Aurovela Fe 1/20

Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate · KIT · Aurobindo Pharma Limited

No Recall History

Plain English

Aurovela Fe 1/20 is a kit containing norethindrone acetate and ethinyl estradiol and ferrous fumarate. Manufactured by Aurobindo Pharma Limited.

Key Facts

Brand Name: Aurovela Fe 1/20
Generic Name: Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
NDC Code (Product): 65862-940
Manufacturer: Aurobindo Pharma Limited
Dosage Form: KIT
Marketing Status
Application #: ANDA207505
Marketing Start: 06/16/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

product dose omission issue15 reports

headache9 reports

nausea8 reports

rash7 reports

dermatitis atopic6 reports

fatigue5 reports

pruritus5 reports

vomiting4 reports

abdominal discomfort3 reports

abdominal distension3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Aurovela Fe 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Method Lowest Expected* Typical** (No contraception) (85) (85) Oral contraceptives 3 combined 0.1 N/A*** progestin only 0.5 N/A*** Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26 Vaginal Sponge nulliparous 9 20 parous 20 40 Implant 0.05 0.05 Injection: depot medroxyprogesterone acetate 0.3 0.3 IUD progesterone T 1.5 2 copper T 380A 0.6 0.8 LNg 20 0.1 0.1 Condom without spermicides female 5 21 mal…

Dosage & Administration

DOSAGE AND ADMINISTRATION The blister pack has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the blister pack above the first row of tablets. Note: Each blister pack has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label stickers have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label sticker that corresponds to her starting day over the preprinted days. Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage and Administration for 28-Day Dosage Regimen To achieve maximum contraceptive effectiveness, Aurovela Fe 1/20 should be taken exactly as directed and at intervals n…

Warnings

WARNINGS The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, …

Contraindications

CONTRAINDICATIONS Oral contraceptives are contraindicated in women who currently have the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders Cerebral vascular or coronary artery disease Current diagnosis of, or history of, breast cancer, which may be hormone sensitive Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see WARNINGS, Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment ) .

Adverse Reactions

ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): Thrombophlebitis Arterial thromboembolism Pulmonary embolism Myocardial infarction Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Hepatic adenomas or benign liver tumors Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 1) (70 to 74). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1) (70,73,75). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8 to 10 yea…

Frequently Asked Questions

What is Aurovela Fe 1/20 used for?

Aurovela Fe 1/20 contains Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate. It is a kit taken as directed. Consult your doctor for specific uses.

Is Aurovela Fe 1/20 a controlled substance?

Aurovela Fe 1/20 is not classified as a controlled substance by the DEA.

What is the generic name for Aurovela Fe 1/20?

The generic name for Aurovela Fe 1/20 is Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate. There are 11 other brand versions of Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate.

What is the NDC code for Aurovela Fe 1/20 ?

The NDC (National Drug Code) for Aurovela Fe 1/20 is 65862-940, listed by Aurobindo Pharma Limited.

Product NDC

65862-940

Package NDC

65862-940-58

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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)