Alfapro Capsule
Tamsulosin Hydrochloride
0.4mg
Deurali Janta Pharmaceuticals Pvt. Ltd.
| Pack size | 1 |
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Indications
Alfapro Capsule is used for:
Benign prostatic hyperplasia
Adult Dose
Oral
Benign prostatic hyperplasia
Adult: 1 (400mcg) capsule once daily. If response is inadequate after 2-4 weeks, may be increased to 800 mcg once daily; if therapy is interrupted, should be resumed at 400 mcg once daily
Hepatic impairment
Mild to moderate: Dosage adjustment not necessary
Severe: Not studied
Child Dose
Renal Dose
Renal impairment
CrCl ?10 mL/min: Dosage adjustment not necessary
CrCl <10 mL/min: Not studied
Administration
Prolonged release tab: May be taken with or without food. Swallow whole, do not chew/crush.
Cap: Should be taken with food. Take ½ hr following the same meal daily. Swallow whole, do not open/chew/crush.
Contra Indications
Hypersensitivity to sulfonamide, severe hepatic impairment, lactation. History of orthostatic hypotension.
Precautions
Hypersensitivity to Tamsulosin Hydrochloride. A history of orthostatic hypotension; severe hepatic insufficiency. As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks).
Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic Hyperplasia. Digital rectal examination and when necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards. The treatment of severely renal impaired patients (creatinine clearance is less than10ml/min) should be approached with caution as these patients have not been studied. Caution should be exercised in porphyria or allergic reaction to this or any other medicine.
Pregnancy-Lactation
Interactions
Increased plasma concentration w/ strong CYP3A4 inhibitors (e.g. ketoconazole). Moderate CYP3A4 inhibitors (e.g. erythromycin), strong (e.g. paroxetine) or moderate (e.g. terbinafine) CYP2D6 inhibitors may increase exposure of tamsulosin. Increased plasma concentration w/ cimetidine. Additive effect w/ other ?-adrenergic blocking agents. Concomitant use w/ PDE5 inhibitors may lead to symptomatic hypotension. Decreased plasma concentration w/ furosemide.
Adverse Effects
Side effects of Tamsulosin Hydrochloride :
>10%
Headache (19-21%),Orthostatic hypotension (6-19%),Rhinitis (13-18%),Abnormal ejaculation (8-18%),Dizziness (15-17%),Arthralgia (11%),Infection (9-11%)
1-10%
Asthenia (8%),Back pain (7-8%),Skin rash (7%),Pharyngitis (5-6%),Diarrhea (4-6%),Myalgia (5%),Chest pain (4%),Cough (3-4%),Somnolence (3-4%),Nausea (2-4%),Sinusitis (2-4%),Abdominal discomfort (2-3%),Bitter taste (2-3%),Decreased libido (1-2%),Insomnia (1-2%)
Mechanism of Action
Tamsulosin is a selective alpha1 adrenoreceptor-blocking agent. Smooth muscle tone is mediated by the sympathetic nervous stimulation of alpha1 adrenoreceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and reduction in symptoms in BPH.
Note
Alfapro 0.4mg Capsule manufactured by Deurali Janta Pharmaceuticals Pvt. Ltd.. Its generic name is Tamsulosin Hydrochloride. Alfapro is availble in Nepal.
Farmaco Nepal drug index information on Alfapro Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.