Doxazosin | Cardura tablets 1 mg 30 pcs.

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SKU
BID483156
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Latin name

Cardura
Latin name

Cardura

Release form

Tablets

Packing

In a blister pack of 10 tablets. There are 3 blisters in the package.

Pharmacological action

Kardura - Alpha 1-blocker.

Benign prostatic hyperplasia The administration of 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 -Adrenoreceptors located in the stroma and capsule of the prostate gland and the neck of the bladder. Is doxazosin proven to be a blocker 1 -adrenoreceptors of subtype 1A, which account for approximately 70% of all subtypes 1 -adrenoreceptors 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).

Arterial hypertension - 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 1 -adrenoreceptors located in the network of vessels. 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 the specified 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 developing 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

Adequate and strictly controlled clinical trials of the safety of using Cardura during pregnancy and lactation (breastfeeding) have not been conducted. The use of the drug during pregnancy and lactation is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or infant.

In experimental animal studies, the drug did not have a teratogenic effect, but when used in exceptionally high doses, a decrease in fetal survival was observed. The indicated doses were approximately 300 times higher than the maximum recommended doses for humans.

Composition

1 tablet contains:

Active ingredient: doxazosin (in the form of mesylate) 1 mg.

Excipients: Sodium starch glycolate, Microcrystalline cellulose, Lactose, Magnesium stearate, Sodium lauryl sulfate

Dosage and administration

The drug can be prescribed for use both in the morning and in the evening.

With benign prostatic hyperplasia: The initial dose of Kardura is 1 mg 1 time / day in order to minimize the possibility of developing postural hypotension and / or syncope (fainting). Depending on the individual characteristics of urodynamics and the presence of symptoms of BPH, the dose can be increased to 2 mg, and then to 4 mg and to the maximum recommended dose - 8 mg. The recommended interval for increasing the dose is 1-2 weeks. The average recommended dose is 2-4 mg 1 time / day.

With arterial hypertension: The dose of the drug varies from 1 to 16 mg / day. Treatment is recommended to start with 1 mg 1 time / day for 1 or 2 weeks in order to minimize the possibility of developing postural hypotension and / or syncope (fainting). Over the next 1 or 2 weeks, the dose can be increased to 2 mg 1 time / day. To achieve the desired reduction in blood pressure, if necessary, the daily dose should be increased gradually, observing uniform intervals, to 4 mg, 8 mg and to a maximum of 16 mg, depending on the severity of the patient's reaction. The average dose is 2-4 mg 1 time / day.

Application for impaired renal function: The pharmacokinetics of doxazosin in patients with renal failure does not change, and the drug itself does not aggravate existing renal impairment, therefore, in patients of this group, Cardura is used in usual doses.

Use in elderly patients: Dosage adjustment is not required when prescribing the drug to elderly patients.

- Use in children There is no experience with the use of Kardura in children.

For ease of dosage, you can use the drug Kardura tab. 2 mg 30 Pfizer or Kardura tab. 4 mg 30 Pfizer.

Side effects

BPH

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

Arterial hypertension

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

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 type 5 inhibitors in some patients may lead to symptomatic hypotension.

The vast majority (98%) of doxazosin in blood plasma is bound to proteins. In vitro studies of human plasma indicate that doxazosin does not affect protein binding of digoxin, warfarin, phenytoin, or indomethacin. In clinical practice, the drug Cardura was used without any signs of interaction with thiazide diuretics, furosemide, beta-blockers, NSAIDs, antibiotics, oral hypoglycemic drugs, uricosuric agents and anticoagulants.

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

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

The drug should be stored in a dry, dark place at a temperature of no higher than 30 РC.

Expiration

5 years.

Deystvuyuschee substances

doxazosin



pharmacy terms of prescription

Dosage form

Dosage form

tablets

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