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Endovelle

Endovelle

dienogest

Manufacturer:

Exeltis

Distributor:

DKLL
Concise Prescribing Info
Contents
Dienogest
Dosage/Direction for Use
Administration
May be taken with or without food: Take w/o any break, preferably at the same time each day w/ some liqd.
Contraindications
Hypersensitivity. Active venous thromboembolic disorder, past or present arterial & CV disease (eg, MI, CVA, ischemic heart disease), DM w/ vascular involvement, known or suspected sex hormone-dependent malignancies, undiagnosed vag bleeding. Presence or history of severe hepatic disease & benign or malignant liver tumours.
Special Precautions
May aggravate uterine bleeding in women w/ adenomyosis uteri or uterine leiomyomata. Discontinue in anemia; long-term immobilization; symptoms of arterial or venous thrombotic event or suspicion; when depression, cholestatic jaundice &/or pruritus recur. Changes in menstrual bleeding pattern; persistent ovarian follicles. May slightly increase risk of stroke in women w/ HTN; VTE (DVT, pulmonary embolism), breast cancer. Increased risk of thromboembolism in the puerperium. Consider hepatic tumour in the differential diagnosis when severe abdominal pain, liver enlargement or signs of intra-abdominal hemorrhage occur. History of depression; diabetic women, especially those w/ history of gestational DM; history of extrauterine pregnancy or tube function impairment. Decrease in bone mineral density (BMD) in lumbar spine. Perform risk-benefit assessment in patients at increased risk of osteoporosis before starting treatment. Adequate intake of Ca & vit D. W/draw treatment in sustained HTN. Avoid exposure to sun or UV radiation during therapy in women w/ tendency to chloasma. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contraindicated in present or past severe hepatic disease. Pregnancy & lactation. Childn prior to menarche.
Adverse Reactions
Increased wt; depressed mood, sleep disorder, nervousness, loss of libido; headache, migraine; nausea, abdominal pain; acne, alopecia; breast discomfort, ovarian cyst, hot flushes, uterine/vag bleeding including spotting; asthenic conditions, irritability.
Drug Interactions
Increased clearance of sex hormones w/ phenytoin, barbiturates, primidone, carbamazepine, rifampicin, & possibly oxcarbazepine, topiramate, felbamate, griseofulvin, & products containing St. John's wort (Hypericum perforatum). Decreased steady state conc & systemic exposure w/ rifampicin. Increased or decreased plasma conc of progestin w/ HIV PIs, NNRTIs & HCV inhibitors. Increased plasma conc w/ strong (eg, ketoconazole) & moderate (eg, erythromycin) CYP3A4 inhibitors.
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
Endovelle tab 2 mg
Packing/Price
1 × 28's
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