TAMSOLIN Tamsulosin Hydrochloride 400mcg Modified-Release Capsule 10's
RXDRUG-DR-XY38119
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Dosage/Direction for Use
BPH: Recommended Dose: 400 mcg once daily. It should be administered approximately ½ hr following the same meal each day.
For those patients who fail to respond to the 400-mcg dose after 2-4 weeks of dosing, the dose of Tamsolin can be increased to 0.8 mg once daily. If Tamsolin administration is discontinued or interrupted for several days at either 400-mcg or 0.8-mg dose, therapy should be started again with the 400-mcg once daily dose.
For those patients who fail to respond to the 400-mcg dose after 2-4 weeks of dosing, the dose of Tamsolin can be increased to 0.8 mg once daily. If Tamsolin administration is discontinued or interrupted for several days at either 400-mcg or 0.8-mg dose, therapy should be started again with the 400-mcg once daily dose.
Overdosage
Acute overdose with tamsulosin HCl 5 mg has been reported. Acute hypotension (systolic blood pressure 70 mmHg), vomiting and diarrhea were observed, which were treated with fluid replacement and the patient could be discharged the same day.
If acute hypotension occurs after overdosage, cardiovascular support should be given and maintained. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this is insufficient then volume expanders and, when necessary, vasopressors could be administered. Renal function should be monitored and general supportive measures applied. Dialysis unlikely to be of help as tamsulosin is very highly bound to plasma proteins.
Measures to impede absorption eg, emesis can be taken. When large quantities of tamsulosin HCl are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative eg, sodium sulfate can be administered.
If acute hypotension occurs after overdosage, cardiovascular support should be given and maintained. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this is insufficient then volume expanders and, when necessary, vasopressors could be administered. Renal function should be monitored and general supportive measures applied. Dialysis unlikely to be of help as tamsulosin is very highly bound to plasma proteins.
Measures to impede absorption eg, emesis can be taken. When large quantities of tamsulosin HCl are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative eg, sodium sulfate can be administered.
Administration
Should be taken with food: Take 30 min after the same meal each day. Swallow whole, do not open/chew/crush.
Contraindications
Known hypersensitivity to tamsulosin HCl or any component of Tamsolin.
Patients with a history of orthostatic hypotension; taking other α-adrenergic blocking agents; with severe hepatic insufficiency.
Tamsulosin HCl is not indicated for use in women & the pediatric population.
Patients with a history of orthostatic hypotension; taking other α-adrenergic blocking agents; with severe hepatic insufficiency.
Tamsulosin HCl is not indicated for use in women & the pediatric population.
Special Precautions
Before therapy with tamsulosin HCl is initiated, the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as BPH. Digital rectal examination and when necessary, determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards.
Patients with end-stage renal disease (CrCl <10 mL/min/1.73 m2) should be approached with caution as these patients have not been studied.
Patients should be advised about the possibility of priapism as a result of treatment with tamsulosin and other similar medications. Patient should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence).
Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in some patients taking or who have previously been treated with α1-adrenoceptor antagonists.
Avoid drinking alcohol, it may increase dizziness caused by tamsulosin HCl.
Discontinue if angina pectoris occur.
Effects on the Ability to Drive or Operate Machinery: As with other α1-blockers, reduction in blood pressure can occur in individual cases during treatment with tamsulosin HCl, as a result of which, very rarely, syncope can occur. At the 1st signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared. Patients so affected should not drive or operate machinery.
Patients with end-stage renal disease (CrCl <10 mL/min/1.73 m2) should be approached with caution as these patients have not been studied.
Patients should be advised about the possibility of priapism as a result of treatment with tamsulosin and other similar medications. Patient should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence).
Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in some patients taking or who have previously been treated with α1-adrenoceptor antagonists.
Avoid drinking alcohol, it may increase dizziness caused by tamsulosin HCl.
Discontinue if angina pectoris occur.
Effects on the Ability to Drive or Operate Machinery: As with other α1-blockers, reduction in blood pressure can occur in individual cases during treatment with tamsulosin HCl, as a result of which, very rarely, syncope can occur. At the 1st signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared. Patients so affected should not drive or operate machinery.
Adverse Reactions
Body as a Whole: Headache, infection, asthenia, back and chest pain.
Nervous System: Dizziness, somnolence, insomnia, decreased libido, erectile disorder (including priapism).
Respiratory System: Rhinitis, pharyngitis, increased cough, sinusitis.
Digestive System: Diarrhea, nausea, tooth disorder, vomiting, constipation.
Urogenital System: Abnormal ejaculation.
Special Senses: Blurred vision.
Dermatological: Rash, pruritus, angioedema.
Nervous System: Dizziness, somnolence, insomnia, decreased libido, erectile disorder (including priapism).
Respiratory System: Rhinitis, pharyngitis, increased cough, sinusitis.
Digestive System: Diarrhea, nausea, tooth disorder, vomiting, constipation.
Urogenital System: Abnormal ejaculation.
Special Senses: Blurred vision.
Dermatological: Rash, pruritus, angioedema.
Drug Interactions
The pharmacokinetic interaction between cimetidine and tamsulosin HCl was investigated. The results indicate significant changes in tamsulosin HCl clearance (26% decrease) and AUC (44% increase). Therefore tamsulosin HCl capsules should be used with caution in combination with cimetidine, particularly at doses >400 mcg.
Caution should be exercised with concomitant administration of warfarin and tamsulosin HCl.
Tamsulosin HCl should be used with caution in combination with moderate or strong inhibitors of CYP2D6 (eg, fluoxetine) or CYP3A4 (eg, ketoconazole), particularly at doses >400 mcg.
Tamsulosin and calcium channel blocker may increase the risk of hypotension. Risk of 1st-dose orthostatic hypotension may increase with β-blocker.
Caution should be exercised with concomitant administration of warfarin and tamsulosin HCl.
Tamsulosin HCl should be used with caution in combination with moderate or strong inhibitors of CYP2D6 (eg, fluoxetine) or CYP3A4 (eg, ketoconazole), particularly at doses >400 mcg.
Tamsulosin and calcium channel blocker may increase the risk of hypotension. Risk of 1st-dose orthostatic hypotension may increase with β-blocker.
Storage
Store at temperatures not exceeding 30°C. Protect from sunlight and moisture.
Action
Pharmacology: Mechanism of Action: Tamsulosin binds selectively and competitively to postsynaptic α1-adrenoceptors, in particular to subtypes α1A and α1D. It brings about relaxation of prostatic and urethral smooth muscle resulting in an increase in urinary flow rate and a reduction in symptoms of benign prostatic hyperplasia (BPH). It also improves the irritative symptoms in which bladder instability plays an important role.
Pharmacokinetics: Absorption: Absorption of tamsulosin HCl is essentially complete (>90%) following oral administration under fasting conditions. The time to maximum concentration (Tmax) is reached by 4-5 hrs under fasting conditions and by 6-7 hrs when tamsulosin HCl capsules are administered with food. Taking tamsulosin HCl capsules under fasted conditions results in a 30% increase in bioavailability (AUC) and 40-70% increase in peak concentrations (Cmax) compared to fed conditions.
Distribution: Tamsulosin HCl is extensively bound to human plasma proteins (94-99%), primarily α1-acid glycoprotein (AAG), with linear binding over a wide concentration range. There is a minimal distribution to the brain, spinal cord and testes.
Metabolism: Tamsulosin HCl has a low first-pass effect, being metabolized slowly. It is extensively metabolized by cytochrome P-450 enzymes in the liver. Most tamsulosin HCl is present in the plasma in the unchanged form.
Excretion: Tamsulosin HCl and its metabolites are mainly excreted in the urine with <10% of a dose being present in the unchanged form. After a single dose of tamsulosin HCl in the fed state and in the steady state in patients, elimination half-lives of about 10 hrs and 13 hrs, respectively, have been measured.
Special Populations: Geriatrics: Intrinsic clearance is independent of tamsulosin HCl binding to AAG, but diminishes with age, resulting in a 40% overall higher exposure (AUC) in subjects 55-75 years compared to subjects 20-32 years.
Renal Impairment: Patients with renal impairment [mild to moderate (CrCl 30-70 mL/min/1.73 m2) or moderate to severe (CrCl ≤10-30 mL/min/1.73 m2)] do not require dose adjustment.
Pharmacokinetics: Absorption: Absorption of tamsulosin HCl is essentially complete (>90%) following oral administration under fasting conditions. The time to maximum concentration (Tmax) is reached by 4-5 hrs under fasting conditions and by 6-7 hrs when tamsulosin HCl capsules are administered with food. Taking tamsulosin HCl capsules under fasted conditions results in a 30% increase in bioavailability (AUC) and 40-70% increase in peak concentrations (Cmax) compared to fed conditions.
Distribution: Tamsulosin HCl is extensively bound to human plasma proteins (94-99%), primarily α1-acid glycoprotein (AAG), with linear binding over a wide concentration range. There is a minimal distribution to the brain, spinal cord and testes.
Metabolism: Tamsulosin HCl has a low first-pass effect, being metabolized slowly. It is extensively metabolized by cytochrome P-450 enzymes in the liver. Most tamsulosin HCl is present in the plasma in the unchanged form.
Excretion: Tamsulosin HCl and its metabolites are mainly excreted in the urine with <10% of a dose being present in the unchanged form. After a single dose of tamsulosin HCl in the fed state and in the steady state in patients, elimination half-lives of about 10 hrs and 13 hrs, respectively, have been measured.
Special Populations: Geriatrics: Intrinsic clearance is independent of tamsulosin HCl binding to AAG, but diminishes with age, resulting in a 40% overall higher exposure (AUC) in subjects 55-75 years compared to subjects 20-32 years.
Renal Impairment: Patients with renal impairment [mild to moderate (CrCl 30-70 mL/min/1.73 m2) or moderate to severe (CrCl ≤10-30 mL/min/1.73 m2)] do not require dose adjustment.
MedsGo Class
Drugs for Bladder & Prostate Disorders
Features
Brand
Tamsolin
Full Details
Dosage Strength
400mcg
Drug Ingredients
- Tamsulosin
Drug Packaging
Modified-Release Capsule 10's
Generic Name
Tamsulosin Hydrochloride
Dosage Form
Modified-Release Capsule
Registration Number
DR-XY38119
Drug Classification
Prescription Drug (RX)
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