Spontaneous hypertension. Symptomatic treatment of benign prostatic hyperplasia.
Composition:
1 tabl contains 1 mg, 2 mg or 4 mg Doxazosin as doxazosin mesilate.
Action:
A selective and competitive inhibitor of postsynaptic α receptors1adrenergic. Doxazosin reduces blood pressure by reducing peripheral vascular resistance. It causes beneficial changes in the lipid profile: a small reduction in total cholesterol, LDL, and a slight reduction in the ratio of total cholesterol to HDL. It does not show adverse metabolic effects and may be used in patients with concomitant diabetes or gout, it increases the tissue sensitivity to insulin in people in whom it is reduced. Administered to patients with symptoms of benign prostatic hyperplasia, it reduces the discomfort experienced by the patient and improves the parameters of urine flow. This effect results from the inhibition of α receptors1-adrenergic cells found in the stromal cells and prostatic bag and in the bladder neck. After oral administration, doxazosin is well absorbed from the gastrointestinal tract, reaching a maximum concentration in the blood after about 2-3 hours. It binds plasma proteins in about 98%. It is metabolized in the liver to inactive metabolites and excreted mainly in the faeces. T0,5 is 22 hours.
Contraindications:
Hypersensitivity to Doxazosin, quinazoline derivatives and other ingredients of the preparation. Hypotension (only for the indication: benign prostatic hyperplasia) or history of orthostatic hypotension. Congestion of the upper urinary tract, chronic urinary tract infection or urolithiasis in patients with benign prostatic hyperplasia. Doxazosin is contraindicated in monotherapy in patients with bladder overload or anuria, with or without progressive renal failure. Breastfeeding period.
Precautions:
Caution in patients with severe heart disease: pulmonary edema caused by aortic stenosis or mitral stenosis, heart failure with a large minute capacity, right ventricular failure caused by pulmonary embolism or pericardial effusion, left ventricular heart failure with low filling pressure. Caution should be exercised when using doxazosin in patients with hepatic impairment and is not recommended for patients with severe hepatic impairment. When co-administering doxazosin with a PDE-5 inhibitor (eg Sildenafil, tadalafil and vardenafil), caution should be used. In order to reduce the risk of postural hypotension, the initiation of PDE-5 inhibitors is recommended only after haemodynamic stabilization of the patient in the treatment with alpha-blocker drugs. In addition, it is recommended to start treatment with PDE-5 inhibitors at the lowest possible dose and to maintain at least a 6-hour break from taking doxazosin. A patient who is scheduled for cataract surgery should inform the surgeon who is to carry out the therapy with alpha-blocker medications now or in the past due to the possibility of an intraoperative flaccid syndrome. The preparation contains lactose, therefore it should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose. There are no studies on the effectiveness and safety of the medicine in children - use is not recommended.
Pregnancy and lactation:
During pregnancy, before using the drug, potential benefits for the mother should be considered in relation to the risk to the fetus. Use during breast-feeding is contraindicated.
Orally.Spontaneous hypertension: initially 1 mg per day. After 1-2 weeks, the dose can be increased to 2 mg a day, and then to 4 mg or 8 mg a day if necessary. The average maintenance dose is 2 mg to 4 mg a day, the maximum daily dose - 16 mg.Benign prostatic hyperplasia: initially 1 mg per day; depending on urodynamic parameters and symptom severity, this dose may be increased to 2 mg, 4 mg or 8 mg per day with a 1-2-week interval while gradually increasing the dose. The maximum daily dose is 8 mg.