active substance:1 tablet contains 1 mg or 2 mg, 5 mg or 10 mg terazosin (as 1,187 mg 2,374 mg 5,935 mg 11.87 mg terazosin hydrochloride, respectively);
excipients:lactose, corn starch, povidone, magnesium stearate, talc
2 mg tabletscontain quinoline yellow (E 104)
tablets 5 mg or 10 mg: yellow sunset FCF (e 110).The
basic physico-chemical properties:
1 mg tablets- white round flat tablets, with chamfer, smooth on one side and engraved with stylized letter E and number 451 on the other side, odorless
tablets 2 mg- round flat tablets are yellow color, with facet, smooth on one side and engraved with a stylized letter E and the number 452 on the other hand, no smell
tablets 5 mg- round flat tablets of light orange color, chamfer, smooth on one side and engraved with a stylized letter E and a number 453 on the other hand, odorless
tablets 10 mg- round flat tablets of orange color, chamfer, smooth on one side and engraved with a stylized letter E and a number 454 on the other hand, odorless.The
Drugs used in benign prostatic hypertrophy. Antagonists of ?-adrenergic receptors. Terazosin.
the ATC Code G04C A03.The
Terazosin selectively blocks peripheral post-synaptic ?1-adrenergic receptors. Blockade of these receptors causes expansion of arterial vessels, decrease in the General peripheral resistance, arterial pressure and post-loading on heart. The tone of the venous vessels also decreases, which leads to a decrease in venous return and overload on the heart. Long - term treatment with terazosin is usually not accompanied by reflex tachycardia; on cardiac output, renal perfusion and glomerular filtration rate terazosine affects little. The drug helps normalize lipid metabolism: reduces total cholesterol, triglycerides, LDL and VLDL, increases HDL levels. With systematic use of the drug, there is a regression of left ventricular hypertrophy.
by Blocking postsynaptic ?1-adrenoreceptors of smooth muscles of the exit wound of the bladder, proximal urethra and prostate, terazosin reduces resistance to urine flow and normalizes urination in patients with benign prostatic hyperplasia. The drug does not affect the size of the prostate.
Terazosin is rapidly and almost completely absorbed in the gastrointestinal tract regardless of meals. This indicates a very low metabolism of the first pass through the liver. The bioavailability of terazosin is almost 90%. Terazosin largely binds (90-94%) with plasma proteins. Terazosin is metabolized in the liver; one of the four known metabolites is pharmacologically active. The half-life is about 12:00 and practically does not change even in violation of kidney function. The maximum concentration in the blood plasma is reached after 1: 00, the maximum effect occurs 2-3 hours after ingestion. Duration of action is 24 hours. Almost 40% of the dose is excreted in the urine and 60% - with feces.
Symptomatic treatment of urinary retention caused by benign prostatic hypertrophy.
Arterial hypertension (in the form of monotherapy or in combination with other antihypertensive drugs).
hypersensitivity to the active substance or to any auxiliary substance and to other ?-adrenoreceptor antagonists similar in structure.The
In clinical studies in patients with benign prostatic hypertrophy treated with terazosin at the same time with ACE inhibitors, blockers, antagonists of calcium ions or diuretics, the incidence of dizziness or other side effects related to treatment was greater than in patients taking only terazosina.
care should be taken while using terazosin with other antihypertensive agents to avoid the development of a pronounced antihypertensive effect. It is recommended to reduce the dose of terazosin with additional inclusion in the treatment regimen of diuretics or other antihypertensive drugs, and the additional drug should be used at low doses. When terazosin is an additional drug, its initial dose should not exceed 1 mg.
When using terazosin simultaneously with analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), theophylline, cardiac glycosides, anxiolitikami, antianginal, hypoglycemic, antiarrhythmic, sedative, antibacterial, hormonal, non-steroidal and protivopodagricakih funds, indication of interaction was not observed.
the development of arterial hypotension was Reported with the simultaneous use of terazosin with phosphodiesterase-5 inhibitors (PDE-5). The combined use of terazosin with sildenafilom or vardenafilom possible only patients resistant to terazosin. In addition, vardenafil should not be taken within 6:00 after taking terazosin and sildenafil - over 4:00.
Antihypertensive effect of the drug may increase ethanol.
Terazosin, like other antagonists of ?-adrenoreceptors, is not recommended for patients with a history of fainting, which was accompanied by involuntary urination.
With caution should designate terazosina patients aged 65 years with a tendency to orthostatic hypotension, ischemic heart disease and other serious heart disease, cerebrovascular disease, hypertensive retinopathy III and IV degree, insulindependent diabetes mellitus, hepatic or renal failure.
For patients with renal failure and elderly dose correction is not required.
Before you start the treatment of benign hypertrophy of the prostate to exclude malignancy of the prostate gland.
caution should be given to prescribe the drug for pheochromocytoma and, if necessary, surgery.
in the first days of treatment and after taking the first dose may be "the effect of the first dose" - a sharp decrease in blood pressure, in particular orthostatic hypotension (accompanied by dizziness, violation of the coordination of movement, loss of consciousness). By reducing the volume of fluid in the body, liposolve the diet can increase the risk of developing postural hypotension. Similar symptoms may develop when the treatment is resumed after a break for several days. In such cases, it is necessary to resume treatment from the starting dose
(1 mg). The incidence of loss of consciousness is approximately 1%.
In addition to the" effect of the first dose", before losing consciousness can also lead to too sharp an increase in the dose of the drug or additional inclusion in the treatment regimen diuretics or other antihypertensive agents. Loss of consciousness is mainly associated with a pronounced orthostatic hypotension, which is sometimes accompanied by tachycardia (120-160 u/Min). The most pronounced orthostatic effect is observed immediately after taking the drug, the risk of loss of consciousness is high 30-90 minutes after taking the drug.
when moving from a sitting or lying position to a vertical position, standing for a long time, under excessive physical stress, hot weather or while drinking alcohol, dizziness, impaired coordination of movement, loss of consciousness may develop. If the patient loses consciousness, it should be put in a horizontal position, lift the legs and, if necessary, prescribe symptomatic therapy.
when adding diuretics or other antihypertensive drugs to terazosin, it is recommended to reduce the dose of terazosin. To avoid excessive lowering of blood pressure, additional therapy should also begin with low doses and under the close supervision of a doctor. Caution should also be exercised when adding terazosin to a diuretic or other antihypertensive agent. In such cases, the initial dose of terazosin should also be 1 mg.
elderly patients may increase sensitivity to the hypotensive action of terazosin. When prescribing the drug to patients with benign prostatic hypertrophy should regularly monitor blood pressure. This should also be taken into account in the selection of dose, dose increase, as well as in the appointment of other antihypertensive agents.
the Efficacy of terazosin in the treatment of benign prostatic hypertrophy should be evaluated after 4-6 weeks of treatment with maintenance doses.
patients who are treated or previously treated ?1blockers, during the operation for cataract was observed intraoperative flaccid iris syndrome (ISDR). This phenomenon is a variant of the dense pupil syndrome, in which the iris is relaxed to such a state, fluctuating under the influence of irrigation rays; despite the preoperative dilation of the pupil with the help of Midriatic agents, the myosis increases and the iris can hang into incisions. In such cases, a surgeon should be modified and surgical equipment hook for rainbow the shell of the expansion ring and a viscoelastic substance. Ophthalmologists should know whether the patient ?1has taken (or is taking) an adrenoblocker in advance to the surgery. Preoperative interruption of treatment with ?1blockers has advantages over long-term therapy.
caution Should be exercised with simultaneous use of terazosina with thiazide diuretics or other antihypertensive agents; if necessary, combination therapy dose terazosin should be reduced. The simultaneous use of inhibitors of PDE5, including sildenafil, tadalafil, vardenafil and drug terazosina can lead to a marked reduction in blood pressure in some patients. In order to minimize the risk of orthostatic hypotension, before starting the use of PDE-5, it is necessary to ensure that the arterial pressure of the patient is stable against the background of treatment with terazosin.
Since 1 mg tablets contain 55 mg lactose, 2 mg lactose or 5 mg lactose or 10 mg lactose or 110 mg lactose, patients with hereditary galactose intolerance, Lapp lactase deficiency and malabsorption of glucose/galactose should not use this drug.
the Patient should be informed that at the first signs of orthostatic hypotension (fainting, dizziness, weakness) the patient should sit down or lie down and remain in this position until the state of health improves, as well as an increase in the risk of a marked decrease in blood PRESSURE with alcohol consumption, prolonged standing or exercise, as well as at high ambient temperatures.
use during pregnancy or lactation.
the Drug is contraindicated for use during pregnancy and lactation.
Ability to influence the reaction rate when driving motor transport or operating other mechanisms.
after taking the initial dose of terazosin, when increasing the dose or re-therapy Setegis may experience dizziness, impaired coordination, loss of consciousness. In this regard, you should avoid driving or operating dangerous machinery for 12: 00 after taking the initial dose or increasing the dose, as well as after the resumption of treatment after a break.
Tablets should be taken independently of meals, without chewing, once a day. The duration of treatment is determined by the doctor individually.
Benign prostatic hypertrophy.
the Initial dose is 1 mg. maintenance dose is 5-10 mg 1 times per day. The maximum daily dose is 20 mg. Therapeutic effect is usually observed after 2 weeks of starting treatment. To achieve a lasting effect, the course of treatment with a maintenance dose should be 4 weeks.
it is Recommended selection of individual daily dose for each patient.
the Initial dose is 1 mg, which should be prescribed at night. The maintenance dose should be increased gradually to 2 mg, 5 mg or 10 mg once a day, doubling it at weekly intervals until the desired blood pressure level. The maximum daily dose is 20 mg.
Safety and efficacy of the drug in children have not been established, so it should not be prescribed to this category of patients.
Symptoms: orthostatic collapse, arterial hypotension, tachycardia, circulatory shock, electrolyte imbalance and severe renal failure.
Treatment: symptomatic therapy. The patient must be put in a horizontal position and lift his legs. If necessary, appoint antishock therapy with the introduction of liquids and vasoconstrictors. It is necessary to restore the water-electrolyte balance. Because terazosina largely associated with the protein, it can be extracted from the body using dialysis.
at the beginning of treatment may develop "effect of the first dose" - orthostatic hypotension to fainting.
if fainting occurs, the patient must be put in a lying position. Dizziness, mild headache or fainting can occur with a rapid rise from a lying or sitting position. Patients should be warned about these conditions and should be invited to lie down if these symptoms appear. It is necessary to lie down for a few minutes before getting up to prevent re-occurrence of symptoms.
These adverse reactions do not require restriction and in most cases have not been repeated after the initial period of therapy or dose selection.
Lab studies:treatment terazosina for 24 months had no significant impact on the level of prostate specific antigen (PSA).
From the cardiovascular system: arrhythmia (unknown connection with the use of terazosin). Orthostatic hypotension, vasodilation, peripheral edema, palpitations, tachycardia, orthostatic hypotension, atrial fibrillation, ventricular fibrillation.
from the blood side:thrombocytopenia, reduction of hemoglobin, leukocytes, hematocrit, total protein, albumin, indicating the possibility of hemodilution.
from nervous system:fainting, dizziness, drowsiness, headache, paresthesia.
from the organ of vision:blurred vision, amblyopia. During surgery for cataract removal in patients treated with ?1blockers, was observed intraoperative flaccid iris syndrome (ISDR). Visual impairment and conjunctivitis (unknown relationship with the use of terazosin).
on the part of the hearing organs:vertigo, tinnitus (unknown connection with the use of terazosin).
from the respiratory system:nasal congestion, rhinitis, shortness of breath, sinusitis.
Bronchitis, epistaxis, flu symptoms, pharyngitis, increased cough (unknown connection with the use of terazosin).
from the gastrointestinal tract:nausea.
abdominal Pain, constipation, diarrhea, dry mouth, dyspepsia, flatulence, vomiting (unknown relationship with the use of terazosin).
from the urinary system:increased urge to urinate, urinary tract infections, urinary incontinence in women in the post-menopausal period (no connection with the use of terazosin).
on the part of the skin and subcutaneous tissue:itching, rash, increased sweating (no connection with the use of terazosin).
From the side of musculoskeletal system:back pain, pain in the limbs.
neck, shoulder, arthralgia, arthritis, joint pain, myalgia (no connection with the use of terazosin).
Endocrine disorders:gout (no connection with the use of terazosin).
General disorders:increased fatigue, asthenia, swelling, weight gain.
chest Pain, swelling of the face, fever (no connection with the use of terazosin).
from the immune system:anaphylactoid reactions, allergic reactions.
on the part of the reproductive system:impotence, priapism.
Mental disorders:decreased libido, depression, nervousness.
Fear, insomnia (no connection with the use of terazosin).The
Store at a temperature not exceeding 30 ° C out of reach of children.The
there are 10 tablets in blister, 3 blisters in a cardboard box.The
According to the recipe.The
ZAO Pharmaceutical factory EGIS, Hungary/EGIS Pharmaceuticals PLC, Hungary.
1165, G.. Budapest, street, Bakerfield, 118-120, Hungary/Budapest 1165, Bokenyfoldi ut. 118-120, Hungary.
Setegis is a member of the pharmacological group of drugs that are used to treat patients with benign prostatic hypertrophy. This tool is an antagonist of alpha-adrenergic receptors.
the Medicine has the form of light orange rounded tablets smooth on one side and engraved with E-453 on the other. Packed in a cardboard box, 10 pieces in three blisters. In one tablet is 5 milligrams of the active substance terazosin.
the Substance terazosin selectively blocks peripheral postsynaptic alpha1-adrenoreceptors of smooth muscle tissue of the exit wound in the bladder. And also in the proximal parts of the prostate with the urethra, which affects the resistance to urine flow, leading urination to normal. Setegis expands blood vessels, reduces blood PRESSURE and cardiac load. in turn due to the drug lipid metabolism is normalized, cholesterol levels are reduced. Long-term therapy reduces the size of the left ventricle.
Among the indications for administration of the drug note:The
the Use of tablets is oral way. The size of the daily dosage and duration of treatment depend on the severity of the disease. The minimum dose is 1 milligram, the maximum-20 milligrams.