Tri-Femynor

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More about Tri-Femynor

ETHINYL ESTRADIOL; NORGESTIMATE (ETH in il es tra DYE ole; nor JES ti mate) is an oral contraceptive. The products combine two types of female hormones, an estrogen and a progestin. They are used to prevent ovulation and pregnancy. Some products are also used to treat acne in females. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
2.1 How to Start Tri Femynor 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. 2.2 How to Take Tri Femynor Table 1: Instructions for Administration of Tri Femynor Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Tri Femynor active tablets are light pink (Day 1 to day 7), light red (Day 8 to Day 15) and red (Day 16 to Day 21). Tri Femynor has white inactive tablets (Day 22 to Day 28). Day 1 Start: Take first light pink “active” tablet without regard to meals on the first day of menses. Take subsequent light pink, light red or red “active” tablets once daily at the same time each day for a total of 21 days. Take one white “inactive” tablet daily for 7 days and at the same time of day that “active” tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last white “inactive” tablet) Sunday Start: Take first light pink “active” tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patients first cycle pack ofTri Femynor. Take subsequent light pink, light red or red “active” tablets once daily at the same time each day for a total of 21 days. Take one white “inactive” tablet daily for the following 7 days and at the same time of day that “active” tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last white “inactive” tablet) and additional non-hormonal contraceptive is not needed. Switching to Tri Femynorfrom 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 StartTri Femynor: Transdermal patch On the day when next application would have been scheduled Vaginal ring On the day when next insertion would have been scheduled Injection On the day when next injection would have been scheduled Intrauterine contraceptive On the day of removal If the IUD is not removed on first day of the patients menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack. Implant On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. Starting Tri Femynorafter Abortion or Miscarriage First-trimester 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. Second-trimester 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 patients 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]. blister for PI 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. 2.3 Missed Tablets Table 2: Instructions for Missed Tri Femynor If one light pink, light red or red “active” tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. If two light pink or light red “active” tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two “active” tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. If two red “active” tablets are missed in the third week or three or more light pink, light red or red “active” tablets are missed in a row in Weeks 1, 2, or 3 Day 1 start: Throw out the rest of the pack and start a new pack that same day. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. 2.4 Advice in Case of Gastrointestinal Disturbances In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking a light pink, light red or red “active” tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling]. 2.5 Tri Femynor Use for Acne The timing of initiation of dosing with Tri Femynor for acne should follow the guidelines for use of Tri Femynor as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section (2.1) for instructions.
Side effects that you should report to your doctor or health care professional as soon as possible: • breast tissue changes or discharge • changes in vaginal bleeding during your period or between your periods • chest pain • coughing up blood • dizziness or fainting spells • headaches or migraines • leg, arm or groin pain • severe or sudden headaches • stomach pain (severe) • sudden shortness of breath • sudden loss of coordination, especially on one side of the body • speech problems • symptoms of vaginal infection like itching, irritation or unusual discharge • tenderness in the upper abdomen • vomiting • weakness or numbness in the arms or legs, especially on one side of the body • yellowing of the eyes or skin Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): • breakthrough bleeding and spotting that continues beyond the 3 initial cycles of pills • breast tenderness • mood changes, anxiety, depression, frustration, anger, or emotional outbursts • increased sensitivity to sun or ultraviolet light • nausea • skin rash, acne, or brown spots on the skin • weight gain (slight) This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Keep out of the reach of children. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
Do not take this medicine with the following medication: • dasabuvir; ombitasvir; paritaprevir; ritonavir • ombitasvir; paritaprevir; ritonavir This medicine may also interact with the following medications: • acetaminophen • antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines • aprepitant • ascorbic acid (vitamin C) • atorvastatin • barbiturate medicines, such as phenobarbital • bosentan • carbamazepine • caffeine • clofibrate • cyclosporine • dantrolene • doxercalciferol • felbamate • grapefruit juice • hydrocortisone • medicines for anxiety or sleeping problems, such as diazepam or temazepam • medicines for diabetes, including pioglitazone • mineral oil • modafinil • mycophenolate • nefazodone • oxcarbazepine • phenytoin • prednisolone • ritonavir or other medicines for HIV infection or AIDS • rosuvastatin • selegiline • soy isoflavones supplements • St. Johns wort • tamoxifen or raloxifene • theophylline • thyroid hormones • topiramate • warfarin This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
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