Drugplain

Etyqa .5 mg/1

ESTRADIOL AND NORETHINDRONE ACETATE · TABLET, FILM COATED · Aurobindo Pharma Limited

No Recall HistoryCurrently in Shortage
Plain English

Etyqa is a tablet, film coated containing estradiol and norethindrone acetate at .5 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.

Key Facts

Brand Name
Etyqa
Generic Name
ESTRADIOL AND NORETHINDRONE ACETATE
NDC Code (Product)
59651-425
Manufacturer
Aurobindo Pharma Limited
Strength
.5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA214729
Drug Class
Estrogen [EPC]
Marketing Start
06/30/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

hot flush11 reports
depression10 reports
breast cancer9 reports
drug ineffective7 reports
vaginal haemorrhage7 reports
headache6 reports
myocardial infarction6 reports
product quality issue6 reports
anxiety5 reports
nausea5 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Etyqa is indicated for: Etyqa is an estrogen and progestin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Prevention of Postmenopausal Osteoporosis ( 1.3 ) Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause . 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. 1.3 Prevention of Postmenopausal Osteoporosis Limitation of Use When…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Use estrogen-alone, or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary. Take a single Etyqa 1 mg/0.5 mg or 0.5 mg/0.1 mg tablet orally once daily for the Treatment of Moderate to severe Vasomotor Symptoms due to Menopause and for the Prevention of Postmenopausal Osteoporosis ( 2.1 , 2.3 ) Etyqa 1 mg/0.5 mg tablets are taken orally once daily for the Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ( 2.2 ) 2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Take a single Etyqa tablet orally once daily for the treatment of moderate to severe vasomotor symptoms due to menopause. Etyqa 1 mg/0.5 mg Etyqa 0.5 mg/0.1 mg 2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Take a single Etyqa tablet orally once daily for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Etyqa 1 mg/0.5 mg 2.3 Preve…

Contraindications

4 CONTRAINDICATIONS Etyqa is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.2) ] Breast cancer or history of breast cancer [see Warnings and Precautions (5.2) ] Estrogen-dependent neoplasia [see Warnings and Precautions (5.2) ] Active DVT, PE, or history of these conditions [see Warnings and Precautions (5.1) ] Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions [see Warnings and Precautions (5.1) ] Known anaphylactic reaction, angioedema, or hypersensitivity to Etyqa Hepatic impairment or disease Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders Undiagnosed abnormal genital bleeding ( 4 ) Breast cancer or a history of breast cancer ( 4 , 5.2 ) Estrogen-dependent neoplasia ( 4 , 5.2 ) Active DVT, PE, or history of these conditions ( 4 , 5.1 ) Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions ( 4 , 5.1 ) Known anaphylactic reaction, angioedema, or hypersensitivity to Etyqa ( 4 ) Hepatic impairment or disease ( 4 , 5.10 ) Protein C, protein S, or antithrombin …

Drug Interactions

7 DRUG INTERACTIONS Co-administration of estradiol with norethindrone acetate did not elicit any apparent influence on the pharmacokinetics of norethindrone acetate. Similarly, no relevant interaction of norethindrone acetate on the pharmacokinetics of estradiol was found within the NETA dose range investigated in a single dose study. Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration. ( 7 ) Estradiol In-vitro and in-vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John’s wort ( Hypericum perforatum ) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and result in adverse reactions. Norethindrone Acetate Drugs or herbal produc…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning , Warnings and Precautions (5.1) ] Malignant Neoplasms [see Boxed Warning , Warnings and Precautions (5.2) ] The most common adverse reactions (incidence ≥ 5 percent) with Etyqa are: back pain, headache, pain in the extremity, nausea, diarrhea, gastroenteritis, insomnia, emotional lability, upper respiratory tract infection, sinusitis, nasopharyngitis, weight increase, breast pain, post-menopausal bleeding, uterine fibroid vaginal hemorrhage, ovarian cyst, endometrial thickening, viral infection, moniliasis genital, and accidental injury. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions reported with Etyqa 1 mg/0.5 mg by investigator…

Frequently Asked Questions

What is Etyqa used for?

Etyqa contains ESTRADIOL AND NORETHINDRONE ACETATE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Etyqa a controlled substance?

Etyqa is not classified as a controlled substance by the DEA.

What is the generic name for Etyqa?

The generic name for Etyqa is ESTRADIOL AND NORETHINDRONE ACETATE. There are 8 other brand versions of ESTRADIOL AND NORETHINDRONE ACETATE.

What is the NDC code for Etyqa .5 mg/1?

The NDC (National Drug Code) for Etyqa .5 mg/1 is 59651-425, listed by Aurobindo Pharma Limited.

Product NDC

59651-425

Package NDC

59651-425-28

Other Etyqa Dosages

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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)