Norcolut

Premenstruation syndrome, postponement of menstruation, mastodynia, cycle disturbance involving shortening of secretory phase, dysfunctional uterine bleeding, cystic glandular endometrial hyperplasia, endometriosis, adenomyosis. Prevention of lactation, ablactation. Dysfunctional bleeding disturbances during menopause.

Premenstrual syndrome, mastodynia, irregular cycles 1-2 tab daily from 16th-25th day of cycle possibly w/ oestrogen. Dysfunctional uterine bleeding & glandular cystic endometrial hyperplasia 1-2 tab daily for 6-12 days. Prevent relapse 1-2 tab daily from 16th-25th day of cycle combined w/ oestrogen. Endometriosis, adenomyosis 1 tab daily from 5th-25th day of cycle for 6 mth or ½ tab daily continuously from 5th day of cycle, increased dose by ½ tab every 2-3 wk for 4-6 mth. Postponement of menstruation 1 tab tds for max: 10-14 days, starting 3 days before expected onset of menstruation. Prevent lactation 3 tab on day 1, 2 tab on days 2-3 then 1 tab on days 4-7 during wk 16-28 in interrupted pregnancies & 3 tab on day 1, 2 tab on days 2-7 during wk 28-36 in interrupted pregnancies. Ablactation 4 tab on days 1-3, 3 tab on days 4-7 then 2 tab on days 8-10 day after delivery. Dysfunctional bleeding disturbances during menopause 1 tab for 10-20 days in 2nd half of cycle completed w/ oestradiol therapy.

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 genital organs or breasts malignancies; undiagnosed vag bleeding. Concomitant use w/ ombitasvir-/paritaprevir-/ritonavir-/dasubuvir-/ glecaprevir-/pibrentasvir-/sofosbuvir-/velpatasvir-/voxilaprevir-containing medicinal products. Severe hepatic disease. Idiopathic jaundice or severe pruritus during pregnancy. Pregnancy & lactation.

Increased risk of VTE or ATE; +ve family history of VTE or ATE, obesity (BMI >30 kg/m²), increasing age (>35 yr), cancer, SLE, haemolytic uraemic syndrome, Crohn's disease or ulcerative colitis, sickle cell disease; smoking, HTN, migraine, DM, hyperhomocysteinaemia, valvular heart disease, atrial fibrillation, dyslipoproteinaemia; breast & cervical cancer; benign or malignant liver tumours; epilepsy, asthma, cardiac dysfunction. Depression; hypertriglyceridaemia, pancreatitis; glucose intolerance/diabetes. Prolonged immobilisation, major surgery or trauma, any leg or pelvis surgery, neurosurgery. May induce or exacerbate symptoms of angioedema. Recurrence of cholestatic jaundice. Chloasma; avoid exposure to sun or UV radiation. Perform mammary & gynaecological exam, oncological check-up, medical exam including BP measurement, breast, abdomen, internal & external genital organs exam, cervical smear & appropriate lab tests prior to therapy. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Acute or chronic hepatic function disturbances. Renal dysfunction. Not indicated during pregnancy. Avoid use during lactation. Not indicated in childn.

Anaphylactic reaction, hypersensitivity, symptomatic exacerbation of angioedema; depression; dizziness, headache, migraine; visual disturbances; cerebral embolism, cerebral & deep vein thrombosis; pulmonary embolism; abdominal pain, nausea, vomiting, cholestatic jaundice; acne, alopecia, chloasma; pain in extremity; amenorrhoea, dysmenorrhoea, menstrual disorder, breakthrough bleeding, breast enlargement, tenderness, soreness & pain, genital discharge, ovarian cyst; oedema; wt gain.

Enhanced metabolism & decrease serum conc by rifampicin, rifabutin & rifamycin derivatives. Diminished efficacy by antiepileptics. Decreased serum conc by antiretroviral drugs eg, PIs (eg, lopinavir, NNRTIs (eg, nevirapine); bile acid sequestrants, colesevelam, prucalopride, sugammadex, lumacaftor, mifepristone, ulipristal, mycophenolate, lesinurad. Increased serum conc by atazanavir, cobicistat, boceprevir, tipranavir; griseofulvin. Reduced efficacy by some antidiabetics, retinoid, 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, tocilizumab. Reduced plasma conc of lamotrigine. Diminished therapeutic efficacy of anticoagulants, antidiabetics. Enhance thrombogenic effect of C1 inhibitors, tranexamic acid, thalidomide, pomalidomide. Increased serum conc of voriconazole. Enhance hepatotoxic effect of cyclosporine. ALT elevations w/ ombitasvir-/paritaprevir-/ritonavir-/dasubuvir-/ glecaprevir-/pibrentasvir-/ sofosbuvir-/velpatasvir-/voxilaprevir-containing medicinal products. Interference w/ lab tests results.

Oestrogens, Progesterones & Related Synthetic Drugs

G03DC02 - norethisterone ; Belongs to the class of estren derivative progestogens used in progestogenic hormone preparations.

C