows:

NDC 50419-021, 21 active, light-orange tablets marked "B" on one side and "21" on the other side, each containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol;

NDC 50419-028, 7 inert pink tablets marked "B" on one side and "28" on the other side.

In packages of:

3 SLIDECASE® dispensers.................... NDC 50419-411-28

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