Etonogestrel And Ethinyl Estradiol (Nuvaring)

Trade Name : NuvaRing

Organon USA Inc.

INSERT, EXTENDED RELEASE

Strength .12.015 mg/dmg/d

ETONOGESTREL; ETHINYL ESTRADIOL Progesterone Congeners [CS],Progestin [EPC],Estrogen Receptor Agonists [MoA],Estrogen [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Etonogestrel And Ethinyl Estradiol (Nuvaring) which is also known as NuvaRing and Manufactured by Organon USA Inc.. It is available in strength of .12; .015 mg/d; mg/d per ml. Read more

Etonogestrel And Ethinyl Estradiol (Nuvaring) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including NuvaRing, should not be used by women who are over 35 years of age and smoke. n
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete boxed warning.

Women over 35 years old who smoke should not use NuvaRing. ()
Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. ()

FOR VAGINAL USE ONLY
NuvaRing is indicated for use by females of reproductive age to prevent pregnancy.
NuvaRing is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy. ()

One NuvaRing is inserted in the vagina. The ring must remain in place continuously for three weeks, followed by a one-week ring-free interval. ()

NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. It is made of ethylene vinylacetate copolymers and magnesium stearate, and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. NuvaRing is not made with natural rubber latex.
NuvaRing is a polymeric vaginal ring containing 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol, which releases on average 0.12 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol. ()

Do not prescribe NuvaRing to women who are known to have or use the following:

A high risk of arterial or venous thrombotic diseases ()
Breast cancer or other estrogen- or progestin-sensitive cancer ()
Liver tumors or liver disease ()
Undiagnosed abnormal uterine bleeding ()
Pregnancy ()
Hypersensitivity, including anaphylaxis and angioedema, to any of the components of NuvaRing ()
Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ()

No data

Vascular risks: Stop NuvaRing use if a thrombotic event occurs. Stop NuvaRing use at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. ()
Toxic Shock Syndrome (TSS): If patient exhibits signs or symptoms of TSS, consider the possibility of this diagnosis and initiate appropriate medical evaluation and treatment. ()
Liver disease: Discontinue NuvaRing use if jaundice develops. ()
High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop NuvaRing use if blood pressure rises significantly. ()
Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. ()
Headache: Evaluate significant change in headaches and discontinue NuvaRing use if indicated. ()
Uterine bleeding: Evaluate irregular bleeding or amenorrhea. ()

The following serious adverse reactions with the use of CHCs are discussed elsewhere in the labeling.
Adverse reactions commonly reported by CHC users are:
The most common adverse reactions (u22652%) in clinical trials were: vaginitis, headache (including migraine), mood changes (e.g., depression, mood swings, mood altered, depressed mood, affect lability), device-related events (e.g., expulsion/discomfort/foreign body sensation), nausea/vomiting, vaginal discharge, increased weight, vaginal discomfort, breast pain/discomfort/tenderness, dysmenorrhea, abdominal pain, acne, and decreased libido. ()
To report SUSPECTED ADVERSE REACTIONS, contact Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of CHCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with CHCs. ()

No data

Nursing mothers: Not recommended; can decrease milk production. ()

There have been no reports of serious ill effects from overdose of CHCs. Overdosage may cause withdrawal bleeding in females and nausea. If the ring breaks, it does not release a higher dose of hormones. In case of suspected overdose, all NuvaRing rings should be removed and symptomatic treatment given.

NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17u03b1-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17u03b1-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. NuvaRing is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. NuvaRing is not made with natural rubber latex. NuvaRing has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively.
The structural formulas are as follows:

No data

No data

In three large one-year clinical trials enrolling 2,834 women aged 18-40 years, in North America, Europe, Brazil, and Chile, the racial distribution was 93% Caucasian, 5.0% Black, 0.8% Asian, and 1.2% Other. Women with BMI u2265 30 kg/m were excluded from these studies.
Based on pooled data from the three trials, 2,356 women aged < 35 years completed 23,515 evaluable cycles of NuvaRing use (cycles in which no back-up contraception was used). The pooled pregnancy rate (Pearl Index) was 1.28 (95% CI [0.8, 1.9]) per 100 women-years of NuvaRing use. In the US study, the Pearl Index was 2.02 (95% CI [1.1, 3.4]) per 100 women-years of NuvaRing use.
Study data indicate the return of ovulation and spontaneous menstrual cycles in most women within a month after discontinuation of NuvaRing use.

No data

Each NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) is individually packaged in a reclosable aluminum laminate sachet consisting of three layers, from outside to inside: polyester, aluminum foil, and low-density polyethylene. The ring should be replaced in this reclosable sachet after use and discarded in a waste receptacle out of the reach of children and pets. It should not be flushed down the toilet.
Prior to dispensing to the user, store refrigerated 2-8u00b0C (36-46u00b0F). After dispensing to the user, NuvaRing can be stored for up to 4 months at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature].
Avoid storing NuvaRing in direct sunlight or at temperatures above 30u00b0C (86u00b0F).
For the Dispenser: When NuvaRing is dispensed to the user, place an expiration date on the label. The date should not exceed either 4 months from the date of dispensing or the expiration date, whichever comes first.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Counsel patients regarding the following:

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary ofn Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2001-2020 Merck Sharp & Dohme B.V., a subsidiary of n All rights reserved.
uspi-mk8342a-rng-2001r014

Patient Information
NuvaRing (NEW-vah-ring)(etonogestrel/ethinyl estradiol vaginal ring)
Hormonal birth control methods help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.
What is NuvaRing?
NuvaRing (NEW-vah-ring) is a flexible birth control vaginal ring used to prevent pregnancy.
NuvaRing contains a combination of a progestin and estrogen, 2 kinds of female hormones. Birth control methods that contain both an estrogen and a progestin are called combination hormonal contraceptives (CHCs).
How well does NuvaRing work?
Your chance of getting pregnant depends on how well you follow the directions for using NuvaRing. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of a US clinical study, approximately 1 to 3 women out of 100 women may get pregnant during the first year they use NuvaRing.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
Who should not use NuvaRing?
Do not use NuvaRing if you:
Hormonal birth control methods may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy or related to previous use of hormonal birth control.
Tell your healthcare provider if you have ever had any of the conditions listed above. Your healthcare provider can suggest another method of birth control.
What should I tell my healthcare provider before using NuvaRing?
Before you use NuvaRing tell your healthcare provider if you
Tell your healthcare provider about all medicines and herbal products you take
Some medicines and herbal products may make hormonal birth control less effective, including, but not limited to:
Use an additional barrier contraceptive method (such as a male condom with spermicide) when you take medicines that may make NuvaRing less effective. Since the effect of another medicine on NuvaRing may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long to help prevent you from becoming pregnant. While using NuvaRing, you should not use certain female barrier contraceptive methods such as a vaginal diaphragm, cervical cap or female condom as your back-up method of birth control because NuvaRing may interfere with the correct placement and position of a diaphragm, cervical cap or female condom.
Some medicines and grapefruit juice may increase the level of ethinyl estradiol in your blood if used together, including:
Hormonal birth control methods may interact with lamotrigine, a medicine used for seizures. This may increase the risk of seizures, so your healthcare provider may need to adjust your dose of lamotrigine.
Women on thyroid replacement therapy may need increased doses of thyroid hormone.
Ask your healthcare provider if you are not sure if you take any of the medicines listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I use NuvaRing?
Your healthcare provider should examine you at least 1 time a year to see if you have any signs of side effects from using NuvaRing.
What are the possible side effects of using NuvaRing?
See n
NuvaRing may cause serious side effects, including:
Other serious risks include:
The most common side effects of NuvaRing are:
Some women have spotting or light bleeding during NuvaRing use. If these symptoms occur, do not stop using NuvaRing. The problem will usually go away. If it doesn't go away, check with your healthcare provider.
Other side effects seen with NuvaRing include breast discharge; vaginal injury (including pain, discomfort, and bleeding) associated with broken rings; and penis discomfort of the partner (such as irritation, rash, itching).
Less common side effects seen with combination hormonal birth control include:
There have been reports of the ring becoming stuck to the vaginal tissue and having to be removed by a healthcare provider. Call your healthcare provider if you are unable to remove your NuvaRing.
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of NuvaRing. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store NuvaRing and throw away used NuvaRings?
Keep NuvaRing and all medicines out of the reach of children.
General information about the safe and effective use of NuvaRing
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. Do not use NuvaRing for a condition for which it was not prescribed. Do not give NuvaRing to other people. It may harm them.
This leaflet summarizes the most important information about NuvaRing. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NuvaRing that is written for health professionals.
For more information on NuvaRing and the applicator for NuvaRing, go to www.nuvaring.com or call 1-800-622-4477.
What are the ingredients in NuvaRing?
Active ingredients:
Inactive ingredients:
NuvaRing is not made with natural rubber latex.
Do Hormonal Birth Control Methods Cause Cancer?
Hormonal birth control methods do not seem to cause breast cancer. However, if you have breast cancer now or have had it in the past, do not use hormonal birth control, including NuvaRing, because some breast cancers are sensitive to hormones.
Women who use hormonal birth control methods may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.
What should I know about my period when using NuvaRing?
When you use NuvaRing you may have bleeding and spotting between periods, called unplanned bleeding. Unplanned bleeding may vary from slight staining between menstrual periods to breakthrough bleeding, which is a flow much like a regular period. Unplanned bleeding occurs most often during the first few months of NuvaRing use, but may also occur after you have been using NuvaRing for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue using the ring on schedule. If the unplanned bleeding or spotting is heavy or lasts for more than a few days, you should discuss this with your healthcare provider.
What if I miss my regular scheduled period when using NuvaRing?
Some women miss periods on hormonal birth control, even when they are not pregnant. Consider the possibility that you may be pregnant if:
What if I want to become pregnant?
You may stop using NuvaRing whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop using NuvaRing.

Instructions for Use
NuvaRing (NEW-vah-ring)(etonogestrel/ethinyl estradiol vaginal ring)
Read these Instructions for Use before you start using NuvaRing and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your treatment.
How should I start using NuvaRing?
If you are not currently using hormonal birth control, you have 2 ways to start using NuvaRing.
If you are changing from a birth control pill or patch to NuvaRing:
If you have been using your birth control method correctly and are certain that you are not pregnant, you can change to NuvaRing any day. Do not start NuvaRing any later than the day you would start your next birth control pill or apply your patch.
If you are changing from a progestin-only birth control method, such as a minipill, implant or injection or from an intrauterine system (IUS):
If you are changing from a minipill, implant or injection or from an intrauterine system (IUS), you should use an extra method of birth control, such as a male condom with spermicide during the first 7 days of using NuvaRing.
If you start using NuvaRing after an abortion or miscarriage:
If you are starting NuvaRing after childbirth:
If you are breastfeeding you should not use NuvaRing. Use other birth control methods until you are no longer breastfeeding.
Step 1. Choose a position for insertion of NuvaRing.
Step 2. Open the pouch to remove your NuvaRing.
Step 3. Prepare NuvaRing for insertion.
Step 4. Insert NuvaRing into your vagina.
Inserting NuvaRing ( and positioning NuvaRing (n
Note:
Step 5. How do I remove NuvaRing?
Step 6. Throw away the used NuvaRing.
What else should I know about using NuvaRing?
What if I leave NuvaRing in too long?
What should I do if my NuvaRing comes out of my vagina?
NuvaRing can slip or accidentally come out (expelled) of your vagina, for example, during sexual intercourse, bowel movements, use of tampons, or if it breaks.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary ofn Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2001-2019 Merck Sharp & Dohme B.V., a subsidiary of n All rights reserved.
Revised: 05/2019
usppi-mk8342a-rng-1905r013

Applicator for NuvaRing (NEW-vah-ring)
For optional use to help insert NuvaRing.
NuvaRing is not included with the applicator.
Important
The applicator is not made with natural rubber latex.
Store the applicators between 41u00b0F to 86u00b0F (5u00b0C to 30u00b0C).
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
Manufactured by: Sonoco Plastics B.V., Berkel en Rodenrijs, The Netherlands
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2016 Merck Sharp & Dohme B.V., a subsidiary of n All rights reserved.
Revised: 09/2016
usifu-mkd920-1609r000

For the Dispenser:
NDC 0052--05
NUVARINGn- (etonogestrel/ethinyl estradiol vaginal ring)delivers 0.120 mg/0.015 mg per day
For Vaginal Use
Keep out of the reach of children.
This product is intended to preventpregnancy. It does not protect againstHIV infection (AIDS) and other sexuallytransmitted diseases.
Rx only
Contains 3 Rings

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Etonogestrel And Ethinyl Estradiol (Nuvaring)

Trade Name : NuvaRing

INSERT, EXTENDED RELEASE

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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Etonogestrel And Ethinyl Estradiol (Nuvaring)

Trade Name : NuvaRing

INSERT, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

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