Etonogestrel and Ethinyl Estradiol .015 mg/d

Etonogestrel and Ethinyl Estradiol · INSERT, EXTENDED RELEASE · Teva Pharmaceuticals USA, Inc.

No Recall HistoryCurrently in Shortage

Plain English

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

Key Facts

Brand Name: Etonogestrel and Ethinyl Estradiol
Generic Name: Etonogestrel and Ethinyl Estradiol
NDC Code (Product): 0093-7679
Manufacturer: Teva Pharmaceuticals USA, Inc.
Strength: .015 mg/d
Dosage Form: INSERT, EXTENDED RELEASE
Route: VAGINAL
Marketing Status
Application #: ANDA204305
Drug Class: Estrogen [EPC]; Progestin [EPC]
Marketing Start: 01/19/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue5 reports

atelectasis4 reports

hepatic steatosis4 reports

pain4 reports

product substitution issue4 reports

dry skin3 reports

injection site rash3 reports

pancreatitis3 reports

pruritus3 reports

alopecia2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE FOR VAGINAL USE ONLY Etonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. Etonogestrel and 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 and 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 ) 2.1 How to Use Etonogestrel and ethinyl estradiol vaginal ring To achieve maximum contraceptive effectiveness, Etonogestrel and ethinyl estradiol vaginal ring must be used as directed [ see Dosage and Administration ( 2.2 )]. One Etonogestrel and 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. An optional alternative is to insert the ring using the applicator for Etonogestrel and ethinyl estradiol vaginal ring [see Applicator for Etonogestrel and ethinyl estradiol vaginal ring Instructions for Use ]. The exact position of Etonogestrel and ethinyl estradiol v…

Contraindications

4 CONTRAINDICATIONS Etonogestrel and 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 a…

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 ) 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/o…

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 AvKARE at 1-855-361-3993 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 trials of a drug cannot be direc…

Frequently Asked Questions

What is Etonogestrel and Ethinyl Estradiol used for?

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

Is Etonogestrel and Ethinyl Estradiol a controlled substance?

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

What is the generic name for Etonogestrel and Ethinyl Estradiol?

The generic name for Etonogestrel and Ethinyl Estradiol is Etonogestrel and Ethinyl Estradiol. There are 10 other brand versions of Etonogestrel and Ethinyl Estradiol.

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

The NDC (National Drug Code) for Etonogestrel and Ethinyl Estradiol .015 mg/d is 0093-7679, listed by Teva Pharmaceuticals USA, Inc..

Product NDC

0093-7679

Package NDC

0093-7679-02

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

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