Amso

Tamsulosin hydrochloride.

Tamsulosin Hydrochloride (Amso) is blue cap/white body color hard gelatin capsule size 2 containing white of white color pellets.
Tamsulosin hydrochloride is an antagonist of alpha1A adrenoreceptors in the prostate. It works by relaxing muscles in the prostate and bladder, which helps to improve urine flow and reduce symptoms of BPH.
Each capsule contains: Tamsulosin Hydrochloride BP 400 mcg (As modified release pellets).

Pharmacotherapeutic Group: α1-adrenoceptor antagonists.
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 (Amso), an alpha1 adrenoreceptor blocking agent, exhibits selectivity for alpha1 receptors in the human prostate.
Pharmacodynamics: Mechanism of Action: Tamsulosin (Amso) binds selectively and competitively to the post-synaptic-α1-adrenoceptors, in particular to subtypes α_1A and α_1D. It brings about relaxation of prostatic and urethral smooth muscle.
Pharmacodynamic Effects: Tamsulosin Hydrochloride (Amso) increases the maximum urinary flow rate. It relieves obstruction by relaxing smooth muscle in prostate and urethra thereby improving voiding symptoms.
It also improves the storage symptoms in which bladder instability plays an important role.
These effects on storage and voiding symptoms are maintained during long-term therapy. The need for surgery or catheterization is significantly delayed.
Pharmacokinetics: Absorption: Tamsulosin Hydrochloride (Amso) is a prolonged release capsule of the non-ionic gel matrix type. The OCAS (Oral Controlled Absorption System) formulation provides consistent slow release of Tamsulosin (Amso), resulting in an adequate exposure, with little fluctuation, over 24 hours.
Tamsulosin (Amso) administered is absorbed from the intestine. Under fasting conditions of the administered dose, approximately 57% is estimated to be absorbed.
Tamsulosin (Amso) shows linear pharmacokinetics.
After single dose of Tamsulosin Hydrochloride (Amso) capsule in the fasted state, plasma concentrations of Tamsulosin peak at a median time of 6 hours. In steady state, which is reached by day 4 of multiple dosing, plasma concentrations of Tamsulosin (Amso) peak at 4 to 6 hours, in the fasted and fed state. Peak plasma concentrations increase from approximately 6 mg/mL after the first dose to 11 mg/mL in steady state.
As a result of the prolonged release characteristics of Tamsulosin Hydrochloride (Amso) capsule the trough concentration of Tamsulosin in plasma amounts to 40% of the peak plasma concentration under fasted and fed condition.
There is a considerable inter-patient variation in plasma levels both after single and multiple dosing.
Distribution: In man, Tamsulosin (Amso) is about 99% bound to plasma proteins. The volume of distribution is small (about 0.2 L/Kg).
Metabolism: Tamsulosin (Amso) has a low first pass effect, being metabolized slowly. Most Tamsulosin (Amso) is present in plasma in the form of unchanged active substance. It is metabolized in the liver.
Excretion: Tamsulosin (Amso) and its metabolites are mainly excreted in the urine.

Benign Prostatic Hyperplasia (BPH) Treatment.
Tamsulosin Hydrochloride (Amso) Capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. Relax smooth muscle in benign prostatic hyperplasia producing an increase in urinary flow-rate and an improvement in obstructive symptoms.

Tamsulosin Hydrochloride (Amso) Capsules 400 mcg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. Can be taken independently of food. It should be administered approximately one half hour following the same meal each day.
The capsule must be swallowed whole and not be crunched or chewed as this interferes with the prolonged release of the active substance.
No dose adjustment is warranted in renal impairment.
No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency.

In case of acute hypotension occurring after overdosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. Of this does help, then volume expanders and, when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins.
Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to, Tamsulosin, other 5 alpha-reductase inhibitors, or any other component of Tamsulosin Hydrochloride (Amso) blockers should be avoided in patients with a history of postural hypotension and micturition syncope.
Hypersensitivity to Tamsulosin Hydrochloride (Amso) or to any of the excipients.

As with other α1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin Hydrochloride (Amso) 400 mcg Capsule, as a result of which, rarely, syncope can occur. At the first sign of orthostatic hypotension (dizziness, weakness), as the patient should sit or lie down until the symptoms have disappeared.
Before therapy with Tamsulosin Hydrochloride (Amso) 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.
Treatment of patients with a history of orthostatic hypotension should be approached with caution.
The treatment of patients with severe renal impairment (creatinine clearance of <10mL/min) should be approached with caution, as these patients have not been studied.
The treatment of patients with severe hepatic dysfunction should be approached with caution.
Interoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) considered to be due to alpha-1 blocking action has been observed during cataract and glaucoma surgery in same patients on or previously treated with Tamsulosin. Ophthalmologists should be aware of possible occurrence of IFIS during the surgery.
Tamsulosin Hydrochloride (Amso) should be used with caution in combination with strong inhibitors of CYP3A4 (see Interactions and Pharmacology: Pharmacokinetics under Actions). Tamsulosin Hydrochloride (Amso) should not be used in combination with strong inhibitors of CYP3A4 in patients known to be CYP2D6 poor metabolizers.
Cases of allergic reaction to Tamsulosin Hydrochloride (Amso) in patients with a past history of sulfonamide allergy have been reported. If a patient reports a previously experienced sulfa allergy, caution is warranted when administrating Tamsulosin Hydrochloride (Amso).
Effects on Ability to Drive and Use of Machines: No studies on the effects on the ability to drive and use machines have been performed. However, patients should be aware of the fact that dizziness can occur.

Not applicable, as Tamsulosin (Amso) is intended for male patients only.

The side-effects reported in ≥2% of patients with Tamsulosin Hydrochloride (Amso) include abnormal ejaculation, back pain, chest pain, cough, include drowsiness, hypotension (notably postural hypotension), syncope, asthenia, depression, diarrhea, constipation, dizziness, headache, infection, nausea, vomiting, tooth disorder, libido decreased, insomnia, somnolence, rhinitis, pharyngitis, sinusitis, blurred vision, dry mouth, gastro-intestinal disturbance 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.
Decrease blood pressure. Tamsulosin Hydrochloride (Amso) may cause a sudden drop in the blood pressure upon standing from a sitting or lying position especially at the start of treatment. (See table.)

Click on icon to see table/diagram/image

No interactions have been seen when Tamsulosin Hydrochloride (Amso) was given concomitantly with either Atenolol, Enalapril, Nifedipine or Theophylline.
Concomitant Cimetidine brings about a rise in plasma levels of Tamsulosin (Amso), while Furosemide a fall, but as levels remain within the normal range posology need to be adjusted.
Concurrent administration of other α1-adrenoceptor antagonists could lead to hypotension effects.

Store at temperatures not exceeding 30°C.

Drugs for Bladder & Prostate Disorders

G04CA02 - tamsulosin ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.

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