Norcolut

Norcolut

norethisterone

Manufacturer:

Gedeon Richter

Distributor:

Pahang Pharmacy
Concise Prescribing Info
Contents
Norethisterone
Indications/Uses
Menorrhagia/hypermenorrhoea; cystic glandular endometrial hyperplasia; inhibition of lactation.
Dosage/Direction for Use
Menorrhagia/hypermenorrhoea 15 mg daily from 5th-26th day of cycle. Cystic glandular endometrial hyperplasia 10-15 mg daily for 6-12 days. Prevention of lactation During 16th-28th wk in interrupted pregnancies: 15 mg on day 1, 10 mg on days 2-3 & 5 mg on days 4-7. During 28th-36th wk in interrupted pregnancies: 15 mg on day 1, 10 mg on days 2-3 & 10 mg on days 4-7. Ablactation Day after delivery: 20 mg on days 1-3, 15 mg on days 4-7 & 10 mg on days 8-10.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Presence or risk of VTE & arterial thromboembolism (ATE); known hereditary or acquired predisposition for VTE & ATE; major surgery w/ prolonged immobilisation; cerebrovascular disease, current stroke, history of stroke or prodromal condition eg, transient ischaemic attack; history of migraine w/ focal neurological symptoms; multiple risk factor(s) for VTE or ATE eg, DM w/ vascular symptoms, severe HTN & dyslipoproteinemia; presence or history of benign or malignant liver tumours, pancreatitis associated w/ severe hypertriglyceridaemia; known or suspected sex steroid-influenced malignancies of genital organs or breasts; undiagnosed vag bleeding. Concomitant use w/ ombitasvir-/paritaprevir-/ritonavir-/dasubuvir-/ glecaprevir-/pibrentasvir-containing medicinal products. Severe hepatic disease. Idiopathic jaundice or severe pruritus during pregnancy. Pregnancy & lactation.
Special Precautions
Increased risk of VTE or ATE; +ve family history of VTE or ATE, obesity (BMI >30 kg/m2), increasing age (>35 yr), smoking, cancer, SLE, haemolytic uraemic syndrome, Crohn's disease or ulcerative colitis, sickle cell disease; HTN, migraine, DM, hyperhomocysteinaemia, valvular heart disease, atrial fibrillation, dyslipoproteinaemia; breast & cervical cancer; benign or malignant liver tumours. Depression; hypertriglyceridaemia, pancreatitis; glucose intolerance/diabetes. Prolonged immobilisation, major surgery or trauma, any leg or pelvis surgery. May induce or exacerbate symptoms of angioedema. Recurrence of cholestatic jaundice. Chloasma; avoid exposure to sun or UV radiation. Perform medical exam including BP measurement, breast, abdomen, internal & external genital organs exam, cervical smear & appropriate lab tests prior to therapy. Avoid exposure to sun or UV radiation. Concomitant use of ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin; glecaprevir/pibrentasvir. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Acute or chronic hepatic function disturbances. Not indicated during pregnancy. Avoid use during lactation.
Adverse Reactions
Anaphylactic reaction, hypersensitivity; depression; dizziness, headache, migraine; visual disturbances; cerebral embolism, cerebral & deep vein thrombosis; pulmonary embolism; abdominal pain, nausea, vomiting, jaundice cholestatic; acne, alopecia, chloasma; pain in extremity; amenorrhoea, dysmenorrhoea, menstrual disorder, breakthrough bleeding, breast enlargement, tenderness, soreness & pain, genital discharge, ovarian cyst; oedema; wt gain.
Drug Interactions
Enhanced metabolism & decrease serum conc by rifampicin, rifabutin & rifamycin derivatives. Diminished efficacy by oxcarbazepine, carbamazepine, eslicabazepin, clobazam, perampanel, primidone, topiramate, rufinamid, felbamate, phenytoin, phosphenytoin. Decreased serum conc by antiretroviral drugs eg, PIs (eg, lopinavir) & NNRTIs (eg, nevirapine); bile acid sequestrant, colesevelam, prucalopride, sugammadex, lumacaftor, mifepriston, ulipristal, mycophenolate, lesinurad. Increased serum conc by atazanavir, cobicistat, boceprevir, tripranavir; griseofulvin. Reduced efficacy by some antidiabetics, retionoid, antiemetic, antimalarial, anticancer drugs. Inhibited metabolism by 5α-reductase inhibitors eg, finasteride & dutasteride. Altered circulating levels by St John's wort, bosentan, deferasirox, mitotane, sarilumab, siltuximab and tocilizumab. Reduced plasma conc of lamotrigine. Diminished therapeutic efficacy of anticoagulants, antidiabetics. Enhance thrombogenic effect of C1 inhibitors, tranexamic acid, thalidomide & pomalidomide. Increase serum conc of voriconazole. Enhance hepatotoxic effect of cyclosporine. Increase the risk of ALT elevations w/ ombitasvir-/paritaprevir-/ritonavir-/dasubuvir-/ glecaprevir-/pibrentasvir-containing medicinal products. Interference w/ lab tests results.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DC02 - norethisterone ; Belongs to the class of estren derivative progestogens used in progestogenic hormone preparations.
Presentation/Packing
Form
Norcolut tab 5 mg
Packing/Price
20's (RM4/pack)
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