Generic
Norethisterone
11 brands available in the market
At a glance
Norethisterone is a synthetic progestin used for menstrual problems including painful, heavy or irregular periods, premenstrual syndrome (PMS) and endometriosis.
Description
Norethisterone has typical effects of a progestogen and converts the endometrium from the proliferative to the secretory phase. It also has contraceptive effects due to negative feedback inhibition of pituitary gonadotropin thus preventing ovulation.
Indications
- Dysfunctional uterine bleeding (Metropathia hemorrhagica)
- Premenstrual syndrome
- Postponement of menstruation
- Endometriosis
- Menorrhagia
Therapeutic class
Drugs for Menopausal Symptoms: Hormone Replacement Therapy, Female Sex Hormones, Oral Contraceptive Preparations
Pharmacological class
Progestin
Pharmacology
Norethisterone converts the endometrium from proliferative to secretory phase and prevents ovulation through negative feedback inhibition of pituitary gonadotropin.
Mechanism of action
Regulates menstrual irregularities and treats endometriosis.
Dosage
Dysfunctional Uterine Bleeding: 1 tablet 3 times daily for 10 days
Premenstrual Syndrome: 2-3 tablets daily (days 19-26)
Postponement of Menstruation: 1 tablet 3 times daily (start 3 days before expected period)
Endometriosis: 2 tablets daily (start day 5); may increase to 4-5 if needed; 4-6 months
Menorrhagia: 1 tablet 2-3 times daily (days 19-26)
Administration
- Swallow tablet whole; do not chew, crush or break
- Take at the same time each day
- May be taken with or without food
Missed dose
If you miss a dose, take it as soon as you remember; skip if it's almost time for next dose; do not double the dose.
Side effects
Common Side Effects:
- Headache
- Dizziness
- Breast discomfort
- Nausea
- Vaginal spotting
- Vomiting
- Abdominal cramp
- Edema
- Visual disturbance
- Migraine
- Dyspnoea
- Hypersensitivity (rash, urticaria)
Precautions & warnings
- Risk of deep vein thrombosis, stroke (especially with history)
- Risk of liver tumors
- May influence carbohydrate metabolism; monitor diabetics regularly
- Stop immediately if severe migraine, perceptual disorders, thrombophlebitis, jaundice, hypertension, pregnancy
- Caution while driving
Contraindications
- Pregnancy
- Severe disturbances of liver function
- Dubin-Johnson syndrome
- Rotor syndrome
- Previous or existing liver tumors
- History of idiopathic jaundice, severe pruritus or herpes gestationis during pregnancy
- Current thromboembolic processes
- Hypersensitivity
Drug interactions
- Concentration may be reduced by CYP450 inducers (phenobarbital, phenytoin, carbamazepine, rifampicin, rifabutin, nevirapine, efavirenz)
- Additive fluid retention with NSAIDs, vasodilators
- May increase ciclosporin concentration
- Adjustment in antidiabetic, thyroid hormone and anticoagulant therapy may be required
Food interactions
Safety with alcohol not known; consult doctor.
Use in pregnancy
Use in Pregnancy: Norethisterone is highly unsafe during pregnancy; definite evidence of fetal harm. Completely contraindicated.
Pregnancy Category: X — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Norethisterone is probably unsafe during breastfeeding; may pass into breast milk and harm the baby.
Pediatric use
Not intended for use in children.
Geriatric use
Elderly may require dose adjustment.
Renal / hepatic impairment
Renal Impairment: Limited information available; consult doctor.
Hepatic Impairment: Not recommended in severe liver disease; caution.
Overdose effects
No reports from overdosage; treatment generally unnecessary; no specific antidotes; symptomatic treatment.
Storage conditions
Store below 30°C in a cool and dry place; keep out of reach of children.
Chemical structure
Norethisterone