Norifam

Each Ampoule of Norifam 1 mL contains· Norethisterone 50 mg and Estradiol Valerate 5 mg in oily solution.

Properties: Norifam Injection is a combination of two hormones Norethisterone and Estradiol Valerate. It is depot preparation. The contraceptive effect is based on an interaction of central and peripheral mechanism, primarily on ovulation inhibition and alteration of the cervical mucus. Norifam also causes morphological and enzymatic changes in the endometrium which have the effect of rendering nidation difficult. The contraceptive effect of Norifam is similar to that achieved by daily ingestion of combine oral contraceptives pills.

Norifam is indicated for the prevention of pregnancy.

The recommended dose is 1 Norifam Injection at the interval of 30 days. The first intramuscular injection is on the first day of menstrual cycle (1^st day of bleeding). The following injection is to be given regardless of the cycle pattern at intervals of 30+/-3 days. i.e, minimum 27, maximum 33 days.
Norifam must be administered extremely slowly as a deep intramuscular injection preferably intragluteal, alternatively into the upper arm. It is advised to place a plaster over the injection site after the injection to prevent any reflux of solution. A vaginal bleeding episode will occur within one to two week after the first injection. This is normal and if the treatment is continued, bleeding episodes will usually occur at 30 days interval. Pregnancy should be ruled out if no withdrawal bleeding occurs within 30 days after an injection.

Pregnancy or suspected pregnancy; Malignancy of breast; Vaginal undiagnosed bleeding; Moderate to severe hypertension; Arterial thrombosis present or in history (e.g. myocardial infarction, cerebrovascular accident); Severe liver disease; cholestatic jaundice or hepatitis; Hypersensitivity to any of the component of Norifam.

Reasons for Immediate discontinuation of Norifam: No further injections should be given in case of: 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 the signs of thrombophlebitis or thromboembolic symptoms (for example, unusual pain in or swelling of the legs, stabbing pain on breathing or coughing for no apparent reason) pain and tightness in the chest, impending operations (six weeks beforehand), immobilization (for instance after accidents). In all these cases there maybe an increased risk of thrombosis.
Further reasons for discontinuation are: Onset of jaundice, hepatitis, itching over the whole body, increase in the frequency of epileptic seizures, significant rise in blood pressure, pregnancy.
Physical Examination: A thorough general medical and Gynecological examination should be carried out before starting Norifam. Pregnancy must be excluded out. Clinical check-ups are recommended about every six months during the use of Norifam.
Retention of Fluid: As progestational drugs may cause fluid retention, conditions that might be influenced are, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction.
Return of Fertility: Ability to conceive is usually resumed within 60 days after the last Norifam injection.

Headaches, Asthenia (weakness & fatigue), Gastric upset, Weight changes, Nervousness, Changes in libido, Menstrual irregularities, Feeling of tension in breasts, Irregular bleeding.

Irregular cycles and reduced reliability of oral contraceptives may occur when this preparation are used concomitantly with drugs such as anti-convulsants, barbiturates, antibiotics, (e.g. tetracyclines, ampicillin, rifampicin, etc.). Since Norifam may interact with other drugs, patient should be informed if other medicine are being taken regularly (e.g. barbiturates, phenylbutazones, hydantoins, rifampicin, ampicillin). The need for oral anti-diabetics or insulin can change.

Store at temperatures not exceeding 30°C.

Depot Contraceptives

G03AA05 - norethisterone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

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