norethindrone acetate


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norethindrone acetate

Aygestin, Camila, Errin, Jolivette, Nora-BE, Nor-QD, Ortho Micronor

Pharmacologic class: Progesterone, hormone

Therapeutic class: Progestin

Pregnancy risk category X

Action

Inhibits pituitary gonadotropin secretion, suppressing follicular maturation and ovulation and stimulating mammary tissue growth

Availability

Tablets: 0.35 mg, 5 mg

Indications and dosages

Endometriosis

Adults: 5 mg Aygestin P.O. daily for 2 weeks, increased in increments of 2.5 mg/day q 2 weeks until 15 mg daily is reached

Amenorrhea; abnormal uterine bleeding

Adults: 2.5 to 10 mg Aygestin P.O. daily starting on day 5 of menstrual cycle

Prevention of pregnancy

Adults: 1 tablet (0.35 mg) P.O. daily

Contraindications

• Hypersensitivity to drug

• Impaired liver function or liver disease

• Thromboembolic disorders

• Known or suspected breast cancer

• Undiagnosed vaginal bleeding

• Known or suspected pregnancy

• As a diagnostic test for pregnancy

Precautions

Use cautiously in:

• hypertension, blood dyscrasias, bone marrow disease, hepatic or renal disease, gallbladder disease, heart failure, diabetes mellitus, depression, migraine, asthma, seizure disorder

• family history of breast or reproductive tract cancer

• breastfeeding patients.

Administration

• Give with or without food.

• When administering for endometriosis, amenorrhea, or abnormal uterine bleeding, know that therapy may continue for 6 to 9 months or until breakthrough bleeding necessitates a temporary halt.

• When administering for prevention of pregnancy, know that drug must be given continuously every day at the same time with no interruptions between pill packs.

Adverse reactions

CNS: migraine, depression, insomnia, drowsiness

EENT: retinal vascular lesions, sudden partial or complete vision loss, proptosis, diplopia, papilledema

GI: nausea

GU: breakthrough bleeding, menstrual flow changes, amenorrhea, changes in cervical erosion and secretions, breast tenderness and secretion

Hepatic: cholestatic jaundice

Metabolic: fluid retention, decreased glucose tolerance

Skin: rash, urticaria, acne, hirsutism, chloasma

Other: edema, weight gain or loss, fever

Interactions

Drug-drug. Hepatic enzyme-inducing drugs (such as carbamazepine, phenobarbital, phenytoin, rifampin): decreased norethindrone efficacy

Drug-diagnostic tests. Alkaline phosphatase; amino acids; factors VII, VIII, IX, and X; nitrogen; pregnanediol: increased levels

Gamma-glutamyltransferase, high-density lipoproteins: decreased levels

Drug-herbs. Cola nut, guarana, yerba maté: increased CNS stimulation St. John's wort: decreased contraceptive efficacy

Drug-behaviors. Smoking: risk of serious cardiovascular reactions

Patient monitoring

• Monitor pretreatment and annual physical exams to check blood pressure, breasts, abdomen, pelvic organs, and Pap smear results.

Assess for signs and symptoms of depression, especially in patients with history of depression. Stop giving drug if significant depression recurs.

• Check blood glucose level in diabetic patients.

Patient teaching

• Instruct patient to avoid pregnancy or to discontinue drug if she gets pregnant (may cause serious fetal anomalies or fetal death).

Advise patient to discontinue drug and consult prescriber if she experiences sudden partial or complete vision loss.

• If patient is receiving drug to treat amenorrhea, tell her to mark administration days on calendar.

• Instruct patient taking drug to prevent pregnancy to take drug every day at the same time without interruption between pill packs.

• Tell diabetic patient to monitor blood glucose level closely and to watch for hyperglycemia.

• Instruct patient to report breakthrough bleeding, spotting, change in menstrual flow, or amenorrhea.

• Caution patient not to smoke during therapy.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

References in periodicals archive ?
Mark Laufer, chief of gynecology at Children's, reported on 129 adolescents with surgically diagnosed endometriosis treated with norethindrone acetate from 1992 to 2010 by one gynecologist at a single children's hospital.
I've always used norethindrone acetate as the one stopgap that could stop women from bleeding," but it didn't work in these cases, Dr.
Use of norethindrone acetate alone for postopera tive suppression of endometriosis symptoms.
Efficacy of continuous sequential transdermal estradiol and norethindrone acetate in relieving vasomotor symptoms associated with menopause.
The agreement also would settle litigation between the two companies over Galen's femhrt hormone therapy and Estrostep oral contraceptives (both containing norethindrone acetate and ethinyl estradiol).
Treatment of symptomatic rectovaginal endometriosis with an estrogen-progestogen combination versus low-dose norethindrone acetate.
Various hormonal regimens were used in these studies, including conjugated equine estrogen (CEE) alone, CEE plus medroxyprogesterone acetate, CEE with trimegestone, estradiol-17[beta] with trimegestone, and estradiol-17[beta] with norethindrone acetate.
Various hormonal regimens were used in these four studies, including conjugated equine estrogen (CEE), CEE plus medroxy-progesterone acetate, CEE with trimegestone, estradiol-17[beta] with trimegestone, and estradiol-17[beta] with norethindrone acetate.
Pharmaceutical company Mylan (NasdaqGS:MYL) revealed on Wednesday the introduction of its Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.
As my coauthors and I pointed out in our article, postoperative suppression with norethindrone acetate, continuous hormonal contraception, or a levonorgestrel intrauterine device is an essential component of long-term management of endometriosis.
Another study comparing Mirena with norethindrone acetate showed that Mirena was significantly more effective in reducing bleeding.