Description
Latin name
Cardura
Release form
Tablets
Packaging
In a blister pack of 10 tablets. There are 3 blisters in the package.
Indications
Arterial hypertension, obstruction of the urinary tract and symptoms due to benign prostatic hyperplasia.
Contraindications
Hypersensitivity (including to other quinazolines).
Pregnancy and lactation
There have been no adequate and strictly controlled clinical trials of the safety of Kardura during pregnancy and lactation (breastfeeding). 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) 2 mg.
Excipients: Sodium starch glycolate, Microcrystalline cellulose, Lactose, Magnesium stearate, Sodium lauryl sulfate
Dosage and administration
The drug can be prescribed for both morning and evening use.
In benign prostatic hyperplasia, the initial dose of Cardura 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 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.
The pharmacokinetics of doxazosin in patients with renal failure does not change, and the drug itself does not exacerbate existing renal dysfunction, therefore, in patients of this group, Cardura is used in usual doses.
When prescribing the drug to elderly patients, correction of the dosage regimen is not required.
There is no experience with the use of Kardura in children.
Side effects of
BPH
According to controlled clinical trials, the same adverse reactions occurred in patients with BPH as in 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, pruritus, 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 during a rapid transition from a lying position to a standing position or to a sitting position – to fainting), 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. The results of human plasma studies in vitro indicate that doxazosin does not affect the binding of digoxin, warfarin, phenytoin or indomethacin to proteins. 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 ° C.
Expiration
5 years.
Deystvuyuschee substances
doxazosin
pharmacy terms of prescription
Dosage form
Dosage form
tablets
