Kardura - alpha 1 -blocker with antihypertensive effect.
Release form and composition
Kardura is available in the form of tablets - 7, 10 and 14 pcs. Each. in blisters, 2, 3 or 1 blister in a package, respectively.
The active ingredient of the drug is doxazosin (in the form of mesylate). 1 tablet contains 1, 2 or 4 mg.
Auxiliary components: sodium lauryl sulfate, lactose monohydrate, carboxymethyl starch sodium, magnesium stearate and microcrystalline cellulose.
Indications for use
- Benign prostatic hyperplasia (BPH);
- Delayed urine flow and other symptoms associated with BPH;
- Arterial hypertension (in combination therapy).
- Urinary tract infections;
- Severe hepatic / renal failure;
- Concomitant obstruction of the upper urinary tract;
- Stones in the bladder;
- Hypotension and tendency to orthostatic disorders (in history including);
- Glucose-galactose malabsorption, lactase deficiency and lactose intolerance;
- Age up to 18 years;
- Hypersensitivity to doxazosin, auxiliary components and quinazolines.
Special supervision during treatment is required in the following cases:
- Heart failure with increased minute discharge;
- Aortic and mitral stenosis;
- Left ventricular failure with low filling pressure;
- Right ventricular failure due to exudative pericarditis or pulmonary embolism;
- Disorders of cerebral circulation;
- The simultaneous use of PDE5 inhibitors (there is a likelihood of symptomatic hypotension, liver failure);
- Elderly age.
Dosing and Administration
Kardura should be taken orally once a day - in the morning or in the evening.
Treatment for BPH starts with 1 mg to minimize the risk of syncope and syncope and / or postural hypotension. Taking into account the individual characteristics of urodynamics, the types and severity of symptoms of the disease, the dose, if necessary, gradually, at intervals of 1–2 weeks, is increased first to 2 mg, then to 4 mg. The maximum permissible daily dose is 8 mg.
Treatment of arterial hypertension (AH) is also recommended to start with 1 mg. Since there is a likelihood of the development of the “first dose” phenomenon, it is recommended to remain in a prone position for 6–8 hours after taking the first pill and monitor blood pressure (BP). When the effect is insufficient, the dose gradually, at intervals of 1–2 weeks, is first increased to 2 mg, then to 4 mg, etc. The average daily dose, as a rule, is 2-4 mg. The maximum allowable - 16 mg. If a diuretic or another antihypertensive drug is additionally prescribed, the dose of Kardura should be adjusted depending on the patient's condition.
If for some reason the treatment was interrupted for several days, you should resume taking Kardura from the initial dose.
In controlled clinical studies of Kardura in patients with hypertension (arterial hypertension), the most frequently observed side effects that can be attributed to the type of postural or nonspecific:
- Central and peripheral nervous system: dizziness, headache, drowsiness, and postural dizziness (after taking the first dose, a pronounced decrease in blood pressure may occur, which can lead to orthostatic dizziness, and in severe cases, especially when quickly changing the prone position to a standing / sitting position - to faint);
- Digestive system: nausea;
- Organ of hearing and vestibular apparatus: vertigo;
- Respiratory system: rhinitis;
- Other: fatigue, weakness, asthenia, edema of the lower extremities.
In the process of marketing the drug in patients with arterial hypertension, the following phenomena were noted: often - a feeling of heartbeat, tachycardia, chest pain; infrequently - angina pectoris, arrhythmias, myocardial infarction; very rarely - bradycardia and disorders of cerebral circulation. However, it should be noted that the symptoms described could have been caused by the underlying disease.
According to controlled clinical trials, patients with BPH had the same side effects as patients with hypertension. With the postmarketing use of Kardura, the following adverse reactions have been reported:
- Blood system: very rarely - leukopenia and thrombocytopenia;
- Organs of hearing and vestibular apparatus: infrequently - tinnitus;
- Organ of vision: often - a violation of color perception; infrequently - atonic iris syndrome;
- The digestive system: often - dryness of the oral mucosa, abdominal pain, dyspepsia, diarrhea; infrequently - constipation, flatulence, vomiting; very rarely - hepatitis, cholestasis, increased activity of liver transaminases, jaundice;
- Immune system: very rarely - anaphylactic reactions;
- Metabolism: infrequently - anorexia, weight gain;
- Urinary tract: infrequently - increased urination, urinary incontinence, polyuria; very rare - hematuria, dysuria, nocturia;
- Central and peripheral nervous system: often - paresthesia, infrequently - tremor, hypesthesia;
- Mind: often - insomnia, agitation, anxiety; infrequently - depression;
- Respiratory system: often - rhinitis, shortness of breath; infrequently - nasal bleeding, cough; very rarely - exacerbation of existing bronchospasm;
- Musculoskeletal system: Infrequently - back pain, arthralgia, myalgia, muscle spasms, muscle weakness;
- Cardiovascular system: infrequently - flushing of the skin of the face, postural hypotension, marked reduction in blood pressure;
- Reproductive system: very rarely - priapism, impotence, gynecomastia, retrograde ejaculation;
- Skin: rarely - skin rash, itching, alopecia, purpura; very rarely - urticaria;
- Other: infrequently - pains of different localization.
With an overdose of doxazosin, a pronounced decrease in blood pressure occurs, sometimes with fainting. In this case, the patient should immediately lay in a horizontal position and lift the legs. Dialysis is ineffective, treatment is symptomatic.
Patients with hypertension should be warned that the risk of orthostatic hypotension increases with hot weather, exercise or prolonged standing, as well as with alcohol.
Before prescribing Kardur to patients with BPH, it should exclude its cancerous degeneration.
During the period of treatment it is necessary to be especially careful when performing potentially hazardous activities and driving.
In animal experiments, doxazosin did not have a teratogenic effect, but when it was used in excessively high doses (300 times higher than the maximum recommended), a decrease in fetal survival was observed. Adequate well-controlled studies of the use of Kardura during pregnancy and lactation were not conducted. Therefore, during these periods of a woman's life, the drug is prescribed only in exceptional cases, after a careful assessment of the ratio of the expected benefits and possible risks.
Caution is needed when the combined use of Kardura with PDE5 inhibitors is necessary, since this can lead to the development of symptomatic hypotension.
Non-steroidal anti-inflammatory drugs, especially indomethacin, as well as sympathomimetic drugs and estrogens can reduce the antihypertensive effect of Cardur.
Doxazosin levels the alpha-adrenostimulating effect of epinephrine, which can lead to tachycardia and arterial hypotension.
With simultaneous use with sildenafil increases the risk of orthostatic hypotension.
Kardura is not recommended in combination with other blockers of alpha-adrenergic receptors.
In the appointment of other antihypertensive drugs dose adjustment is necessary, since doxazosin enhances their action.
Inductors of microsomal oxidation in the liver can increase the effectiveness of Kardura, inhibitors - reduce.
Terms and conditions of storage
Store in a dry, dark place inaccessible to children at a temperature up to 30 ºС.
Shelf life - 5 years.