| Composition |
Each Prandosin 4 capsule contains 4 mg silodosin.
Each Prandosin 8 capsule contains 8 mg silodosin. |
| Side effect |
| Diarrhea, hypotension, Headache, Nasopharyngitis, Nasal Congestion, Retrograde Ejaculation. |
| Pharmacodynamics properties |
Silodosin is a selective antagonist of post-synaptic alpha1- adrenoceptors, which are located in the human prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra. Blockade of these alpha1- adrenoceptors can cause smooth muscle in these tissues to relax, resulting in an improvement in urine flow and a reduction in BPH symptoms.
In vitro study examining binding affinity of silodosin to the three subtypes of the alpha1- adrenoceptors (alpha1A, alpha1B, and alpha1D) was conducted. The results of the study demonstrated that silodosin binds with high affinity to the alpha1A subtype. |
| Therapeutic indications |
| Prandosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). |
| Contraindication |
– Patients with severe renal impairment [Creatinine Clearance (CCr < 30 mL/min)].
– Patients with severe hepatic impairment.
– Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir). |
| Warnings and precautions |
The dose of Prandosin should be reduced to 4 mg in patients with moderate renal impairment.
Carcinoma of the prostate and BPH cause many of the same symptoms, therefore, patients thought to have BPH should be examined prior to starting therapy with Prandosin to rule out the presence of carcinoma of the prostate.
Intraoperative Floppy Iris Syndrome has been observed during cataract surgery in some patients on alpha-1 blockers. Patients planning cataract surgery should be told to inform their ophthalmologist that they are taking Prandosin.Postural hypotension, may develop when beginning Prandosin treatment. Patients should be cautioned about driving, operating machinery when initiating therapy.
LABORATORY TEST INTERACTIONS:
No laboratory test interactions were observed during clinical evaluations. Treatment with Prandosin for up to 52 weeks had no significant effect on prostate-specific antigen (PSA). |
| Pregnancy and lactation |
Pregnancy Category B. Prandosin is not indicated for use in women so it is not recommended for pregnant women and nursing mothers.
GERIATRIC USE:
There were no significant differences in safety or effectiveness between older and younger patients.
RENAL IMPAIRMENT:
Prandosin should be reduced to 4 mg per day in patients with moderate renal impairment.
Prandosin has not been studied in patients with severe renal impairment.
HEPATIC IMPAIRMENT:
No dosing adjustment is required in patients with mild or moderate hepatic impairment.
Prandosin has not been studied in patients with severe hepatic impairment. |
| Drug interactions |
Moderate and Strong CYP3A4 Inhibitors:
Use of strong CYP3A4 inhibitors such as itraconazole or ritonavir may cause plasma concentrations of silodosin to increase. Concomitant administration of strong CYP3A4 inhibitors and Prandosin is contraindicated.
The effect of moderate CYP3A4 inhibitors on the pharmacokinetics of silodosin has not been evaluated. Concomitant administration with moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil) may increase concentration of silodosin. Exercise caution and monitor patients for adverse events when co-administering Prandosin with moderate CYP3A4 inhibitors.
Strong P-glycoprotein (P-gp) Inhibitors:
In vitro studies indicated that silodosin is a P-gp substrate. Ketoconazole, a CYP3A4 inhibitor that also inhibits P-gp, caused significant increase in exposure to silodosin. Inhibition of P-gp may lead to increased silodosin concentration. Prandosin is therefore not recommended in patients taking strong P-gp inhibitors such as cyclosporine.
Alpha-Blockers:
Prandosin should not be used in combination with other alpha-blockers.
Digoxin:
Concomitant administration of Prandosin and digoxin did not significantly alter the steady state pharmacokinetics of digoxin. No dose adjustment is required.
PDE5 Inhibitors:
No events of symptomatic orthostasis or dizziness were reported in subjects receiving Prandosin with a PDE5 inhibitor.
Other Concomitant Drug Therapy:
Exercise caution during concomitant use with antihypertensives and monitor patients for possible adverse events.
FOOD INTERACTIONS:
Patients should be instructed to take silodosin with a meal to reduce risk of adverse events. |
| DOSAGE & ADMINISTRATION |
– Prandosin 8 capsules taken orally once daily with a meal.
– Prandosin 4 capsules taken orally once daily with a meal for those with moderate renal impairment. |
| Overdose |
Prandosin was evaluated at doses of up to 48 mg/day in healthy male subjects.
The dose-limiting adverse event was postural hypotension.
Should overdose of Prandosin lead to hypotension, support of the cardiovascular system has to be provided. |
| Package |
| Carton box of 20 Capsules with inserted leaflet. |
| Storage |
Store at (15-30)°C. Protect from light and moisture.
Keep out of reach of children. |
