Cornam tablets 5mg, no. 30

Х Benign prostatic hyperplasia (symptomatic treatment).
Х Arterial hypertension (in combination therapy).

Inside, whole, without chewing, regardless of the meal.
The dose of Kornam Ѓ for the treatment of BPH should be selected based on the patient's individual response to the therapy.
The initial dose for all patients, which should not be exceeded during the first week of therapy, is 1 mg (1/2 tablet of 2 mg) at bedtime, after which the patient should be in bed for 6-8 hours. It is necessary to observe the patient when using the first dose of the drug (risk of developing arterial hypotension).
The dose of KornamЃ can be increased to 2 mg per day for 14 days, after which up to 5 mg per day for 7 days (usually at night). Increasing the dose is possible only if the previously taken dose is well tolerated. The therapeutic response is assessed within four weeks.
Usually, to achieve a therapeutic effect, maintenance doses of 5-10 mg are required once a day. The maximum daily dose is 10 mg.
If the use of KornamЃ is interrupted for several days or more, therapy should be resumed from the initial dose.
Arterial hypertension The
dose and intervals between doses (12-24 hours) of KornamЃ should be selected in accordance with the blood pressure lowering response for each patient individually.
When adding the drug KornamЃ to the already conducted antihypertensive therapy, the patient should be carefully monitored in case of arterial hypotension. If a diuretic or other antihypertensive agent is added to the regimen of KornamЃ, the dose of KornamЃ may need to be reduced and titrated again under medical supervision.
The starting dose for all patients, which should not be exceeded, is 1 mg (1/2 2 mg tablet) at bedtime. Patient monitoring is necessary to reduce the risk of developing a pronounced decrease in blood pressure.
The dose can be gradually increased in order to achieve the desired reduction in blood pressure.
The usual dose ranges from 1 mg to 5 mg once a day. The maximum daily dose is 20 mg.
At the end of the interval between doses, blood pressure should be measured to ensure that proper blood pressure is maintained. It may also be helpful to measure blood pressure 2 or 3 hours after taking the drug to ensure that the decrease in blood pressure is stable.
If the effect of the drug KornamЃ after 24 hours significantly decreases, you can try to increase the dose or apply the drug 2 times a day. In the latter case, you should also find out if there are side effects such as dizziness, palpitations or orthostatic hypotension 2 to 3 hours after taking the drug.
If the intake of KornamЃ is interrupted for several days or more, therapy should be resumed from the initial dose of the drug.
Use in patients with moderate renal and / or hepatic impairment.
In patients with mild to moderate impairment of renal / liver function, use KornamЃ with caution.
Application in elderly patients
Correction of KornamЃ is not required for the treatment of elderly patients, but constant monitoring of the patient's condition is required.

For a dosage of 5 mg,
1 tablet contains: active substance: terazosin (in the form of terazosin hydrochloride dihydrate) 5 mg; excipients: lactose monohydrate 89,200 mg, microcrystalline cellulose 40,000 mg, corn starch 12,500 mg, talc 1,500 mg, iron dye yellow oxide 0.300 mg, colloidal silicon dioxide 0.750 mg, magnesium stearate 0.750 mg.

Х hypersensitivity to terazosin and other alpha-blockers, as well as to other auxiliary components of the drug;
Х concomitant use of phosphodiesterase-5 (PDE-5) inhibitors (such as sildenafil, tadalafil and vardenafil);
Х pregnancy and lactation period;
Х age up to 18 years (efficacy and safety have not been established);
Х lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;
Х concomitant obstruction of the upper urinary tract;
Х chronic urinary tract infections or bladder stones;
Х tendency to orthostatic dysregulation (including a history);
Х decrease in the rate of urine outflow;
Х anuria;
Х severe renal / hepatic impairment.

Carefully

In diseases of the cardiovascular system: pulmonary edema with aortic or mitral stenosis, heart failure with increased minute output, right ventricular failure due to pulmonary embolism or pericardial effusion, left ventricular failure with low ventricular filling pressure; arterial hypotension, mild and moderate renal and / or hepatic failure, cerebrovascular accident, advanced age over 65 years, dehydration, reduced consumption of table salt (for example, salt-free diet), imbalance in water and electrolyte balance.

Trade name of the drug

KornamЃ

International non-proprietary name

Terazosin

Dosage form

Pills

Composition

For a dosage of 2 mg,
1 tablet contains: active substance: terazosin (in the form of terazosin hydrochloride dihydrate) 2 mg; excipients: lactose monohydrate 92.200 mg, microcrystalline cellulose 40.000 mg, corn starch 12.500 mg, talc 1.500 mg, quinoline yellow dye E 104 0.300 mg, colloidal silicon dioxide 0.750 mg, magnesium stearate 0.750 mg.
For a dosage of 5 mg,
1 tablet contains: active substance: terazosin (in the form of terazosin hydrochloride dihydrate) 5 mg; Excipients: lactose monohydrate 89,200 mg, microcrystalline cellulose 40,000 mg, corn starch 12,500 mg, talc 1,500 mg, iron dye yellow oxide 0.300 mg, colloidal silicon dioxide 0.750 mg, magnesium stearate 0.750 mg.

Description

2 mg tablets: yellow, round, flat, scored on one side and beveled. The surface of the tablet is sloped to the risk.
5 mg tablets: orange-yellow, round, flat, scored on one side and beveled. The surface of the tablet is sloped to the risk.

Pharmacotherapeutic group:

alpha1-blocker

Pharmacological properties

Pharmacodynamics
Blocker of peripheral postsynaptic alpha1-adrenergic receptors. It causes expansion of arterioles and venules, reduces total peripheral vascular resistance (OPSS) and venous return to the heart, has an antihypertensive effect.
Symptoms caused by benign prostatic hyperplasia are associated with outflow tract obstruction of the bladder, which occurs as a result of static obstruction due to enlargement of the prostate gland, and dynamic obstruction, which depends on the smooth muscle tone of the prostate and bladder neck, controlled by the sympathetic nerve system.
By blocking alpha1-adrenergic receptors of smooth muscles of the prostate gland and bladder neck, the drug helps to normalize urination in patients with benign prostatic hyperplasia (BPH).
The decrease in BPH-related symptoms with the use of terazosin may be associated with a decrease in muscle tone caused by blockade of alpha1-adrenergic receptors in the smooth muscle of the bladder neck and prostate.
The antihypertensive effect of terazosin is a direct consequence of peripheral vasodilation. The exact mechanism for lowering blood pressure (BP) is unknown; relaxation of blood vessels appears to be caused mainly by selective blockade of postsynaptic alpha1-adrenergic receptors.
With prolonged use, the antihypertensive effect is not accompanied, as a rule, by reflex tachycardia.
Pharmacokinetics
Absorption - fast and high, does not depend on meal time; bioavailability - more than 90%. The time to reach the maximum concentration (T—max) is 1 hour. The connection with blood plasma proteins is 90-94%.
Terazosin is metabolized in the liver through hydrolysis, demethylation and dealkylation to form five different metabolites, one of which (piperazine derivative of terazosin) has antihypertensive activity. Plasma clearance is approximately 80 ml / min.
The half-life (T1 / 2) is 12 hours.
After oral administration, it is excreted mainly through the intestines (60%, of which 20% is unchanged) and by the kidneys (40%, of which 10% is unchanged).
It is not known whether terazosin is excreted in breast milk.
Application in patients with impaired renal function
The use of the drug KornamЃ in patients with impaired renal function requires careful monitoring of the patient's condition. Limited pharmacokinetic studies of low doses (1 mg) did not show clear differences in the pharmacokinetic parameters of terazosin compared with patients with normal renal function.

Indications for use

Х Benign prostatic hyperplasia (symptomatic treatment).
Х Arterial hypertension (in combination therapy).

Contraindications

Х hypersensitivity to terazosin and other alpha-blockers, as well as to other auxiliary components of the drug;
Х concomitant use of phosphodiesterase-5 (PDE-5) inhibitors (such as sildenafil, tadalafil and vardenafil);
Х pregnancy and lactation period;
Х age up to 18 years (efficacy and safety have not been established);
Х lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;
Х concomitant obstruction of the upper urinary tract;
Х chronic urinary tract infections or bladder stones;
Х tendency to orthostatic dysregulation (including a history);
Х decrease in the rate of urine outflow;
Х anuria;
Х severe renal / hepatic impairment.

Carefully

In diseases of the cardiovascular system: pulmonary edema with aortic or mitral stenosis, heart failure with increased minute output, right ventricular failure due to pulmonary embolism or pericardial effusion, left ventricular failure with low ventricular filling pressure; arterial hypotension, mild and moderate renal and / or hepatic failure, cerebrovascular accident, advanced age over 65 years, dehydration, reduced consumption of table salt (for example, salt-free diet), imbalance in water and electrolyte balance.

Application during pregnancy and during breastfeeding

The use of KornamЃ during pregnancy and during breastfeeding is not recommended.
It is not known whether terazosin is excreted in breast milk.
If it is necessary to use the drug KornamЃ during lactation, breastfeeding should be discontinued.

Method of administration and dosage

Inside, whole, without chewing, regardless of the meal.
The dose of Kornam Ѓ for the treatment of BPH should be selected based on the patient's individual response to the therapy.
The initial dose for all patients, which should not be exceeded during the first week of therapy, is 1 mg (1/2 tablet of 2 mg) at bedtime, after which the patient should be in bed for 6-8 hours. It is necessary to observe the patient when using the first dose of the drug (risk of developing arterial hypotension).
The dose of KornamЃ can be increased to 2 mg per day for 14 days, after which up to 5 mg per day for 7 days (usually at night). Increasing the dose is possible only if the previously taken dose is well tolerated. The therapeutic response is assessed within four weeks.
Usually, to achieve a therapeutic effect, maintenance doses of 5-10 mg are required once a day. The maximum daily dose is 10 mg.
If the use of KornamЃ is interrupted for several days or more, therapy should be resumed from the initial dose.
Arterial hypertension The
dose and intervals between doses (12-24 hours) of KornamЃ should be selected in accordance with the blood pressure lowering response for each patient individually.
When adding the drug KornamЃ to the already conducted antihypertensive therapy, the patient should be carefully monitored in case of arterial hypotension. If a diuretic or other antihypertensive agent is added to the regimen of KornamЃ, the dose of KornamЃ may need to be reduced and titrated again under medical supervision.
The starting dose for all patients, which should not be exceeded, is 1 mg (1/2 2 mg tablet) at bedtime. Patient monitoring is necessary to reduce the risk of developing a pronounced decrease in blood pressure.
The dose can be gradually increased in order to achieve the desired reduction in blood pressure.
The usual dose ranges from 1 mg to 5 mg once a day. The maximum daily dose is 20 mg.
At the end of the interval between doses, blood pressure should be measured to ensure that proper blood pressure is maintained. It may also be helpful to measure blood pressure 2 or 3 hours after taking the drug to ensure that the decrease in blood pressure is stable.
If the effect of the drug KornamЃ after 24 hours significantly decreases, you can try to increase the dose or apply the drug 2 times a day. In the latter case, you should also find out if there are side effects such as dizziness, palpitations or orthostatic hypotension 2 to 3 hours after taking the drug.
If the intake of KornamЃ is interrupted for several days or more, therapy should be resumed from the initial dose of the drug.
Use in patients with moderate renal and / or hepatic impairment.
In patients with mild to moderate impairment of renal / liver function, use KornamЃ with caution.
Application in elderly patients
Correction of KornamЃ is not required for the treatment of elderly patients, but constant monitoring of the patient's condition is required.

Side effect

After using the first dose of the drug, a pronounced decrease in blood pressure may develop (within 1-1.5 hours), which can lead to orthostatic dizziness, in severe cases - to fainting, as well as while taking other alpha 1-adrenergic receptor blockers. In isolated cases, before fainting, the heart rate (HR) can sharply increase to 120-160 beats / min.
According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (? 1/10); often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (> 1/10000, <1/1000) and very rarely (<1/10000), the frequency is unknown - according to the available data, it was not possible to establish the frequency of occurrence.
From the side of the immune system, it is
very rare:anaphylactic reactions.
From the side of the blood and lymphatic system, the
frequency is unknown: thrombocytopenia.
On the part of metabolism and nutrition, the
frequency is unknown: exacerbation of the course of gout.
On the part of the nervous system,
often: dizziness, weakness, headache, asthenia, increased irritability, drowsiness, paresthesia;
infrequently: depression;
frequency unknown: anxiety, insomnia.
On the part of the organ of vision,
often: decreased visual acuity, impaired color perception;
frequency unknown: conjunctivitis.
From the side of the organ of hearing and labyrinth disorders are
very common:vertigo;
frequency unknown: tinnitus.
On the part of the respiratory system,
often: shortness of breath, nasal congestion;
frequency unknown: cough, nosebleeds.
From the side of the cardiovascular system,
often: fainting (especially with a rapid transition from a lying position to a standing position or to a sitting position - postural hypotension), palpitations, tachycardia, chest pain, peripheral edema;
the frequency is unknown: atrial fibrillation (however, a causal relationship with the drug intake has not been established), heart rhythm disturbances, vasodilation, orthostatic hypotension.
On the part of the digestive system,
often: nausea;
frequency unknown: abdominal pain, constipation, diarrhea, vomiting, dyspepsia, dryness of the oral mucosa, flatulence.
On the part of the musculoskeletal system and connective tissue,
often: pain in the limbs, back pain;
frequency unknown: arthralgia, arthritis, arthropathy, algia, neck pain, shoulder pain.
On the part of the skin and subcutaneous tissues, the
frequency is unknown: hyperhidrosis, skin rash and itching, urticaria.
On the part of the urinary system, the
frequency is unknown: urinary tract infections and urinary incontinence (mainly in postmenopausal women), increased urge to urinate.
On the part of the reproductive system,
often: erectile dysfunction;
infrequently: decreased libido;
frequency unknown: priapism.
General disorders and disorders at the injection site are
very common: asthenia;
often: increased fatigue, peripheral edema, edema of the mucous membranes;
frequency unknown: facial edema, hyperthermia, chest pain.
Laboratory and instrumental data are
rare: weight gain;
frequency unknown: results indicate hemodilution (eg, decreased hematocrit, hemoglobin, leukocytes, total protein, and albumin). Even after long-term treatment (24 months) with terazosin, there was no significant effect on the concentration of total or free prostate-specific antigen (PSA).
Infectious and parasitic diseases
are often: sinusitis;
frequency unknown: bronchitis, pharyngitis, rhinitis, flu-like syndrome.

Overdose

Symptoms: a pronounced decrease in blood pressure, impaired coordination of movements, fainting, imbalance in water and electrolyte balance.
Treatment: if an overdose occurs, first of all, it is necessary to stop taking the drug, wash the stomach, take adsorbing agents, with a pronounced decrease in blood pressure, the patient should be placed in a horizontal position, raise the legs and take measures to replenish the circulating blood volume (BCC), followed by the introduction of vasoconstrictor drugs.
It is necessary to monitor kidney function, as well as a number of measures aimed at maintaining the activity of the cardiovascular system.
Hemodialysis is ineffective.

Interaction with other medicinal products

When used in conjunction with other drugs, caution should be exercised due to the development of severe arterial hypotension. When diuretics or antihypertensive drugs are added to the treatment, it may be necessary to re-adjust the dose of the drug.
It is not recommended to use concomitantly terazosin with other alpha-adrenergic receptor blockers.
The antihypertensive effect can be enhanced when used together with vasodilators and nitrates.
The concomitant use of PDE-5 inhibitors (such as sildenafil, tadalafil, and vardenafil) and terazosin can lead to the development of arterial hypotension. Terazosin can inhibit the peripheral vasoconstrictor effect of dopamine, epinephrine, ephedrine, phenylephrine, metaraminol, methoxamine.
Terazosin can affect plasma activity and renal excretion of vanillyl mandelic acid. Care should be taken when interpreting laboratory tests to diagnose pheochromocytoma.
Non-steroidal anti-inflammatory drugs (especially indomethacin) and estrogens can reduce the hypotensive effect of terazosin, due to suppression of prostaglandin synthesis and / or fluid and sodium retention. Sympathomimetics may reduce the antihypertensive effect of terazosin. Adsorbents and antacids reduce the absorption of terazosin in the gastrointestinal tract (GIT).
Terazosin reduces the antihypertensive effect of intravenous clonidine.

special instructions

Prostate cancer must be ruled out before starting BPH therapy. The effectiveness of the therapy is assessed after 4-6 weeks of treatment with maintenance doses of Kornam Ѓ.
A decrease in BPH symptoms is possible as early as the second week, but the onset of the therapeutic effect can take up to 6 weeks or more. If, after 6 weeks of using the maximum recommended dose of KornamЃ, the improvement in uroflowmetry indices does not differ significantly from the initial values, it is recommended to stop taking the drug. Treatment with the drug should be discontinued if the side effects that occur are more serious than the symptoms of BPH, or if the patient develops complications from the urinary tract while taking the drug.
The drug KornamЃ can affect the activity of blood plasma renin and the excretion of vanillyl mandelic acid by the kidneys. This should be taken into account when conducting laboratory research.
The risk of orthostatic hypotension (first 'dose' phenomenon) is highest within 30 to 90 minutes. after taking the drug and increased in patients simultaneously receiving beta-blockers and diuretics, with a decrease in BCC, a low-salt diet, and also when the drug is resumed after a break (several days).
In the course of treatment, the concentration of prostate-specific antigen of the prostate gland does not change.
The patient should be informed of the increased risk of orthostatic hypotension with alcohol consumption, prolonged standing or exercise, and in hot weather.
In some patients who had previously taken tamsulosin, during surgery for cataracts, 'intraoperative flabby iris syndrome' (ISDR, a type of narrow pupil syndrome) was noted. Separate reports have also been obtained with the use of other blockers of alpha-1-adrenergic receptors, therefore, the possible influence of the class of these drugs cannot be ruled out.
When carrying out a surgical intervention (for cataracts), it is necessary to inform the ophthalmologist about the use of alpha1-adrenergic receptor blockers.
Use in elderly patients
The drug KornamЃ should be used with caution in elderly patients due to the possibility of orthostatic hypotension. The risk of dizziness, visual impairment and fainting increases with age. In patients over 75 years of age, the effectiveness of KornamЃ is reduced.

Special precautions for the destruction of unused medicinal product .

There is no need for special precautions when disposing of unused KornamЃ.

Influence on the ability to drive vehicles and engage in other activities that require concentration of attention and speed of psychomotor reactions .

During the period of treatment with KornamЃ, care must be taken, especially within 12 hours after taking the first dose, increasing the dose or interrupting the course of therapy while driving and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form

Tablets 2 mg, 5 mg
10 tablets per Al / PVC blister. 2 or 3 blisters, together with instructions for use, are placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 ? C.
Keep out of the reach of children!

Shelf life

3 years
Do not use the drug after the expiration date printed on the package.

Vacation conditions

Dispensed by prescription.