Giane
Generic Name
Dienogest 2 mg
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| giane 2 mg tablet | ৳ 199.50 | N/A |
Description
Overview of the medicine
Giane 2 mg tablet contains Dienogest, a synthetic progestogen, used primarily for the treatment of endometriosis. It works by suppressing the growth of endometrial tissue outside the uterus.
Uses & Indications
Dosage
Adults
One tablet (2 mg) once daily, without interruption, preferably at the same time each day, regardless of menstrual bleeding.
Elderly
Not indicated for use in elderly patients.
Renal_impairment
No specific dosage adjustment needed for mild to moderate renal impairment. No data for severe renal impairment.
How to Take
Oral. Take one tablet daily, with or without food, at approximately the same time each day. Treatment can be started on any day of the menstrual cycle.
Mechanism of Action
Dienogest acts as a selective progestin that binds to the progesterone receptors in the uterus, but also has anti-androgenic effects. It causes decidualization of endometrial tissue and inhibits the growth of ectopic endometrial implants. It also reduces the production of estrogen by suppressing the hypothalamic-pituitary-ovarian (HPO) axis, leading to a hypoestrogenic state that helps in the regression of endometriosis.
Pharmacokinetics
Onset
Clinical effects may be observed within a few weeks, with full therapeutic effect typically seen after 3-6 months of continuous use.
Excretion
Mainly through urine (approximately 60%) and feces (approximately 40%) as metabolites.
Half life
Approximately 9-10 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations are reached approximately 1.5 hours after intake.
Metabolism
Extensively metabolized by cytochrome P450 3A4 (CYP3A4) in the liver.
Side Effects
Contraindications
- Active venous thromboembolic disorder
- Arterial and cardiovascular disease (e.g., myocardial infarction, cerebrovascular accident, ischemic heart disease)
- Diabetes mellitus with vascular involvement
- Severe hepatic disease, history of severe hepatic disease (as long as liver function values have not returned to normal)
- Hepatic tumours (benign or malignant)
- Known or suspected hormone-dependent malignant tumours (e.g., of the breast or genital organs)
- Undiagnosed vaginal bleeding
- Hypersensitivity to the active substance or to any of the excipients
Drug Interactions
Oral Anticoagulants
No clinically significant interactions expected, but caution advised.
CYP3A4 Inducers (e.g., Rifampicin, Phenytoin, Carbamazepine, Barbiturates)
May decrease Dienogest plasma concentrations, reducing therapeutic effect.
CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Erythromycin, Grapefruit juice)
May increase Dienogest plasma concentrations, increasing risk of side effects.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
No serious harmful effects have been reported from overdose. Symptoms may include nausea, vomiting, and mild vaginal bleeding. No specific antidote is available; treatment should be symptomatic.
Pregnancy & Lactation
Contraindicated during pregnancy and breastfeeding. It should not be used in pregnant women because there is no need to treat endometriosis during pregnancy. Small amounts of dienogest are excreted in breast milk, so it is contraindicated during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Dienogest has been extensively studied in various clinical trials demonstrating its efficacy and safety in the treatment of endometriosis. Key studies have shown significant reduction in pelvic pain and endometriotic lesions.
Lab Monitoring
- Regular monitoring of liver function for patients with a history of hepatic disease.
- Blood pressure monitoring, especially in patients with pre-existing hypertension.
- Bone mineral density (BMD) assessment for long-term use, especially in adolescents, due to potential impact on bone health.
Doctor Notes
- Advise patients about potential irregular bleeding, especially in the initial months of treatment.
- Emphasize the importance of continuous daily administration.
- Counsel on the risk of decreased bone mineral density with prolonged use, particularly for younger patients.
Patient Guidelines
- Take the tablet at the same time every day.
- Do not stop taking the tablet without consulting your doctor.
- Inform your doctor about all other medications you are taking.
- Report any unusual vaginal bleeding or other severe side effects to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Dienogest is not known to impair the ability to drive or operate machinery. However, if you experience dizziness or other side effects that affect your concentration, avoid these activities.
Lifestyle Advice
- Maintain a healthy diet and regular exercise.
- Avoid smoking, as it may increase the risk of thromboembolic events.
- Discuss any concerns about mood changes or depression with your doctor.
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Global Brand Names
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