Junel Fe 24

Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate · KIT · Teva Pharmaceuticals USA, Inc.

No Recall History

Plain English

Junel Fe 24 is a birth control pill that contains hormones to prevent pregnancy. It also includes iron supplements in the reminder pills to help maintain iron levels during your cycle.

Key Facts

Brand Name: Junel Fe 24
Generic Name: Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
NDC Code (Product): 0093-5328
Manufacturer: Teva Pharmaceuticals USA, Inc.
Dosage Form: KIT
Marketing Status
Application #: ANDA090938
Marketing Start: 06/08/2015

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea93 reports

headache68 reports

drug ineffective66 reports

fatigue63 reports

pain58 reports

vomiting53 reports

diarrhoea47 reports

dizziness47 reports

rash45 reports

anxiety43 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Junel ® Fe 24 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) is indicated for use by women to prevent pregnancy [see Clinical Studies ( 14 )] . The efficacy of Junel Fe 24 in women with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. Junel ® Fe 24 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) 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 Junel Fe 24 in women with a body mass index (BMI) of >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 ) Junel Fe 24 may be administered without regard to meals ( 12.3 ) 2.1 How to Start Junel Fe 24 Junel Fe 24 is dispensed in a blister card [see How Supplied/Storage and Handling ( 16 )] . Junel Fe 24 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 Junel Fe 24 Table 1: Instructions for Administration of Junel Fe 24 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: Junel Fe 24 active tablets are light yellow (Day 1 to Day 24). Junel Fe 24 inactive tablets are brown (Day 25 to Day 28). Day 1 Start: Take first light yellow active tablet without regard to meals on the first day of menses. Take subsequent active tablets once daily at the same time each day for a total of 24 …

Contraindications

4 CONTRAINDICATIONS Junel Fe 24 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 tu…

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 break…

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 (≥ 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 Teva at 1-888-838-2872 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 Junel Fe 24 was evaluated in 743 subjects who participated in an open-label, randomized, active-controlled, multicenter clinical trial o…

Frequently Asked Questions

What is Junel Fe 24 used for?

Junel Fe 24 is a birth control pill that contains hormones to prevent pregnancy. It also includes iron supplements in the reminder pills to help maintain iron levels during your cycle.

Is Junel Fe 24 a controlled substance?

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

What is the generic name for Junel Fe 24?

The generic name for Junel Fe 24 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 Junel Fe 24 ?

The NDC (National Drug Code) for Junel Fe 24 is 0093-5328, listed by Teva Pharmaceuticals USA, Inc..

Product NDC

0093-5328

Package NDC

0093-5328-62

Other Norethindrone Brands

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

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