Sedron
Generic Name
Cyproterone Acetate + Ethinylestradiol
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sedron 35 tablet | ৳ 35.25 | ৳ 352.50 |
Description
Overview of the medicine
Sedron-35 Tablet is a combination oral contraceptive and anti-androgen preparation used to treat severe acne, hirsutism, and as a contraceptive for women who also need anti-androgen therapy.
Uses & Indications
Dosage
Adults
One tablet daily for 21 consecutive days, starting on the first day of menstruation. This is followed by a 7-day tablet-free interval. A new pack is started after this interval.
Elderly
Not indicated for post-menopausal women. Safety and efficacy not established.
Renal_impairment
No specific dose adjustment is generally required, but caution is advised in patients with severe renal impairment due to limited data.
How to Take
Take one tablet orally at approximately the same time each day, with some liquid if necessary. Tablets should be taken in the order directed on the blister pack. It can be taken with or without food.
Mechanism of Action
Cyproterone acetate is an anti-androgen that blocks androgen receptors and reduces androgen production. Ethinylestradiol enhances the contraceptive effect, stabilizes the menstrual cycle, and potentiates cyproterone's anti-androgenic effects by increasing sex hormone binding globulin (SHBG) levels.
Pharmacokinetics
Onset
Contraceptive protection starts after 7 consecutive days of correct tablet intake. Anti-androgenic effects on acne or hirsutism may take 3-4 months to become noticeable.
Excretion
Cyproterone acetate is excreted mainly through feces and urine (ratio ~3:7). Ethinylestradiol is primarily excreted via urine and feces as glucuronide and sulfate conjugates.
Half life
Cyproterone acetate has a terminal half-life of approximately 43 hours. Ethinylestradiol has a terminal half-life of approximately 26 hours.
Absorption
Both cyproterone acetate and ethinylestradiol are rapidly and almost completely absorbed after oral administration, reaching peak plasma concentrations within 1-2 hours.
Metabolism
Both components undergo extensive hepatic metabolism, primarily via hydroxylation and conjugation pathways.
Side Effects
Contraindications
- Current or history of venous or arterial thrombotic/thromboembolic events (e.g., DVT, PE, MI, stroke).
- Presence or history of severe liver disease as long as liver function values have not returned to normal.
- Undiagnosed vaginal bleeding.
- Known or suspected hormone-dependent malignancies (e.g., breast cancer, endometrial cancer).
- Pancreatitis if associated with severe hypertriglyceridemia.
- Migraine with focal neurological symptoms.
- Pregnancy and lactation.
Drug Interactions
Lamotrigine
Combined oral contraceptives can significantly decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
Warfarin, other anticoagulants
May alter anticoagulant effects; dose adjustments may be necessary.
HIV protease inhibitors (e.g., Ritonavir)
May affect the metabolism of ethinylestradiol, potentially altering efficacy.
Griseofulvin, some antibiotics (e.g., Tetracycline)
May reduce the contraceptive effectiveness.
Enzyme-inducing drugs (e.g., Rifampicin, Phenytoin, Carbamazepine, Barbiturates)
May lead to increased clearance of sex hormones, resulting in reduced efficacy and breakthrough bleeding.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There have been no reports of serious harmful effects from overdose. Symptoms of overdose may include nausea, vomiting, and withdrawal bleeding (in females). No specific antidote exists; treatment should be symptomatic.
Pregnancy & Lactation
Sedron-35 is contraindicated during pregnancy. If pregnancy occurs while taking Sedron-35, discontinue immediately. It is also not recommended during lactation as it may reduce the quantity and change the composition of breast milk, and small amounts of active substances may pass into breast milk.
Side Effects
Contraindications
- Current or history of venous or arterial thrombotic/thromboembolic events (e.g., DVT, PE, MI, stroke).
- Presence or history of severe liver disease as long as liver function values have not returned to normal.
- Undiagnosed vaginal bleeding.
- Known or suspected hormone-dependent malignancies (e.g., breast cancer, endometrial cancer).
- Pancreatitis if associated with severe hypertriglyceridemia.
- Migraine with focal neurological symptoms.
- Pregnancy and lactation.
Drug Interactions
Lamotrigine
Combined oral contraceptives can significantly decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
Warfarin, other anticoagulants
May alter anticoagulant effects; dose adjustments may be necessary.
HIV protease inhibitors (e.g., Ritonavir)
May affect the metabolism of ethinylestradiol, potentially altering efficacy.
Griseofulvin, some antibiotics (e.g., Tetracycline)
May reduce the contraceptive effectiveness.
Enzyme-inducing drugs (e.g., Rifampicin, Phenytoin, Carbamazepine, Barbiturates)
May lead to increased clearance of sex hormones, resulting in reduced efficacy and breakthrough bleeding.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There have been no reports of serious harmful effects from overdose. Symptoms of overdose may include nausea, vomiting, and withdrawal bleeding (in females). No specific antidote exists; treatment should be symptomatic.
Pregnancy & Lactation
Sedron-35 is contraindicated during pregnancy. If pregnancy occurs while taking Sedron-35, discontinue immediately. It is also not recommended during lactation as it may reduce the quantity and change the composition of breast milk, and small amounts of active substances may pass into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24 to 36 months from the date of manufacture, specific details on packaging.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Expired
Clinical Trials
Extensive clinical trials have demonstrated the efficacy of cyproterone acetate/ethinylestradiol in treating androgen-dependent skin conditions (acne, hirsutism) and as an effective oral contraceptive. Long-term studies have also assessed safety profiles, including cardiovascular risks.
Lab Monitoring
- Regular blood pressure monitoring.
- Periodic liver function tests.
- Lipid profile assessment, especially in patients with risk factors for cardiovascular disease.
- Blood glucose monitoring in diabetic or pre-diabetic patients.
Doctor Notes
- Prior to prescribing, conduct a thorough medical history, including family history, and a complete physical examination.
- Assess for risk factors of venous thromboembolism (VTE) and arterial thromboembolism (ATE) carefully.
- Counsel patients on the importance of strict adherence to the dosage regimen for optimal efficacy and contraception.
- Advise patients to report any signs of thrombosis (e.g., severe leg pain, sudden chest pain) immediately.
Patient Guidelines
- Take Sedron-35 exactly as prescribed by your doctor and do not miss any doses.
- Use additional barrier contraception (e.g., condoms) for the first 7 days of the first cycle or if you miss multiple doses.
- Report any unusual symptoms such as severe leg pain, sudden chest pain, shortness of breath, severe headache, or vision changes to your doctor immediately.
- Do not stop taking the medicine abruptly without consulting your doctor, as this may lead to withdrawal bleeding or return of symptoms.
Missed Dose Advice
If a tablet is missed by less than 12 hours, take it as soon as remembered and continue with the next tablet at the usual time. If a tablet is missed by more than 12 hours, contraceptive protection may be reduced. Refer to the patient information leaflet for specific instructions, and consider additional barrier contraception for 7 days.
Driving Precautions
Sedron-35 is generally not expected to impair the ability to drive or operate machinery. However, if you experience side effects like headaches or mood changes, exercise caution.
Lifestyle Advice
- Avoid smoking, especially if you are over 35 years old, as it significantly increases the risk of serious cardiovascular side effects.
- Maintain a healthy weight through diet and exercise.
- Regular physical activity can help mitigate some cardiovascular risks.
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