Dyana
Generic Name
Dienogest 2 mg + Ethinylestradiol 0.03 mg
Manufacturer
Bayer
Country
Germany
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
dyana 2 mg tablet | ৳ 210.00 | N/A |
Description
Overview of the medicine
Dyana is a combined oral contraceptive pill containing Dienogest and Ethinylestradiol. It is primarily used for contraception and for the treatment of moderate acne and symptoms of mild to moderate hirsutism in women who choose oral contraception.
Uses & Indications
Dosage
Adults
One tablet daily for 21 consecutive days, followed by a 7-day tablet-free interval. Start a new pack after the 7-day interval, even if bleeding has not stopped or has not started. Tablets should be taken at approximately the same time each day.
Elderly
Not indicated for postmenopausal women. No specific dosage adjustment required for elderly women in reproductive age, but use with caution and consider individual risk factors.
Renal_impairment
No specific studies have been conducted. Dyana is contraindicated in severe renal impairment. In mild to moderate cases, use with caution under medical supervision.
How to Take
Dyana tablets should be swallowed whole with a little liquid, at approximately the same time each day. The first tablet should be taken on the first day of the menstrual cycle (first day of bleeding).
Mechanism of Action
This medicine works by suppressing ovulation, altering cervical mucus to make it more difficult for sperm to penetrate, and thinning the endometrium to prevent implantation. Dienogest also has anti-androgenic properties that help in the treatment of acne and hirsutism.
Pharmacokinetics
Onset
Contraceptive efficacy begins after 7 consecutive days of correct use, with full effect typically after one menstrual cycle.
Excretion
Metabolites of Dienogest are excreted via urine and feces. Ethinylestradiol metabolites are primarily excreted renally and fecally, predominantly as glucuronide and sulfate conjugates.
Half life
Dienogest has a terminal half-life of approximately 9-10 hours. Ethinylestradiol has a terminal half-life of approximately 10-24 hours.
Absorption
Both Dienogest and Ethinylestradiol are rapidly and almost completely absorbed after oral administration. Peak plasma concentrations are reached within 1-4 hours.
Metabolism
Both components are extensively metabolized in the liver. Dienogest undergoes hydroxylation and conjugation. Ethinylestradiol is primarily metabolized via aromatic hydroxylation.
Side Effects
Contraindications
- Presence or history of venous or arterial thrombotic/thromboembolic events (e.g., DVT, PE, MI, stroke)
- Presence or history of prodromi of a thrombosis (e.g., transient ischaemic attack, angina pectoris)
- Severe liver disease (current or history)
- Known or suspected hormone-sensitive malignancies (e.g., breast or genital organ cancers)
- Undiagnosed vaginal bleeding
- Pancreatitis or a history of pancreatitis if associated with severe hypertriglyceridaemia
- Migraine with focal neurological symptoms (e.g., with aura)
- Diabetes mellitus with vascular complications
- Severe hypertension
- Hypersensitivity to the active substances or to any of the excipients
Drug Interactions
Lamotrigine
Combined oral contraceptives can significantly reduce plasma concentrations of lamotrigine, potentially leading to a loss of seizure control.
Some antibiotics (e.g., Ampicillin, Tetracycline)
May decrease efficacy by reducing enterohepatic circulation of estrogens, though clinical relevance is debated.
Protease inhibitors (e.g., Ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g., Nevirapine)
Can affect the metabolism of combined oral contraceptives, potentially reducing efficacy.
Enzyme-inducing drugs (e.g., Phenytoin, Barbiturates, Rifampicin, Carbamazepine, Oxcarbazepine, Topiramate, Felbamate, Griseofulvin, St. John's Wort)
Can lead to increased clearance of sex hormones, resulting in reduced contraceptive efficacy and breakthrough bleeding.
Storage
Store below 30°C. Protect from light and moisture. Keep out of the sight and reach of children.
Overdose
There have been no reports of serious harmful effects from overdose. Symptoms that may occur include nausea, vomiting, and withdrawal bleeding in females.
Pregnancy & Lactation
Dyana is contraindicated during pregnancy. If pregnancy occurs while taking Dyana, the preparation must be withdrawn immediately. It is generally not recommended during lactation, as it may reduce the quantity and change the composition of breast milk, and small amounts of the active substances may be excreted into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture. Refer to the specific packaging for exact expiry date.
Availability
Available in pharmacies
Approval Status
Approved
Patent Status
Off-patent
Clinical Trials
Extensive clinical trials have established the efficacy and safety of combined oral contraceptives for contraception, and specific trials have demonstrated the efficacy of Dienogest and Ethinylestradiol combination in treating moderate acne and hirsutism.
Lab Monitoring
- Regular blood pressure monitoring
- Lipid profile (periodically, especially with risk factors)
- Liver function tests (if symptoms arise)
- Glucose tolerance test (especially in patients with diabetes risk factors)
Doctor Notes
- Emphasize the importance of strict adherence to the dosage regimen for optimal contraceptive efficacy and cycle control.
- Thoroughly assess patient's medical history for contraindications, especially regarding thrombotic risk factors (e.g., smoking, age, family history, obesity, hypertension).
- Educate patients about the signs and symptoms of serious adverse events (e.g., DVT, stroke) and advise them to seek immediate medical attention if these occur.
- Advise on concomitant medications, especially enzyme inducers, and the need for additional contraceptive methods.
Patient Guidelines
- Take one tablet daily at the same time each day for 21 days, followed by a 7-day break.
- Never skip tablets. If you miss a tablet, follow the instructions in the patient leaflet immediately.
- Use additional barrier contraception (e.g., condoms) if you vomit or have severe diarrhea within 3-4 hours of taking a tablet, or if you are taking interacting medications.
- Attend regular medical check-ups, including blood pressure measurements and gynecological examinations.
Missed Dose Advice
If a tablet is missed, take it as soon as remembered. If it is less than 12 hours late, contraceptive protection is not reduced. If it is more than 12 hours late, contraceptive protection may be reduced. Refer to the patient information leaflet for specific guidance based on the week of missed dose, and consider using additional barrier methods.
Driving Precautions
Dyana is not known to affect the ability to drive or operate machinery.
Lifestyle Advice
- Avoid smoking, especially if you are over 35, as it significantly increases the risk of serious cardiovascular events.
- Maintain a healthy weight and engage in regular physical activity to reduce the risk of thrombosis.
- Discuss any personal or family history of blood clots or other cardiovascular conditions with your doctor.
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