Each film coated tablet contains Silodosin 4 mg.
Pharmacology: Pharmacodynamics: Silodosin is a selective antagonist of post-synaptic alpha-1 adrenoreceptors, which are found in the human prostate, bladder neck, prostatic capsule, and prostatic urethra. As a result of blockage of these alpha-1 adrenoreceptors, smooth muscle in these tissue relaxes, resulting in an improvement in urine flow and reduction in benign prostatic hyperplasia symptoms.
Pharmacokinetics: Absorption: Tmax: 2.6 hours.
Bioavailability: 32%.
Effect of food: Cmax decreased by approximately 18% to 43% and AUC decreased by 4% to 49%.
Protein binding: 97%.
Distribution: Vd: 49.5 L.
Metabolism: Hepatic: extensive via glucuronidation, alcohol and aldehyde dehydrogenase, and CYP3A4 pathways.
Active metabolite is glucuronide conjugate (KMD-3213G).
Excretion: Renal: Approximately 33.5%, Fecal: Approximate by 54.9%.
Total body clearance: 10 L/hr.
Elimination half life: Silodosin: 13.3 hours.
Glucuronide conjugate: 24 hours.
Bladder outlet obstruction associated with benign prostatic hyperplasia.
The adult dosage for oral use is 4 mg of silodosin twice daily after breakfast and evening meals. The dosage may be reduced according to the patient's conditions.
Silodosin is alpha-adrenergic blocker. Overdose results in excessive vasodilation cause hypotension and reflex tachycardia.
Hypotension usually responds to IV fluids. Hypotension that does not respond to IV fluids should be treated with adrenergic vasopressors.
Patients who are awake after a significant ingestion should be treated with activated charcoal to limit the potential for symptomatic hypotension.
Hypersensitivity to silodosin or any other ingredients of the product.
Concomitant use of strong CYP3A4 inhibitors.
Severe hepatic impairment.
Severe renal impairment.
Avoid concomitant use with other alpha-blockers or strong P-glycoprotein inhibitors.
Intraoperative floppy iris syndrome may occur during cataract surgery.
Postural hypotension may occur when initial therapy.
Syncope may occur.
Important precautions: Abnormal ejaculation (e.g. retrograde ejaculation) has been reported. Therefore, SIDORY 4 should be used after obtaining the understanding of patients by carefully explaining.
Orthostatic hypotension may occur. Therefore, caution should be exercised regarding fluctuation in blood pressure due to changes in body posture.
Prior the commencement of treatment with SIDORY 4, the patients should be asked whether they are taking any hypotensive drugs and, in the event that any hypotensive drugs are used, attention should be paid to changes in blood pressure while using SIDORY 4. If a decrease in blood pressure occurs, appropriate therapeutic actions, such as a dosage reduction or discontinuation of treatment, should be taken.
It should be borne in mind that treatment with SIDORY 4 does not eliminate the cause of the disease, but gives symptomatic relief. If treatment with SIDORY 4 does not result in the expected effect, consideration should be given to other appropriate therapeutic.
Effects on ability to drive and operate machine: The symptom such as dizziness may occur. Therefore, the patients should be advised to exercise caution when engaging in hazardous activities such as working at heights or driving a car.
Not applicable as silodosin is intended for male patients only.
Cardiovascular: Orthostatic hypotension.
Gastrointestinal: Diarrhea.
Neurologic: Dizziness, headache.
Reproductive: Retrograde ejaculation.
Respiratory: Nasal congestion, nasopharyngitis.
Silodosin is a substrate of CYP3A4 and P-glycoprotein.
Silodosin is a substrate of UDP-glucuronosyltransferase 2B7 (UGT2B7).
Concurrent use of silodosin and itraconazole, selected strong CYP3A4 inhibitors, or boceprevir may result in increased silodosin exposure.
Concurrent use of silodosin and cyclosporine may result in increased silodosin concentration.
Concurrent use of silodosin and tadalafil, sildenafil, or avanafil may result in increased risk of hypotension.
Store at temperature not more than 30°C.
G04CA04 - silodosin ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.
Sidory 4 FC tab 4 mg
3 × 10's
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