Setegis
Setegis: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Setegis
ATX code: G04CA03
Active ingredient: terazosin (terazosin)
Manufacturer: CJSC Pharmaceutical Plant EGIS (Hungary)
Description and photo update: 2019-26-08
Prices in pharmacies: from 790 rubles.
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Setegis is an alpha 1- adrenergic blocker that lowers blood pressure, as well as reduces resistance to urine flow and normalizes urination in patients with benign prostatic hyperplasia.
Release form and composition
Dosage form - tablets: round, flat, beveled, odorless:
- 1 mg - white, with "E451" engraving on one side;
- 2 mg - yellow (color irregularity is possible), with “E452” engraving on one side;
- 5 mg - light pink (color irregularity is possible), with “E453” engraving on one side;
- 10 mg - light orange (color variation is possible), with "E454" engraving on one side.
Tablets are packaged in 10 pieces. in blisters, 3 blisters are packed in a cardboard box.
Active ingredient: terazosin (in the form of dihydrate hydrochloride), in 1 tablet - 1, 2, 5 or 10 mg.
Auxiliary components: talc, magnesium stearate, povidone K-30, lactose monohydrate, pregelatinized corn starch.
Pharmacological properties
Pharmacodynamics
The active component of Setegis is terazosin, an alpha 1- adrenergic blocker, which improves urodynamics in patients with benign prostatic hyperplasia (BPH). The symptomatology of this disease is due to an increase in the smooth muscle tone of the outlet of the bladder (proximal urethra, neck and triangle of the bladder) and prostate. This tone is controlled by alpha 1 -adrenergic receptors. In vitro, terazosin inhibited phenylephrine-induced contractions of prostate smooth muscle. In clinical trials, terazosin eliminated BPH symptoms and improved urodynamics.
Due to competitive antagonism against postsynaptic alpha 1 -adrenergic receptors, terazosin dilates the arteries. Causes a gradual decrease in blood pressure, subsequently has a long-term hypotensive effect.
When used in therapeutic doses, Setegis reduces total blood cholesterol by 2-5%, the sum of low-density lipoprotein cholesterol and very low-density lipoprotein cholesterol concentrations by 3-7% compared to the baseline values that were observed before starting drug treatment. In addition, there is no increase in total cholesterol while taking other antihypertensive drugs, if terazosin is used simultaneously.
The onset of action of Setegis is observed approximately 15 minutes after taking a single dose, the maximum effect - after 2-3 hours. The duration of action is 24 hours.
Pharmacokinetics
After taking Setegis inside, terazosin is rapidly and almost completely absorbed from the gastrointestinal tract. It is slightly affected by the effect of the first passage through the liver.
It is characterized by a high biological activity - about 90% and a connection with plasma proteins - 90–94%.
The maximum concentration in the blood reaches within 1 hour.
Biotransformation undergoes in the liver. Of the four known metabolites, only one has pharmacological activity.
It is excreted: through the intestines - 60% of the dose taken, by the kidneys - 40% of the dose. The half-life is an average of 12 hours.
Elimination of the drug does not depend on renal function. The half-life does not change in patients with impaired renal function.
Indications for use
- arterial hypertension;
- benign prostatic hyperplasia (symptomatic therapy).
Contraindications
- childhood;
- period of breastfeeding;
- hypersensitivity to the components of Setegis tablets or other alpha-blockers.
Carefully:
- period of pregnancy;
- type I diabetes mellitus (insulin dependent);
- impaired renal and / or liver function;
- disorders of cerebral circulation;
- hypertensive retinopathy of III or IV degree;
- predisposition to orthostatic hypotension;
- arterial hypotension;
- coronary artery disease or other heart disease.
Instructions for using Setegis: method and dosage
Setegis tablets should be taken orally: swallow whole and drink plenty of liquid.
At the beginning of treatment, 1 mg is prescribed 1 time per day before bedtime. Then gradually - once a week - the dose is increased until an effective one is achieved.
Optimal maintenance doses:
- arterial hypertension - 2-10 mg once a day (taking the drug in a dose over 20 mg rarely improves the effect, taking higher doses has not been studied);
- benign prostatic hyperplasia - 5-10 mg 1 time per day (effectiveness in doses over 10 mg has not been proven).
Side effects
- from the central nervous system: visual disturbances, drowsiness, headache;
- from the digestive system: dyspepsia, nausea, vomiting;
- on the part of the cardiovascular system: after the first dose of Setegis - arterial hypotension with dizziness, in more severe cases - with fainting; often (when taking the drug in high doses) - weakness, dizziness, peripheral edema, orthostatic hypotension; in some cases - a feeling of palpitations, tachycardia, angina pectoris;
- others: swelling of the nasal mucosa, asthenia, shortness of breath, muscle pain, weight gain, anaphylactic reactions, priapism.
Overdose
Symptoms: impaired coordination of movements, arterial hypotension, fainting.
The patient should be given a horizontal position with slightly raised legs. There is no specific antidote to terazosin. Hemodialysis is ineffective due to the high degree of binding of the drug to blood plasma proteins. Treatment is symptomatic. In case of shock, plasma-substituting agents are prescribed to increase the volume of circulating blood, then vasopressor drugs are administered. It is necessary to maintain a water-electrolyte balance.
special instructions
After taking the first dose of Setegis and in the first days of treatment, the development of the "effect of the first dose" is possible, ie, a pronounced drop in blood pressure, usually manifested by orthostatic hypotension, accompanied by a feeling of uncertainty, dizziness and fainting. The risk of this effect is increased by hypovolemia and a diet with limited salt intake. The same phenomenon can be observed if the drug is resumed after several days of interruption, and therefore it is necessary to resume treatment from the initial dose, gradually increasing it.
In addition to the "effect of the first dose", fainting can be caused by increasing the dose too quickly, the simultaneous use of diuretics or other antihypertensive drugs. Although fainting is most often due to severe orthostatic hypotension, it can also be associated with tachycardia (an increase in heart rate to 120–160 beats / minute). Orthostatic hypotension usually develops shortly after taking Setegis, and the risk of fainting is greatest after 30–90 minutes. Dizziness, a feeling of insecurity and even loss of consciousness can be caused by intense physical activity, prolonged standing on your feet, high ambient temperature, getting up from a lying or sitting position, and the simultaneous use of alcohol. In case of fainting, the patient should be laid down and his legs elevated,in some cases, it may be necessary to use other supportive therapy measures.
It is recommended to reduce the dose of Setegis in patients receiving diuretics or other antihypertensive drugs. To avoid arterial hypertension, a concomitant drug should be prescribed in a minimum dose, and treatment should be carried out under close medical supervision. The same precautions should be taken when adding Setegis to the ongoing antihypertensive therapy, in which case its initial dose should also be 1 mg.
In elderly patients, there may be an increased sensitivity to the antihypertensive effect of terazosin.
In the case of benign prostatic hyperplasia, Setegis is prescribed only after a complete examination of the patient, which makes it possible to exclude malignant processes. During treatment, blood pressure should be monitored, especially at the beginning of treatment and at each dose change. The effectiveness of the drug is evaluated after 4–6 weeks of maintenance therapy.
Patients with lactose intolerance should take into account its content in the preparation: in Setegis tablets 1 mg - 55 mg of lactose, in tablets 2, 5 and 10 mg - 110 mg of lactose.
Influence on the ability to drive vehicles and complex mechanisms
Due to the risk of developing orthostatic hypotension at the beginning of treatment and when the dose is increased, it is recommended to refrain from driving and performing other activities that require speed of reactions and increased attention. In the future, the degree of restrictions is set individually for each patient.
Application during pregnancy and lactation
There are no clinical data on the safety of using terazosin during pregnancy and lactation, therefore, Setegis is prescribed to pregnant women only in cases where the expected benefits of therapy significantly outweigh the potential risks to the fetus. If therapy is required during lactation, breastfeeding should be discontinued.
Pediatric use
According to the instructions, Setegis is prohibited for use in children and adolescents.
With impaired renal function
In case of impaired renal function, dose adjustment of the drug is not required, however, Setegis should be used with caution.
For violations of liver function
In case of impaired hepatic function, Setegis should be used with caution.
Use in the elderly
No dose adjustment of Setegis is required, however, it should be borne in mind that in old age, sensitivity to the antihypertensive effect of terazosin may be increased.
Drug interactions
According to clinical studies, in patients with BPH receiving combination therapy with terazosin and angiotensin-converting enzyme inhibitors or diuretics, the incidence of dizziness or concomitant side effects is higher than in patients receiving only terazosin.
Caution should be exercised with the simultaneous use of other antihypertensive drugs, since significant hypotension may develop. If Setegis is added to diuretics or other antihypertensive drugs, a dose reduction or re-titration may be required.
Non-steroidal anti-inflammatory drugs (especially indomethacin) can reduce the hypotensive effect of terazosin (due to fluid and sodium ion retention and / or suppression of Pg synthesis).
Adrenostimulants reduce the effectiveness of terazosin, antacids and adsorbents reduce its absorption.
Reception of sildenafil or vardenafil can be started only if the patient's condition is stable while using Setegis. In this case, sildenafil should be taken no earlier than 4 hours after terazosin, vardenafil - at least 6 hours after.
There are known cases of hypotension with the simultaneous use of PDE-5 inhibitors with terazosin.
Analogs
Analogues of Setegis are: Alfuprost MR, Artezin, Artezin retard, Hyperprost, Glansin, Dalfaz retard, Dalfaz SR, Doxazosin, Zoxon, Kamiren, Kardura, Kornam, Omnik, Omnik Okas, Omsulozin, Proflosin, Sonizin, Tamsuzulozin, U, Fokusin et al.
Terms and conditions of storage
Keep out of reach of children at a temperature of 15-30 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Setegis
Most often, reviews about Setegis are left by patients taking the drug in connection with benign prostatic hyperplasia. Their opinions were divided. Some describe the high efficiency of Setegis and its quick action, others write about the insufficiency or lack of effect.
According to the doctors, a significant improvement in the condition is noted within 4 months of treatment: the volume of urination and the flow rate of urine increase, the time of urination and the volume of residual urine decrease. Setegis is well tolerated. Side effects are caused in no more than 9% of patients, while withdrawal of therapy due to adverse reactions is required only in about 3% of cases.
Price for Setegis in pharmacies
Approximate prices of Setegis: 30 tablets of 2 mg - 640-832 rubles, 30 tablets of 5 mg - 1105-1316 rubles.
Setegis: prices in online pharmacies
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Drug name Price Pharmacy |
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Setegis 2 mg tablets 30 pcs. RUB 790 Buy |
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Setegis tablets 2mg 30 pcs. 841 RUB Buy |
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Setegis 5 mg tablets 30 pcs. 1161 RUB Buy |
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Setegis tablets 5mg 30 pcs. 1456 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
