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Junel FE

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Junel Fe

Junel™ 21 Day
(norethindrone acetate and ethinyl estradiol) Tablets, USP
Junel™ Fe 28 Day
(norethindrone acetate and ethinyl estradiol) Tablets, USP and (ferrous fumarate) Tablets*

*Ferrous fumarate tablets are not USP for dissolution and assay.

Junel™ 1/20
(Each light yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.)
Junel™ 1.5/30
(Each pink tablet contains 1.5 mg norethindrone acetate and 30 mcg ethinyl estradiol.)
Junel™ Fe 1/20
(Each light yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Each brown tablet contains 75 mg ferrous fumarate.)
Junel™ Fe 1.5/30
(Each pink tablet contains 1.5 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each brown tablet contains 75 mg ferrous fumarate.)

Patients should be counseled that this product does not protect against HIV infections (AIDS) and other sexually transmitted diseases.

Junel Fe

DRUG DESCRIPTION

Junel™ 21 and Junel™ Fe28 are progestogen-estrogen combinations.

Junel™ Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose.

Each light yellow tablet contains norethindrone acetate (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized starch.

Each pink tablet contains norethindrone acetate (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized starch.

Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose.

Junel™ (norethindrone acetate and ethinyl estradiol tablets) Structural Formula Illustration

C22H28O3 Molecular Weight: 340.46........................C20H24O2 Molecular Weight: 296.40

What are the possible side effects of ethinyl estradiol and norethindrone?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • chest...

Read All Potential Side Effects and See Pictures of Junel Fe »

Last reviewed on RxList: 12/10/2008
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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