Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) - 5 mg oral tablets.

Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP), (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder. The structural formula is as follows:

Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) contain the following inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose.

Norethindrone acetate induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as norethindrone.

INDICATIONS AND USAGE

Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.

The following adverse reactions have been observed in women taking progestins:

Therapy with Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) must be adapted to the specific indications and therapeutic response of the individual patient.

2.5 to 10 mg Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen.

Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP).

Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) are available as:

5 mg: White, oval, flat-faced, beveled edge tablet scored on one side. Debossed with 5 Aygestin (Norethindrone acetate) on the unscored side and b / 424 on the scored side. Available in bottles of 50 tablets.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Teva Women’s Health, IncSubsidiary of Teva Pharmaceuticals USA, Inc.Sellersville, PA 18960

Iss. 2/2010

Read this before you start taking Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) and read what you get each time you refill Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP). There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition.

 

Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP)  is similar to the progesterone hormones naturally produced by the body. Your healthcare provider may provide Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP)  as individual tablets.

Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) are used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period who are not pregnant), the treatment of endometriosis, and the treatment of irregular menstrual periods due to hormone imbalance.

You should not take Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) if you have the following conditions:

Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) should not be used if you are pregnant. Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) are contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. There is an increased risk of minor birth defects in children whose mothers take this drug during the first 4 months of pregnancy. Several reports suggest an association between mothers who take these drugs in the first trimester of pregnancy and congenital abnormalities in male and female babies. Although it is not clear that these events were drug related, you should check with your healthcare provider about the risks to your unborn child of any medication taken during pregnancy.

You should avoid using Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP) during pregnancy. If you take Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP)  and later find you were pregnant when you took it, be sure to discuss this with your healthcare provider as soon as possible.

Use of progestational drugs, such as Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP), has been associated with changes in the blood-clotting system. These changes allow the blood to clot more easily, possibly allowing clots to form in the bloodstream. If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), visual loss or blindness (by cutting off blood vessels in the eye), or other problems. Any of these conditions may cause death or serious long-term disability. Call your healthcare provider right away if you suspect you have any of these conditions. He or she may advise you to stop using the drug.

Discontinue Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP)  tablets and call your healthcare provider right away if you experience sudden partial or complete loss of vision, blurred vision, or sudden onset of bulging eyes, double vision, or migraine.

 Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

 

These are not all the possible side effects of progestin and/or estrogen therapy. For more information, ask your healthcare provider or pharmacist.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP)  for conditions for which it was not prescribed. Do not give Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP)  tablets  to other people, even if they have the same symptoms you have. It may harm them.

This leaflet provides a summary of the most important information about progestin and/or estrogen therapy. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP)  that is written for health professionals.

Aygestin (Norethindrone acetate) (norethindrone acetate tablets, USP)  contain the following inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose.

Teva Women’s Health, IncSubsidiary of Teva Pharmaceuticals USA, Inc.Sellersville, PA 18960

Iss. 2/2010

Aygestin (Norethindrone acetate)
(norethindrone acetate
tablets, USP)
ORALLY ACTIVE PROGESTIN
5 mg
PHARMACIST: Dispense the accompanying

PATIENT INFORMATION leaflet to each patient.

Rx only
TEVA
TEVA WOMAN'S HEALTH

50 TABLETS