HALOETTE

ETONOGESTREL AND ETHINYL ESTRADIOL

Manufacturer: Mayne Pharma Inc.

Score: 141.0

Quick Summary

Etonogestrel/Ethinyl Estradiol Vaginal Ring is a combination hormonal contraceptive used to prevent pregnancy in females of reproductive age. The ring is inserted into the vagina and releases etonogestrel and ethinyl estradiol over a three-week period. Key clinical findings indicate that the ring is effective in preventing pregnancy, with a low risk of adverse reactions. However, important safety information and contraindications should be considered, including the risk of serious cardiovascular events, liver disease, and hypersensitivity reactions. The main dosing recommendation is to insert one ring into the vagina and leave it in place for three weeks, followed by a one-week ring-free interval. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Prevention of pregnancy in females of reproductive age
Effective in preventing pregnancy with a low risk of adverse reactions
Combination hormonal contraceptive

Important Safety Information

Warning

Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use

Contraindications

High risk of arterial or venous thrombotic diseases
Liver tumors, benign or malignant or liver disease
Undiagnosed abnormal uterine bleeding
Pregnancy
Hypersensitivity reactions, including anaphylaxis and angioedema

Adverse Reactions

Irregular uterine bleeding
Nausea
Breast tenderness
Headache
Vaginitis
Mood changes
Device-related events

Dosing Recommendations

General Guidance

No dose adjustments are necessary for this medication

Prevention of pregnancy

Adult Dose

One ring inserted into the vagina for three weeks, followed by a one-week ring-free interval

Pediatric Dose

Special Population Considerations

Pregnancy

Etonogestrel/Ethinyl Estradiol Vaginal Ring is contraindicated during pregnancy
No adverse developmental outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis

Nursing Mothers

Advise women who are breastfeeding not to use Etonogestrel/Ethinyl Estradiol Vaginal Ring

Pediatric Use

Safety and efficacy of Etonogestrel/Ethinyl Estradiol Vaginal Ring have been established in women of reproductive age
Use of this product before menarche is not indicated