NORETHINDRONE ACETATE (norethindrone acetate)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Carcinoma of breast
Porphyria
Pregnancy

There are 13 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Acute myocardial infarction
Cerebrovascular accident
Deep venous thrombosis
Disease of liver
Edema
Obesity
Papilledema
Predisposition to thrombosis
Pulmonary thromboembolism
Systemic lupus erythematosus
Thromboembolic disorder
Thrombophlebitis
Tobacco smoker

There are 8 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Chronic heart failure
Depression
Diabetes mellitus
Hyperlipidemia
Hypertension
Kidney disease with reduction in glomerular filtration rate (GFr)
Migraine
Seizure disorder

There are 26 severe adverse reactions.

More Frequent	Less Frequent
Abdominal distension Abnormal vaginal bleeding Irregular menstrual periods	Endometrial hyperplasia

Rare/Very Rare

Abnormal hepatic function tests Acute myocardial infarction Anaphylaxis Angioedema Depression Ectopic pregnancy Erythema multiforme Erythema nodosum Galactorrhea not associated with childbirth Hypersensitivity drug reaction Hypertension Malignant neoplasm of the ovary Menorrhagia Obstructive hyperbilirubinemia Optic neuritis Ovarian cyst Pancreatitis Pruritus of skin Pulmonary thromboembolism Retinal thrombosis Thromboembolic disorder Thrombophlebitis

There are 37 less severe adverse reactions.

More Frequent	Less Frequent
Back pain Edema Fatigue Headache disorder Myalgia Vaginitis Weight loss	Dizziness Dyspepsia Ectropion of cervix Hypertonia Palpitations Vaginal discharge

Rare/Very Rare
Acne vulgaris Alopecia Amenorrhea Body fluid retention Cervical discharge Chloasma Constipation Cystitis Drowsy Fever Fibrocystic breast disease Hirsutism Hyperglycemia Insomnia Irritability Mastalgia Migraine Nausea Nervousness Pain in extremities Skin rash Urinary incontinence Urticaria Weight gain

Although progestins have been used beginning in the first trimester of pregnancy to prevent habitual abortion or to treat threatened abortion, there is no adequate evidence from well-controlled studies to substantiate the efficacy of progestins for these uses; however, there is evidence of potential adverse effects on the fetus when these drugs are administered during the first 4 months of pregnancy. In addition, in most women, the cause of abortion is a defective ovum, which progestins could not be expected to influence. Because of their uterine-relaxant effects, progestins may delay spontaneous abortion of fertilized defective ova.

Masculinization of the female fetus has reportedly occurred when progestins were used during pregnancy. Clitoral hypertrophy and fusion of the labia have been reported in a few female neonates born to women who had received medroxyprogesterone during pregnancy; hypospadias in male neonates born to women receiving progestational agents occurs at approximately twice the rate of occurrence in male neonates born to women not receiving the drugs. An association between intrauterine exposure to female sex hormones and congenital anomalies, including cardiovascular and limb defects, has been suggested.

(See Cautions: Pregnancy, Fertility, and Lactation, in Estrogen-Progestin Combinations 68:12.) Use of progestins, including norethindrone, is not recommended during the first 4 months of pregnancy. If a woman becomes pregnant while receiving norethindrone or is inadvertently exposed to the drug during the first 4 months of pregnancy, she should be advised of the potential risks to the fetus. Norethindrone should not be used to induce withdrawal bleeding as a test for pregnancy.

Progestins are reportedly distributed into milk. The manufacturers warn that the possible effects of progestins in milk on nursing infants have not been determined.

No enhanced Geriatric Use information available for this drug.