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Vinca

Vinca

dienogest

Manufacturer:

Laboratorios Leon Farma

Distributor:

Exeltis
Concise Prescribing Info
Contents
Dienogest
Dosage/Direction for Use
1 tab daily w/o any break. May start on any day of menstrual cycle.
Administration
May be taken with or without food: Preferably taken at the same time each day.
Contraindications
Hypersensitivity. Active venous thromboembolic disorder; DM w/ vascular involvement; known or suspected sex hormone-dependent malignancies; undiagnosed vag bleeding. Presence or history of arterial & CV disease (eg, MI, CVA, ischemic heart disease); severe hepatic disease as long as liver function values have not returned to normal; liver tumours (benign or malignant).
Special Precautions
May slightly increased risk of stroke in women w/ HTN; venous thromboembolism (DVT, pulmonary embolism); breast cancer. Discontinue use in case of long-term immobilization & not to resume treatment until 2 wk after complete remobilization (at least 4 wk in advance in the case of elective surgery); recurrence of cholestatic jaundice &/or pruritus which occurred 1st during pregnancy or previous use of sex steroids. Increased risk of thromboembolism in the puerperium. Stop treatment at once if there are symptoms of arterial or venous thrombotic event or suspicion thereof. Consider hepatic tumour in the differential diagnosis when severe abdominal pain, liver enlargement or signs of intra-abdominal hemorrhage occur. Changes in bleeding pattern. Presence of significant risk factors for osteoporosis; should have adequate intake of Ca & vit D. History of depression; discontinue if depression recurs to a serious degree. Diabetic women, especially those w/ history of gestational DM. History of chloasma gravidarum; avoid exposure to the sun or UV radiation during therapy. Women w/ history of extrauterine pregnancy or tube function impairment. Persistent ovarian follicles may occur. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Non-hormonal (eg, barrier method) methods should be used if contraception is required. Should not be administered during pregnancy. Not recommended during lactation. Not indicated in childn prior to menarche. Adolescents 12-18 yr (mean decrease in bone mineral density over a treatment period of 12 mth).
Adverse Reactions
Wt increase; depressed mood, sleep disorder, nervousness, loss of libido, altered mood; headache, migraine; nausea, abdominal pain/distension, flatulence, vomiting; acne, alopecia; back pain; breast discomfort, ovarian cyst, hot flushes, uterine/vag bleeding including spotting; asthenic conditions, irritability.
Drug Interactions
Increased clearance w/ enzyme inducers eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin; oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort-containing products. Decreased systemic exposure at steady state w/ rifampicin. Increased or decreased plasma conc w/ HIV/HCV PIs & NNRTIs. May increase plasma levels w/ strong & moderate CYP3A4 inhibitors eg, azole antifungals (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem & grapefruit juice. Increased steady state plasma levels w/ ketoconazole & erythromycin. May influence the results of lab tests including biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of proteins (eg, lipid/lipoprotein fractions, carbohydrate metabolism parameters, & coagulation & fibrinolysis parameters).
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DB08 - dienogest ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
Presentation/Packing
Form
Vinca tab 2 mg
Packing/Price
28's
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