Cardura tablets 4 mg 30 pcs. (doxazosin)

release form

tablets



packaging 30 pcs

Pharmacological action

Kardura - Alpha 1-blocker.

Benign prostatic hyperplasia: Prescribing doxazosin to patients with symptoms of benign prostatic hyperplasia (BPH) leads to a significant improvement in urodynamics and a decrease in the manifestation of symptoms of the disease. This action of the drug is associated with selective blockade of a-adrenergic receptors located in the stroma and capsule of the prostate gland and the neck of the bladder. Proven that doxazosin is a blocker of A1-adrenergic receptors of subtype 1A, which account for approximately 70% of all subtypes of A1-adrenergic receptors present in the prostate. This explains its effect in patients with BPH. The supporting effect of Kardura treatment and its safety have been proven with prolonged use of the drug (for example, up to 48 months).

The use of Cardura in patients with arterial hypertension leads to a significant decrease in blood pressure as a result of a decrease in OPSS. The appearance of this effect is associated with selective blockade of A1-adrenergic receptors located in the vascular network. When taking the drug 1 time / day, the clinically significant hypotensive effect persists for 24 hours. Blood pressure decreases gradually, the maximum effect is usually observed 2-6 hours after taking the drug. In patients with arterial hypertension, blood pressure during treatment with doxazosin was the same when lying and standing. In contrast to non-selective alpha-blockers, long-term treatment with doxazosin did not develop drug tolerance. During maintenance therapy, increased plasma renin and tachycardia are rare. Doxazosin has a beneficial effect on the lipid profile of the blood, significantly increasing the ratio of HDL to total cholesterol and significantly lowering total triglycerides and total cholesterol. In this regard, it has an advantage over diuretics and beta-blockers, which do not favorably affect these parameters. Given the established relationship between arterial hypertension and the lipid profile of blood with coronary heart disease, the beneficial effect of doxazosin on blood pressure and lipid levels simultaneously reduces the risk of coronary heart disease. Treatment with doxazosin led to regression of left ventricular hypertrophy, inhibition of platelet aggregation and increased activity of tissue plasminogen activator. In addition, doxazosin improves insulin sensitivity in patients with impaired glucose tolerance. Doxazosin does not have metabolic side effects and can be used in patients with bronchial asthma and diabetes mellitus, with left ventricular failure and gout. In vitro studies have shown the antioxidant properties of 6 'and 7'-hydroxymetabolites of doxazosin at a concentration of 5 μmol. In controlled clinical trials in patients with arterial hypertension, treatment with doxazosin was accompanied by an improvement in erectile function. In addition, in patients receiving doxazosin, newly arising erectile dysfunction was noted less frequently than in patients receiving antihypertensive drugs.

Indications

Arterial hypertension, urinary tract obstruction, and symptoms due to benign prostatic hyperplasia.

Contraindications

Hypersensitivity (including to other quinazolines).

Use during pregnancy and lactation

It is possible if the expected effect of therapy exceeds the potential risk to the fetus and newborn.

Dosage and administration

Kardura is taken orally (morning or evening).

Arterial hypertension. Dosage varies from 1 to 16 mg / day. The initial dose of Kardura is 1 mg once a day for 1 or 2 weeks. Over the next 1 or 2 weeks, it is possible to increase the dose to 2 mg 1 time per day. To achieve the desired reduction in blood pressure, if necessary, the daily dose should be increased gradually, observing uniform intervals to 4, 8 and 16 mg, depending on the severity of the patient's response. The usual recommended dose is 2-4 mg once a day.

Benign prostatic hyperplasia. The initial dose of Kardura is 1 mg once a day. Depending on the individual characteristics of urodynamics and the presence of symptoms of the disease, the dose can be increased to 2 mg, and then to 4 mg and to a maximum recommended dose of 8 mg. The recommended interval for increasing the dose is 1-2 weeks. The usual recommended dose is 2-4 mg once a day.

Experience with the use of doxazosin in children is absent.

Side effects

BPH

According to controlled clinical trials, patients with BPH experienced the same adverse reactions as patients with hypertension.

Following post-marketing use of the drug, the following adverse reactions have been reported.

From the hemopoietic and lymphatic system: very rarely - leukopenia, thrombocytopenia.

From the side of the organ of hearing and the vestibular apparatus: infrequently - tinnitus.

From the side of the organ of vision: often - violation of color perception infrequently - atonic iris syndrome.

From the gastrointestinal tract: often - abdominal pain, diarrhea, dyspepsia, dry oral mucosa infrequently - flatulence, constipation, vomiting.

From the liver: very rarely - cholestasis, hepatitis, jaundice.

From the side of the immune system: very rarely - anaphylactic reactions.

Laboratory indicators: infrequently - weight gain is very rare - increased activity of hepatic transaminases.

From the side of metabolism: infrequently - anorexia.

From the musculoskeletal system: infrequently - arthralgia, back pain, muscle cramps, muscle weakness, myalgia.

From the side of the central nervous system and peripheral nervous system: often - paresthesia infrequently - hypesthesia, tremor.

From the psyche: often - excitement, anxiety, insomnia infrequently - depression.

From the urinary tract: infrequently - increased urination, polyuria, urinary incontinence is very rare - dysuria, hematuria, nocturia.

From the reproductive system: very rarely - gynecomastia, impotence, priapism very rarely - retrograde ejaculation.

From the respiratory system: often - shortness of breath, rhinitis infrequently - cough, nosebleeds are very rare - exacerbation of existing bronchospasm.

From the skin: infrequently - alopecia, itching, skin rash, purpura very rarely - urticaria.

From the CCC side: infrequently - flushing of the face skin, marked decrease in blood pressure, postural hypotension.

Other: infrequently - pains of various localization.

Hypertension

In controlled clinical trials of the drug Kardura, the most common adverse reactions that can be classified as postural (occasionally associated with fainting) or nonspecific, which included the following reactions.

On the part of the organ of hearing and the vestibular apparatus: often - vertigo.

From the gastrointestinal tract: often - nausea.

From the side of the central nervous system and peripheral nervous system: very often - dizziness, headache often - postural dizziness (after taking the first dose, a marked decrease in blood pressure may develop, which can lead to orthostatic dizziness, in severe cases, especially when quickly moving from lying down to standing or sitting - to faint), drowsiness.

From the respiratory system: often - rhinitis.

Other: often - asthenia, swelling of the lower extremities, fatigue, weakness.

Drug Interaction

Co-administration of Cardur with PDE-5 inhibitors may lead to symptomatic hypotension in some patients (see “Special Instructions”).

The vast majority (98%) of doxazosin in blood plasma is associated with proteins. The results of a human blood plasma study in vitro indicate that doxazosin does not affect protein binding of digoxin, warfarin, phenytoin or indomethacin.

In clinical practice, Cardura was used without any signs of interaction with thiazide diuretics, furosemide, beta-blockers, antibiotics, hypoglycemic agents for oral administration, uricosuric agents and anticoagulants.

NSAIDs (especially indomethacin), estrogens and sympathomimetic drugs may reduce the antihypertensive effect of doxazosin.

Doxazosin, eliminating the alpha-adrenostimulating effects of epinephrine, can lead to the development of tachycardia and arterial hypotension.

When taken with sildenafil for the treatment of pulmonary hypertension, the risk of orthostatic hypotension is increased.

With a single dose of Kardur at a dose of 1 mg / day for 4 days in combination with cimetidine 400 mg twice a day, a 10% increase in mean AUC and a statistically insignificant increase in mean plasma Cmax and mean T1 were observed. / 2 doxazosin. Such a 10% increase in the mean AUC of doxazosin on the background of cimetidine administration is within the variability (27%) of the mean AUC for doxazosin compared with placebo.

When used with other antihypertensive agents, increases the severity of their action (dose adjustment is required).

It is not recommended to take alpha-adrenoceptor blockers at the same time.

When used with inducers of microsomal oxidation in the liver, it is possible to increase the effectiveness of doxazosin, and with inhibitors - a decrease.

overdose

Symptoms: marked decrease in blood pressure, sometimes accompanied by fainting.

Treatment: it is necessary to immediately lay the patient on his back and lift his legs, if necessary to carry out symptomatic therapy. The binding of doxazosin to blood plasma proteins is high, so dialysis is ineffective.

Storage conditions

In a dry, dark place, at a temperature not exceeding 30 ° C.

Expiration

5 years.

Deystvuyuschee substances

doxazosin

dosage form

Dosage form

tablets



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