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Norethindrone Acetate

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Overview

What is Aygestin?

AYGESTIN (norethindrone acetate tablets USP) - 5 mg oral tablets.

AYGESTIN (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:

CHO M.W. 340.46

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



What does Aygestin look like?



What are the available doses of Aygestin?

Sorry No records found.

What should I talk to my health care provider before I take Aygestin?

Sorry No records found

How should I use Aygestin?

AYGESTIN (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.

Therapy with AYGESTIN must be adapted to the specific indications and therapeutic response of the individual patient.


What interacts with Aygestin?


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What are the warnings of Aygestin?

Cardiovascular Disorders

Visual Abnormalities

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What are the precautions of Aygestin?

General

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Information for the Patient

Healthcare providers are advised to discuss the leaflet with patients for whom they prescribe AYGESTIN.

Drug/Laboratory Tests Interactions

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The following laboratory test results may be altered by the use of estrogen/progestin combination drugs:

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Some beagle dogs treated with medroxyprogesterone acetate developed mammary nodules. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas nodules in treated animals were larger and more numerous, and persisted. There is no general agreement as to whether the nodules are benign or malignant. Their significance with respect to humans has not been established.

Pregnancy

Norethindrone acetate is contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and congenital abnormalities in male and female fetuses. Some progestational drugs induce mild virilization of the external genitalia of female fetuses.

Nursing Mothers

Detectable amounts of progestins have been identified in the milk of mothers receiving them. Caution should be exercised when progestins are administered to a nursing woman.

Pediatric Use

AYGESTIN tablets are not indicated in children.


What are the side effects of Aygestin?

See  and .

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

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What should I look out for while using Aygestin?


What might happen if I take too much Aygestin?

Sorry No Records found


How should I store and handle Aygestin?

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.AYGESTIN (norethindrone acetate tablets USP) is available as: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, INC.Subsidiary of TEVA PHARMACEUTICALS USA, INC.Rev. A 10/2015AYGESTIN (norethindrone acetate tablets USP) is available as: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, INC.Subsidiary of TEVA PHARMACEUTICALS USA, INC.Rev. A 10/2015AYGESTIN (norethindrone acetate tablets USP) is available as: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, INC.Subsidiary of TEVA PHARMACEUTICALS USA, INC.Rev. A 10/2015AYGESTIN (norethindrone acetate tablets USP) is available as: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, INC.Subsidiary of TEVA PHARMACEUTICALS USA, INC.Rev. A 10/2015AYGESTIN (norethindrone acetate tablets USP) is available as: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, INC.Subsidiary of TEVA PHARMACEUTICALS USA, INC.Rev. A 10/2015AYGESTIN (norethindrone acetate tablets USP) is available as: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, INC.Subsidiary of TEVA PHARMACEUTICALS USA, INC.Rev. A 10/2015AYGESTIN (norethindrone acetate tablets USP) is available as: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, INC.Subsidiary of TEVA PHARMACEUTICALS USA, INC.Rev. A 10/2015


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Clinical Information

Chemical Structure

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Clinical Pharmacology

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

Non-Clinical Toxicology
No drug interactions have been identified. Studies with famotidine in man, in animal models, and have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.

See  and .

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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