NUVARING VAGINAL RING 1PC @

Indications

Approved Uses

Prevention of pregnancy in females of reproductive potential

Dosage & Administration

Dosing by Condition

Contraception: Insert 1 ring vaginally and leave in place for 3 continuous weeks, then remove for a 1‑week (7‑day) ring‑free interval; insert a new ring after the interval (ring‑free interval should not exceed 7 days).

Initial Dose

One vaginal ring inserted on or before Day 5 of menstrual cycle (or as directed based on prior contraceptive method)

Maintenance Dose

One ring per 4-week cycle: 3 weeks in, 1 week out

Maximum Dose

One ring per cycle: insert 1 ring for 3 weeks, remove for 1 week; do not leave the same ring in place for more than 4 weeks continuously.

Children's Dosage

Not approved for use before menarche; not applicable in prepubertal females

Dose Adjustment Notes

No dose adjustment is recommended for renal impairment; avoid use in hepatic disease-contraindicated in severe hepatic impairment and in liver tumors.

How to Take

Compress the ring and insert into the vagina; exact position is not critical. Leave in place continuously for 3 weeks (21 days), then remove for a 7‑day ring‑free interval and insert a new ring on the same day of the week/time. To remove, hook a finger under the rim and pull out; dispose in the foil pouch/trash (do not flush).

Side Effects

Common Side Effects

Common adverse effects include vaginal discharge/vaginitis, headache (including migraine), nausea/vomiting, breast tenderness/pain, abdominal pain, dysmenorrhea, acne, mood changes (including depression), decreased libido, breakthrough bleeding/spotting, and device-related events (foreign body sensation/discomfort, expulsion).

Side Effect Frequency

Common adverse reactions (≥2% in clinical trials) include: vaginitis, headache, mood changes, device-related events (e.g., expulsion/foreign body sensation), nausea/vomiting, vaginal discharge, increased weight, vaginal discomfort, breast pain/tenderness, dysmenorrhea, abdominal pain, acne, and decreased libido; serious but rare risks include venous thromboembolism and other arterial/venous events.

Safety & Warnings

Contraindications

Contraindicated in: high risk/history of arterial or venous thromboembolism (DVT/PE, stroke, MI) or known thrombophilia; migraine with aura; breast cancer/estrogen- or progestin-sensitive malignancy; liver tumors or severe hepatic disease; uncontrolled hypertension; diabetes with vascular disease; undiagnosed abnormal uterine bleeding; pregnancy; hypersensitivity; women >35 who smoke; and concomitant use with HCV regimens containing ombitasvir/paritaprevir/ritonavir (± dasabuvir) due to ALT elevations.

Warnings & Precautions

Key warnings/precautions: increased risk of VTE/arterial thrombosis (avoid in smokers >35); monitor blood pressure; discontinue for thrombotic symptoms, significant BP elevation, or jaundice/hepatic dysfunction; migraine with aura is a contraindication; does not protect against HIV/STIs; counsel on expulsion/reinsertion rules and not leaving ring in >4 weeks; consider mood changes/depression and metabolic effects (lipids/glucose).

Age Restriction

Not indicated before menarche; intended for females of reproductive potential (no specific upper age cutoff, but risk/contraindications apply-especially smokers ≥35 years).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Efficacy reduced by enzyme inducers (e.g., rifampin/rifabutin, carbamazepine, phenytoin, phenobarbital, topiramate, St. John’s wort; some antiretrovirals); contraindicated with ombitasvir/paritaprevir/ritonavir (± dasabuvir) due to ALT elevations; azole antifungals such as vaginal miconazole may increase hormone exposure; CHCs can lower lamotrigine levels.

Interaction Severity

MAJOR: Strong enzyme inducers (e.g., rifampin/rifabutin; carbamazepine; phenytoin; phenobarbital/primidone) and certain antiretrovirals can reduce efficacy-use alternative/backup contraception; ombitasvir/paritaprevir/ritonavir ± dasabuvir is contraindicated due to ALT elevations. MODERATE: St. John’s wort; topiramate (especially ≥200 mg/day); aprepitant (may reduce hormone levels)-backup advised. MINOR/CLINICALLY RELEVANT: CHCs can lower lamotrigine concentrations (risk of loss of seizure control).

Food Interaction

No clinically meaningful food restrictions; grapefruit/grapefruit juice is not routinely contraindicated but may theoretically increase ethinyl estradiol exposure via CYP3A4 inhibition.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Consult Doctor

Children

Not approved for use before menarche; not applicable in prepubertal females

Elderly

Not indicated for use in postmenopausal women.

Kidney Impairment

No renal dose adjustment recommended (limited data); use usual clinical caution in significant renal disease.

Liver Impairment

No dose adjustment recommended; contraindicated in severe hepatic impairment or liver tumors (avoid use in active/severe liver disease).

Storage & Patient Advice

Storage Conditions

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature].

Missed Dose

If the ring is expelled/removed for <3 hours: rinse with cool to lukewarm water and reinsert ASAP-no backup needed. If out >3 hours in Week 1 or 2: reinsert ASAP and use backup contraception for 7 days. If out >3 hours in Week 3: either insert a new ring immediately (start a new 3‑week period) OR have a ring‑free interval of up to 7 days (counting time out) and then insert a new ring; use backup for 7 days and consider emergency contraception if unprotected sex occurred in the preceding days.

Stopping the Medicine

Can be removed/discontinued at any time; if used for contraception, counsel that fertility may return quickly and alternative contraception is needed immediately if pregnancy prevention is desired; routine schedule is 3 weeks in/1 week out (do not leave in >4 weeks).

Overdose

Overdose is unlikely via vaginal use; if overdose/accidental ingestion occurs, symptoms may include nausea, vomiting, and withdrawal/vaginal bleeding-remove the ring and provide symptomatic/supportive care (no specific antidote).

Patient Counseling

Counsel on correct use: insert 1 ring into the vagina and leave in place for 3 weeks (21 days), then remove for 1 week (7 days) and insert a new ring on the same day of the week/time; position is not critical as long as it remains in the vagina. If expelled, rinse with cool-to-lukewarm (not hot) water and reinsert as soon as possible; if out for >3 hours during weeks 1-2, reinsert and use backup contraception for 7 days; if out for >3 hours during week 3, discard and either insert a new ring immediately (start a new 3-week cycle; backup 7 days) or have a ring-free interval up to 7 days then insert a new ring (backup 7 days if ring-free interval >7 days). Does not protect against HIV/STIs. Review serious warning signs of thromboembolism/stroke (e.g., chest pain/SOB, severe headache, vision changes, unilateral leg pain/swelling) and avoid use in smokers ≥35 years or those with VTE risk factors/contraindications; advise to contact clinician for severe mood changes/depression. Disposal: place used ring in the reclosable foil pouch and discard in household trash (do not flush). Storage: keep refrigerated (2-8°C) prior to dispensing; after dispensing, may be stored at room temperature up to 30°C for up to 4 months, protected from direct sunlight.

Monitoring Requirements

Check blood pressure before initiation and periodically thereafter; routine follow-up/annual review is typical, with targeted monitoring (e.g., lipids in dyslipidemia, glucose in diabetes) based on comorbidities and CHC risk factors.

Pharmacology

Mechanism of Action

Continuous vaginal release of etonogestrel and ethinyl estradiol suppresses gonadotropins (inhibits ovulation) and also thickens cervical mucus and alters the endometrium.

Onset of Action

If inserted on Day 1 of menses: immediate contraceptive protection. If started at any other time (including Days 2-5 or later): use backup contraception for 7 days.

Duration of Effect

Each ring provides contraceptive hormone delivery for 3 weeks (21 days) of continuous in‑vagina use per cycle.

Bioavailability

Etonogestrel: ~100% (vaginal). Ethinyl estradiol: ~56% (vaginal).

Metabolism

Etonogestrel: hepatic metabolism primarily via CYP3A4. Ethinyl estradiol: hepatic metabolism via CYP3A4 and conjugation (glucuronidation/sulfation) with enterohepatic recirculation.

Excretion

Etonogestrel (as metabolites): excreted in urine and feces. Ethinyl estradiol (as metabolites): excreted in urine and feces (approximately 40% urine, 60% feces).

Product Information

Available Dosage Forms

Vaginal ring (extended‑release vaginal delivery system/insert).

Composition per Dose

Each vaginal ring: Etonogestrel 11.7 mg + Ethinyl estradiol 2.7 mg; releases approximately 120 mcg/day etonogestrel and 15 mcg/day ethinyl estradiol over 3 weeks

Generic Availability

No

OTC Alternatives

No OTC alternative

Hormone Type

Combined

Method

Vaginal Ring

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