logo image

Tamsulosin information from DrugsUpdate  

See Available Brands of Tamsulosin in India

P - Caution when used during pregnancy
L - Contraindicated in Lactation
FI - Food *

Tamsulosin is an α1a-selective alpha blocker used in the symptomatic treatment of benign prostatic hyperplasia (BPH). Tamsulosin was developed by Yamanouchi Pharmaceuticals (now part of Astellas Pharma) and is marketed by various companies under licence, including Boehringer-Ingelheim and CSL. Tamsulosin hydrochloride extended-release capsules are marketed under the trade names Flomax, Flomaxtra and Urimax, though generic non-modified release capsules are still approved and marketed in many countries, such as Canada. The U.S. patent for Flomax is set to expire October 2009.

Pharmacodynamics

Pharmacokinetics

Tamsulosin is a selective α1 adrenoreceptor-blocking agent. Smooth muscle tone is mediated by the sympathetic nervous stimulation of α1 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.

Absorption
Completely absorbed from the GI tract. Peak plasma concentrations after 1 hr; 6 hr (modified-release preparation).

Distribution
Protein-binding: 99%.

Metabolism
Metabolised slowly in the liver primarily by CYP2D6 and CYP3A4.

Excretion
Excreted in urine (76%) and faeces (21%). Plasma elimination half life: 4-5.5 hr; as modified-release preparation : 10-13 hours.

Tamsulosin Indications / Tamsulosin Uses

Information Not Available

Tamsulosin Adverse Reactions / Tamsulosin Side Effects

Postural hypotension, dizziness and vertigo, malaise, headache, rhinitis, pharyngitis, cough, sinusitis, diarrhoea, nausea, infection, asthenia, back pain, tooth disorder, chest pain, somnolence, insomnia, decreased libido, abnormal ejaculation, priapism, blurred vision. Risk of intraoperative floppy iris syndrome during phacoemulsification surgery.

Precautions

Information Not Available

Special Precautions

Prostate carcinoma should be ruled out before starting the therapy. Risk of intraoperative floppy iris syndrome in patients who undergo cataract surgery. May cause orthostatic hypotension or syncope especially with first dose, if dosage is increased or an antihypertensive drug or a phosphodiesterase-5 inhibitor is added to the treatment regimen. Caution when used in patients with sulfa allergy. May cause priapism (rare); immediate medical attention is recommended. Pregnancy.

Other Drug Interactions

Concomitant admin with moderate or strong inhibitors of CYP2D6 (eg. fluoxetine) or CYP34A (eg. ketoconazole, cimetidine) increases serum concentration.

Other Interactions

Food Interaction


Food reduced extent and rate of absorption.


 

Dosage

Oral
Benign prostatic hyperplasia
Adult: As HCl: As modified-release preparation: 400 mcg once daily. May increase to 800 mcg once daily after 2-4 wk if necessary. If therapy is interrupted for several days, restart with 400 mcg once daily. Dose to be taken 30 minutes after the same meal each day.
CrCl (ml/min)    Dosage Recommendation
≥10                      No dose adjustment needed.
<10                       Not studied.
Hepatic impairment: Moderate hepatic impairment (Child-Pugh classification A and B): No dose adjustment needed. Severe hepatic impairment: Avoid.

Food(before/after)

Should be taken with food. (Take ½ hr following the same meal daily. Swallow whole, do not open/chew/crush.)

List of Contraindications

Tamsulosin and Pregnancy

Caution when used during pregnancy.


Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Tamsulosin and Lactation

Contraindicated in Lactation

Tamsulosin and Children

Safety and efficacy not established

Tamsulosin and Geriatic

Information Not Available

Tamsulosin and Other Contraindications

Information Not Available

Storage

Oral
Store at 25°C.

Lab interference

Oral
Store at 25°C.

© 2011-2018 DrugsUpdate.com. Disclaimer | Site Map

Feedback