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.)
|
