Tamzor

Description

FORMULATION

Each capsule contains:

Tamsulosin Hydrochloride BP (as modified pellets)……………. 400 mcg

Excipients ……………………………………………………………. q.s.

 

DESCRIPTION

Tamsulosin Hydrochloride is an antagonist of alpha 1A adrenoceptors in the prostate. It works by relaxing muscles in the prostate and bladder which helps improve urine flow and reduce symptoms of BPH.

 

PHARMACOLOGY

General

The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic. The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate. Tamsulosin Hydrochloride, an alpha-1-adrenoceptor blocking agent, exhibits selectivity for alpha1 receptors in the human prostate. At least three discrete alpha-1-adrenoceptor subtypes have been identified: apha1A, alpha1B and alpha1D: their distribution differs between human organs and tissues. Approximately 70% of the alpha1-receptors in human prostate are of the alpha1A subtype. Tamsulosin Hydrochloride capsule is not intended for use as an antihypertensive drug.

 

PHARMACOKINETICS

Tamsulosin Hydrochloride is absorbed from the gastrointestinal tract and is almost completely bioavailable. The extent and rate of absorption are reduced by food. After oral doses of an immediate-release preparation, peak plasma concentrations occur after about 1 hour. Tamsulosin Hydrochloride is about 99% bound to plasma proteins. It is metabolized slowly in the liver primarily by the cytochrome P450 isoenzymes CYP2D6 and CYP3A4; it is excreted mainly in the urine as metabolites and some as unchanged drug. The plasma elimination half-life has been reported to be between 4 and 5.5 hours.

Some of the pharmacokinetic values cited above may be altered when Tamsulosin Hydrochloride is given as a modified-release preparation the form in which it is usually used, for instance, peak-plasma concentrations occur about 6 hours after a dose and the apparent elimination half-life may be 10-15 hours.

 

INDICATION

Benign Prostatic Hyperplasia (BPH) treatment:

Tamsulosin Hydrochloride capsules are indicated for the treatment of symptomatic BPH in men with enlarged prostate. It relaxes smooth muscle in benign prostatic hyperplasia producing an increase in urinary flow rate and improvement in obstructive symptoms.

 

DOSAGE AND ADMINISTRATION

Tamsulosin Hydrochloride capsule 400 mcg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one half hour following the same mean each day. For those patients who fail to respond to the 400 mcg dose after two to four weeks of dosing, the dose of Tamsulosin Hydrochloride capsules can be increased to 800 mcg once daily. If Tamsulosin Hydrochloride capsule administration is discontinued or interrupted for several days at either the 400 mcg or 800 mcg dose, therapy should be started again with the 400 mcg once daily dose.

 

CONTRAINDICATIONS

Patients with previously demonstrated, clinically significant hypersensitivity (eg. serious skin reactions, angioedema) to tamsulosin, other 5 alpha-reductase inhibitors, or any other component of Tamsulosin Hydrochloride capsule, concomitant use with other alpha-1-adrenoceptor, history of postural hypotension, severe liver impairment and syncope.

 

ADVERSE REACTIONS

The adverse effects reported in >2% of patients with Tamsulosin Hydrochloride include abnormal ejaculation, back pain, chest pain, cough, drowsiness, hypotension (notably postural hypotension), syncope, asthenia, depression, diarrhea, constipation, dizziness, headache, infection, nausea, vomiting, tooth disorder, decreased libido, insomnia, somnolence, rhinitis, pharyngitis, sinusitis, asthenia, blurred vision, dry mouth, gastrointestinal disturbances, oedema, blurred vision, rhinitis, erectile disorders (including priapism), tachycardia and palpitations. Hypersensitivity reactions including rash, pruritus and angioedema have also been reported.

Swelling of face, tongue or throat. Decreased blood pressure.

Tamsulosin Hydrochloride may cause a sudden drop in your blood pressure upon standing from a sitting of lying position especially at the start of treatment.

 

WARNINGS

Since selective alpha-blockers reduce blood pressure, patients receiving antihypertensive treatment may require reduced dosage and specialist supervision.

The signs and symptoms of orthostasis (postural hypotension, dizziness and vertigo) were detected more frequently in Tamsulosin Hydrochloride capsule treated patients than in placebo recipients. As with other alpha-adrenergic blocking agents there is a potential risk of syncope.

Patients beginning treatment with Tamsulosin Hydrochloride capsules should be cautioned to avoid situations where injury could result should syncope occur. Rarely (probably less than one in fifty thousand patients), Tamsulosin Hydrochloride, like other alpha1 antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition.

 

PRECAUTIONS

As with other alpha1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin Hydrochloride, as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (eg. Dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared.

Use Tamsulosin Hydrochloride with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it, it may take up to 2 to 4 weeks of Tamsulosin Hydrochloride to work fully. Do not stop using  Tamsulosin Hydrochloride or change your dose of Tamsulosin Hydrochloride without checking with your doctor. Caution may be required in the elderly and in patients with hepatic impairment.

 

DRUG INTERACTIONS

Interaction studies have only been performed in adults.

No interactions have been seen when Tamsulosin Hydrochloride was given concomitantly with either atenolol, enalapril, or theophylline.

Tamsulosin Hydrochloride should be used with caution in combination with strong and moderate inhibitors of CYP3A4.

 

OVERDOSAGE

Overdosage with Tamsulosin Hydrochloride could potentially lead to hypotension due to the Tamsulosin Hydrochloride component. In case of hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then administration of intravenous fluids should be considered. If necessary, vasopressors should then be used and renal function should be monitored and supported as needed. Dialysis is unlikely to be of benefit.

 

AVAILABILITY

Alu-Alu Blister pack x 10’s in a box.

 

STORAGE

Store at temperatures not exceeding to 30°C.

 

Manufactured by

AMN Lifescience PVT. Ltd.

150 Sahajananand Estate, Sarkhej Tai City, Ahmedabad, Gujarat, India

Distributed by

The Cathay Drug Co., Inc.

2/F Vernida I Condominium 120 Amorsolo St. Legaspi Village, Makati City

Date of revision: January 2014