Nordrone 5

Rx

Indications

• Dysfunctional bleeding,
• Primary and secondary amenorrhoea,
• Premenstrual syndrome,
  Cyclical mastopathy,
• Timing of menstruation,
• Endometriosis.

Dosage

• Dysfunctional bleeding
  01 tablet is to be taken 03 times daily for 10 days.
• Occasionally, slight bleeding may occur after the initial suspension of bleeding. Also in these cases tablet intake should not be interrupted or stopped.
• Prevention of recurrenceTo prevent dysfunctional bleeding recurrence in patients with anovulatory cycles norethindrone can be administered prophylactically (1 tablet 1 to 2 times daily from the 16^th to the 25th day of the cycle (1st day of the cycle = 1st day of the last bleeding). Withdrawal bleeding occurs a few days after the last tablet intake.)
• Amenorrhoea

  Hormone treatment of secondary amenorrhoea can be carried out only after the exclusion of pregnancy. Before treatment of primary or secondary amenorrhoea is commenced the presence of a prolactin-producing pituitary tumour should be excluded. The possibility cannot be ruled out that macroadenomas increase in size when exposed to high doses of estrogen for prolonged periods of time.

• Endometrial priming with an estrogen must be carried out (e.g., for 14 days) before beginning treatment with norethindrone. Thereafter 1 tablet of norethindrone is given 1 to 2 times daily for 10 days. Withdrawal bleeding occurs within a few days after intake of the last tablet.
  In patients in whom sufficient endogenous estrogen production has been achieved, an attempt can be made to stop the estrogen treatment and to induce cyclical bleeding byadministering 1 tablet of norethindrone twice daily from the 16th to the 25th day of the cycle.
• Premenstrual syndrome, mastopathy
  One tablet of norethindrone taken 1 to 3 times daily.
• Timing of menstruation
  Monthly menstrual bleeding can be postponed with administration of norethindrone. However, this method should be restricted to users who are not at risk of pregnancy during the treatment cycle.
  1 tablet norethindrone 2 to 3 times daily for not longer than 10 – 14 days, beginning about 3 days before the expected menstruation. Bleeding will occur 2 to 3 days after medication has been stopped.
• Endometriosis
  Treatment should begin between the first and 5th day of the cycle with 1 tablet norethindrone twice daily. In the event of spotting, the dose can be increased to 2 tablets twice daily. If bleeding ceases, dose reduction to the initial dose should be considered.
  Treatment is to be continued for at least 4 to 6 months. With uninterrupted daily intake, ovulation and menstruation do not usually occur. After discontinuation of hormone treatment withdrawal bleeding will occur.

Usage

• The tablets are to be swallowed whole with some liquid.
  
• The efficacy of norethindrone could be reduced if the user forgets to take a tablet as directed.
  
• The woman should take only the last missed tablet as soon as she remembers and then continue tablet intake at her usual time on the next day.
  
• If contraceptive protection is required, additional non-hormonal (barrier) contraceptive methods should be used.

• Known or suspected pregnancy.
• Lactation.
• Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident.
• Presence or a history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris).
• A high risk of venous or arterial thrombosis.
• History of migraine with focal neurological symptoms.
• Diabetes mellitus with vascular involvement.
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
• Use of direct-acting antiviral (DAA) medicinal products containing ombitasvir, paritaprevir, or dasabuvir and combination of these.
• Presence or history of liver tumours (benign or malignant).
• Known or suspected sex hormone-dependent malignancies (e.g. of the genital organs or the breasts).
• Hypersensitivity to any ingredients of the drug.
• Dubin-Johnson syndrome.
  Rotor syndrome.
  Missed abortion.
  Undiagnosed vaginal or urinary bleeding.
  Undiagnosed breast pathology.

• Undesirable effects are more common during the first months after start of intake of norethindrone, and subside with duration of treatment.
• In the indication of endometriosis, changes in bleeding pattern including irregular bleeding, scanty bleeding and amenorrhoea may occur.

Commons

• Visual disturbances.
• Nausea.
• Headache, oedema.
• Migraine.
• Dyspnoea.
• Rash, urticaria.
• Hypersensitivity reactions.

• One should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic diseases. Treatment should be stopped at once if there are symptoms of an arterial or venous thrombotic event or suspicion thereof.
• Strict medical supervision is necessary if the patient suffers from diabetes.
• Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
• This drug may cause some degree of fluid retention.
• Breakthrough bleeding is likely to occur in patients being treated for endometriosis.
• A decrease in glucose tolerance has been observed in some patients on progestogens.
• Weight gain may be associated with the use of the medication.
• Norethindrone tablets are not to be used as a test for pregnancy or where pregnancy is suspected.
• A complete medical history should be taken and a physical and gynaecological examination should be performed prior to the initiation or reinstitution of the use of norethindrone.
• An increase in frequency or severity of migraine during treatment (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the medicine.
• Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches, sudden perceptual disorders (e.g. disturbances of vision or hearing), first signs of thrombophlebitis or thromboembolic symptoms (for example,unusual pains in or swelling of the legs, stabbing pains on breathing or coughing for no apparent reason), a feeling of pain and tightness in the chest, pending operations (sixweeks beforehand), immobilisation (for instance, following accidents), onset of jaundice, onset of anicteric hepatitis, generalised pruritus, significant rise in blood pressure, pregnancy.
• Norethindrone is only indicated after menarche.
• The use of progestogens may influence the results of certain laboratory tests.
• Nordrone 5 contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Norethindrone should not be used during pregnancy and lactation.
• The effects of this medicine on a person’s ability to drive and use machines were not assessed. However, adverse effects of this medicine include visual disturbances, dizziness and somnolence, which could affect the ability to drive or use machines.