Ureleve

Ureleve

silodosin

Manufacturer:

Ajanta Pharma Phil

Distributor:

Ajanta Pharma Phil
Concise Prescribing Info
Contents
Silodosin
Indications/Uses
Signs & symptoms of benign prostatic hyperplasia (BPH).
Dosage/Direction for Use
8 mg once daily. Moderate renal impairment (CrCl 30-50 mL/min) 4 mg once daily.
Administration
Should be taken with food: For patients w/ swallowing difficulties, open cap & sprinkle powd in 1 tbsp applesauce. Swallow immediately (w/in 5 min) w/o chewing & follow w/ 8 oz glass of cool water to ensure complete swallowing of powd.
Contraindications
Hypersensitivity. Co-administration w/ strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, itraconazole, ritonavir). Severe renal (CrCl <30 mL/min) & hepatic (Child-Pugh score ≥10) impairment.
Special Precautions
Not indicated for HTN. Postural hypotension. Interactions may be expected w/ other α-blockers. Concomitant use w/ antihypertensive & monitor patients for possible adverse events. Potential symptomatic hypotension w/ PDE5 inhibitors. Examine patients thought to have BPH prior to starting therapy to rule out presence of carcinoma of the prostate. Intraoperative floppy iris syndrome during cataract surgery in patients on or previously treated w/ α-1 blockers. Refrain from driving & operating machinery. Moderate renal impairment. Mild or moderate hepatic impairment. Not indicated for use in women. Pregnancy & lactation. Not indicated for use in ped patients.
Adverse Reactions
Retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, nasal congestion. Insomnia, increased PSA, sinusitis, abdominal pain, asthenia, & rhinorrhea; syncope & priapism; intraoperative floppy iris syndrome. Toxic skin eruption, purpura, skin rash, pruritus, urticaria; jaundice, impaired hepatic function associated w/ increased transaminase values; allergic-type reactions, skin reactions including swollen tongue & pharyngeal edema.
Drug Interactions
Increased Cmax & exposure w/ strong CYP3A4 inhibitor that also inhibits P-gp eg, ketoconazole. Increased plasma conc w/ strong CYP3A4 inhibitors eg, itraconazole or ritonavir. Conc may be increased w/ moderate CYP3A4 inhibitors (eg, diltiazem, erythromycin, verapamil). Inhibition of P-gp may lead to increased conc w/ strong P-gp inhibitors eg, cyclosporine. Interactions may be expected w/ other α-blockers. Orthostatic vital signs were monitored w/ PDE5 Inhibitors (sildenafil or tadalafil). Higher incidence of dizziness & orthostatic hypotension w/ antihypertensive.
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04CA04 - silodosin ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.
Presentation/Packing
Form
Ureleve cap 8 mg
Packing/Price
30's (P26/cap)
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