Kardura - Instructions For The Use Of Tablets, Reviews, Analogs, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Kardura

Kardura: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacodynamics and pharmacokinetics
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Use in the elderly
12. 12. Application for violations of liver function
13. 13. Application for impaired renal function
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Cardura

ATX code: C02CA04

Active ingredient: Doxazosin (Doxazosinum)

Manufacturer: PFIZER (Germany)

Description and photo update: 2019-05-08

Prices in pharmacies: from 350 rubles.

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Cardura is an alpha1-blocker. An antihypertensive agent used for urinary disorders in the presence of benign prostatic hyperplasia.

Release form and composition

Dosage form - tablets: round biconvex, white, engraved with "Pfizer" on one side and "CN 1", "CN 2" or "CN 4" - on the other (in blisters of 7 pcs., In a cardboard box 2 blisters, 10 pcs., in a cardboard box 3 blisters, 14 pcs., in a cardboard box 1 blister).

The active substance is doxazosin mesylate, its content in 1 tablet with an engraving:

• CN 1 - 1.213 mg, or 1 mg of doxazosin;
• CN 2 - 2.43 mg, or 2 mg of doxazosin;
• CN 4 - 4.85 mg, or 4 mg of doxazosin.

Auxiliary components: lactose monohydrate, sodium carboxymethyl starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

Pharmacodynamics and pharmacokinetics

The use of Kardura in the treatment of benign prostatic hyperplasia can significantly improve urodynamic parameters and reduce the manifestation of symptoms of the disease. This effect is associated with the ability of doxazosin to block alpha-1-adrenergic receptors located in the prostate gland and bladder neck. The effect of using the drug lasts for a long time (for example, up to 48 months).

The use of Kardura in patients with arterial hypertension leads to a decrease in the total peripheral vascular resistance and a significant decrease in blood pressure. When the drug is taken once a day, the pressure decrease occurs gradually, and a significant antihypertensive effect develops within 24 hours. After oral administration, the maximum effect is usually observed after 2-6 hours. In the treatment of Kardura in patients with arterial hypertension, blood pressure values in the standing and lying positions are the same.

With prolonged use of doxazosin, tolerance to the drug does not develop (in contrast to non-selective alpha1-blockers). During maintenance therapy, the incidence of tachycardia and increased plasma renin activity is low.

Cardura has a positive effect on blood lipid profile, significantly increasing the ratio of high density lipoprotein to total cholesterol and lowering total cholesterol and total triglycerides. This fact is an advantage over beta-blockers and diuretics, which do not have a beneficial effect on these parameters. 

A reliable relationship has been established between the lipid profile of blood and arterial hypertension with coronary heart disease, therefore, the normalization of lipid concentration and blood pressure during doxazosin administration reduces the risk of developing coronary heart disease.

The following effects were observed with doxazosin therapy:

• inhibition of platelet aggregation;
• regression of left ventricular hypertrophy;
• increased activity of tissue plasminogen activator;
• increased sensitivity to insulin with impaired glucose tolerance.

Reception of Kardura does not cause the development of side metabolic effects, so the drug can be prescribed to patients with diabetes mellitus, bronchial asthma, gout and left ventricular failure.

The results of controlled clinical trials in patients with arterial hypertension indicate that taking doxazosin may be accompanied by an improvement in erectile function. Also, patients who received doxazosin were less likely to have repeated violations of erectile function (in comparison with patients who received antihypertensive drugs).

After oral administration of therapeutic doses, the drug is well absorbed: the maximum concentration in the blood is observed after 2 hours. Doxazosin is capable of binding to blood plasma proteins by about 98%. The primary metabolic pathways of this substance are hydroxylation and O-demethylation.

The process of removing Kardura from blood plasma is two-phase. The final half-life is 22 hours, so the drug can only be taken once a day. Less than 5% of the dose is excreted unchanged.

Pharmacokinetic studies have shown that in patients with renal insufficiency and in elderly patients, the pharmacokinetics of the drug does not differ significantly from those in younger patients with normal renal function.

The results of a clinical study, which involved 12 patients with moderate hepatic impairment, showed that with a single dose of doxazosin, there was an increase in AUC by 43% and a decrease in true oral clearance by 40%.

Indications for use

• Arterial hypertension (as part of combination therapy);
• Benign prostatic hyperplasia (BPH);
• Delayed urine flow and other symptoms associated with BPH.

Contraindications

• Hepatic impairment in severe or progressive form;
• Anuria;
• Bladder stones;
• Urinary tract infections;
• Concomitant obstruction of the upper urinary tract;
• Age under 18;
• Hypotension and tendency to orthostatic disorders, including a history;
• Glucose-galactose malabsorption, lactose intolerance, lactase deficiency;
• Hypersensitivity to drug components and quinazolines.

Kardura is prescribed with caution to patients with aortic and mitral stenosis, heart failure with increased minute output, right ventricular failure (caused by pericardial effusion or pulmonary embolism), left ventricular failure with low filling pressure, impaired cerebral circulation, and the simultaneous use of PDE5 inhibitors hypotension), liver failure, elderly patients.

Application during pregnancy and breastfeeding is possible if, in the opinion of the doctor, the expected effect of therapy for the mother significantly outweighs the potential threat to the fetus or child.

Instructions for the use of Kardura: method and dosage

The tablets are taken orally 1 time per day, in the morning or in the evening.

The doctor prescribes and selects the dose of the drug individually based on clinical indications.

Recommended daily dosage:

• Arterial hypertension: the first 1-2 weeks - 1 mg 1 time per day. After taking the first dose, the patient needs to monitor blood pressure (BP) for the first 6-8 hours in order to prevent a sharp decrease in it, especially against the background of previous diuretic therapy. Then, with an interval of 1-2 weeks, a gradual multiple (up to 2 mg, up to 4 mg, up to 8 mg) increase in the daily dose is made until the therapeutically effective is achieved. The average dose of the drug is 2-4 mg per day, the maximum dose is 16 mg;
• Benign prostatic hyperplasia: to prevent the development of syncope and / or postural hypotension, the initial dose is prescribed in the amount of 1 mg. The dose should be increased gradually with an interval of 1-2 weeks, taking into account the presence of BPH symptoms and the individual characteristics of urodynamics. The average daily dose is 2-4 mg, the maximum is 8 mg.

When combined therapy with diuretics or other antihypertensive drugs, the dose of Kardura must be adjusted taking into account the tolerance of the drug and the patient's condition.

In case of interruption of taking the drug for several days, it is necessary to resume treatment from the initial dose.

In renal failure and in elderly patients, correction of the dosage regimen is not required.

Side effects

The use of Kardura for arterial hypertension can most often cause the following side effects:

• From the nervous system: drowsiness, postural dizziness (a sharp decrease in blood pressure while taking the first dose, which may result in orthostatic dizziness, fainting with a rapid change in body position); very often - dizziness, headache;
• From the vestibular apparatus and the organ of hearing: vertigo;
• From the respiratory system: rhinitis;
• From the digestive system: nausea;
• Others: weakness, asthenia, fatigue, edema of the lower extremities.

Adverse reactions noted in the process of marketing research of the action of Kardura in the treatment of patients with arterial hypertension, the development of which may not be associated with the use of the drug: chest pain, palpitations, tachycardia; infrequently - arrhythmia, angina pectoris, myocardial infarction; very rarely - a violation of cerebral circulation, bradycardia.

The use of Kardura in benign prostatic hyperplasia can cause the same side effects that occur in the treatment of patients with arterial hypertension.

In addition, post-marketing studies report the following possible adverse drug effects:

• From the side of the cardiovascular system: infrequently - flushes of blood to the skin of the face, postural hypotension, a marked decrease in blood pressure;
• From the hematopoietic system: very rarely - thrombocytopenia, leukopenia;
• From the urinary tract: infrequently - polyuria, increased frequency of urination, urinary incontinence; very rarely - dysuria, nocturia, hematuria;
• From the digestive system: often - dryness of the oral mucosa, abdominal pain, dyspepsia, diarrhea; infrequently - vomiting, flatulence, constipation; very rarely - increased activity of liver enzymes, hepatitis, cholestasis, jaundice;
• From the side of the organ of vision: often - violation of color perception; infrequently - atonic iris syndrome;
• From the nervous system: often - paresthesia; infrequently - tremor, hypesthesia;
• From the vestibular apparatus and the organ of hearing: infrequently - tinnitus;
• From the side of metabolism: infrequently - anorexia;
• From the immune system: very rarely - anaphylactic reactions;
• From the musculoskeletal system: infrequently - back pain, arthralgia, muscle spasms, myalgia, muscle weakness;
• From the side of the psyche: often - insomnia, anxiety, agitation; infrequently - depression;
• On the part of the skin: infrequently - itchy skin, rash, alopecia, purpura; very rarely - urticaria;
• Reproductive system disorders: very rarely - impotence, priapism, gynecomastia; very rarely - retrograde ejaculation;
• From the respiratory system: often - rhinitis, shortness of breath; infrequently - nosebleeds, cough; very rarely - exacerbation of existing bronchospasm;
• Laboratory indicators: infrequently - an increase in body weight;
• Others: infrequently - pains of different localization.

Overdose

In case of an overdose, a pronounced decrease in blood pressure is possible, which is sometimes accompanied by fainting.

With the development of such an effect, the patient must be immediately laid on his back and his legs raised. If necessary, symptomatic therapy is carried out. Due to the high binding of doxazosin to blood plasma proteins, dialysis is not effective.

special instructions

The use of alpha-blockers, especially at the beginning of therapy, in a small proportion of patients causes the development of postural hypotension in the form of weakness, dizziness, and sometimes loss of consciousness (fainting). Therefore, when prescribing the drug, the doctor should give the patient recommendations on caution, including avoiding an abrupt change in body position. It should be warned about the possibility of orthostatic hypotension, especially in hot weather, during physical exertion or prolonged standing and in the case of alcohol consumption.

The drug should be used with extreme caution in elderly patients, since the risk of orthostatic hypotension and the occurrence of visual impairment, dizziness and fainting increases with age.

Prescribing the drug to patients with BPH is indicated both with normal blood pressure and with arterial hypertension. Normal blood pressure in patients with BPH does not change significantly from the use of the drug. Treatment of BPH in combination with arterial hypertension can be monotherapy.

In case of prostatic hyperplasia, the drug is prescribed after excluding its cancerous degeneration.

Doxazosin has no effect on the concentration of prostate-specific antigen (PSA) in plasma.

During cataract surgery, patients who are taking or have undergone alpha1-blocker therapy may experience intraoperative atonic iris syndrome. In order to prevent complications during the operation, the patient must inform the surgeon before it begins about the therapy with alpha1-adrenergic blockers or taking them earlier.

Kardura is prescribed with caution to patients with impaired liver function, avoiding the use of maximum doses.

During the period of use of the drug, it is recommended to be careful with all potentially hazardous activities, the implementation of which requires increased attention and high speed of psychomotor reactions, including the management of vehicles and mechanisms.

Application during pregnancy and lactation

Animal experiments did not provide data on the teratogenic effect of doxazosin, however, the use of extremely high doses (300 times higher than recommended for humans) led to a decrease in fetal survival. The lack of well-controlled adequate studies does not allow us to conclude about the safety of the drug during pregnancy or lactation, therefore, when prescribing Kardura during these periods, it is necessary to carefully analyze the benefits to the mother and possible harm to the fetus or child.

Pediatric use

It is forbidden to use the drug in the treatment of children and adolescents under 18 years of age.

Use in the elderly

When treating patients from this category, the drug is used with caution.

Application for violations of liver function

According to the instructions, Kardura undergoes complete biotransformation in the liver, therefore, when treating patients with impaired liver function, the drug should be used with caution.

Application for impaired renal function

When treating this category of patients, dose adjustment is not required.

Drug interactions

Concomitant use with PDE5 inhibitors can cause symptomatic hypotension.

The drug should not be administered concurrently with other alpha-adrenergic blockers.

The combination of doxazosin with warfarin, indomethacin, digoxin or phenytoin does not affect their binding to proteins in blood plasma.

The absence of clinical interaction of the drug was noted with simultaneous use with furosemide, thiazide diuretics, beta-blockers, oral hypoglycemic agents, antibiotics, anticoagulants, uricosuric agents.

The antihypertensive effect of the drug can be reduced by estrogens, sympathomimetic and non-steroidal anti-inflammatory drugs, especially indomethacin.

When combined with epinephrine, arterial hypotension and tachycardia may develop, since Kardura eliminates its alpha-adrenostimulating effect; with sildenafil - the likelihood of orthostatic hypotension increases; with inhibitors of microsomal oxidation in the liver, a decrease in the effectiveness of doxazosin is possible, and with inductors - an increase; with other antihypertensive drugs - it is necessary to adjust their dose, since the severity of their action increases.

Analogs

Analogues of Kardura are: Doxazosin, Doxazosin-FPO, Doxazosin Belupo, Doxazosin Sandoz, Doxazosin Zentiva, Doxazosin-Teva, Kamiren, Kamiren HL, Artezin, Tonokardin, Cardura Neo, Zoxon, Doxaprostan, Urocard.

Terms and conditions of storage

Store in a dry, dark place at temperatures up to 30 ° C. Keep out of the reach of children.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Kardura

Reviews about Kardura are predominantly positive: the drug is effective in the treatment of prostatic hyperplasia and hypertension. Side effects are rare.

Price for Kardura in pharmacies

The price for Kardura is about 497-530 rubles for a pack of 30 1 mg tablets, 550-630 rubles for a pack of 30 2 mg tablets and 697 rubles for a pack of 30 4 mg tablets.

Kardura: prices in online pharmacies

Drug name Price Pharmacy

Kardura 2 mg tablets 30 pcs. RUB 350 Buy

Kardura 1 mg tablets 30 pcs. 441 r Buy

Cardura 2mg tablets 30 pcs. 553 r Buy

Kardura 4 mg tablets 30 pcs. RUB 619 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!