Aurovela 24 Fe

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

No Recall History

Plain English

Aurovela 24 Fe is a kit containing norethindrone acetate and ethinyl estradiol and ferrous fumarate. Manufactured by Aurobindo Pharma Limited.

Key Facts

Brand Name: Aurovela 24 Fe
Generic Name: Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
NDC Code (Product): 65862-934
Manufacturer: Aurobindo Pharma Limited
Dosage Form: KIT
Marketing Status
Application #: ANDA207504
Marketing Start: 06/15/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

product dose omission issue7 reports

abdominal discomfort4 reports

nausea4 reports

vomiting4 reports

abdominal distension3 reports

condition aggravated3 reports

dermatitis atopic3 reports

product substitution issue3 reports

pruritus3 reports

rash3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Aurovela 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m 2 has not been evaluated. Aurovela 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. ( 1 ) The efficacy of Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m 2 has not been evaluated. ( 1 , 8.8 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day for 28 days (2.1) Take tablets in the order directed on the blister pack (2.1) Aurovela 24 Fe may be administered without regard to meals (12.3) 2.1 How to Start Aurovela 24 Fe Aurovela 24 Fe is available in a blister pack [see How Supplied/Storage and Handling (16) ]. Aurovela 24 Fe may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception must be used until after the first 7 consecutive days of administration. 2.2 How to Take Aurovela 24 Fe Table 1: Instructions for Administration of Aurovela 24 Fe Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Aurovela 24 Fe active tablets are light yellow to yellow (Day 1 to Day 24). Aurovela 24 Fe inactive tablets are brown (Day 25 to Day 28). Day 1 Start: Take first light yellow to yellow active tablet without regard to meals on the first day of menses. Take subsequent active tablets once daily at the s…

Contraindications

4 CONTRAINDICATIONS Aurovela 24 Fe 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 inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see Warnings and Precautions (5.4) ] Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6) ] Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7) ] Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7) ] Liver tumors, b…

Drug Interactions

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

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs 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 (5.2) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions (greater than or equal to 2%) were: headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, mood changes, bacterial vaginitis, acne, and weight gain. (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 Trial 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets were evaluated …

Frequently Asked Questions

What is Aurovela 24 Fe used for?

Aurovela 24 Fe contains Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate. It is a kit taken as directed. Consult your doctor for specific uses.

Is Aurovela 24 Fe a controlled substance?

Aurovela 24 Fe is not classified as a controlled substance by the DEA.

What is the generic name for Aurovela 24 Fe?

The generic name for Aurovela 24 Fe is Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate. There are 12 other brand versions of Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate.

What is the NDC code for Aurovela 24 Fe ?

The NDC (National Drug Code) for Aurovela 24 Fe is 65862-934, listed by Aurobindo Pharma Limited.

Product NDC

65862-934

Package NDC

65862-934-58

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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)