Etiro-N Dosage & Drug Information

Indications/Uses

Dysfunctional bleeding, primary & secondary amenorrhea, premenstrual syndrome, cyclic mastopathy, timing of menstruation, endometriosis.

Dosage/Direction for Use

Dysfunctional bleeding 1 tab 3 times daily for 10 days. Prophylaxis: 1 tab 1-2 times daily on day 16-25. Primary & secondary amenorrhea 1 tab 1-2 times daily for 10 days. In patients whose endogenous estrogen production has reached the target, menstrual cycle induction can be started by 1 tab 2 times daily on day 16-25. Premenstrual syndrome & cyclic mastopathy 1 tab 1-3 times daily. Timing of menstruation 1 tab 2-3 times daily for ≤10-14 days, 3 days prior to menstrual expectations. Endometriosis 1 tab 2 times daily on the 5th day of cycle, may increase to 2 tab twice daily if bleeding/spotting occurs.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Current or have a history of venous or arterial thrombosis or thromboemboli (eg, DVT, pulmonary emboli, MI) or cerebrovascular attack. Current or have a history of prodromal thrombosis (transient ischemic attack, angina pectoris). High risk of venous or arterial thrombosis. Migraine history w/ focal neurological symptoms. DM w/ vascular inclusion. Current or have a history of severe liver disease; liver tumor (benign or malignant). Known or suspected malignancy which is influenced by sex hormones. Suspected pregnancy. Lactation.

Special Precautions

Patients w/ a personal or family history of VTE. Hepatic tumor should be considered in patients suffering from upper abdominal pain, liver enlargement or signs of intra-abdominal bleeding. Close medical supervision should be performed in patients w/ diabetes. Women w/ tendency of chloasma should avoid sunlight exposure or UV radiation. Patients w/ a history of depression.

Adverse Reactions

Uterine or vag bleeding including spotting & hypomenorrhea, amenorrhea, edema, nausea, headache, migraine, hypersensitivity reactions, urticaria, rash, visual disturbances, dyspnea.

View ADR Reporting Link

Drug Interactions

Concomitant use w/ phenytoin, barbiturate, primidone, carbamazepine, rifampicin, oxcarbazepine, St. John’s wort, rifabutin, griseofulvin, cyclosporins.

MIMS Class

Oestrogens, Progesterones & Related Synthetic Drugs

ATC Classification

G03AC01 - norethisterone ; Belongs to the class of progestogens. Used as systemic contraceptives.

Regulatory Classification

K

Presentation/Packing

Form

Etiro-N tab 5 mg

Packing/Price

3 × 10's

Etiro-N

norethisterone

Manufacturer:

Lapi