Drugplain

Etonogestrel/Ethinyl Estradiol .015 mg/d

etonogestrel and ethinyl estradiol · INSERT, EXTENDED RELEASE · Prasco Laboratories

No Recall HistoryCurrently in Shortage
Plain English

Etonogestrel/Ethinyl Estradiol is a insert, extended release containing etonogestrel and ethinyl estradiol at .015 mg/d, taken vaginal. Manufactured by Prasco Laboratories.

Key Facts

Brand Name
Etonogestrel/Ethinyl Estradiol
Generic Name
etonogestrel and ethinyl estradiol
NDC Code (Product)
66993-605
Manufacturer
Prasco Laboratories
Strength
.015 mg/d
Dosage Form
INSERT, EXTENDED RELEASE
Route
VAGINAL
Marketing Status
Application #
NDA021187
Drug Class
Estrogen [EPC]; Progestin [EPC]
Marketing Start
06/01/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

product substitution issue31 reports
anxiety11 reports
headache11 reports
vaginal haemorrhage11 reports
depression10 reports
mood swings10 reports
muscle spasms10 reports
fatigue9 reports
migraine9 reports
vulvovaginal discomfort9 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE FOR VAGINAL USE ONLY Etonogestrel/Ethinyl Estradiol Vaginal Ring is indicated for use by females of reproductive age to prevent pregnancy. Etonogestrel/Ethinyl Estradiol Vaginal Ring is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION One Etonogestrel/Ethinyl Estradiol Vaginal Ring is inserted in the vagina. The ring must remain in place continuously for three weeks, followed by a one-week ring-free interval. 2.1 How to Use Etonogestrel/Ethinyl Estradiol Vaginal Ring To achieve maximum contraceptive effectiveness, Etonogestrel/Ethinyl Estradiol Vaginal Ring must be used as directed [see Dosage and Administration (2.2) ] . One Etonogestrel/Ethinyl Estradiol Vaginal Ring is inserted in the vagina. The ring is to remain in place continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed usually occurs. A new ring is inserted one week after the last ring was removed. The user can choose the insertion position that is most comfortable to her, for example, standing with one leg up, squatting, or lying down. The ring is to be compressed and inserted into the vagina. The exact position of Etonogestrel/Ethinyl Estradiol Vaginal Ring inside the vagina is not critical for its function. The vaginal ring must 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 sa…

Contraindications

4 CONTRAINDICATIONS Etonogestrel/Ethinyl Estradiol Vaginal Ring is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] Have cerebrovascular disease [see Warnings and Precautions (5.1) ] Have coronary artery disease [see Warnings and Precautions (5.1) ] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1) ] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] Have uncontrolled hypertension [see Warnings and Precautions (5.5) ] Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.9) ] Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.10) ] Women over age 35 with any migraine headaches [see Warnings and Precaution…

Drug Interactions

7 DRUG INTERACTIONS Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of CHCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with CHCs. 7.1 Effects of Other Drugs on CHCs Substances decreasing the plasma concentrations of CHCs and potentially diminishing the effectiveness of CHCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of CHCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between CHCs and other drugs may lead to breakthrough bleeding and/or cont…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions with the use of CHCs are discussed elsewhere in the labeling. Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.3) ] Adverse reactions commonly reported by CHC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions (≥2%) in clinical trials were: vaginitis, headache (including migraine), mood changes (e.g., depression, mood swings, mood altered, depressed mood, affect lability), device-related events (e.g., expulsion/discomfort/foreign body sensation), nausea/vomiting, vaginal discharge, increased weight, vaginal discomfort, breast pain/discomfort/tenderness, dysmenorrhea, abdominal pain, acne, and decreased libido. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon USA LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical…

Frequently Asked Questions

What is Etonogestrel/Ethinyl Estradiol used for?

Etonogestrel/Ethinyl Estradiol contains etonogestrel and ethinyl estradiol. It is a insert, extended release taken vaginal. Consult your doctor for specific uses.

Is Etonogestrel/Ethinyl Estradiol a controlled substance?

Etonogestrel/Ethinyl Estradiol is not classified as a controlled substance by the DEA.

What is the generic name for Etonogestrel/Ethinyl Estradiol?

The generic name for Etonogestrel/Ethinyl Estradiol is etonogestrel and ethinyl estradiol. There are 9 other brand versions of etonogestrel and ethinyl estradiol.

What is the NDC code for Etonogestrel/Ethinyl Estradiol .015 mg/d?

The NDC (National Drug Code) for Etonogestrel/Ethinyl Estradiol .015 mg/d is 66993-605, listed by Prasco Laboratories.

Product NDC

66993-605

Package NDC

66993-605-36

Other Etonogestrel/Ethinyl Estradiol Dosages

Other Etonogestrel Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)