Adult Dosing

Secondary amenorrhea

• 2.5-10 mg/day PO x 5-10 days; give during 2nd half of the theoretical menstrual cycle

Abnormal uterine bleeding

• 2.5-10 mg/day PO x 5-10 days; give during 2nd half of the theoretical menstrual cycle

Endometriosis

• 5 mg/day PO x 2 wks; then increase by 2.5 mg/day q2 wks until 15 mg/day is achieved. Continue for 6-9 months or until breakthrough bleeding demands temporary termination

Note:

• Not to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection

Pediatric Dosing

• Not indicated in pediatric patients

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding caused by hormonal imbalance in the absence of organic pathology (submucous fibroids, uterine cancer)

• Hypersensitivity to any of the ingredients of product
• Concomitant estrogen therapy in postmenopausal women for endometrial protection
• Undiagnosed vaginal bleeding
• Known, suspected or history of breast cancer
• Active deep vein thrombosis
• History of pulmonary embolism
• Active or recent arterial thromboembolic disease such as MI or stroke
• Impaired liver function or hepatic disease
• Pregnancy
• Missed abortion
• Papilledema
• Sudden onset vision loss or changes
• Retinal vascular lesions
• Genital organ cancer

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined; caution advised

Hepatic Dose Adjustment

• Hepatic impairment/disease: Contraindicated

• Patients who are at risk of arterial vascular disease and/or venous thromboembolism should be managed appropriately
• Discontinue therapy pending examination if there is a sudden partial or complete loss of vision or sudden onset of proptosis, diplopia, or migraine. If evaluation indicates papilledema or retinal vascular lesions, discontinue use
• Carefully monitor patients with epilepsy, migraine, cardiac or renal dysfunctions as fluid retention caused by norethindrone acetate may worsen these conditions
• Consider adequate diagnostic measures in the event of breakthrough bleeding
• Monitor patients closely with a history of depression and discontinue use if depression recurs to a serious degree
• Carefully monitor women with hyperlipidemias and/or diabetes during progestin therapy as the drug may have adverse effects on lipid and carbohydrate metabolism
• Inform the pathologist regarding progestin therapy when relevant specimens are submitted

Cautions: Use cautiously in

• Renal impairment
• Cerebrovascular disease
• Hypertension
• Diabetes mellitus
• Obese patients
• History of depression
• Hypothyroidism
• Seizure disorder
• Smokers
• SLE
• Asthma
• Surgery or prolonged immobilization

Pregnancy Category:X

Breastfeeding: Detectable amounts of the drug have been identified in the breast milk. Manufacturer advises caution for use in nursing mothers.

• CNS: Headache, migraine, insomnia, cerebral thrombosis and embolism, stroke
• PSYCHIATRY: Depression, mood swings
• CV: Thromboembolism, thrombophlebitis, DVT, hypertension, MI
• RESP: Pulmonary embolism
• GI: Nausea
• HEPA: Cholestatic jaundice, liver function abnormalities (AST, ALT, bilirubin), hepatic adenoma
• EENT: Optic neuritis, retinal vascular thrombosis
• DERM: Rash, urticaria, pruritus, melasma, chloasma, acne, hirsutism, alopecia
• METABOLIC: Weight changes, decreased HDL cholesterol and increased LDL/HDL ratio, appetite changes
• REPRODUCTIVE: Breakthrough bleeding, spotting, amenorrhea, changes in the cervical squamo-columnar junction and secretions, menstrual irregularities, breast enlargement/tenderness, galactorrhea
• HYPERSENSITIVITY: Anaphylactic/anaphylactoid reactions
• MISC: Fluid retention, edema

• Progestin; induces secretory changes in an estrogen-primed endometrium
• Extensively metabolized in the liver; CYP450: 3A4 substrate
• Excreted in urine and feces
• Half-life: Approximately 9 hrs

US Trade Name(s)

• Aygestin

US Availability

norethindrone acetate (generic)

• TABS: 5 mg

Aygestin

• TABS: 5 mg

Canadian Trade Name(s)

• Norlutate

Canadian Availability

Norlutate

• TABS: 5 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Endocrine/Metabolic

Sex Hormones

Progestins

Obstetrics/Gynecology

Sex Hormones

Progestins

Pricing data from www.DrugStore.com in U.S.A.

• Norethindrone Acetate 5 MG TABS [Bottle] (TEVA PHARMACEUTICALS USA)
  30 mg = $76.99
  90 mg = $209.96
• Aygestin 5 MG TABS [Bottle] (TEVA/WOMENS HEALTH)
  30 mg = $104.98
  90 mg = $304.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Aygestin 5 MG Oral Tablet

Pill Image:

[
See full size image]

Ingredient(s): Norethindrone

Imprint: 5;AYGESTIN;b/424

Color(s): White

Shape: Oval

Size (mm): 11.00

Score: 2

Inactive Ingredient(s): lactose / magnesium stearate / microcrystalline cellulose

Drug Label Author:
DURAMED PHARMACEUTICALS, INC.

DEA Schedule:
Non-Scheduled