Dienosis

Dienosis

dienogest

Manufacturer:

NaariEsta

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dienogest
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Thromboembolic disorder. History of or current severe arterial disease including CV disease (eg, heart attack, stroke or heart disease causing angina pectoris). Patients w/ diabetes w/ vascular damage. Patients who suffered, are suffering or suspected to be suffering from malignant sex-hormone dependent tumour (eg, breast or genital cancer). Unexplained vag bleeding. History of or current severe hepatic disease; benign or malignant hepatic tumour. Monitor for signs & symptoms of hepatic disease (eg, skin yellowing &/or whole-body itching). Pregnancy & lactation.
Special Precautions
Not for concomitant use w/ hormonal contraceptives of any form (tab, patch, IUD). Not a contraceptive. Patient or family history of VTE at a relatively early age. Family history of breast cancer. History of depression. Patients w/ high BP or who developed high BP & hepatic disease, or suffering from lower abdominal pain during therapy. Diabetes. Temporary diabetes during previous pregnancy. Avoid too much sun or UV radiation exposure in patients who had chloasma. May worsen benign uterine tumours; discontinue when anemia occurs during treatment. Possible changes in menstrual bleeding pattern. Increased risk of VTE in the elderly, patients who are overwt, has or w/ family history of thrombosis, embolism or pulmonary embolism at an early age, for surgery or w/ history of serious accident or is on a long-term immobilization. Increased risk of stroke in women w/ HTN. Increased risk of arterial blood clot in smokers, overwt, patient or family history of heart attack or stroke at a young age, patients w/ HTN. Regularly monitor for breast lumps. Patients w/ glucose intolerance. May affect the result of blood tests. Development of hepatic disease during therapy. Patients w/ hepatic disease symptoms during previous pregnancy. Reduced chances of pregnancy during therapy. Increased risk of extrauterine pregnancy when taken during pregnancy. Possible risk of osteoporosis in adolescents <18 yr. Not for girls premenarche.
Adverse Reactions
Wt gain; depressed mood, sleeping problems, nervousness, loss of libido, changed mood; headache or migraine; nausea, abdominal pain, bloating, swollen stomach or vomiting; acne or hair loss; back pain; breast discomfort, ovarian cyst or hot flushes; uterine or vag bleeding including spotting; weakness or irritability.
Drug Interactions
Possible influence on blood levels w/ medicines used for epilepsy (eg, phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate); TB (eg, rifampicin); HIV & hepatitis C virus infections [PIs & non-nucleoside reverse transcriptase inhibitors (eg, ritonavir, nevirapine, efavirenz); fungal infections (eg, griseofulvin, ketoconazole); St. John's wort. Blood levels & risk of side effects may be increased by w/ grapefruit juice. May affect some lab test results.
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
Dienosis tab 2 mg
Packing/Price
2 × 14's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in