Medication Guide App

Contraceptives, Vaginal Ring (Combination Product)

Pronunciation: CON-tra-CEP-tives, VAG-i-nal RING
Class: Hormonal Contraceptive

Trade Names

NuvaRing
- Ring, vaginal etonogestrel 11.7 mg/ethinyl estradiol 2.7 mg

Pharmacology

Inhibits ovulation by suppressing gonadotropins; alters cervical mucus, which increases the difficulty of sperm entry into the uterus; and alters the endometrium, which reduces the likelihood of implantation.

Indications and Usage

Prevention of pregnancy.

Contraindications

Thrombophlebitis; thromboembolic disorders; history of deep vein thrombophlebitis; history of thromboembolic disorders; past or current history of cerebral vascular disease; past or current history of coronary artery disease; valvular heart disease with thrombogenic complications; severe hypertension; diabetes with vascular involvement; headaches with focal neurological symptoms; major surgery with prolonged immobilization; known or suspected carcinoma of the breast; personal history of breast cancer; carcinoma of the endometrium; known or suspected estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy; jaundice with prior hormonal contraceptive use; benign or malignant hepatic tumors; active liver disease; known or suspected pregnancy; smoking at least 15 cigarettes per day and older than 35 yr of age; hypersensitivity to any component of the product.

Dosage and Administration

Adults

Intravaginal 1 ring is inserted into the vagina and is to remain in place continuously for 3 wk. Remove the ring for a 1-wk break. A new ring is inserted 1 wk after the last ring is removed.

General Advice

  • The vaginal ring is to be compressed and inserted into the vagina. The exact position of the ring inside the vagina is not critical for its function.
  • The vaginal ring may be removed by hooking the index finger under the forward rim or grasping the rim between the index and middle fingers and pulling it out.
  • The used vaginal ring should be placed in the provided foil pouch and discarded in a waste receptacle, not flushed into the toilet.
  • Withdrawal bleeding usually occurs 2 to 3 days after removal of the vaginal ring and may not finish before inserting the next ring.
  • To maintain contraceptive effectiveness, the new vaginal ring must be inserted 1 wk after the previous ring was removed, even if menstrual bleeding has not finished.
  • Insert the vaginal ring on the first day of the natural cycle (ie, the first day of menstrual bleeding). The ring may also be inserted on days 2 to 5 of the cycle, but in that case a barrier method (eg, male condom, spermicide) is recommended for the first 7 days in the first cycle of use of the vaginal ring.
  • A woman may switch from her previous combined hormonal contraceptive on any day, but at the latest on the day following the usual hormone-free interval, if she has been using a hormonal method consistently and correctly, or if it is reasonably certain that she is not pregnant.
  • A woman may switch on any day from the minipill. An additional barrier method (eg, male condom, spermicide) should be used for the first 7 days.
  • A woman should switch from an implant or intrauterine system on the day of its removal and from an injectable on the day when the next injection would be due. An additional barrier method (eg, male condom, spermicide) should be used for the first 7 days.
  • A woman may start using the vaginal ring within the first 5 days following a complete first trimester abortion and does not need to use an additional method of contraception. If use is not started within 5 days following a first trimester abortion, insert the ring on the first day of the natural cycle (ie, the first day of menstrual bleeding). The ring may also be inserted on days 2 to 5 of the cycle, but in that case a barrier method (eg, male condom, spermicide) is recommended for the first 7 days in the first cycle of use of the ring.
  • Use of the vaginal ring may be initiated 4 wk postpartum in women who elect not to breast-feed. Advise women who are breast-feeding not to use the ring but to use other forms of contraception until the child is weaned. When the ring is used postpartum, the risk of thromboembolic disease may be increased. If use of the ring begins postpartum, an additional method of contraception (eg, male condom, spermicide) should be used for the first 7 days. If the woman has not had a period, consider the possibility of ovulation and conception occurring prior to initiation of the ring use.
  • Vaginal ring use may be initiated 4 wk after a second trimester abortion. However, the risk of thromboembolic disease may be increased.
  • To prevent loss of efficacy, women should not deviate from the recommended regimen.
  • If the vaginal ring is accidentally expelled and is left outside the vagina for less than 3 h, contraceptive efficacy is not reduced. The ring can be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible, but at the latest within 3 h. If the ring is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration. If the ring-free interval has been extended beyond 1 wk, the possibility of pregnancy should be considered, and an additional method of contraception (eg, male condom, spermicide) must be used until the ring has been used continuously for 7 days.
  • If the vaginal ring has been left in place for up to 1 extra week (ie, up to 4 wk total), the woman will remain protected. The ring should be removed and a new ring should be inserted after a 1-wk ring-free interval. If the vaginal ring has been left in place for longer than 4 wk, pregnancy should be ruled out, and an additional method of contraception (eg, male condom, spermicide) must be used until a new vaginal ring has been used continuously for 7 days.
  • If the vaginal ring has been out of the vagina for more than 3 h or the preceding ring-free interval has extended beyond 1 wk, the possibility of pregnancy should be considered at the time of the first missed period and use of the vaginal ring should be discontinued if pregnancy is confirmed.
  • If the prescribed regimen is adhered to and 2 consecutive periods are missed, pregnancy should be ruled out.
  • If a vaginal ring has been retained for longer than 4 wk, pregnancy should be ruled out.

Storage/Stability

Store under refrigeration at 36° to 46°F. After dispensing, store for up to 4 mo at 59° to 86°F. Avoid storing in direct sunlight or at temperatures above 86°F.

Drug Interactions

Acetaminophen, ascorbic acid, atorvastatin, itraconazole, ketoconazole

Ethinyl estradiol concentrations may be elevated, increasing the risk of adverse reactions.

Acetaminophen, clofibric acid, lamotrigine, morphine, salicylic acid, temazepam, valproic acid

Plasma concentrations of these agents may be reduced, decreasing their effectiveness.

Barbiturates (eg, phenobarbital, primidone), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, oxcarbazepine, penicillin, protease inhibitors (eg, nelfinavir, ritonavir), rifampin, St. John's wort, tetracyclines, topiramate, troglitazone

Hormonal contraceptive effectiveness may be decreased. Use an additional, nonhormonal form of birth control during concomitant therapy.

Benzodiazepines, caffeine, corticosteroids, cyclosporine, metoprolol, prednisolone, selegiline, theophylline, tricyclic antidepressants

Plasma concentrations of these agents may be elevated, increasing the risk of adverse reactions.

Miconazole vaginal

Ethinyl estradiol and etonogestrel concentrations may be elevated, increasing the risk of adverse reactions.

Laboratory Test Interactions

Increased

Increased APTT, platelet aggregation time, and PT; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulation activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta thromboglobulin; increased levels of fibrinogen activity; increased plasminogen antigen and activity, increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine; increased corticosteroid binding globulin; increased angiotensinogen/renin substrate, alpha-1 antitrypsin, ceruloplasmin; increased TG and levels of various other lipids and lipoproteins may be affected; increased sulfobromophthalein retention.

Decreased

Decreased levels of anti-factor Xa and antithrombin III; decreased antithrombin III activity; T3 resin uptake is decreased, reflecting elevated TBG; reduced response to metyrapone test; reduced serum folate concentration.

Adverse Reactions

Cardiovascular

Hypertension, MI.

CNS

Headache (5% to 14%); cerebral hemorrhage, cerebral thrombosis.

EENT

Retinal thrombosis.

Endocrine

Weight gain (5% to 14%).

GI

Nausea (5% to 14%); mesenteric thrombosis.

Genitourinary

Vaginal secretion, vaginitis (5% to 14%).

Hepatic

Benign liver tumors, gallbladder disease; hepatic adenomas.

Hematologic-Lymphatic

Arterial thromboembolism, thrombophlebitis, venous thrombosis.

Respiratory

Sinusitis, upper respiratory tract infection (5% to 14%); pulmonary embolism.

Precautions

Warnings

Smoking: Cigarette smoking increases the risk of serious CV adverse reactions. The risk increases with age (ie, older than 35 yr of age) and smoking at least 15 cigarettes/day. Smoking is not recommended during combination hormonal contraceptive therapy.


Monitor

Monitor blood glucose in women with diabetes. Perform routine annual medical evaluation, including physical examination and relevant laboratory tests. Closely monitor women being treated for hyperlipemia. Carefully monitor women with conditions that may be aggravated by fluid retention.


Pregnancy

Category X .

Lactation

Undetermined; however, contraceptive steroids are excreted in breast milk.

Children

Safety and efficacy are expected to be the same for postpubertal adolescents younger than 16 yr of age and for users 16 yr of age and older. Use before menarche is not indicated.

Elderly

Use of this product has not been studied in women older than 65 yr of age and is not indicated in elderly patients.

Special Risk Patients

Use with caution in women with CV disease risk factors.

Bleeding irregularities

Breakthrough bleeding and spotting may occur.

Blood pressure

Encourage women with hypertension or hypertension-related diseases to use another nonhormonal method of contraception.

Carbohydrate and lipid metabolism

Glucose tolerance may be decreased. Changes in serum triglycerides and lipoprotein levels have been reported.

Depression

Use with caution in women with a history of depression.

Disconnected ring

Disconnection of the ring at the weld joint has been reported. This does not affect the contraceptive effectiveness, but expulsion and vaginal discomfort are more likely to occur.

Ectopic pregnancy

Ectopic or intrauterine pregnancy may occur in contraceptive failure.

Expulsion

Accidental expulsion (eg, while removing a tampon, during intercourse, straining during bowel movement) has occurred.

Fluid retention

May occur. Use with caution in women with conditions that may be aggravated by fluid retention.

Gallbladder disease

Existing gallbladder disease may be worsened or development of this condition may be accelerated in previously asymptomatic women.

Headache

The contraceptive vaginal ring should be discontinued in women if there is exacerbation of migraine or development of headache with a new pattern that is recurrent, persistent, or severe.

Liver dysfunction

Hormonal contraceptive metabolism may be impaired.

Oral contraceptives as a risk factor

Risk of carcinoma of the reproductive organs and breasts, CV disease, cerebrovascular diseases, hepatic neoplasm, MI, ocular lesions (including retinal thrombosis), and thromboembolic and thrombotic disease are increased in oral contraceptive users. It is not known whether contraceptive vaginal rings are distinct from oral contraceptives with regard to the above risks. Consider the possibility.

Tampon use

Contraceptive vaginal ring may be expelled while removing a tampon.

Toxic shock syndrome

Toxic shock syndrome (TSS) has occurred in association with use of tampons and certain barrier contraceptives. Although a causal association has not been established, TSS has been reported in women using a contraceptive vaginal ring; some women were also using tampons.

Urinary bladder insertion

Inadvertent insertions of this product into the urinary bladder have been reported.

Vaginal use

Vaginal/cervical erosion or ulceration has been reported. This product may not be suitable for women with conditions that cause the vagina to be more susceptible to vaginal irritation or ulceration.

Overdosage

Symptoms

It is unlikely that overdosage will occur with contraceptive vaginal rings. Hormonal contraceptive overdose has caused nausea, menstrual irregularities, vaginal bleeding, and vomiting.

Patient Information

  • Advise women that this product does not protect against HIV infection or other STDs.
  • Advise women to contact health care provider if they experience any of the following symptoms: breast lumps; crushing chest pain or heaviness in the chest; coughing blood; dark-colored urine or light-colored bowel movements; difficulty sleeping, weakness, lack of energy, fatigue, or a change in mood; dizziness or fainting; irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than a few days; pain in calf; loss of appetite; problems with vision or speech; sharp chest pain; severe pain, swelling, or tenderness in the abdomen; sudden fever, vomiting, diarrhea, dizziness, fainting, or sunburn-like rash on the face or body; sudden shortness of breath; weakness or numbness in arm or leg; sudden partial or complete loss of vision; sudden severe headache or vomiting; swelling of the fingers or ankles; tiredness; yellowing of the skin or whites of the eyes, especially with fever.
  • Instruct women that if the ring is accidentally expelled and is left outside the vagina for less than 3 h, contraceptive efficacy is not reduced. The ring can be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible, but at the latest within 3 h. If the ring is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration. If the ring-free interval has been extended beyond 1 wk, the possibility of pregnancy should be considered, and an additional method of contraception (eg, male condoms, spermicide) must be used until the ring has been used continuously for 7 days.
  • Inform women that if the vaginal ring has been left in place for up to 1 extra week (ie, up to 4 wk total), she will remain protected. The ring should be removed and a new ring should be inserted after a 1-wk ring-free interval. If the ring has been left in place for longer than 4 wk, pregnancy should be ruled out, and an additional method of contraception (eg, male condoms, spermicide) must be used until a new vaginal ring has been used continuously for 7 days.
  • Inform women that if the ring has been out of the vagina for more than 3 h or the preceding ring-free interval has extended beyond 1 wk, to consider the possibility of pregnancy at the time of the first missed period and to discontinue use of the vaginal ring if pregnancy is confirmed.

Copyright © 2009 Wolters Kluwer Health.

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