What is NuvaRing (Etonogestrel, Ethinyl Estradiol Vaginal Ring)? What Is It Used For?

What is NuvaRing?

NuvaRing is a prescription medicine used to treat the symptoms of endometrial hyperplasia and the symptoms of secondary amenorrhea (menstrual or amenorrhea). It belongs to a class of drugs called progestins. NuvaRing can be used alone or in combination with other medications. It is not known if NuvaRing is safe and effective in children.

What Are the Possible Side Effects of Nuvaring?

NuvaRing can cause serious side effects, including:

  • sudden numbness or weakness (especially on one side of the body), tiredness
  • sudden severe headache
  • speech disorder
  • problems with vision or balance, mood changes, thoughts of harming yourself
  • sudden vision loss
  • stabbing chest pain, shortness of breath, coughing up blood
  • pain radiating to the jaw or shoulder
  • nausea, vomiting, diarrhea, loss of appetite
  • sweating, sudden fever, skin rash
  • dizziness, upper abdominal pain, dark urine, jaundice

If you have any of the symptoms listed above, seek medical attention immediately.

WARNING

* FOR VAGINAL USE ONLY.

Smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, especially in women over 35 and the number of cigarettes smoked. For this reason, Decrees, including NuvaRing, should not be used by women over 35 and smokers.

What are the indications?

NuvaRing is indicated for use by women of reproductive age to prevent pregnancy.

What are the Usage Suggestions?

To achieve maximum contraceptive effectiveness, NuvaRing should be used as directed. A NuvaRing is inserted into the vagina. The ring should remain in place continuously for three weeks. It is usually removed for a one-week break during which menstrual bleeding occurs. A new ring is inserted one week after the last ring is removed.

The user can choose the most comfortable docking position for him. The ring should be compressed and inserted into the vagina. An optional alternative is to insert the ring using the NuvaRing applicator. The exact position of the NuvaRing inside the vagina is not critical to its function. The vaginal ring should be inserted on the appropriate day and left in place for three consecutive weeks. This means that the ring should be removed three weeks later on the same day of the week and at approximately the same time it was fitted.

The NuvaRing can be removed by hooking the index finger under the front edge or by holding it between the index and middle finger and pulling it out. The used ring should be placed in a bag (foil bag) and disposed of in a bin out of the reach of children and pets.

What are the Storage Conditions?

NuvaRing should be refrigerated and stored at 2-8°C (36-46°F) prior to administration to the user. After administration to the user, the NuvaRing can be stored at 25°C (77°F) for up to 4 months; can be found outside up to 15-30°C (59-86°F). NuvaRing should be discarded if the expiration date on the label has passed. Direct sunlight should be avoided. Used NuvaRing should be placed in a resealable foil bag and disposed of properly out of reach of children and pets.

Warnings and Precautions

Thromboembolic Disorders and Other Vascular Problems: Use of NuvaRing should be discontinued if an arterial thrombotic or venous thromboembolic event (VTE) occurs. If there is unexplained vision loss, proptosis, diplopia, papilledema, or retinal vascular lesions, NuvaRing should be discontinued and retinal vein thrombosis evaluated. If possible, NuvaRing should be stopped at least four weeks before and two weeks after major surgery or other surgeries known to have a high risk of thromboembolism, and during and after prolonged immobilization. In non-breastfeeding women, NuvaRing should be started no later than 4 weeks after delivery.

Toxic Shock Syndrome (TSS): Cases of TSS have been reported by NuvaRing users. TSS has been associated with tampons and certain barrier contraceptives, and in some cases NuvaRing users also use tampons. A causal relationship between the use of NuvaRing and TSS has not been established. If a patient exhibits signs or symptoms of TSS, this possibility of diagnosis should be considered and appropriate medical evaluation and treatment instituted.

Impaired Liver Function: NuvaRing should not be used in women with liver disease such as acute viral hepatitis or severe (decompensated) liver cirrhosis. Acute or chronic disorders of liver function may require discontinuation of CHC use until liver function markers return to normal and CHC causation is removed. NuvaRing should be discontinued if jaundice develops. NuvaRing is contraindicated in women with benign and malignant liver tumors. Liver adenomas are associated with the use of COCs. Rupture of liver adenomas can cause death through intra-abdominal bleeding.

Risk of Liver Enzyme Elevation with Concomitant Hepatitis C Treatment: In clinical studies with the Hepatitis C combination drug regimen containing ombitasvir / paritaprevir / ritonavir with and without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN) were significantly greater than 20 times the ULN, including some cases. level has been. NuvaRing should be discontinued before starting treatment with the combination drug regimen ombitasvir / paritaprevir / ritonavir with or without dasabuvir. NuvaRing can be restarted approximately 2 weeks after completion of treatment with the Hepatitis C combination drug regimen.

Hypertension: NuvaRing is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease. For women with well-controlled hypertension, blood pressure should be monitored and use of NuvaRing should be discontinued if blood pressure rises significantly.

Vaginal Use: NuvaRing may not be suitable for women with conditions that make the vagina more susceptible to irritation or ulceration. There have been reports of vaginal/cervical erosions or ulcers in women using NuvaRing. In some cases, the ring has stuck to the vaginal tissue and required removal by a healthcare provider. Some women are aware of the ring from time to time during 21 days of use or during sexual intercourse, and sexual partners may feel NuvaRing in the vagina.

Carbohydrate and Lipid Metabolic Effects: Prediabetic and diabetic women using NuvaRing should be carefully monitored. CHCs can reduce glucose tolerance. An alternative method of contraception should be considered for women with uncontrolled dyslipidemia. Some women will have adverse lipid changes on COCs. Women with hypertriglyceridemia or a family history of it may be at increased risk of pancreatitis while using a CHC.

Headache: If a woman using NuvaRing develops new headaches that are recurrent, persistent, or severe, the cause should be evaluated and NuvaRing discontinued if indicated. Discontinuation of NuvaRing should be considered if there is an increase in migraine frequency or severity during the use of COCs.

Bleeding Irregularities and Amenorrhea: Unplanned bleeding and spotting may occur in women using COCs, especially during the first three months of use. If bleeding continues or occurs after previous regular cycles, causes such as pregnancy or malignancy should be checked. If there is no planned menstruation, the possibility of pregnancy should be considered. If the patient did not comply with the prescribed dosing schedule, the possibility of pregnancy during the first missed period should be considered and appropriate diagnostic measures taken. If the patient adheres to the prescribed regimen and misses two consecutive periods, pregnancy is unlikely.

Accidental Bladder Placement: There have been reports of inadvertent insertion of the NuvaRing into the bladder, which required cystoscopic removal. Ring placement in the bladder should be considered in NuvaRing users who present with persistent urinary symptoms and cannot find the ring.

Depression: Women with a history of depression should be carefully observed and NuvaRing should be discontinued if depression recurs to a severe degree.

Breast and Cervical Carcinoma: NuvaRing is contraindicated in women who already have or have had breast cancer, as breast cancer is a hormonally sensitive tumor.

Tracing: A woman using the NuvaRing should make an annual visit to her healthcare provider for blood pressure control and other health care as indicated.

Chloasma: Chloasma can sometimes occur, especially in women with a history of chloasma gravidarum. Women who are prone to chloasma should avoid exposure to the sun or ultraviolet radiation while using NuvaRing.

Pregnancy: NuvaRing is contraindicated during pregnancy because there is no need to prevent pregnancy in a woman who is already pregnant. Epidemiological studies and meta-analyses have not demonstrated an increased risk of genital or non-genital birth defects following maternal exposure to low-dose COCs before conception or during early pregnancy. If pregnancy is confirmed, use of NuvaRing should be discontinued.

Breastfeeding Period: Small amounts of contraceptive steroids and/or metabolites, including etonogestrel and ethinyl estradiol, are transferred into breast milk. No harmful effects have been observed in breastfed infants exposed to COCs through breast milk. CHCs can reduce milk production in nursing mothers. This is less likely once breastfeeding is well established; however, it can occur at any time in some women. If possible, the nursing mother should be advised to use estrogen-free contraception until she has completely weaned her child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NuvaRing and any potential adverse effects on the breastfed child from NuvaRing or the underlying maternal condition.

Pediatric Use: The safety and efficacy of NuvaRing have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under 18 and users aged 18 and over. This product is not indicated for use before menarche.

Geriatric Use: NuvaRing has not been studied in postmenopausal women and is not indicated in this population.

What Conditions Does Overdose Cause?

Serious side effects from overdose of COCs have not been reported. Overdose can cause non-menstrual bleeding and nausea in women. If the ring is broken, it will not release a higher dose of hormone. If overdose is suspected, all NuvaRing rings should be removed and symptomatic treatment instituted.

What are the contraindications?

NuvaRing should not be prescribed to women known to have or use:

  • High risk of arterial or venous thrombotic disease
  • History of deep vein thrombosis or pulmonary embolism
  • cerebrovascular disease
  • coronary artery disease
  • Thrombogenic valve or thrombogenic rhythm diseases in the heart
  • Hereditary or acquired hypercoagulopathies
  • uncontrollable hypertension
  • Vascular disease with diabetes mellitus
  • Headache with focal neurological symptoms or migraine
  • Liver tumors or liver disease
  • Undiagnosed abnormal uterine bleeding
  • Pregnancy
  • breast cancer history
  • Hypersensitivity to any component of NuvaRing
  • Use of hepatitis C drug combinations containing ombitasvir / paritaprevir / ritonavir with or without dasabuvir due to the potential for ALT elevations

Movement Mechanism

Combined hormonal contraceptives act by suppressing gonadotropins. Although the primary effect of this action is to inhibit ovulation, other changes include changes in the cervical mucus and endometrium. Etonogestrel and ethinyl estradiol released by NuvaRing are rapidly absorbed. The bioavailability of etonogestrel after vaginal administration is about 100% and that of ethinyl estradiol after vaginal administration is about 56%. Etonogestrel and ethinyl estradiol are eliminated mainly in urine, bile and faeces.

The use of tampons had no effect on etonogestrel and ethinyl estradiol concentrations during NuvaRing use.

Necessary Information for Safe and Effective Use

Medications are sometimes prescribed for purposes other than those listed in the patient information leaflet. NuvaRing should not be used or given to others for a condition for which it was not prescribed.

Source: Nuvaring (Etonogestrel, Ethinyl Estradiol Vaginal Ring) Drug, 2020

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