Tamsulostad 0.4mg, 30 capsules — Made in Germany — Free Delivery
(Tamsulostad )
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Description Tamsulostad 0.4mg, 30 capsules — Made in Germany — Free Delivery
Indications
Treatment of functional disorders of the lower urinary tract in benign prostatic hyperplasia.
Application
Doses and duration of treatment should be selected individually. The recommended dose for adults is 1 capsule per day. taken after breakfast. The capsule should be swallowed whole with plenty of water, standing or sitting. take the capsule without breaking it, as this will prevent the modified release of the active ingredient.
Contraindications
Hypersensitivity reactions, including angioedema angioedema to tamsulosin hydrochloride or any other component of the preparation; orthostatic hypotension; severe liver failure.
Side effects
Common side effects (1/100, 1/10)
- From the side of the central nervous system: dizziness.
- From the reproductive system: retrograde ejaculation.
Infrequent (1/1000, 1/100)
- From the side of the central nervous system: headache.
- From the side of the cardiovascular system: palpitations, orthostatic hypotension.
- Respiratory-mediastinal disorders: rhinitis.
- From the digestive tract: constipation, diarrhea, nausea, vomiting.
- From the skin and mucous membranes: rash, urticaria, itching.
- General disorders: asthenia.
Rare (1/10,000, 1/1000)
- From the side of the central nervous system: fainting.
- On the part of the skin and mucous membranes: angioedema angioedema.
Very rare (1/10,000)
- From the reproductive system: priapism.
- Diseases of the skin and subcutaneous tissue: Stevens-Johnson syndrome.
There are spontaneous reports of cases of atrial fibrillation, arrhythmia, tachycardia and dyspnea in the post-registration period, the frequency of reports and the role of tamsulosin in this case cannot be reliably established.
Cases of intraoperative instability of the iris (constricted pupil syndrome) have been described during cataract and glaucoma surgery in patients who have been taking tamsulosin for a long time (see SPECIAL INSTRUCTIONS).
special instructions
Instability of the iris (constricted pupil syndrome) associated with blockade of α1-adrenergic receptors during cataract surgery and glaucoma has been observed in some patients who have taken or are taking tamsulosin. for this reason, tamsulosin is not recommended for patients scheduled for cataract and glaucoma surgery.
As a rule, it is recommended to stop treatment with tamsulosin 1-2 weeks before cataract and glaucoma surgery. However, the feasibility and timing of discontinuation of tamsulosin treatment has not yet been clearly established.
In preparation for surgery, ophthalmic surgeons should find out if the patient has taken (or is taking) tamsulosin in order to prevent possible complications associated with iris instability.
As with the use of other α1-adrenergic blockers, in some cases, when using Tamsulostad, a decrease in blood pressure is possible, which can sometimes lead to loss of consciousness. When the first signs of orthostatic hypotension (dizziness, weakness) appear, the patient should take a horizontal position until the above symptoms disappear.
Before starting treatment with Tamsulostad, you should undergo a medical examination to identify other concomitant diseases that can cause symptoms such as benign prostatic hyperplasia. Before starting treatment, it is necessary to conduct a rectal examination of the prostate gland and, if necessary, a prostate specific antigen (PSA) test at the beginning and at regular intervals during treatment.
It is necessary to prescribe to patients with severe renal insufficiency (creatinine clearance 10 ml / min) with extreme caution, since clinical studies using Tamsulostad in such patients have not been conducted.
Tamsulosin hydrochloride should not be used 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 CYP 3A4 inhibitors (see Interactions).
Use during pregnancy and lactation. Tamsulostad is indicated for use in men only.
Children. The preparation is not used in children.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Studies of the effect of the preparation on the ability to drive vehicles or work with mechanisms have not been conducted. However, patients should be warned about the possibility of dizziness.
Interactions
Interaction does not occur with the simultaneous use of tamsulosin hydrochloride with atenolol, enalapril, nifedipine or theophylline.
With simultaneous use with cimetidine, an increase in the concentration of tamsulosin in the blood plasma was noted, and with furosemide - a decrease in concentration, however, since these levels remain within the normal range, there is no need for a special dose adjustment of tamsulosin.
In in vitro studies, diazepam, propranolol, trichlormethazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not affect the free fraction of tamsulosin in human plasma. Similarly, tamsulosin does not change the level of free fractions of diazepam, propanolol, trichlormethiazide and chlormadinone in human plasma.
The simultaneous use of tamsulosin hydrochloride with strong inhibitors of CYP 3A4 may lead to an increase in the effect of tamsulosin hydrochloride. The combined use with ketoconazole (a known strong inhibitor of CYP 3A4) leads to an increase in Cmax and AUC to 2.2 and 2.8, respectively.
The simultaneous use of tamsulosin hydrochloride and paroxetine (a strong inhibitor of CYP 2D6) leads to an increase in Cmax and AUC to 1.3 and 1.6, respectively, but this is not clinically significant.
Tamsulosin hydrochloride should not be given in combination with strong CYP 3A4 inhibitors in patients with low CYP 2D6 metabolism.
Tamsulosin hydrochloride should be used with caution in combination with strong and moderate CYP3A4 inhibitors.
Simultaneous use with other α1-adrenergic blockers may enhance the hypotensive effect.
Overdose
In the event of a sharp decrease in blood pressure due to an overdose, supportive therapy should be carried out aimed at restoring the normal function of the cardiovascular system (for example, the patient should take a horizontal position). if this measure is not effective, infusion therapy is carried out and vasopressors are prescribed. it is necessary to monitor renal function and carry out general maintenance therapy. as a result of the high degree of binding of tamsulosin to blood plasma proteins, hemodialysis is unlikely to be appropriate.
In order to stop further absorption of the preparation, you can artificially induce vomiting. In case of an overdose of a significant amount of the preparation, the patient needs to wash the stomach with activated charcoal and low-osmotic laxatives, such as sodium sulfate.
Storage conditions
In original packaging at a temperature not exceeding 25 ° C.
Tags: Tamsulostad
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