Tysul
Generic Name
Tamsulosin Hydrochloride + Solifenacin Succinate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Tysul is a fixed-dose combination medication containing Tamsulosin Hydrochloride, an alpha-blocker, and Solifenacin Succinate, an antimuscarinic. It is used to treat moderate to severe storage symptoms and voiding symptoms associated with Benign Prostatic Hyperplasia (BPH) in men who are inadequately responding to monotherapy.
Uses & Indications
Dosage
Adults
One tablet (Tamsulosin 0.4 mg / Solifenacin 5 mg) orally once daily.
Elderly
No dosage adjustment is required for elderly patients, but caution should be exercised due to potential for increased sensitivity.
Renal_impairment
For mild to moderate renal impairment, no dose adjustment is necessary. Use with caution in severe renal impairment (creatinine clearance <30 mL/min).
Hepatic_impairment
For mild to moderate hepatic impairment, no dose adjustment is necessary. Contraindicated in severe hepatic impairment (Child-Pugh C).
How to Take
Take one tablet orally once daily with or after a meal. The tablet should be swallowed whole and not crushed or chewed.
Mechanism of Action
Tamsulosin is an alpha1A-adrenoceptor antagonist that relaxes the smooth muscle in the prostate and bladder neck, improving urine flow and reducing BPH symptoms. Solifenacin is a competitive muscarinic receptor antagonist that reduces the activity of the detrusor muscle, thereby treating symptoms of overactive bladder such as urinary urgency, frequency, and urge incontinence.
Pharmacokinetics
Onset
Tamsulosin's effect on urine flow may be observed within days, while the full effect of Solifenacin on OAB symptoms may take several weeks.
Excretion
Both drugs are primarily excreted via urine, with a small portion excreted in feces.
Half life
Tamsulosin has an effective half-life of approximately 10-13 hours. Solifenacin has a half-life of approximately 45-68 hours.
Absorption
Tamsulosin is well absorbed, achieving peak plasma concentrations in approximately 4-5 hours. Solifenacin is well absorbed, with an absolute bioavailability of approximately 90%, reaching peak plasma concentrations in 3-8 hours.
Metabolism
Both Tamsulosin and Solifenacin are extensively metabolized in the liver, primarily by CYP3A4 enzymes.
Side Effects
Contraindications
- Hypersensitivity to the active substances or to any of the excipients.
- Severe hepatic impairment (Child-Pugh C).
- Severe renal impairment (creatinine clearance <30 mL/min) with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole).
- Conditions that predispose to urinary retention, severe gastrointestinal conditions, myasthenia gravis, or narrow-angle glaucoma.
Drug Interactions
Anticholinergic Agents
Concomitant use with other anticholinergic agents may result in more pronounced anticholinergic adverse effects.
Other Alpha-Adrenergic Blockers
Concomitant use may lead to additive hypotensive effects. Avoid concurrent use.
P-glycoprotein Inhibitors (e.g., Ciclosporin)
May increase Solifenacin exposure.
Strong CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
Concomitant administration with strong CYP3A4 inhibitors may increase systemic exposure to both Tamsulosin and Solifenacin. Use with caution, especially in patients with renal or hepatic impairment.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to severe anticholinergic effects (e.g., dry mouth, constipation, urinary retention, blurred vision) from Solifenacin and severe hypotensive effects (e.g., dizziness, fainting) from Tamsulosin. Treatment should be symptomatic and supportive, including gastric lavage, activated charcoal, and cardiovascular support if hypotension occurs.
Pregnancy & Lactation
Not indicated for use in women. If accidentally used, Tamsulosin is Category B and Solifenacin is Category C. Due to potential risks, use should be avoided during pregnancy and lactation.
Side Effects
Contraindications
- Hypersensitivity to the active substances or to any of the excipients.
- Severe hepatic impairment (Child-Pugh C).
- Severe renal impairment (creatinine clearance <30 mL/min) with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole).
- Conditions that predispose to urinary retention, severe gastrointestinal conditions, myasthenia gravis, or narrow-angle glaucoma.
Drug Interactions
Anticholinergic Agents
Concomitant use with other anticholinergic agents may result in more pronounced anticholinergic adverse effects.
Other Alpha-Adrenergic Blockers
Concomitant use may lead to additive hypotensive effects. Avoid concurrent use.
P-glycoprotein Inhibitors (e.g., Ciclosporin)
May increase Solifenacin exposure.
Strong CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
Concomitant administration with strong CYP3A4 inhibitors may increase systemic exposure to both Tamsulosin and Solifenacin. Use with caution, especially in patients with renal or hepatic impairment.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to severe anticholinergic effects (e.g., dry mouth, constipation, urinary retention, blurred vision) from Solifenacin and severe hypotensive effects (e.g., dizziness, fainting) from Tamsulosin. Treatment should be symptomatic and supportive, including gastric lavage, activated charcoal, and cardiovascular support if hypotension occurs.
Pregnancy & Lactation
Not indicated for use in women. If accidentally used, Tamsulosin is Category B and Solifenacin is Category C. Due to potential risks, use should be avoided during pregnancy and lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date
Availability
Available in pharmacies and hospitals
Approval Status
Approved (in most major markets)
Patent Status
Generic versions available
Clinical Trials
Multiple clinical trials have demonstrated the efficacy and safety of Tamsulosin + Solifenacin combination therapy for symptoms of BPH and OAB.
Lab Monitoring
- Monitor renal function (creatinine clearance) in patients with kidney impairment.
- Monitor liver function tests periodically in patients with hepatic impairment.
Doctor Notes
- Consider Tysul for male patients with moderate to severe BPH symptoms who also exhibit bothersome OAB symptoms and have not responded adequately to monotherapy.
- Educate patients on potential orthostatic hypotension and anticholinergic side effects.
- Monitor patients for urinary retention, especially those with pre-existing conditions.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not crush, chew, or break the tablet.
- Report any severe dizziness, fainting, or vision changes 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 your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, drowsiness, or blurred vision. Patients should be advised not to drive or operate machinery if they experience these symptoms.
Lifestyle Advice
- Maintain adequate hydration to help with dry mouth and constipation.
- Avoid situations that may lead to overheating or dehydration, which can worsen some side effects.
- Limit alcohol consumption, as it may enhance hypotensive effects.
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