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 ?
Formation of ethinyl estradiol in women during treatment with norethindrone acetate. J Clin Endocrinol Metab.
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.
Option 5 is based on extrapolation from high-quality studies of leuprolide acetate depot plus norethindrone acetate add-back.
In my practice, I frequently use oral norethindrone acetate 5 mg daily to treat pelvic pain caused by endometriosis.
Allergan plc, a leader in women's healthcare and the maker of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets), announced today the launch of the Know Your Birth ControlSM campaign with top comedic actress Vanessa Bayer and OB/GYN Jessica Shepherd, M.D., M.B.A.
Eligible women will be randomized to one of three groups: relugolix 40 mg orally once daily co-administered with low-dose hormonal add-back therapy (1 mg estradiol/0.5 mg norethindrone acetate) for 24 weeks, relugolix 40 mg orally once daily monotherapy for 12 weeks followed by relugolix 40 mg once daily co-administered with hormonal add-back therapy for an additional 12 weeks, or placebo once daily for a period of 24 weeks.
The company said TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), 1mg/20mcg is the first and only oral contraceptive in a softgel capsule for the prevention of pregnancy.
The company also says that it has received final approval from the FDA for norethindrone acetate and ethinyl estradiol tablets (0.5 mg/2.5 meg and 1 mg/5 meg), a generic version of Warner Chilcott Ltd.'s FemHRT, a treatment for osteoporosis as well as the symptoms of menopause, including hot flashes and vaginal dryness, burning and irritation.
"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.
Drug Daily Dosage norgestimate and ethinyl estradiol 180-250 [micro]g (Ortho Tri-Cyclen) norgestimate and 35 [micro]g ethinyl estradiol norethindrone acetate and 1 mg norethindrone acetate ethinyl estradiol (Estrostep) and 20-35 [micro]g ethinyl estradiol Ievonorgestrel and ethinyl 100 [micro]g levonorgestrel estradiol (Alesse) and 20 [micro]g ethinyl estradiol Drug Cost/Day * norgestimate and ethinyl estradiol $1.11 (Ortho Tri-Cyclen) norethindrone acetate and $1.18 ethinyl estradiol (Estrostep) Ievonorgestrel and ethinyl $1.13 estradiol (Alesse) Drug Comment ** norgestimate and ethinyl estradiol First birth conrol pill with (Ortho Tri-Cyclen) FDA approval for acne.
The OEPs with drospirenone, norgestimate, desogestrel, or norethindrone acetate may be optimal choices for the treatment of acne caused by PCOS.
llergan plc,a leading global pharmaceutical company, today announced the availability of TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), 1mg/20mcg, the first and only oral contraceptive in a softgel capsule for the prevention of pregnancy."As a leader in women's healthcare, we are pleased to bring to market TAYTULLA, the first and only oral contraceptive in a softgel capsule, providing women with an important new and effective option to consider with their healthcare providers," said Bill Meury, Chief Commercial Officer at Allergan.