SETEGIS
Active material: Terazosin
When ATH: C02CA
CCF: Alpha1-adrenoblokator. Antihypertensive drugs. Preparation, used in violation of urination in benign prostate hyperplasia glands
ICD-10 codes (testimony): I10, N40
When CSF: 01.01.02.02
Manufacturer: EGIS PHARMACEUTICALS Plc (Hungary)
Pharmaceutical form, composition and packaging
Pills round, flat, white, chamfered, Engraved “E451” on one side, without smell.
| 1 tab. | |
| terazosin (the hydrochloride dihydrate) | 1 mg |
Excipients: magnesium stearate, talc, povidone K-30, pregelatinized corn starch, lactose monohydrate.
10 PC. – blisters (3) – packs cardboard.
Pills round, flat, yellow color (possible heterogeneity of color), chamfered, Engraved “E452” on one side, without smell.
| 1 tab. | |
| terazosin (the hydrochloride dihydrate) | 2 mg |
Excipients: magnesium stearate, talc, povidone K-30, pregelatinized corn starch, lactose monohydrate, ariavit quinoline zheltыy.
10 PC. – blisters (3) – packs cardboard.
Pills round, flat, light pink (possible heterogeneity of color), chamfered, Engraved “E453” on one side, without smell.
| 1 tab. | |
| terazosin (the hydrochloride dihydrate) | 5 mg |
Excipients: magnesium stearate, talc, povidone K-30, pregelatinized corn starch, lactose monohydrate, ariavit Sunset yellow.
10 PC. – blisters (3) – packs cardboard.
Pills round, flat, light orange (possible heterogeneity of color), chamfered, Engraved “E454” on one side, without smell.
| 1 tab. | |
| terazosin (the hydrochloride dihydrate) | 10 mg |
Excipients: magnesium stearate, talc, povidone K-30, pregelatinized corn starch, lactose monohydrate, ariavit Sunset yellow.
10 PC. – blisters (3) – packs cardboard.
Pharmacological action
Блокатор a1-adrenoreceptorov. Блокируя a1-adrenoceptors triangle and smooth muscle of the bladder neck, the proximal urethra and prostate, Setegis® It reduces resistance to current urine and normalizes urination in patients with benign prostatic hyperplasia. No effect on the size of the prostate.
The antihypertensive effect of the drug due to the expansion of arterioles and venules. Terazosin reduces peripheral vascular resistance and venous return to the heart, reduced before- and afterload on the heart and blood pressure. Long-term treatment Setegisom® generally it does not cause the development of reflex tachycardia. The drug has little effect on cardiac output, renal perfusion and glomerular filtration rate.
Maximal therapeutic effect develops in 2-3 hours after ingestion and lasts for 24 no.
Pharmacokinetics
Absorption
After oral terazosin rapidly and almost completely absorbed from the gastrointestinal tract. Eating does not affect the absorption. The bioavailability of terazosin 90%. Cmax It reached within 1 no.
Distribution
Plasma protein binding is 90-94%.
Metabolism
Terazosin metabolized in the liver by hydrolysis, demethylation and dealkylation to form 4 metabolites, one of which is pharmacologically active.
Deduction
T1/2 is 12 no. About 10% the dose is excreted in the urine and 20% – with feces in unchanged form, the rest of the output in the form of metabolites.
Pharmacokinetics in special clinical situations
T1/2 It does not change with impaired renal function.
Testimony
- Simptomaticheskaya therapy dobrokachestvennoy giperplazii predstatelynoy zhelezы;
- Arterial hypertension (as monotherapy or in combination therapy).
Dosage regimen
Adults the drug is prescribed in an initial dose 1 mg 1 time / day before bedtime. Due to an increased risk of hypotension after the first dose of the initial dose should not exceed 1 mg. Increasing the daily dose should be gradual, at intervals of 1 week to reach the maintenance dose.
At benign prostatic hyperplasia maintenance dose is 5-10 mg 1 time / day. The maximum daily dose – 20 mg.
At hypertension maintenance dose is 1-5 mg 1 time / day.
Patients with renal insufficiency and elderly patients dose adjustment is required.
Tablets should be taken as a whole, without chewing.
Side effect
Cardio-vascular system: after the first administration of the drug may develop hypotension, accompanied by dizziness, and in more severe cases, – swoon; often (after taking the drug at the high dose) – orthostatic hypotension, dizziness, weakness, peripheral edema; perhaps – tachycardia, palpitations, angina.
CNS: headache, drowsiness, visual impairment.
From the digestive system: nausea, vomiting, dyspepsia.
Other: anaphylactic reactions, asthenia, myalgia, swelling of the nasal mucosa, breathlessness, weight gain, priapism.
Contraindications
- Children's age;
- Hypersensitivity to terazosin, or other alpha-blockers.
FROM caution should be prescribed the drug for hypotension.
Pregnancy and lactation
Due to the lack of clinical data on the use of the drug Setegis® Pregnancy and lactation, his appointment at these times is possible only in cases when the anticipated benefits justify the potential risk.
Cautions
After the first dose or during the first days of treatment may occur “the effect of the first dose”: pronounced fall in blood pressure, mainly in the form of orthostatic hypotension and vertigo, a sense of uncertainty and fainting. Hypovolemia and limiting salt intake increases the risk of “the effect of the first dose”. The same phenomenon can be observed when resuming treatment after a few days break,, why should resume treatment, using an initial dose.
Fainting observed approximately 1% cases. Besides “the effect of the first dose” too rapid dose escalation and the simultaneous use of diuretics and other antihypertensive drugs can also cause fainting. Fainting primarily due to orthostatic hypotension, but it may be associated with tachycardia (120-160 u. / min). Orthostatic hypotension is most pronounced shortly after taking the drug, and the risk of fainting is greatest between the 30th and 90th minutes. Rising from a sitting or horizontal position, prolonged standing on his feet, intense physical effort, high ambient temperatures and the simultaneous use of alcohol can trigger dizziness, a feeling of uncertainty, or even loss of consciousness. When syncope patient should be put, make legs elevated position, and if necessary to use other measures of maintenance therapy.
When using Setegisa® in conjunction with diuretics and / or other agents to reduce the dose recommended. To prevent the development of severe arterial hypotension concomitant medications recommended to prescribe a low dose and exercise at the same time careful medical monitoring of the patient. The same precautions are required when adding Setegisa® the current antihypertensive therapy. The initial dose Setegisa® in these cases also 1 mg.
Elderly patients may be increased sensitivity to the hypotensive effect of terazosin.
Precautions should be prescribed to patients with a predisposition to orthostatic hypotension, while coronary heart disease or other heart disease, cerebrovascular disorders, гипертензивной ретинопатии III или IV степени, insulin-dependent diabetes mellitus, human liver and kidneys.
Before treatment Setegisom® benign prostatic hyperplasia, should be excluded malignancy of the prostate. In appointing the drug to patients with benign prostatic hyperplasia should monitor blood pressure at the beginning of treatment and when changing the dose during therapy. Efficiency Setegisa® in this disease is assessed 4-6 weeks of treatment maintenance doses.
If lactose intolerance should be considered its content in tablets (55 mg per tablet 1 mg, 110 mg per tablet 2 mg, 5 mg 10 mg).
Use in Pediatrics
The efficacy and safety of the drug in children have not been established.
Effects on ability to drive vehicles and management mechanisms
At the beginning of treatment and with increasing doses of the drug to patients is not recommended to engage in potentially dangerous activities, require increased attention and psychomotor speed reactions (incl. driving vehicles) over a period of time, the duration of which is determined individually. Subsequently, the degree of restriction to be set depending on the individual response of the patient.
Overdose
Symptoms: hypotension, dystaxia, fainting.
Treatment: the patient should be given a horizontal position with raised legs. Symptomatic therapy. No specific antidote. Hemodialysis nyeeffyektivyen, tk. terazosin is highly bound to plasma proteins. With the development of the shock is necessary to increase the bcc followed by vasopressor.
Drug Interactions
In an application Setegisa® with other antihypertensive drugs may increase antihypertensive action.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children at temperature from 15 ° to 30 ° C. Shelf life – 3 year.
