Norethindrone Acetate

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Norethindrone Acetate Recall

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Side Effects & Adverse Reactions

Cardiovascular Disorders
Patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of (VTE), obesity, and systemic lupus erythematosus) should be managed appropriately.
Visual Abnormalities
Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be discontinued.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Norethindrone Acetate Tablets USP are 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. Norethindrone Acetate Tablets USP is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

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History

There is currently no drug history available for this drug.

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Other Information

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:

Norethindrone Acetate structural formula

C22H28O3 M.W. 340.46

Each Norethindrone Acetate Tablet USP, for oral administration, contains norethindrone acetate 5 mg. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose.

Sources

Norethindrone Acetate Manufacturers

Kaiser Foundation Hospitals

Norethindrone Acetate | Kaiser Foundation Hospitals

Therapy with Norethindrone Acetate Tablets USP must be adapted to the specific indications and therapeutic response of the individual patient.
Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology
2.5 to 10 mg 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 Norethindrone Acetate Tablets USP therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Norethindrone Acetate Tablets USP.
Endometriosis
Initial daily dosage of 5 mg Norethindrone Acetate Tablets USP for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Norethindrone Acetate Tablets USP is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

No Recall
Avpak

Norethindrone Acetate | Avpak

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

Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 to 10 mg norethindrone acetate, 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 norethindrone acetate, USP therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with norethindrone acetate tablets, USP.

Endometriosis: Initial daily dosage of 5 mg norethindrone acetate, USP for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of norethindrone acetate, USP is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

No Recall
Barr Laboratories Inc.

Norethindrone Acetate | Barr Laboratories Inc.

Therapy with Norethindrone Acetate Tablets USP must be adapted to the specific indications and therapeutic response of the individual patient.
Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology
2.5 to 10 mg 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 Norethindrone Acetate Tablets USP therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Norethindrone Acetate Tablets USP.
Endometriosis
Initial daily dosage of 5 mg Norethindrone Acetate Tablets USP for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Norethindrone Acetate Tablets USP is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

No Recall
Amneal Pharmaceuticals

Norethindrone Acetate | Amneal Pharmaceuticals Of New York, Llc

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

Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 to 10 mg norethindrone acetate, 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 norethindrone acetate, USP therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with norethindrone acetate tablets, USP.

Endometriosis: Initial daily dosage of 5 mg norethindrone acetate, USP for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of norethindrone acetate, USP is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

No Recall
Avkare, Inc.

Norethindrone Acetate | Avkare, Inc.

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

Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 to 10 mg norethindrone acetate, 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 norethindrone acetate, USP therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with norethindrone acetate tablets, USP.

Endometriosis: Initial daily dosage of 5 mg norethindrone acetate, USP for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of norethindrone acetate, USP is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

No Recall
Glenmark Generics Inc., Usa

Norethindrone Acetate | Glenmark Generics Inc., Usa

Therapy with norethindrone acetate must be adapted to the specific indications and therapeutic response of the individual patient.
Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology:
2.5 to 10 mg norethindrone acetate 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 norethindrone acetate therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with norethindrone acetate.
Endometriosis:
Initial daily dosage of 5 mg norethindrone acetate for two weeks. Dosage should be increased by2.5 mg per day every two weeks until 15 mg per day of norethindrone acetate is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

No Recall