Mono-Linyah Dailymed

Mono-Linyah tablets are indicated for use by females of reproductive potential to prevent pregnancy .

Mono-Linyah tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )].

Starting Mono-Linyah after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Mono-Linyah may be started immediately. An additional method of contraception is not needed if Mono-Linyah is started immediately. If Mono-Linyah is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Mono-Linyah. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Mono-Linyah, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Mono-Linyah.[see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and FDA-Approved Patient Labeling.] Starting Mono-Linyah after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Mono-Linyah following the instructions in Table 1 for women not currently using hormonal contraception. Mono-Linyah is not recommended for use in lactating women[see Use in Specific Populations ( 8.3 )] . If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Mono-Linyah.[See Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 and 8.3 ), and FDA-Approved Patient Labeling]. Compact Buler Dispenser If the patient starts pill-taking on Sunday, the first active pill should be taken on the first Sunday after the patient's menstrual period begins. Remove the first active pill at the top of the dispenser (Sunday) by pressing the pill through the buler foil. If the patient will start pill-taking on "Day 1", place a day-label sticker on the compact which starts with the day of the week the patient will take the first pill. Remove the first active pill at the top of the dispenser (Day 1) by pressing the pill through the buler foil.

Do not prescribe Mono-Linyah to women who are known to have the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35[ see Boxed Warning and Warnings and Precautions (5.1)] Have deep vein thrombosis or pulmonary embolism, now or in the past[see Warnings and Precautions (5.1) ] Have inherited or acquired hypercoagulopathies[see Warnings and Precautions (5.1) ] Have cerebrovascular disease[see Warnings and Precautions (5.1) ] Have coronary artery disease[see Warnings and Precautions (5.1) ] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)[see Warnings and Precautions (5.1) ] Have uncontrolled hypertension[see Warnings and Precautions (5.4)] Have diabetes mellitus with vascular disease[see Warnings and Precautions (5.6)] Have headaches with focal neurological symptoms or have migraine headaches with aura[see Warnings and Precautions (5.7)]                     Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)] Liver tumors, benign or malignant, or liver disease[see Warnings and Precautions (5.2)] Undiagnosed abnormal uterine bleeding[see Warnings and Precautions (5.8)] Pregnancy, because there is no reason to use COCs during pregnancy[ see Warnings and Precautions (5.9) and Use in Specific Populations (8.1) ] Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past[see Warnings and Precautions (5.11) ] Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations[see Warnings and Precautions (5.3)]

Stop Mono-Linyah if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. Stop Mono-Linyah if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately[see Adverse Reactions ( 6.2 )] . If feasible, stop Mono-Linyah at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization. Start Mono-Linyah no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke. Use COCs with caution in women with cardiovascular disease risk factors.

Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for COC related cholestasis.

Unscheduled Bleeding and Spotting Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product. In clinical trials of norgestimate and ethinyl estradiol Tablets 0.25mg/0.035mg, the frequency and duration of breakthrough bleeding and/or spotting was assessed in 1,647 patients (21,275 evaluable cycles) and 4,826 patients (35,546 evaluable cycles), respectively. A total of 100 (7.5%) women discontinued norgestimate and ethinyl estradiol Tablets 0.25mg/0.035mg, at least in part, due to bleeding or spotting. Based on data from the clinical trials, 14-34% of women using norgestimate and ethinyl estradiol Tablets 0.25mg/0.035mg experienced unscheduled bleeding per cycle in the first year. The percent of women who experienced breakthrough/unscheduled bleeding tended to decrease over time. Amenorrhea and Oligomenorrhea Women who use Mono-Linyah may experience amenorrhea. Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was pre-existent. If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue Mono-Linyah use if pregnancy is confirmed.

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue Mono-Linyah use if pregnancy is confirmed. Administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy [see Use in Specific Populations ( 8.1 )].

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not  use COCs during pregnancy to treat threatened or habitual abortion.

Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

In three US clinical trials with norgestimate and ethinyl estradiol 0.25mg/0.035mg, 1,651 women aged 18 to 38 years were studied for up to 24 cycles, proving a total of 24,272 cycles of exposure. The racial demographic was about 73-86% Caucasian, 8-13% African-American, 6-14% Hispanic with the remainder Asian or Other (≤1%). There were no exclusions on the basis of weight; the weight range for women treated was 82-303 lbs, with a mean weight of about 135 lbs. The pregnancy rate was approximately 1 pregnancy per 100 women-years.