Kornam - instructions for use, doses, side effects, contraindications

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, talcum powder 1.500 mg, dye quinoline yellow E 104 0.300 mg, silicon dioxide colloid 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 mg, iron oxide dye yellow 0.3300 mg, silicon dioxide colloid 0.750 mg, magnesium stearate 0.750 mg.

Description:

Tablets 2 mg: yellow, round, flat tablets with a risk on one side and bevel. The surface of the tablet is chamfered to the risk.

Tablets 5 mg: orange-yellow, round, flat tablets with a risk on one side and bevel. The surface of the tablet is chamfered to the risk.

Pharmacotherapeutic group:Alpha-blocker

ATX: & nbsp

G.04.C.A.03 Terazozin

Pharmacodynamics:

The blocker of peripheral postsynaptic alpha 1-adrenergic receptors. It causes an expansion of the arterial and venules, reduces the overall peripheral vascular resistance (OPSS) and venous; return to the heart, has antihypertensive effect.

Symptoms caused by benign prostatic hyperplasia, associated with obstruction, outlet tract mochevogo- bladder which occurs as a result of static "obstruction due to an enlarged prostate, and dynamic obstruction, which depends on muscle tone gladkoy- prostate, and cervix The bladder, controlled by the sympathetic nervous system.

Alpha1-adrenoceptor blocking smooth muscle of the prostate and bladder neck, the drug contributes to the normalization, voiding in patients with benign prostatic hyperplasia (BPH).

Reduction of symptoms associated with BPH, with terazosin application may be associated with a reduction in muscle tone caused by blockade of alpha 1 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 of lowering blood pressure (BP) is unknown, the relaxation of blood vessels, apparently, is caused mainly by a selective blockade of postsynaptic alpha 1-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 the time of eating; bioavailability - more than 90%. Time to reach the maximum concentration (TC_max) -1h. Connection with proteins; blood plasma - 90-94%.

Terazosin is metabolized in the liver by hydrolysis, demethylation and dealkylation to form five different metabolites, one of which (the piperazine derivative of terazosin) has antihypertensive activity. Plasma clearance is approximately 80 ml / min.

Half-life (T_1/2) -12 hours.

After ingestion, it is excreted mainly through the intestine (60%, 20% unchanged) and kidneys (40%, 10% of them unchanged).

It is not known whether terazosin with breast milk.

Use in patients with impaired renal function

The use of Kornam® in patients with impaired renal function requires careful monitoring of the patient's condition. Limited low-dose pharmacokinetic studies (1 mg) did not show any clear differences in the pharmacokinetic parameters of terazosin compared to patients with normal renal function.

Indications:

- Benign prostatic hyperplasia (symptomatic treatment).

- Arterial hypertension (as part of combination therapy).

Contraindications:

- Increased sensitivity to terazosin and other alpha-adrenoblockers, as well as to other auxiliary components of the drug;

- simultaneous administration of phosphodiesterase-5 inhibitors (PDE-5) (such as sildenafil, tadalafil and vardenafil);

- pregnancy and lactation;

- age under 18 years (effectiveness and safety not established);

- deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

- concomitant obstruction of the upper urinary tract;

- chronic infectious diseases of the urinary tract or stones in the bladder;

- propensity to orthostatic disorders of regulation (including in anamnesis);

- decrease in the rate of urine outflow;

- anuria;

- severe renal / hepatic insufficiency.

Carefully:

With diseases of the cardiovascular system,conviction system: pulmonary edema with aortic or mitral stenosis, heart failure with an increased minute emission, right ventricular failure, caused by pulmonary embolism arteries or exudative pericarditis, left ventricular low-pressure failure filling of the ventricles;

arterial hypotension, mild and moderate severity of renal and / or hepatic impairment, disorders cerebral blood circulation, elderly age over 65, dehydration, reduced intake of table salt (for example, salt-free diet), disturbance of water-electrolyte balance.

Pregnancy and lactation:

The use of Cornam® during pregnancy and during breastfeeding is not recommended.

It is not known whether terazosin with breast milk.

If you need to use Cornam® during lactation - breastfeeding should be stopped.

Dosing and Administration:

Inside, whole, not liquid, regardless of the meal.

Dose Kornam ® for the treatment of BPH should be selected on the basis of an individual patent application for ongoing therapy:

The initial dose for all patients that should not be exceeded during the first week of therapy is 1 mg (1/2 tablets 2 mg) before bed, after which the patient should be in bed for 6-8 hours. It is necessary to observe the patient with the first dose of the drug (the risk of developing arterial hypotension).

The dose of Cornam® can be increased to 2 mg per day for 14 days, then to 5 mg per day for 7 days (usually overnight). An increase in the dose is only possible with a good tolerability of the previously taken dose. The therapeutic response is evaluated within four weeks.

Usually, to achieve a therapeutic effect, maintenance doses of 5-10 mg once a day are required. The maximum daily dose is 10 mg.

If Kornam® is discontinued 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 Cornham® should be selected according to the reduction reaction. BP for each patient individually.

When adding the drug Kornam ® to the already conducted antihypertensive therapy, for the patient should be carefully monitored for, if any, arterial hypotension: If a diuretic or other antihypertensive agent is added to the Kornam® drug regimen, it may be necessary to reduce the dose of Cornham® and re-titrate it under the supervision of the physician.

The initial dose for all patients that should not be exceeded is 1 mg. (1/2 tablet 2 mg each) before bed. It is necessary to monitor the patient in order to reduce the risk of a pronounced decrease in blood pressure.

The dose can be gradually increased in order to achieve the desired decrease 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, the 'AD should be measured in order to be sure of maintaining the proper blood pressure level. It may also be useful to measure blood pressure 2 or 3 hours after taking the drug in order to make sure that the decrease in blood pressure is stable.

If the effect of Cornham® is significantly reduced after 24 hours, 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, palpitation or orthostatic hypotension 2-3 hours after taking the drug.

If the Cornam® drug is interrupted for several days or more, therapy should be resumed from the initial dose of the drug.

Application the patients with moderate renal and / or hepatic impairment

In patients with mild to moderate renal / hepatic impairment, use KORNAM® with caution.

Application in elderly patents

For the treatment of elderly patients, correction of the Kornam® preparation is not required, but constant monitoring of the patients' condition is necessary.

Side effects:

After applying the first dose of the drug, a marked decrease in blood pressure (within 1-1.5 hours) may develop, which can lead to orthostatic dizziness, in severe cases - to fainting, as well as against the use of other alpha 1-adrenoreceptor blockers. In single cases, before a syncope, the heart rate (HR) can dramatically increase to 120-160 beats / min.

According to the World Health Organization (WHO) undesirable reactions 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 available data to establish the frequency of occurrence was not possible.

From the immune system

rarely: anaphylactic reaction.

On the part of the blood and lymphatic system

frequency unknown: thrombocytopenia.

From the side of metabolism and nutrition

frequency is unknown: exacerbation gout current.

From the nervous system

often: dizziness, weakness, headache, asthenia, increased irritability, drowsiness, paresthesia; infrequently: depression; frequency is unknown: anxiety, insomnia.

From the side of the organ of vision

often: decreased visual acuity, violation of color perception;

frequency is unknown: conjunctivitis.

From the side of the organ of hearing and labyrinthine disorders

Often: vertigo; frequency is unknown: noise in ears.

On the part of the respiratory system

often: shortness of breath, nasal congestion; frequency is unknown: cough, nasal bleeding.

From the side of the cardiovascular system

often: fainting (especially with rapid transition from the situation "lying" in the "standing" position or in sitting position - postural hypotension), a feeling of heartbeat, tachycardia, chest pain, peripheral edema;

frequency is unknown: fibrillation atrium (however,investigative link with admission drug has not been established), violation of the rhythm of the heart, vasodilatation, orthostatic hypotension.

From the digestive side systems

often: nausea;

frequency is unknown: pain in the region abdomen, constipation, diarrhea, vomiting, dyspepsia, dryness of the oral mucosa, flatulence.

From the side of the locomotor system apparatus and connective tissue

often: pain in the extremities, pain in the back;

frequency is unknown: arthralgia, Arthritis, arthropathy, algia, pain in neck area, shoulder pain.

From the skin and subcutaneous fabrics

frequency is unknown: hyperhidrosis, skin rash and itching, hives.

From the urinary systems

frequency is unknown: infection urinary tract and urinary incontinence (in mainly in postmenopausal women), increased urge to urinate.

On the part of reproductive systems

often: erectile dysfunction;

infrequently: decreased libido; frequency is unknown: priapism.

General disorders and disorders in place of introduction

Often: asthenia; often: increased fatigue, peripheral edema, edema mucous membranes;

frequency is unknown: swelling of the face, hyperthermia, chest pain.

Laboratory and instrumental data

rarely: increase in body weight; frequency is unknown: the results indicate hemodilution (eg, reduction of hematocrit, hemoglobin, leukocytes, total protein and albumin). Even after prolonged 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

often: sinusitis; frequency is unknown: bronchitis, pharyngitis, rhinitis, flu-like syndrome.

Overdose:

Symptoms: a marked decrease in blood pressure, a violation of coordination of movements, fainting, a violation of the water-electrolyte balance.

Treatment: if an overdose occurs, first of all, stop taking the medication, rinse the stomach, take adsorption drugs, with a pronounced decrease in blood pressure, the patient should be placed in a horizontal position, raise his legs and take measures to fill the circulating blood (BCC), followed by the introduction of vasoconstrictive drugs .

It is necessary to monitor the function of the kidneys, as well as a number of measures aimed at maintaining the activity of the cardiovascular system.

Hemodialysis is ineffective.

Interaction:

When used in conjunction with other drugs should be careful because of the development of severe arterial hypotension. When adding to the treatment diuretics or hypotensive drugs may require repeated dose adjustment.

Not recommended at the same time terazosin with other blockers alpha-adrenergic receptors.

Antihypertensive action can be intensified when combined with vasodilators and nitrates.

Accompanying application of inhibitors of PDE-5 (such as sildenafil, tadalafil and vardenafil) and terazosin can lead to the development of arterial hypotension. Terazozin can oppress peripheral vasoconstrictive effect of dopamine, epinephrine, ephedrine, phenylephrine, metamaminol, methoxamine.

Terazosin can affect plasma activity and excretion by the kidneys vanillylmindal acid. Care should be taken when interpreting laboratory tests for the diagnosis of 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 antihypertensive Effect terazosin. Adsorbents and antacids reduce the absorption of terazosin in the gastrointestinal tract (GIT). Terazozin reduces antihypertensive Effect clonidine administered intravenously.

Special instructions:

Before starting BPH therapy, prostate cancer should be excluded. Efficiency The therapy is given after 4-6 weeks of treatment maintenance doses of Kornam ®.

Reduction of BPH symptoms is possible already in the second week, but the onset The therapeutic effect can last up to 6 or more weeks. If after 6 weeks the maximum recommended dose of Cornam® uroflowmetry indices slightly differs from the baseline, it is recommended to stop the drug. Treatment - drug should be discontinued if The resulting side effects are more serious than the symptoms of BPH, or when developing the patient has complications from the urinary tract during the administration of the drug.

The drug Kornam ® can affect the activity of renin and blood plasma excretion vanillylmandelic acid by the kidneys. This should be taken into account when conducting laboratory research.

The risk of orthostatic hypotension (the phenomenon of the first "dose") is the most high for 30-90 minutes. after taking the drug and increased y. patients, simultaneously receiving beta-adrenoblockers and diuretics, with a decrease in BCC, malosalic diet, as well as the resumption of treatment with the drug after a break (a few days).

During treatment, the concentration of prostate-specific antigen of the prostate gland does not change.

The patient should be informed of the increased risk of developing orthostatic hypotension with alcohol, prolonged standing or exercise, and in hot weather.

In some patients who had previously taken tamsulosin, during the operative intervention for cataracts, "intraoperative syndrome flabby (IRD, a type of narrow pupil syndrome), and separate reports have also been obtained, and when using other alpha-1-adrenoreceptor blockers, it is therefore not possible to exclude the possible effect of the class of these drugs.

When conducting a surgical procedure (for cataracts), it is necessary to inform the ophthalmologist about the use of alpha 1-adrenoreceptor blockers.

Application in elderly patients

The drug KORNAM ® should be used with caution in elderly patients due to the possibility of developing orthostatic hypotension. With age, the risk of dizziness, visual impairment and fainting increases. In patients older than 75 years, the effectiveness of Kornam ® is reduced.

Special Precautions at, destruction of unused medicinal product.

There is no need for special precautions when destroying an unused Cornam®.

Effect on the ability to drive transp. cf. and fur:

Care should be taken during the treatment with Kornam ®, especially within 12 hours after taking the first dose, increasing the dose or discontinuing the course of therapy while driving vehicles and engaging in other potentially dangerous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Tablets 2 mg. 5 mg.

Packaging:For 10 tablets in a blister of A1 / PVC. For 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 product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015973 / 01

Date of registration:03.11.2009

Expiration Date:Unlimited

The owner of the registration certificate: Lek dd Lek dd Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp04.02.2018

Illustrated instructions

Instructions

Kornam (Kornam)