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MoonDragon's Contraception Information
VAGINAL HORMONE RINGS CONTRACEPTION
CONTRACEPTIVE VAGINAL RING (CVR)
(NuvaRing® & Progering®)


"For Informational Use Only"
For more detailed information contact your health care provider
about options that may be available for your specific situation.




BASIC INFORMATION


DESCRIPTION

The goal of contraception (or birth control) is to prevent an unplanned pregnancy. The majority of methods of contraception enable sexually active couples to temporarily avoid pregnancy. Permanent birth control is accomplished through sterilization. Be sure you know and understand the different types of birth control available to you, the risks and benefits of each, and any side effects, so that you can make an informed choice.

MoonDragon's Contraception Methods Compared





CONTRACEPTIVE VAGINAL RINGS (CVR) OVERVIEW

The capacity of the vaginal epithelium to absorb hormonal steroids and the ability of silicone elastomers to release these hormones at an almost constant rate form the basis for the use of synthetic rubber vaginal rings for therapeutic purposes. The first prototypes were made for contraception purposes but were later used for hormone replacement therapy (HRT) and, more recently, for the release of antiviral drugs. Contraceptive vaginal rings (CVRs) used in hormone replacement therapy (HRT) was recently extensively reviewed and there are no publications on microbicide-delivering vaginal rings, available to date.

Numerous models of CVRs have been studied, but only two have reached the market: NuvaRing® that releases ethinylestradiol and etonogestrel; and Progering® that releases progesterone, for use in lactating women. Hormone-releasing rings are kept in the vagina and remaining in place day and night for three weeks or one year, depending on the formulation.

Combined rings offer better cycle control with more steadily released hormones than combined oral contraceptives. Combined rings release sufficient amounts of estrogen and progestin to prevent ovulation. In addition, the progestin thickens cervical mucus and suppresses endometrial growth. In a pooled analysis of 2,322 women using NuvaRing in Canada, the US, and Europe, there were 1.2 to 1.5 pregnancies per 100 women in the first year of typical use. Women used the ring correctly in 86 percent of cycles.

They work by releasing progestin alone or progestin with estrogen into the vaginal walls and through to the bloodstream, preventing ovulation, thickening cervical mucus, and suppressing endometrial growth.

Women can control the use of vaginal rings. To use the vaginal ring, a woman inserts it into the vagina with her fingers, placing it anywhere that feels comfortable. It fits best in the higher part of the vagina. Studies in developed countries have found that women follow rules for correct use at rates higher than those seen in studies of combined oral contraceptives.

The ring remains in place all day and night and requires no further attention. Hormones diffuse continuously from a reservoir within the ring, first into vaginal tissues and then into the bloodstream. If necessary, the ring can be removed for up to three hours for comfort during sexual intercourse, for cleaning, or for any other reason. Rings come both as combined formulations - containing a progestin and an estrogen - and as progestin-only formulations.

NuvaRing releases 120 µg (micrograms) of the progestin etonogestrel and 15 µg of the estrogen ethinyl estradiol per day. Women use NuvaRing for three weeks, then remove it for one week, during which they have withdrawal bleeding. A new NuvaRing is needed for each four-week cycle. Thus a woman would require 13 rings per year; a single ring can last up to 35 days. While large studies have not examined continuous use of the vaginal ring, smaller studies suggest that women may be able to safely use combined vaginal rings consecutively for four weeks at a time, skipping the withdrawal bleeding. Studies on continuous use are underway.

Another ring, still in clinical trials, releases a combination of 150 µg of a different progestin, Nestorone®, and 15 µg of the estrogen ethinyl estradiol per day. The Population Council, with USAID support, is developing this ring specifically for use in developing countries. It will be effective for over 12 months, making it more cost-effective than NuvaRing. Users would keep the ring in place for three weeks, then remove it for the fourth week to allow a withdrawal bleed, and then reinsert the same ring for another three weeks. Early clinical trials have been promising (136), and phase III trials are planned to begin in 2005.

In general, bleeding problems are less frequent among users of combined vaginal rings than among users of combined oral contraceptives or of progestin-only rings. Breakthrough bleeding can occur, but this side effect is not common.

Other side effects occur about as often among users of combined rings as with combined oral contraceptions. In the pooled analysis of 2,322 women, the most commonly reported side effects were headache and vaginitis, each of which occurred among less than 6 percent of users. Less than 5 percent reported white vaginal discharge, vaginal discomfort, weight increase, nausea, mood changes, breast tenderness, uterine cramps, or acne.





PROGERING (PROGESTIN-ONLY RING)

Two Progestin-Only Rings: Two types of progestin-only rings are available or in development - Progering, a ring containing the natural hormone progesterone, and a ring yet to be named containing the synthetic progestin Nestorone. Progestin-only rings function mainly by thickening cervical mucus to prevent sperm penetration. They also have some effect on preventing ovulation and build-up of the endometrium.

While progestin-only rings are less effective overall than rings containing both a progestin and an estrogen, they are highly effective among breastfeeding women because breastfeeding itself provides some protection from pregnancy. Also, they may be more appropriate than combined rings for breastfeeding women because they do not contain estrogen, which could reduce milk production. The most common reason for discontinuation of progestin-only rings is weaning, as mothers choose more effective contraception after they stop breastfeeding. Bleeding disturbances, a common side effect of all progestin-only methods, is another frequent reason for discontinuation, but it is less likely to be noticed while a woman is breastfeeding.

Progesterone rings. Progesterone rings are highly effective at preventing pregnancy among lactating women, studies show - not significantly different from the IUD. Each ring releases 10 mg (milligrams) of progesterone daily and lasts for three months. Women can use these rings continuously for up to one year, after which effectiveness declines. Progering was registered and approved in Chile and Peru in 1998 for use by breastfeeding women. The Population Council, CONRAD, and the private company Silesia, funded its research and development.

In clinical trials women using the progesterone ring reported experiencing vaginal problems related to discharge, urinary discomfort, bleeding disturbances, and reproductive tract infection. In a Chilean study of breastfeeding women, less than 5 percent of users experienced any one of these side effects.

Nestorone rings. Nestorone rings, which also were developed by the Population Council, are similar to progesterone rings but rely on ST-1435, a more potent synthetic progestin that has unique properties. This ring will release 50, 75, or 100 µg of Nestorone per day.

The Population Council focused research on Nestorone after discovering that, when taken orally, it is rapidly metabolized and inactivated. This feature makes it particularly appropriate for use by breastfeeding women, because infants who ingest breast milk will not absorb the progestin in the breast milk, not even in the tiny and probably unimportant amounts that are ingested when other progestin-only methods are used.

Nestorone-releasing rings provide effective protection from pregnancy for lactating women for up to one year, even if weaning takes place earlier. Clinical trials on Nestorone rings have been suspended until the Population Council obtains more funding to continue them.





NuvaRing contraception ring


NUVARING® (ESTROGEN-PROGESTIN COMBO)

NuvaRing® (Etonogestrel-Ethinyl Estradiol) is a vaginal contraceptive ring manufactured by Organon USA Inc. NuvaRing is the first vaginal ring to be widely available. It releases a combined formula of a progestin and an estrogen. It was approved by the US FDA in 2001. It is a thin, flexible doughnut-like vaginal ring that contains two hormones - an estrogen and a progestin (2.7 mg ethinyl estradiol and 11.7 mg etonogestrel).

You insert the ring into the vagina yourself. Because it is not a barrier method, you do not need to place it exactly over the cervix. It releases hormones that keep you from getting pregnant. These hormones are the same ones used in most birth control pills. The ring is left in the vagina for 3 weeks. It does not have to be in a specific position in the vagina. After 3 weeks, you remove the ring, and your period will start. After 7 days, you insert a new ring.

Medication is absorbed directly into the blood stream through the vaginal wall membrane providing a consistent level of medication in the blood, which improves effectiveness and helps limit side effects. Oral contraceptives take time to be absorbed into the blood stream and this causes peaks and valleys in the hormone blood levels. If the ring is out of your vagina for more than 3 hours, it may not work effectively when you put it back in. To protect against pregnancy, you will need to use another form of birth control until the ring has been in all the time for 7 days in a row.

The estrogen and progestin hormones are similar to the natural hormones produced by the ovaries. The progestin component is absorbed in small amounts and prevents the ovary from releasing an egg (ovulation). The uterine lining also becomes thinner than usual, which would inhibit implantation of a fertilized egg. In addition, the cervical mucus also becomes thicker and this helps prevent sperm from entering the uterus. When properly placed, the ring is held in place by the vaginal muscle structure, even during exercise or intercourse. The NuvaRing® cannot "get lost" in the vagina. The vagina is flexible, but no longer than the palm of your hand. The cervix forms the back wall of the vagina so the ring remains in the vagina.

According to studies provided to the Food and Drug Administration (FDA) during the approval process, effectiveness ratings are listed at 99% when used according to label instructions. This is comparable to the patch and better than the Pill's effectiveness ratings. Non-fertility is easily reversible with ovulation returning quickly when use of the ring is discontinued and pregnancy is desired. However, women who have irregular menstrual cycles will probably return to the irregular cycle.

OTHER CONSIDERATIONS:

  • Provides a regular menstrual period, but menses are usually lighter and may be shorter than a normal period.


  • Thickened cervical mucus helps decrease the risk of pelvic inflammatory infections.


  • Reduces the chances of ovarian cysts and tubal pregnancy.


  • Vomiting and diarrhea should not interfere with the effectiveness of the ring.


  • Insertion and removal require that a woman insert her finger inside the vagina; therefore she must be comfortable touching her genitalia and vagina.


  • NuvaRing® does not offer any protection against transmission of sexually transmitted diseases (STDs), such as chlamydia, gonorrhea, syphilis, hepatitis or HIV. Condoms may be used with the ring to reduce the risk of STIs.


  • Disposal is easy - Keep the original foil package and when the ring is removed just place it back in the foil pack, seal and throw away.


  • NuvaRing® is non-absorbent, odorless, and contains no latex.


  • Do not breastfeed while using NuvaRing®.





  • ADVANTAGES

    The particular advantages of using CVRs are:
    • The Ring causes fewer hormonal ups and downs than most hormonal methods.
    • The user's ability to control initiation and discontinuation.
    • Their effectiveness (similar or slightly better than the pill).
    • Ease of use, negating the need to remember a daily routine. It is inserted and removed once a month.
    • Convenient, once-a-month dosing. You do not have to remember a pill each day, as with oral contraceptives.
    • The ring does not need to be fitted by a health care provider.
    • You can use it to control the timing and start of your periods. The good cycle control with the combined ring.
    • Does not require any interruption of sex play to protect against pregnancy.
    • The nearly constant release rate allowing for lower doses. This method uses less than half of the estrogen used in some birth control pills. Since the Ring releases a steady, consistent dose of hormones each month, it produces a lower incidence of headaches, nausea, breakthrough bleeding and breast tenderness then most oral contraceptives.





    DISADVANTAGES

    The particular disadvantages of CVRs are:
    • Cigarette smoking increases the risk of high blood pressure and heart disease; women who use combination hormonal contraceptives are strongly advised not to smoke.
    • The risk of getting blood clots may be greater with the type of progestin in NuvaRing® than with some other progestins in certain low-dose birth control pills.
    • NuvaRing® requires a prescription.
    • Vaginal insertion may be unpleasant for some women.
    • Headaches.
    • Increased vaginal irritation, discharge, or infection.
    • The ring may accidentally slip out during sex. Ring expulsion is not uncommon. Normally, the Ring stays in place. If it should fall out, follow the manufacturer's instructions for reinsertion. If it is out for longer than 3 hours, you will need to reinsert the Ring, and then use another form of birth control for the next 7 days.
    • You, or your partner may feel the ring during sex and may be unpleasant for some partners.
    • NuvaRing® does not protect you from HIV or other infections.





    PRECAUTIONS

    Before using this medication ring, tell your health care provider or pharmacist if you are allergic to ethinyl estradiol or etonogestrel; or to other estrogens or progestins; or if you have any other allergies.

    This medication should not be used if you have certain medical conditions. Before using this product, consult health care provider or pharmacist if you have:
    • History of stroke or other blood clots (e.g., in the legs, eyes, lungs).
    • Severe high blood pressure.
    • Abnormal breast exam.
    • Cancer (especially endometrial or breast cancer).
    • Diabetes that has caused kidney/eye/nerve/blood vessel disease.
    • Severe headaches.
    • History of heart disease (e.g., heart attack, chest pain), heart valve disease.
    • Kidney disease.
    • Liver problems (e.g., liver tumor, active liver disease).
    • Current or suspected pregnancy.
    • Recent major surgery.
    • Long periods of sitting or lying down (e.g., immobility such as being bedridden).
    • History of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills.
    • Unexplained vaginal bleeding.
    • Heavy tobacco use (especially if 35 or over).

    Before using this product, tell your health care provider your medical history, especially of:
    • Depression.
    • Tobacco Smoking.
    • A Blood Clot within the Blood Vessels of the Eye.
    • Metabolic Syndrome X.
    • Toxic Shock.
    • Breathing problems (e.g., asthma).
    • Worsening Headache Disorder.
    • Migraine headaches.
    • Long Period of being Bed-Ridden after Major Surgery.
    • Diabetes or Diabetes with Blood Vessel Disease.
    • High Blood Pressure.
    • Severe Uncontrolled High Blood Pressure.
    • Heart Attack.
    • Non-Q Wave Heart Attack.
    • Disease of the Arteries of the Heart.
    • Heart Valve Disease.
    • Stroke.
    • Any Disorder of the Blood Vessels of the Brain.
    • Obstruction of a Blood Vessel by a Blood Clot.
    • Blood Clot in Vein.
    • Blood Clot in a Deep Vein.
    • Liver Problems.
    • Disease of the Gallbladder or Gallbladder Problems.
    • Bleeding Not Related to Menstrual Period.
    • Jaundice associated with Pregnancy.
    • Pregnancy or Recent Pregnancy.
    • Benign Tumor of Liver Cells.
    • Liver Cancer.
    • Cancer of Epithelial Tissue in the Breast.
    • Cancer in the Lining of the Uterus.
    • Tumor that is Dependent on Estrogen for Growth.
    • Diabetes.
    • High Cholesterol.
    • High Amount of Triglyceride in the Blood.
    • Water (Fluid) Retention (edema).
    • Overweight (Obesity).
    • Allergies to estrogen and/or progestin compounds.
    • Irregular/missed/very light periods.
    • Thyroid problems.
    • Vaginal conditions (e.g., vaginal stenosis, cervical prolapse).

    Do not smoke cigarettes or use tobacco. Hormonal birth control (e.g., pills, injections, devices) combined with smoking cigarettes significantly increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. The risk of heart problems increases with age (especially in smokers over 35) and also with frequent smoking (15 or more cigarettes a day). For more details, ask your health care provider or pharmacist or consult the Patient Information Leaflet that comes with this product.

    If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your health care provider. Tell your health care provider the results and any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

    Notify your health care provider beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions.





    SIDE EFFECTS

    Side effects may be severe or mild and include:
    • Acute infection of the nose, throat or sinus.
    • Sinus irritation and congestion.
    • Inflammation, discomfort, irritation or infection of the vagina.
    • Increased discharge from the vagina.
    • Bleeding not related to menstrual period.
    • Nausea.
    • vomiting.
    • Headache.
    • Stomach cramping and/or bloating.
    • Dizziness.
    • Breast tenderness and/or enlargement may occur.
    • Weight gain.
    • Mood changes.

    Less Severe Side Effects:
    • Depression.
    • Migraine Headache.
    • Problems with Eyesight.
    • Protrusion of the Cornea of the Eye.
    • Yellowing of Skin or Eyes from Bile Flow Problems.
    • Breast Tenderness.
    • Breast Fullness due to Milk Production.
    • Fluid Secretion from the Breast.
    • Change in the Tissue Lining the Canal of the Cervix.
    • Absence of Menstrual Periods.
    • Irregular Periods.
    • Female Problems Causing Trouble in Getting Pregnant.
    • Deficiency of Milk Production.
    • Yellow-Brown Patches on Skin.
    • Rash.
    • Visible Water Retention.
    • Weight Loss.
    • Yeast Infection of Vagina and Vulva.
    • Throwing Up.
    • Bloating.
    • Stomach Cramps.

    Severe Side Effects:
    • A Blood Clot within the Blood Vessels of the Eye.
    • High Blood Pressure.
    • Heart Attack.
    • Blood Clot in Lung.
    • Hemorrhage in the Brain.
    • Blood Clot in the Brain.
    • Acute Blood Clot in an Artery.
    • Blood Clot in Vein (Severe).
    • Blood Clot Formation in Veins.
    • Disease of the Gallbladder.
    • Benign Tumor of Liver Cells.
    The estrogen component is responsible for many of the side effects that occur with all of the combined hormonal methods of birth control (ring, patch or pill). The ring has less estrogen than either the pill or the patch; therefore nausea, headaches and breast tenderness may occur less often or be less severe.

    The most common side effect is an increased amount of normal vaginal discharge. Occasionally women report an increased number of vaginal infections and irritation. Clinical studies show women using the ring experience an increased amount of lactobacillus in the vagina. Lactobacillus is a normal bacteria present in the vagina that actually helps decrease the incidence of yeast infections.

    Headaches may occur. These should be reported to your health care provider right away if the headache or accompanying symptoms (light sensitivity, nausea, vomiting, etc.) is more severe than you have experienced before, do not respond to over-the-counter medications or last more than one month.

    Mild nausea may occur with initial use, but usually will resolve within a few days. Rarely, vomiting may occur. If nausea lasts throughout the month or occurs persistently at the beginning of every ring cycle, report it to your health care provider. Vitamin B-6 (50 mg, 1-2 tablets daily) may help reduce nausea.

    Weight gain may occur, but is usually limited to a few pounds.

    Moodiness may occur within the first 1-2 months of use, but will usually diminish with continued use. Vitamin B-6 (50 mg, 1-2 tablets daily) may help decrease moodiness as well as relieve nausea. Notify your provider right away if severe depression symptoms occur.

    Occasionally spotting and mid-cycle bleeding may occur while the ring is in the vagina. The amount of bleeding is usually minimal and will normally be reduced as you continue use, but may occur from time to time for no apparent reason. This is a normal occurrence and does not indicate that it is not working as a contraceptive.

    Reactions to any method of birth control will vary from person to person. For some the reaction will be beneficial, but others may find them detrimental. For instance, acne may improve for some, but worsen for others; cramps usually improve, but occasionally a woman will experience increased cramps instead.




    GENERAL MEASURES


    INSTRUCTIONS FOR USE

    NuvaRing (Etonogestrel-Ethinyl Estradiol) is a vaginal contraceptive ring. It is a thin, flexible doughnut-like vaginal ring that contains two hormones - an estrogen and a progestin (2.7 mg ethinyl estradiol and 11.7 mg etonogestrel). You insert the ring into the vagina yourself. Because it is not a barrier method, you do not need to place it exactly over the cervix. It releases hormones that keep you from getting pregnant. These hormones are the same ones used in most birth control pills. The ring is left in the vagina for 3 weeks. It does not have to be in a specific position in the vagina. After 3 weeks, you remove the ring, and your period will start. After 7 days, you insert a new ring.

    If the ring is out of your vagina for more than 3 hours, it may not work effectively when you put it back in. To protect against pregnancy, you will need to use another form of birth control until the ring has been in all the time for 7 days in a row.

    The estrogen and progestin hormones are similar to the natural hormones produced by the ovaries. The progestin component is absorbed in small amounts and prevents the ovary from releasing an egg (ovulation). The uterine lining also becomes thinner than usual, which would inhibit implantation of a fertilized egg. In addition, the cervical mucus also becomes thicker and this helps prevent sperm from entering the uterus. When properly placed, the ring is held in place by the vaginal muscle structure, even during exercise or intercourse. The NuvaRing® cannot "get lost" in the vagina. The vagina is flexible, but no longer than the palm of your hand. The cervix forms the back wall of the vagina so the ring remains in the vagina.

    The implants are usually inserted during the first 7 days of a woman's menstrual cycle (ensuring she is not pregnant). However, they can be inserted anytime if pregnancy has been ruled out. Another form of birth control (non-hormonal) should be used for the remainder of the cycle.

    SWITCHING FROM OTHER BIRTH CONTROL METHODS:

    If you are starting NuvaRing® and HAVE NOT been using any other hormonal method of birth control (i.e. birth control pills or the patch): insert the ring between day one and five of your menses, even if you have not finished bleeding. Count the first day of your period as day one. You should use a condom during each act of intercourse for the first seven days during the first ring cycle.

    If you are switching from birth control pills to the NuvaRing®: Insert the ring at any time during the seven days immediately following your last active birth control pill. It may be easiest to insert the ring on the day that you would have normally started a new pill pack. There should never be more than seven days between the last active pill and insertion of the ring. The ring may be inserted even if there is still some bleeding. No back up birth control is needed.

    If you are switching from the patch to NuvaRing®: Insert the ring at any time during the seven days immediately following the removal of Patch #3. There should be no more than seven days between removing the patch and inserting the ring. The ring may be inserted even if there is still some bleeding. No back up birth control is needed.

    If you are switching from a progestin-only pill: Insert the NuvaRing® on any day of the month. Do not skip any days between your last pill and the first day of NuvaRing® use. Use a back-up method of birth control (condoms) for seven days.

    If switching from DepoProvera® to NuvaRing®: Insert NuvaRing® on the day your next injection is due. (12 weeks from previous injection plus or minus a week) Use a back up method of birth control (condoms) for seven days.

    If starting NuvaRing® after a first trimester abortion: Insert NuvaRing® within the first five days after the abortion. No back up birth control is needed. If not started within the first five days, wait until the next menstrual period starts and insert within the first five days of bleeding. During the first cycle, use a back up method of birth control for seven days.

    A patient information booklet will be provided for you to read prior to the implants being inserted. Be sure any questions or concerns you have are answered or explained.

    TO INSERT:

    The muscles in the vaginal wall keep NuvaRing ® in place. While in the vagina, it slowly releases low doses of the hormones progestin and estrogen. This prevents the ovaries from releasing an egg (ovulation).

    nuvaring positions for insertion


    The NuvaRing® may be inserted while standing, squatting or lying down.

    nuvaring pressing sides together for insertion


    Holding NuvaRing® and Pressing the Sides Together

    Using your thumb and index finger, press the sides of the ring together.


    nuvaring insertion into vagina


    Gently push it deep into the vagina.

    The exact position is not important. You should not be able to feel the ring when it is properly placed.



    TO REMOVE:

    To remove the ring, reach into the vagina using your index finger. Hook the tip of your finger around the ring and pull gently. The ring will naturally fold slightly as it is removed from the vagina.

    For more information, please visit the NuvaRing site, maintained by the manufacturer, Organon.

    www.nuvaring.com

    WHAT IF I FORGET TO REMOVE THE RING ON TIME?

    If NuvaRing® remains in the vagina for 1-7 extra days, remove it and re-insert a new ring after a one-week break. You will still have contraceptive protection during the extra week and during your period. Do not leave the ring out more than seven consecutive days.

    If it remains in place longer than four weeks, you may not have adequate protection against pregnancy. Remove the ring, take a one-week break and reinsert. Use a condom for back-up birth control until one week after the ring is re-inserted. If you do not have a menstrual cycle in three weeks, when you remove the re-inserted NuvaRing® you should do a home pregnancy test.

    VAGINAL MEDICATIONS & LUBRICANTS

    You may use vaginal medications or water-based lubricants while the NuvaRing® is in place in the vagina. There will be no decrease in the contraceptive benefit.

    RING SLIPS OR FALLS OUT

    If for any reason, the ring is removed or slips out, it may be rinsed in cool water and reinserted. If it is out for three hours or more, there will be reduced contraceptive protection and an alternative method of birth control must be used until the ring has been in place for seven consecutive days. Emergency contraception is available if it is out three hours or longer.

    If the ring is lost, reinsert a new ring and use it following the original insertion/removal schedule. If the ring is out of place for more than three hours, you must use condoms as a back up birth control method for seven days. You may also wish to consider using Plan B Emergency Contraception. If you are having problems with the ring slipping out of place frequently, talk with your health care provider.

    RING STORAGE

    Unopened NuvaRing® packs will expire in four months unless stored in the refrigerator. (Refer to the package insert for additional information or talk with the pharmacist.)

    If unopened NuvaRing® packs are stored in temperatures greater than 86°F the effectiveness may be lessened.

    WHEN DO I REMOVE THE NuvaRing®?

    Remove the ring three weeks after insertion, at approximately the same time of day, if possible. Place it in the foil envelope in which it was originally packaged and throw away. Contraceptive protection continues throughout the ring-free week.

    You should expect your period during the ring-free week. Occasionally, due to the low dose of hormones used in the ring, you may experience a "missed" period (the absence of bleeding during the ring-free week). If this occurs, and the ring has been used properly, following all instructions, re-insert the ring as scheduled. For reassurance you may do a pregnancy test if you wish. If you miss two periods in a row, you should talk with your health care provider.

    Seven days after removing the old ring, insert a new one. It is recommended that you insert and remove it at the same time of day each month. For example if you insert the first ring at 7 a.m. Sunday morning, it should be removed at approximately 7a.m. Sunday three weeks later and reinserted on the following Sunday at approximately the same time. The ring may be inserted sooner than this time if it is more convenient. It should not be inserted later than seven days.

    MISSED DOSE:

    If this product is out of the vagina for more than 3 hours, or if you forget to insert or remove this product at the recommended time, read the Patient Information Leaflet or consult your health care provider or pharmacist to establish a new dosing schedule. If the hormone ring has been removed for longer than 3 hours, using a back-up method of birth control for 7 days is recommended. See the How to Use section. Consult your doctor or pharmacist for more information.

    If you have trouble remembering to remove and reinsert the ring as directed, or if it falls out repeatedly, contact your health care provider or midwife to discuss switching to another form of birth control.

    STORAGE: Pharmacist: Prior to dispensing, store in the refrigerator between 36-46°F (2-8°C). Do not freeze.

    Patient: Store at room temperature at 77°F (25°C) away from light and moisture for up to 4 months. Brief storage up to 59-86°F (15-30°C) is permitted. Do not use after the expiration date. Do not store in the bathroom. Keep all medicines away from children and pets.





    MEDICATIONS & INTERACTIONS

    This product should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your health care provider or midwife immediately. If you have just given birth and are not breastfeeding, or if you have had a pregnancy loss or abortion after the first trimester, wait at least 4 weeks before starting the ring. Talk with your health care provider or midwife about other forms of birth control and to find out when it is safe to start using the ring.

    The medication from this ring passes into breast milk. This may affect how much milk you make and may also have undesirable effects on the nursing infant. Breastfeeding is not recommended while using this product. Consult your health care provider or midwife before breastfeeding.

    The drugs in this ring may cause blotchy, dark areas on your skin (melasma). Sunlight may intensify this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.

    Your health care professionals (e.g., health care provider or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

    This drug should not be used with the following medications because very serious interactions may occur: aromatase inhibitors (e.g., anastrazole, exemestane), sodium tetradecyl sulfate, troleandomycin.

    If you are currently using any of these medications listed above, tell your health care provider or pharmacist before starting this medication.

    Before taking this medication, tell your health care provider of all prescription and non-prescription medications you may use, especially of: raloxifene, tamoxifen, medication for under-active thyroid (hypothyroidism), drugs that may increase blood levels of this drug such as acetaminophen, ascorbic acid (vitamin C), atorvastatin, azole antifungals such as itraconazole/ketoconazole/vaginal miconazole.

    Certain drugs can decrease the effectiveness of combination-type birth control by decreasing the amount of birth control hormones in your system. This can result in pregnancy. These drugs include: many antibiotics (e.g., cephalosporins, chloramphenicol, macrolides such as erythromycin, penicillins, sulfas), aprepitant, bexarotene, bosentan, dapsone, felbamate, griseofulvin, certain HIV protease inhibitors (e.g., amprenavir, nelfinavir, ritonavir), modafinil, nevirapine, phenylbutazone, rifamycins (e.g., rifampin), many seizure medications (e.g., barbiturates, carbamazepine, phenytoin, lamotrigine, topiramate), St. John's wort. Consult your health care provider or pharmacist for details, and ask them if you should use additional reliable birth control methods while taking any of the drugs mentioned above.

    This drug can speed up or slow down the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include acetaminophen, aspirin, clofibrate, cyclosporine, morphine, corticosteroids such as prednisolone, certain benzodiazepines such as lorazepam/temazepam, and theophylline, among others. If you are currently using any of these medications listed above, tell your health care provider or pharmacist before starting this medication.

    This medication can affect the results of certain lab tests (e.g., blood tests for clotting factors, thyroid). Make sure laboratory personnel and all your health care providers know you use this medication.

    The NuvaRing Vaginal Ring may interact with the following medications -

    Severe Interactions: These medications are not usually taken together. Consult your health care provider or pharmacist) for more information:
    • Hormonal Contraceptive Agents - Nevirapine.
    • Contraceptives - Amprenavir.
    • Contraceptives - Sodium Tetradecyl Sulfate.

    Serious Interactions: These medications may interact and cause very harmful effects. Consult your health care provider or pharmacist) for more information:
    • Estrogens Contraceptives - Rifamycins.
    • Contraceptives - Penicillins.
    • Contraceptives - Tetracyclines.
    • Contraceptives - Troleandomycin.
    • Contraceptives - Griseofulvin.
    • Contraceptives - Carbamazepine.
    • Estrogen Contraceptives - St. John's Wort.
    • Hormonal Contraceptive Agents - Bosentan.
    • Contraceptives - Selected Protease Inhibitors.
    • Contraceptives - Troglitazone.
    • Contraceptives - Anticonvulsants.

    Moderate Interactions: These medications may cause some risk when taken together. Consult your health care provider or pharmacist for more information:
    • Contraceptives - Theophyllines.
    • Steroidal Contraceptives - Aprepitant.
    • Hormonal Contraceptives - Lamotrigine.
    • Estrogens - Barbiturates.
    • Estrogens - Hydantoins.
    • Steroidal Contraceptives - Modafinil.
    • Oral Estrogen Contraceptives - Corticosteroids.

    This product may be harmful if swallowed. Overdose with this product is highly unlikely. Do not use more than one ring at a time. If overdose or swallowing is suspected, remove the ring if possible and contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

    NOTES: Do not share this product with others.

    Keep all laboratory and medical appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your health care provider's instructions for examining your own breasts, and report any lumps immediately. Consult your health care provider for more details.




    NOTIFY YOUR MIDWIFE OR HEALTH CARE PROVIDER IF...

    If any of these effects persist or worsen, notify your health care provider promptly.
    • Bleeding not related to menstrual period.


    • Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If you miss 2 periods in a row (or 1 period if the ring has not been used properly), contact your health care provider for a pregnancy test.

    Remember that your health care provider has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

    Tell your health care provider immediately if any of these serious side effects occur:
    • Changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods).


    • Problem wearing contact lenses.


    • Dark patches on the skin (melasma).


    • Swelling of the ankles and/or feet.


    • Weight changes (gain or loss).

    This medication may rarely cause serious (sometimes fatal) blood clot-related problems (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience:
    • Sudden shortness of breath.
    • Chest/jaw/left arm pain.
    • Confusion.
    • Coughing up blood.
    • Sudden dizziness/fainting.
    • Pain/swelling/warmth in the groin/calf.
    • Tingling/weakness/numbness in the arms/legs.
    • Headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches).
    • Slurred speech.
    • Weakness on one side of the body.
    • Vision problems or changes in visions. If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye care practitioner if these problems occur.

    Tell your health care provider immediately if any of these highly unlikely but very serious side effects occur:
    • Lumps in the breast.
    • Severe stomach/abdominal/pelvic pain.
    • Mental and/or mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping).
    • Unusual tiredness.
    • Dark urine.
    • Yellowing eyes and/or skin.

    A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.

    If you notice other effects not listed above, contact your health care provider or pharmacist.





    MOONDRAGON'S RELATED LINKS

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