Emzahh .35 mg/1

NORETHINDRONE · TABLET · Aurobindo Pharma Limited

No Recall History

Plain English

Emzahh is a tablet containing norethindrone at .35 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.

Key Facts

Brand Name: Emzahh
Generic Name: NORETHINDRONE
NDC Code (Product): 59651-136
Manufacturer: Aurobindo Pharma Limited
Strength: .35 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA216796
Drug Class: Progestin [EPC]
Marketing Start: 01/06/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea227 reports

headache220 reports

off label use195 reports

drug ineffective180 reports

fatigue174 reports

pain159 reports

hot flush155 reports

vaginal haemorrhage141 reports

abdominal pain137 reports

diarrhoea124 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. Method (1) % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Typical Use 1 (2) Perfect Use 2 (3) (4) No method 4 85 85 Spermicides 5 28 18 42 Fertility awareness-based methods 24 47 Standard Days method 6 5 TwoDay method 6 4 Ovulation method 6 3 Symptothermal method 6 0.4 Withdrawal 22 4 46 Sponge 36 Parous Women 24 20 Nulliparous Women 12 9 Condom 7 Female (fc) 21 5 41 Male 18 2 43 Diaphragm 8 12 6 57 Combined pill and progestin-only pill 9 0.3 67 Norelgestromin and ethinyl estradiol patc…

Dosage & Administration

DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Emzahh ™ tablets must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See Detailed Patient Labeling for detailed instruction.

Warnings

WARNINGS Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke. Norethindrone does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives (COCs). The healthcare professional is referred to the prescribing information of combined oral contraceptives for a discussion of those risks. The relationship between progestin-only oral contraceptives and these risks is not fully defined. The healthcare professional should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate. 1. Ectopic Pregnancy The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Healthcare profe…

Contraindications

CONTRAINDICATIONS Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected pregnancy Known or suspected carcinoma of the breast Undiagnosed abnormal genital bleeding Hypersensitivity to any component of this product Benign or malignant liver tumors Acute liver disease

Drug Interactions

4. Drug Interactions Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Effects of Other Drugs on Hormonal Contraceptives Substances decreasing the systemic concentrations of hormonal contraceptives (HCs) and potentially diminishing the efficacy of HCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the systemic concentrations of HCs and potentially diminish the effectiveness of HCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme i…

Adverse Reactions

ADVERSE REACTIONS Adverse reactions reported with the use of POPs include: Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely. Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies. Androgenic side effects such as acne, hirsutism, and weight gain occur rarely. The following adverse reactions were also reported in clinical trials or during post-marketing experience: Gastrointestinal Disorders: vomiting, abdominal pain; General Disorders and Administration Site Conditions: fatigue, edema; Psychiatric Disorders: depression, nervousness; Musculoskeletal and Connective Tissue Disorders: pain in extremity; Reproductive System and Breast Disorders: genital discharge; breast pain, menstruation delayed, suppressed lactation, vaginal hemorrhage, menorrhagia, withdrawal bleed when product is stopped; Immune System Disorders: anaphylactic/anaphylactoid reaction, hypersensitivity ; Hepatobiliary Disorders: hepatitis, jaundice cholestatic; Skin and Subcutaneous Tissue Disorders: alopecia, rash…

Frequently Asked Questions

What is Emzahh used for?

Emzahh contains NORETHINDRONE. It is a tablet taken oral. Consult your doctor for specific uses.

Is Emzahh a controlled substance?

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

What is the generic name for Emzahh?

The generic name for Emzahh is NORETHINDRONE. There are 11 other brand versions of NORETHINDRONE.

What is the NDC code for Emzahh .35 mg/1?

The NDC (National Drug Code) for Emzahh .35 mg/1 is 59651-136, listed by Aurobindo Pharma Limited.

Product NDC

59651-136

Package NDC

59651-136-28

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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)