A round, white, convex, plain tablet with single score on one side and "SW" debossed on the other side.
Each tablet contains: Norethisterone 5 mg.
Pharmacology: Pharmacodynamics: Norethisterone has progestational actions similar to those of progesterone. It acts on the endometrium by converting the proliferative phase induced by oestrogen to a secretory phase. It inhibits the secretion of pituitary gonadotropins, which in turn presents follicular maturation and ovulation. Norethisterone is a more potent inhibitor of ovulation than progesterone and, in addition, it has weak oestrogenic and androgenic properties.
Pharmacokinetics: Norethisterone has pharmacological properties similar to progesterone.
Norethisterone is absorbed from the gastrointestinal tract, and its effect lasts for at least 24 hours.
When injected, it is detectable in the plasma after 2 days and is not completely excreted in the urine after 5 days.
At low dose: Dysfunctional uterine bleeding, polymenorrhoea, menorrhagia, metropathia haemorrhagia, pre-menstrual syndrome, postponement of menstruation.
At high dose: Disseminated carcinoma of the breast.
Recommended Dosage: Low dose: Dysfunctional uterine bleeding, polymenorrhoea, menorrhagia, dysmenorrhoea, and metropathia haemorrhagia: 1 tablet three times daily for 10 days; bleeding usually stops within 48 hours. Withdrawal bleeding resembling true menstruation occurs a few days after the end of treatment. One tablet twice daily, from days 19 to 26 of the two subsequent cycles, should be given to prevent recurrence of the condition.
Endometriosis: 1 tablet three times daily for a minimum treatment period of six months. The dosage should be increased to 4 or 5 tablets a day if spotting occurs. The initial dosage should be resumed when bleeding or spotting stops.
Postponement of menstruation: 1 tablet three times daily, starting three days before the expected onset of menstruation. Menstruation usually follows within three days of finishing the treatment.
Pre-menstrual syndrome: 1 tablet daily from days 16 to 25 of the menstrual cycle.
High dose: For disseminated breast carcinoma, the starting dose is 8 tablets (40 mg) per day, increasing to 12 tablets (60 mg) if no regression is noted.
Route of Administration: Oral.
Symptoms and Treatment of Overdose: Symptoms of overdosage include nausea, vomiting, breast enlargement, and vaginal bleeding.
There is no specific antidote and treatment should be symptomatic. Gastric lavage may be employed if the overdosage is large and the patient is seen sufficiently early (within 4 hours).
Thrombophlebitis, thromboembolic disorders, cerebral apoplexy or patients with a past history of these conditions.
Known or suspected carcinoma of the breast.
Undiagnosed vaginal bleeding.
Missed abortion.
As a diagnostic test for pregnancy.
Because of the occasional occurrence of thrombophlebitis and pulmonary embolism in patients taking progestogens, the physician should be alerted to the earliest manifestations of the disease.
This drug may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, asthma, cardiac or renal dysfunction, require careful observation.
In cases of breakthrough bleeding, as in all cases of irregular bleeding per vagina, non-functional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated.
A decrease in glucose tolerance has been observed in a small percentage of patients on oestrogen-progestogen combination drugs. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving progestogen therapy. Steroid hormones are metabolized by the liver, therefore, these drugs should be administered with caution in patients with impaired liver function.
Effects on Ability to Drive and Use Machines: Not applicable.
The use of norethisterone during the first four months of pregnancy is not recommended.
Norethisterone given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. Detectable amounts of progesterone.
Breakthrough bleeding; Spotting; Change in menstrual flow; Amenorrhea; Oedema; Changes in weight; Changes in cervical mucous and cervical secretion; Cholestatic jaundice; Rash (allergic) with and without pruritus; Melasma or chloasma; Mental depression; Nausea; Headache; Visual disturbances.
The concomitant use of oestrogens with progestogens may render less effective, and an increased incidence of breakthrough bleeding may occur by virtue of drug interaction with rifampicin, isoniazid, ampicillin, tetracycline, neomycin, penicillin, chloramphenicol, sulphonamides, nitrofurantoin, barbiturates, phenytoin, primidone, analgesics, tranquilisers, antimigraine preparations and antihistamines.
They may also alter the effectiveness of drugs such as oral anticoagulants, anticonvulsants, tricyclic antidepressants, antihypertensive agents (e.g. guanethidine), vitamins, hypoglycaemic agents, tranquilisers, hypnotic preparations and theophylline.
Store at or below 30°C.
Shelf-life: 4 years.
G03DC02 - norethisterone ; Belongs to the class of estren derivative progestogens used in progestogenic hormone preparations.
Sunolut tab 5 mg
5 × 10 × 10's
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