TRI FEMYNOR- norgestimate and ethinyl estradiol kit

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Mevcut itibaren:

Amneal Pharmaceuticals NY LLC

INN (International Adı):

NORGESTIMATE

Kompozisyon:

NORGESTIMATE 0.18 mg

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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) ]. Do not prescribe Tri Femynor 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 (5.3) ] - Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.5) ] - Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.6) ] - Women over age 35 with any migraine headaches [see Warnings and Precautions (5.6) ] - Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2) ] - Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.7) ] - Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.8) 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 (5.10) ] 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. Safety and efficacy of Tri Femynor has been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated. There was no significant difference between Tri Femynor and placebo in mean change to total lumbar spine (L1-L4) and total hip bone mineral density between baseline and Cycle 13 in 123 adolescent females with anorexia nervosa in a double blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the Intent-To-Treat (ITT) population. Tri Femynor has not been studied in postmenopausal women and are not indicated in this population. The pharmacokinetics of Tri Femynor has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. [See Contraindications (4) andWarnings and Precautions (5.2) .] The pharmacokinetics of Tri Femynor has not been studied in women with renal impairment.   Tri Femynor™ (trye feh’ mi nore) ( norgestimate and ethinyl estradiol tablets, USP) Important Information about taking Tri Femynor - Take 1 pill every day at the same time. Take the pills in the order directed on your blister pack. - Do not skip your pills, even if you do not have sex often. If you miss pills (including starting the pack late) you could get pregnant . The more pills you miss, the more likely you are to get pregnant. - If you have trouble remembering to takeTri Femynor, talk to your healthcare provider. When you first start takingTri Femynor, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months. - You may feel sick to your stomach (nauseous), especially during the first few months of takingTri Femynor. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider. - Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills (see What should I do if I miss any Tri Femynor pills ? below), you could also feel a little sick to your stomach. - It is not uncommon to miss a period. However, if you miss a period and have not taken Tri Femynor according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop takingTri Femynor. - If you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra blister pack. If you do not have an extra blister pack, take the next pill in your blister pack. Continue taking all your remaining pills in order. Start the first pill of your next blister pack the day after finishing your current blister pack. This will be 1 day earlier than originally scheduled. Continue on your new schedule. - If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms and a spermicide, until you check with your healthcare provider. - Stop taking Tri Femynor at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms and spermicide) during this time period. Before you start taking Tri Femynor : - Decide what time of day you want to take your pill. It is important to take it at the same time every day and in the order as directed on your blister pack. - Have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed. When should I start taking Tri Femynor ? If you start taking Tri Femynor and you have not used a hormonal birth control method before: - There are 2 ways to start taking your birth control pills. You can either start on a Sunday (Sunday Start) or on the first day (Day 1) of your natural menstrual period (Day 1 Start). Your healthcare provider should tell you when to start taking your birth control pill. - If you use the Sunday Start, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you takeTri Femynor. You do not need back-up contraception if you use the Day 1 Start. If you start taking Tri Femynor and you are switching from another birth control pill: - Start your new Tri Femynor pack on the same day that you would start the next pack of your previous birth control method. - Do not continue taking the pills from your previous birth control pack. If you start taking Tri Femynor and previously used a vaginal ring or transdermal patch: - Start using Tri Femynor on the day you would have reapplied the next ring or patch. If you start taking Tri Femynor and you are switching from a progestin-only method such as an implant or injection: - Start taking Tri Femynor on the day of removal of your implant or on the day when you would have had your next injection. If you start taking Tri Femynor and you are switching from an intrauterine device or system (IUD or IUS): - Start taking Tri Femynor on the day of removal of your IUD or IUS. - You do not need back-up contraception if your IUD or IUS is removed on the first day (Day 1) of your period. If your IUD or IUS is removed on any other day, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you takeTri Femynor. Keep a calendar to track your period: If this is the first time you are taking birth control pills, read, "When should I start taking Tri Femynor ?" above. Follow these instructions for either a Sunday Start or a Day 1 Start . Sunday Start: You will use a Sunday Start if your healthcare provider told you to take your first pill on a Sunday. - Take pill 1 on the Sunday after your period starts . - If your period starts on a Sunday, take pill "1 " that day and refer to Day 1 Start instructions below. - Take 1 pill every day in the order on the blister pack at the same time each day for 28 days. - After taking the last pill on Day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack (Sunday). Take the first pill in the new pack whether or not you are having your period. - Use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days of the first cycle that you takeTri Femynor. Day 1 Start: You will use a Day 1 Start if your doctor told you to take your first pill (Day 1) on the first day of your period . - Take 1 pill every day in the order of the pill blister pack, at the same time each day, for 28 days. - After taking the last pill on Day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack. Take the first pill in the new pack whether or not you are having your period. Tri Femynor comes in a blister pack. Read the instructions below for using your blister pack. Instructions for using your blister pack: Each blister pack contains 28 pills: - 7 light pink pills with hormone, for Days 1 to 7 - 7 light red pills with hormone, for Days 8 to 14 - 7 red pills with hormone, for Days 15 to 21 - 7 white pills (without hormones), for Days 22 to 28 . Step 1. SET THE DAY - 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. - Day 1 Start: Take the first pill of the first blister pack during the first 24 hours of your period.   Step 2. Remove the first pill of the blister pack (SUN or Day 1) by pressing the pill through the back of the blister foil. Step 3. Swallow the pill. You will take 1 pill every day, at the same time each day. Step 4. Wait 24 hours to take your next pill. Continue to take one pill each day until all pills have been taken. Step 5. Take your pill at the same time every day. It is important to take the correct pill each day and not miss any pills. To help you remember, take your pill at the same time as another daily activity, like turning off your alarm clock or brushing your teeth. What should I do if I miss any Tri Femynor pills ? If you miss 1 light pink, light red or red “active” pill in Weeks 1, 2, or 3, follow these steps: - Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day. - Then continue taking 1 pill every day until you finish the pack. - You do not need to use a back-up birth control method if you have sex. If you miss 2 light pink or light red “active” pills in Week 1 or Week 2 of your pack, follow these steps: - Take the 2 missed pills as soon as possible and the next 2 pills the next day. Then continue to take 1 pill every day until you finish the pack. - Then continue to take 1 pill every day until you finish the pack. - Use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after missing your pills. If you miss 2 red “active” pills in a row in Week 3, or you miss 3 or more light pink, light red or red “active” pills in a row during Weeks 1, 2, or 3 of the pack, follow these steps: - If you are a Day 1 Starter : Throw out the rest of the pill pack and start a new pack that same day. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. You could become pregnant if you have sex during the first 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. - Throw out the rest of the pill pack and start a new pack that same day. - You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. - You could become pregnant if you have sex during the first 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. - If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day. Use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. - Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day. - Use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. If you have any questions or are unsure about the information in this leaflet, call your healthcare provider. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2016-00

Ürün özeti:

Tri Femynor™ (norgestimate and ethinyl estradiol tablets, USP) are available in a blister pack (NDC 69238-1607-6): Each blister pack (28 tablets) contains in the following order: Keep out of reach of children.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

TRI FEMYNOR- NORGESTIMATE AND ETHINYL ESTRADIOL
AMNEAL PHARMACEUTICALS NY LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TRI
FEMYNOR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRI FEMYNOR.
TRI FEMYNOR™ (NORGESTIMATE AND ETHINYL ESTRADIOL) TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
TRI FEMYNOR IS CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE.
(4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVES (COC) USE. (4)
INDICATIONS AND USAGE
Tri Femynor is estrogen/progestin COCs, indicated for use by women to
prevent pregnancy. (1.1)
Tri Femynor is also 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 birth
control. (1.2)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.2)
Take tablets in the order directed on the blister pack. (2.2)
Do not skip or delay tablet intake. (2.2)
DOSAGE FORMS AND STRENGTHS
Tri Femynor consists of 28 round, biconvex, film-coated tablets in the
following order (3):
7 light pink tablets each containing 0.18 mg norgestimate, USP and
0.035 mg ethinyl estradiol, USP
7 light red tablets each containing 0.215 mg norgestimate, USP and
0.035 mg ethinyl estradiol, USP
7 red tablets each containing 0.25 mg norgestimate, USP and 0.035 mg
ethinyl estradiol, USP
7 white tablets (inert)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
WARNINGS AND PRECAUTIONS
Thromboembolic D