Aygestin (norethindrone acetate)
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.
Usual: 2.5-10mg qd for 5-10 days
Initial: 5mg qd for 2 weeks
Increase dose by 2.5mg/day every 2 weeks until 15mg/day is reached
May hold therapy for 6-9 months or until breakthrough bleeding demands temporary termination
Abnormal Uterine Bleeding
Usual: 2.5-10mg qd for 5-10 days
Tab: 5mg* *scored
Known/suspected pregnancy, undiagnosed vaginal bleeding, known/suspected/history of breast cancer, active or history of deep vein thrombosis (DVT)/pulmonary embolism (PE), active or recent arterial thromboembolic disease (eg, stroke, myocardial infarction [MI]), liver dysfunction or disease, as a diagnostic test for pregnancy.
Not intended, recommended, or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection. Patients with risk factors for arterial vascular disease (eg, HTN, diabetes mellitus [DM], tobacco use, hypercholesterolemia, obesity) and/or venous thromboembolism (eg, personal history or family history of venous thromboembolism, obesity, systemic lupus erythematosus) should be managed appropriately. If visual abnormalities or migraine occurs, d/c pending examination. If examination reveals papilledema or retinal vascular lesions, d/c therapy. May cause fluid retention; caution with epilepsy, migraine, cardiac/renal dysfunction. In cases of breakthrough bleeding and irregular vaginal bleeding, consider nonfunctional causes and perform adequate diagnostic measures. Caution with history of clinical depression; d/c if depression recurs to a serious degree. May produce adverse effects on carbohydrate and lipid metabolism; closely monitor patients with hyperlipidemias and/or DM during therapy. When relevant specimens are submitted, inform pathologist of therapy. May affect certain endocrine tests, LFTs, and blood components in laboratory tests.
Breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, edema, weight changes, cholestatic jaundice, rash, melasma, chloasma, clinical depression, acne, breast enlargement, headache, urticaria.
Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
PREGNANCY AND LACTATION
Category X, caution in nursing.
MECHANISM OF ACTION
Progestogen; induces secretory changes in an estrogen-primed endometrium.
Absorption: Rapid; Cmax=26.19ng/mL; Tmax=1.83 hrs; AUC=166.9ng/mL•hr. Distribution: Vd=4L/kg; sex hormone binding globulin (SHBG) (36%); albumin binding (61%); found in breast milk. Metabolism: Extensive, via reduction followed by sulfate and glucuronide conjugation. Elimination: Urine and feces (primarily as metabolites); T1/2=8.51 hrs.
Assess for known/suspected pregnancy, undiagnosed vaginal bleeding, known/suspected/history of breast cancer, active or history of DVT/PE, active or recent arterial thromboembolic disease (eg, stroke, MI), liver dysfunction or disease, hyperlipidemia, DM, any other conditions where treatment is contraindicated or cautioned, and possible drug interactions.
Monitor for cardiovascular disorders, visual abnormalities (eg, loss of vision, proptosis, diplopia), fluid retention, breakthrough bleeding. Monitor for depression recurrence in patients with previous history. Monitor patients with hyperlipidemias and DM for changes in lipid and carbohydrate metabolism. Monitor thyroid function if on thyroid replacement therapy.
Instruct not to use the product if pregnant, breastfeeding or trying to conceive, had previous blood clot, stroke, or heart attack, or if postmenopausal. Inform that therapy may increase the risk to the fetus and risk for abnormal blood clotting and eye abnormalities. Instruct to report any breast lumps, dizziness and faintness, changes in speech, severe headaches, chest pain, SOB, leg pains, or changes in vision to the physician. Inform about common adverse reactions of therapy (eg, headache, breast pain, irregular bleeding/spotting, stomach/abdominal cramps/bloating, N/V, hair loss). Instruct to have an annual breast exam and mammogram and more often (breast exam) if have family history of breast cancer or had breast lumps or an abnormal mammogram.
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