NORGESTIMATE AND ETHINYL ESTRADIOL kit

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

AvKARE

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Norgestimate and Ethinyl Estradiol Tablets, USP is indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)] . Norgestimate and Ethinyl Estradiol Tablets, USP 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-Estarylla™ should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see CLINICAL STUDIES ( 14)]. Estarylla™ is contraindicated in females who are known to have or develop 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 migraine headaches with aura [see WARNINGS AND PRECAUTIONS ( 5.7)] Women over age 35 with any migraine headaches [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)] - Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [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)] 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 norgestimate and ethinyl estradiol have 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-Estarylla™ tablets and placebo in mean change in 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. Norgestimate and ethinyl estradiol  has not been studied in postmenopausal women and are not indicated in this population. The pharmacokinetics of norgestimate and ethinyl estradiol 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) and WARNINGS AND PRECAUTIONS (5.2).] The pharmacokinetics of norgestimate and ethinyl estradiol has not been studied in women with renal impairment. Norgestimate and Ethinyl Estradiol Tablets, USP Important Information about taking Norgestimate and Ethinyl Estradiol Tablets, USP - 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 blister 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 take Norgestimate and Ethinyl Estradiol Tablets, USP, talk to your healthcare provider. When you first start taking Norgestimate and Ethinyl Estradiol Tablets, USP, 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 taking Norgestimate and Ethinyl Estradiol Tablets, USP. 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 Norgestimate and Ethinyl Estradiol Tablets, USP 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 Norgestimate and Ethinyl Estradiol Tablets, USP 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 taking Norgestimate and Ethinyl Estradiol Tablets, USP. - 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 pill blister pack. If you do not have an extra pill blister pack, take the next pill in your pill blister pack. Continue taking all your remaining pills in order. Start the first pill of your next pill blister pack the day after finishing your current pill 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 Norgestimate and Ethinyl Estradiol Tablets, USP 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 Norgestimate and Ethinyl Estradiol Tablets, USP: - 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 blister pack of pills as needed. When should I start taking Norgestimate and Ethinyl Estradiol Tablets, USP? If you start taking Norgestimate and Ethinyl Estradiol Tablets, USP 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 take Norgestimate and Ethinyl Estradiol Tablets, USP. You do not need back-up contraception if you use the Day 1 Start. If you start taking Norgestimate and Ethinyl Estradiol Tablets, USP and you are switching from another birth control pill: - Start your new Norgestimate and Ethinyl Estradiol Tablets, USP 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 Norgestimate and Ethinyl Estradiol Tablets, USP and previously used a vaginal ring or transdermal patch: - Start using Norgestimate and Ethinyl Estradiol Tablets, USP on the day you would have reapplied the next ring or patch. If you start taking Norgestimate and Ethinyl Estradiol Tablets, USP and you are switching from a progestin-only method such as an implant or injection: - Start taking Norgestimate and Ethinyl Estradiol Tablets, USP on the day of removal of your implant or on the day when you would have had your next injection. If you start taking Norgestimate and Ethinyl Estradiol Tablets, USP and you are switching from an intrauterine device or system (IUD or IUS): - Start taking Norgestimate and Ethinyl Estradiol Tablets, USP 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 take Norgestimate and Ethinyl Estradiol Tablets, USP. 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 Norgestimate and Ethinyl Estradiol Tablets, USP?" 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 blister pack, on the same day of the week as the first blister 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 take Norgestimate and Ethinyl Estradiol Tablets, USP. 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 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. Norgestimate and Ethinyl Estradiol Tablets, USP comes in a blister pack. Read the instructions below for using your blister pack. BEFORE YOU START TAKING YOUR PILLS: - BE SURE TO READ THESE DIRECTIONS: - BE SURE TO READ THESE DIRECTIONS: Before you start taking your pills. Anytime you are not sure what to do. 2.THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. 3.MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1 to 3 PACKS OF PILLS. If you feel sick to your stomach or have spotting or light bleeding, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare professional. 4.MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. 5.IF YOU HAVE VOMITING OR DIARRHEA, OR IF YOU TAKE SOME MEDICINES, Including some antibiotics, your pills may not work as well. Use a back-up method (such as a condom or spermicide) until you check with your healthcare professional. 6.IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your healthcare professional about how to make pill-taking easier or about using another method of birth control. 7.IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your healthcare professional. BEFORE YOU START TAKING YOUR PILLS 1.DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day. 2.LOOK AT YOUR PILL PACK - The pill pack has 21 active pills (with hormones) to take for 3 weeks. This is followed by 1 week of reminder green pills (without hormones). 3.ALSO FIND: 1.where on the pack to start taking pills, 2.in what order to take the pills (follow the arrows) 3.the week numbers as shown in the diagram below. - 4.BE SURE YOU HAVE READY AT ALL TIMES: ANOTHER KIND OF BIRTH CONTROL (such as a condom or spermicide) to use as a back-up method in case you miss pills. AN EXTRA, FULL PILL PACK. What should I do if I miss any Norgestimate and Ethinyl Estradiol Tablets, USP pills? If you miss 1 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 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. - 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 pills in a row in Week 3, or you miss 3 or more 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. 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. 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 has been approved by the U.S. Food and Drug Administration. The brands listed are the registered trademark of their respective owners and are not trademarks of AvKARE. Manufactured For: AvKARE Pulaski, TN 38478 Rev. 04/2020

Ringkasan produk:

Norgestimate and Ethinyl Estradiol Tablets, USP is available in blisters containing 28 tablets as follows: Each blister card contains 21 active tablets and 7 inactive tablets. 7 white (active) tablets are round, debossed with SZ on one side and T2 on the other side and contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol . 7 light blue (active) tablets are round, debossed with SZ on one side and T3 on the other side and contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol . 7 blue (active) tablets are round, debossed with SZ on one side and T4 on the other side and contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol . 7 green (inert) tablets are round, debossed with SZ on one side and J1 on the other side. NDC 42291-590-28, one box containing 1 individual unit carton NDC 42291-590-84, one box containing 3 individual unit cartons Keep out of reach of children

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL
ESTRADIOL
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORGESTIMATE AND ETHINYL
ESTRADIOL TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS, USP.
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS, USP 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)
RECENT MAJOR CHANGES
Contraindications (4) 11/2021
Warnings and Precautions (5.3) 11/2021
INDICATIONS AND USAGE
Norgestimate and Ethinyl Estradiol Tablets, USP is an
estrogen/progestin COCs, indicated for use by
women to prevent pregnancy. ( 1.1)
Norgestimate and Ethinyl Estradiol Tablets, USP 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.
Norgestimate and Ethinyl Estradiol Tablets, USP should be used for the
treatment of acne only if the
patient desires an oral contraceptive for 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
Norgestimate and Ethinyl Estradiol Tablets, USP consists of 28 tablets
in the following order ( 3):
7 white tablets each containing 0.18 mg norgestimate and 0.035 mg
ethinyl estradiol
7 light blue tablets each containing 0.215 mg norgestimate and 0.035
mg ethinyl estradiol
7 blue tablets each containing 0.25 mg norgestimate and 0.035mg of
ethinyl estradiol
7 green tablets (inert)
CONTRA