Tamsin Forte tabl.prolong.action.0.4 mg №30 (10 x 3) blister

Tamsin Forte tabl.prolong.action.0.4 mg №30 (10 x 3) blister

Product Code: 12403
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Composition

active substance:tamsulosin hydrochloride

1 prolonged action tablet contains tamsulosin hydrochloride 0.4 mg

Excipients:hypromellose (hydroxypropylmethyl cellulose), microcrystalline cellulose, carbomer, silicon dioxide colloidal, iron oxide red (E172), magnesium stearate.

The

Dosage form

extended-release Tablets.

The

drug description

Tools used in benign prostatic hyperplasia. Antagonists of ?1adrenergic receptors.

ATC Code G04C A02.

Reading

Treatment of functional disorders of the lower urinary tract in benign prostatic hyperplasia.

Contra

Hypersensitivity to tamsulosin hydrochloride, including drug angioedema or to any of the excipients, orthostatic hypotension, severe liver failure.

Method of application and doses

for oral administration.

the recommended 1 tablet daily, with or without food. The tablet should be swallowed whole without chewing it, as this will prevent the prolonged release of the active substance.

impaired renal function do not require dose reduction.

patients with impaired hepatic function of mild to moderate severity also do not require dose reduction.

Side effects

the part of the nervous system: dizziness, headache, syncope.

From the urogenital system: retrograde ejaculation, priapism.

From the side of cardiovascular system: palpitations, orthostatic hypotension.

the respiratory system: rhinitis.

from the digestive system: constipation, diarrhea, nausea, vomiting.

skin and mucous membranes: rash, urticaria, itching, Stevens-Johnson syndrome, angioedema quince.

General Disorders: asthenia.

there are spontaneous reports of cases of atrial fibrillation, arrhythmia, tachycardia and shortness of breath in the post-registration period, the frequency of reactions and the role of tamsulosin in this case cannot be reliably established.

Describes the cases of intraoperative instability of the iris (narrowed pupil syndrome) during cataract and glaucoma surgery in patients, long-term use of tamsulosin (see section "Peculiarities of application").

Overdose

there were No reports of acute overdose tamsulosin hydrochloride 5 mg. there was an acute hypotension (systolic blood pressure 70 mm Hg. St.), Vomiting and diarrhea, which were treated with infusion therapy, and the patient could be discharged on the same day.

in the case of acute arterial hypotension, which occurs after an overdose, it is necessary to support the cardiovascular system. Blood pressure and heart rate are normalized in the horizontal position. If this does not help, then apply plasma-substituting means and, if necessary, decongestants. Kidney function should be monitored and supportive measures applied. Dialysis is ineffective due to the high degree of binding of tamsulosin with plasma proteins.

to prevent absorption, cause vomiting. Wash the stomach, assign activated charcoal, osmotic laxative agent such as sodium sulfate.

pregnancy and lactation

this drug is used only for the treatment of men.

The

Children

there is no relevant evidence for tamsulosin in children.

application Features

As in the case of other ?1adrenoreceptors, the treatment of tamsulosin can rarely cause a decrease in blood pressure, causing a fainting state. At the first signs of orthostatic hypotension (dizziness, weakness), the patient must be transferred to a sitting or lying position until the symptoms disappear.

tamsulosin treatment should be preceded by examination of the patient in order to eliminate any other disease that can cause the same symptoms as benign prostatic hyperplasia. Before starting treatment and regularly during therapy should be carried out finger rectal examination and, if necessary, to determine the specific prostatic antigen (PSA). It should be cautiously prescribed to patients with severe renal insufficiency (creatinine clearance

"Intraoperative flaccid iris syndrome" (ISVR, a kind of narrow pupil syndrome) has been observed during cataract surgery in some patients who used tamsulosin during surgery or in the preoperative period. ISVR may lead to increased procedural complications during the operation. Initiation of therapy with the use of tamsulosin patients scheduled for a cataract operation, is not recommended. Cancellation of tamsulosin 1-2 weeks before surgery to remove cataracts and glaucoma according to some reports is considered appropriate, but the benefits and duration of cessation of therapy in cataract surgery have not yet been established.

ophthalmologists should know whether the patient has been taking tamsulosin before surgery to prevent possible complications associated with the instability of the iris.

Tamsulosin hydrochloride should not be administered in combination with strong CYP3A4 inhibitors in patients with low CYP2D6 metabolism.

Tamsulosin hydrochloride should be used with caution in combination with strong and moderate inhibitors of CYP3A4 (see Interaction with inemi medicinal products and other forms of interaction).

The

Ability to influence the reaction rate when driving motor transport or operating other mechanisms

study of the effect of the drug on the ability to drive vehicles and work with the mechanisms were not carried out. However, patients should be informed about the possible occurrence of dizziness.

The

Interaction with other medicinal products and other forms of interaction

the Simultaneous application of tamsulosin hydrochloride with strong inhibitors of CYP3A4 may lead to increased effects of tamsulosin hydrochloride. Concomitant use with ketoconazole (a known strong CYP3A4 inhibitor) leads to an increase in CmOhand AUC to 2.2 and 2.8, respectively.

the Simultaneous use of tamsulosin hydrochloride and paroxetine (a strong CYP2D6 inhibitor) results in an increase frommAhand AUC to 1.3 and 1.6 respectively, but this is not clinically significant.

Tamsulosin hydrochloride should not be administered in combination with strong CYP3A4 inhibitors in patients with low CYP2D6 metabolism.

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

no drug interactions were observed with atenolol, enalapril, nifedipine or theophylline when tamsulosin was used simultaneously. Concomitant use with cimetidine increases, and with furosemide reduces the concentration of tamsulosin in plasma, but since these levels remain within normal limits, in a special correction of tamsulosin dose is not necessary.

in studiesin vitrodiazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not affect the free fraction of tamsulosin in human blood plasma. Likewise, tamsulosin does not change the level of the free fractions of diazepam, propanolol, trichlormethiazide and chlormadinone in human blood plasma.

in studiesin vitrofound no interaction at the level of hepatic metabolism involving microsomal fractions in the liver (indicative was the system of enzymatic metabolism involving cytochrome P450 on amitriptyline, salbutamol, glibenclamide and finasteride). However, diclofenac and warfarin can accelerate the elimination of tamsulosin from plasma.

the Simultaneous use of other ?1adrenergic receptors may enhance hypotensive effect.

The

Pharmacological properties

Pharmacodynamics.Tamsulosin selectively and competitively binds to postsynaptic ?1adrenoreceptors, especially subtypes ?lAand ?lD. This leads to a decrease in the tone of the smooth muscles of the prostate, the neck of the bladder and the prostatic part of the urethra.

Tamsulosin increases the maximum urinary flow rate. It facilitates obstruction by relaxing the smooth muscles of the prostate and urethra, thus facilitating urination. At the same time, symptoms of obstruction and irritation associated with benign prostatic hyperplasia (difficulty starting urinating, weakening of the urine stream, the presence of residual urination, feeling of incomplete emptying of the bladder, frequent calls for urination at night, urination) decrease.

These effects on the accumulation and urination are stored in long-term therapy. The observation data indicate that the use of tamsulosin may postpone the need for surgical intervention or catheterization.

?1A-blockers can lower blood pressure by reducing peripheral resistance. No decrease in blood pressure was observed during studies using tamsulosin in patients with normal blood pressure.

Pharmacokinetics.

Absorption.Tamsin Forte is a prolonged-acting tablet with controlled release that provides long-term and slow release tamsulosin, which gives exposure with weak fluctuations for 24 hours.

After receiving 57% of tamsulosin is absorbed in the intestine. Speed and absorption do not depend on eating. Tamsulosin exhibits linear pharmacokinetics.

after a single dose of tamsulosin on an empty stomach, the maximum concentration of tamsulosin in blood plasma is averaged after 6:00. In the equilibrium state is achieved on the fourth day of taking the drug, peak concentration of tamsulosin in plasma after 4-6 hours without food. The maximum concentration in plasma increased from 6 ng/ml after the first dose to 11 ng/ml at steady state. As a result of prolonged release of prolonged-acting tablets, the low concentration of tamsulosin in plasma is 40% of the maximum concentration, regardless of meals.

there is a significant difference in plasma levels between patients, both after single and multiple use.

Distribution.plasma protein Binding - 99%. The distribution volume is insignificant - up to 0.2 l/kg.

Metabolism.Tamsulosin has a low "first pass" effect, metabolizing slowly. Most tamsulosin is present in plasma as an unchanged active substance. Metabolized in the liver.

no induction of microsomal liver enzymes caused by tamsulosin was observed in rats.

no dose adjustment is required for liver failure. None of the metabolites is more active than the original compound.

Output.Tamsulosin hydrochloride is excreted by the kidneys, 4-6% of the dose is excreted unchanged. The half-life of tamsulosin with a single intake and in equilibrium - 19 and 15 hours, respectively. No dose adjustment is required for renal failure.

Basic physical and chemical properties

White, smooth surface, round, biconvex with engraving "T9SL" on one side and "0.4" on the other side.

The

shelf Life

3 years.

storage Conditions

keep out of reach of children.

to Protect from light.

Store in its original packaging at a temperature not exceeding 25 ° C in a dry place.

The

Packaging

there are 10 tablets in blister, 3 blisters in a cardboard box.

The

Category vacation

According to the recipe.

The

Manufacturer

Sinton of Hispania, S. L. Synthon Hispania SL

The

Location

Range Industrial Les Salines, Carrer Castello, 1, 08830 Sant Boi where Llobregat (Barcelona), Spain/Poligono Industrial Les Salines, Carrer Castello, 1, 08830 Sant Boi de Llobregat (Barcelona), Spain.

PROTEX RECTAL SUPPOSITORIES 0.03 G 

Protex suppositories – a drug used in urology for the treatment of ailments of the prostate gland. The active ingredient is bullish prostate extract obtained by lyophilization from an aqueous solution. Every candle has 30 milligrams. Packing by carton, 5 pieces in 2-contour the blisters.

the Effect on the body, the testimony

Extract of bull prostate gland features a powerful protoprotestant effect in comparison to the male prostate. Due to organotropic and anti-inflammatory effects, swelling and leukocyte infiltration of the gland is reduced. Along with that, microcirculation and the process of thrombocytic-vascular hemostasis are adjusted. Sperm become more functionally active, it improves muscle tone in the bladder.

the drug is successfully used for prevention and treatment:

    The
  • of Chronic prostatitis.
  • The
  • Complications after surgery on the prostate.

the Use and dosage

Suppositories are used for insertion into the anus. Daily rate – one thing 2 times/day (morning and bedtime) for one week. The nature and severity of the disease directly affects the duration of therapy.

& nbsp;

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