TRI FEMYNOR- norgestimate and ethinyl estradiol
Amneal Pharmaceuticals NY LLC
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) ].
Tri Femynor Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ].
Tri Femynor is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri Femynor should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14) ].
Tri Femynor tablets are dispensed in a blister pack [see How Supplied/Storage and Handling (16) ]. Tri Femynor may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.
Table 1: Instructions for Administration of Tri Femynor
Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start)
Consider the possibility of ovulation and conception prior to initiation of this product.
Day 1 Start:
Switching to Tri Femynor from another oral contraceptive
Start on the same day that a new pack of the previous oral contraceptive would have started.
Switching from another contraceptive method to Tri Femynor
Start Tri Femynor :
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.
Starting Tri Femynorafter Abortion or Miscarriage
- After a first-trimester abortion or miscarriage, Tri Femynor may be started immediately. An additional method of contraception is not needed if Tri Femynor is started immediately.
- If Tri Femynor 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 Tri Femynor.
- Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Tri Femynor, 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 Tri Femynor. [See Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]
Starting Tri Femynorafter Childbirth
- Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri Femynor following the instructions in Table 1 for women not currently using hormonal contraception.
- Tri Femynor 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 Tri Femynor. [See Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].
SET THE DAY:
Day 1 Start: Take the first pill of the first blister pack during the first 24 hours of your period.
Sunday Start: Take the first pill of the first blister pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the blister pack that same day.
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