Zydus Healthcare Ltd.
Primolut N 5Mg Tablets
Primolut N 5Mg Tablets
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SPECIFICATION
Requires Prescription (YES/NO)
Yes
Generics
Norethisterone
Used For
Menstrual Problem
How it works
As a synthetic progestin, norethisterone acts similarly to endogenous progesterone but with a much higher potency - it acts at the pelvic level to alter cervical and endometrial function, as well as via the inhibition of pituitary hormones that play a role in follicular maturation and ovulation.
USAGE AND SAFETY
Dosage
Norethisterone
Side Effects
Liver disturbances , virilization.
Drug Interactions
Substances increasing the clearance of sex hormones (diminished efficacy by enzyme induction), e.g: Phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, rifabutin and products containing St. John’s wort. Substances with variable effects on the clearance of sex hormones, e.g.: When co-administered with sex hormones, many HIV/HCV protease inhibitors and nonnucleoside reverse transcriptase inhibitors can increase or decrease plasma concentrations of estrogen or progestin. These changes may be clinically relevant in some cases. Substances decreasing the clearance of sex hormones (enzyme inhibitors): Strong and moderate CYP3A4 inhibitors such as azole antifungals (e.g. itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of the estrogen, or the progestin, or both .
Indication
Postponement of menstruation , Dysmenorrhoea, Menorrhagia and pre-menstrual syndrome, Metropathia haemorrhagic, polymenorrhoea and Endometriosis.
When not to Use
Hypersensitivity to the active substance or to any of the excipients • 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 of a history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris).
Precaution
Treatment should be stopped at once if there are symptoms of an arterial or venous thrombotic event or suspicion thereof.
Warning 1
Diabetes mellitus must be actively excluded as this disease requires careful supervision. The requirements for oral antidiabetics or insulin may change.
Warning 2
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation when taking this medicine.
Warning 3
Depressed mood and depression are well-known undesirable effects of hormonal containing products. Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their medical practitioner in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
ADDITIONAL INFORMATION
Pregnancy category
Always consult your physician before using any medicine.
Storage (YES/NO)
Store this medicine at room temperature, away from direct light and heat.
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