Table. 1 mg, 2 mg, 4 mg. Treatment of: essential hypertension; clinical symptoms of benign prostatic hyperplasia.Table. about modifications. release (XL). Treatment of: hypertension (as monotherapy or in combination with other antihypertensive agents such as thiazide diuretics, β-adrenergic blockers, Calcium antagonists or ACE inhibitors); clinical symptoms caused by benign prostatic hyperplasia (both in hypertensive patients and in patients with normal blood pressure, in patients with hypertension can simultaneously lower blood pressure, in patients with normal blood pressure, the effect on blood pressure is usually clinically insignificant)
Composition:
1 tabl contains 1 mg, 2 mg or 4 mg Doxazosin as mesilate. 1 tabl with modified release contains 4 mg doxazosin as mesilate. The preparations contain lactose.
Action:
A selective, competitive antagonist of postsynaptic α receptors1adrenergic. Doxazosin reduces blood pressure by reducing peripheral vascular resistance. It reduces triglycerides and total cholesterol and increases the ratio of HDL to total cholesterol in the blood, inhibits left ventricular hypertrophy, reduces platelet aggregation, reduces the LV hypertrophy of the left ventricle after long-term use, increases the sensitivity of tissues to insulin in patients with impaired insulin sensitivity. In patients with benign prostatic hyperplasia, it reduces the contractility of the smooth muscle of the bladder neck and prostatic muscles surrounding and including the urethral meatus. After oral administration, doxazosin is well absorbed from the gastrointestinal tract, reaching a maximum concentration in the blood after about 1.5-3 h, and after 8-9 h after tabling. with modified release. It binds to plasma proteins in about 98%. It is metabolized in the liver to inactive metabolites. Less than 5 - 10% of the dose is excreted unchanged. T0,5 is 16-22 hours.
Contraindications:
Hypersensitivity to quinazolines (e.g. prazosin, terazosin, doxazosin) or any of the excipients. Orthostatic hypotension. Benign prostatic hyperplasia and simultaneous congestion of the upper part of the urinary tract, chronic urinary tract infection or bladder stones. Breast-feeding period (only for indications of hypertension). Hypotension (only for indications of benign prostatic hyperplasia). Doxazosin is contraindicated in monotherapy in patients with overcrowding or anuria with or without progressive renal failure. The modified-release (XL) tablets are contraindicated in patients with a history of obstruction of the gastrointestinal tract, esophagus or decreased diameter of the digestive tract.
Precautions:
Due to the risk of orthostatic symptoms, blood pressure should be monitored at the beginning of treatment with Doxazosin, and the patient should be advised to avoid situations of risk of injury if dizziness or weakness occurs at the beginning of treatment. Caution should be exercised when administering doxazosin to patients with the following acute cardiac disorders: pulmonary edema due to aortic valve stenosis or mitral valve; heart failure with a large minute capacity; right ventricular failure due to pulmonary embolism or pericardial effusion; left ventricular failure with low filling pressure. In patients with impaired liver function, doxazosin should be administered with caution; it is not recommended for patients with severe hepatic impairment. Caution should be exercised when co-administering doxazosin with type 5 phosphodiesterase inhibitors (eg Sildenafil, tadalafil and vardenafil). To reduce the risk of orthostatic hypotension, it is recommended to start treatment with phosphodiesterase type 5 inhibitors only if the patient is haemodynamically stable during treatment with α-blockers.In addition, it is recommended to start treatment with a type 5 phosphodiesterase inhibitor from the lowest possible dose and to maintain a 6-hour break from doxazosin. No studies on extended-release doxazosin have been performed. Due to the risk of intraoperative flaccid iris syndrome (IFIS) during pre-operative assessment, the cataract surgeon and ophthalmologist team should determine whether or not the patient who is scheduled for cataract surgery is or has been treated with α1-adrenergicznymi. Table. about modifications. XL release - improperly short passage time through the gastrointestinal tract (eg after surgical resection) may result in incomplete absorption. Due to the long half-life of doxazosin, the clinical significance of this is unclear. The preparation contains lactose - it should not be used in patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
Pregnancy and lactation:
During pregnancy, doxazosin can only be used if the potential benefits outweigh the risks. Doxazosin is contraindicated during breast-feeding.
Orally. Adults.Table. 1 mg, 2 mg and 4 mg. spontaneous narterial hypotension: treatment should start at 1 mg once a day. In individual cases, after 1-2 weeks, the dose may be increased to 2 mg doxazosin once a day, then to 4 mg doxazosin once a day, and finally to 8 mg doxazosin once a day. The average maintenance dose is 2 to 4 mg of doxazosin once a day. The maximum recommended dose is 16 mg doxazosin per day.Benign prostatic hyperplasia: treatment should start at a dose of 1 mg once a day. If necessary, after 1-2 weeks, the dose can be increased to 2 mg doxazosin once a day, and then to 4 mg once a day, depending on the patient's response. The maximum recommended daily dose is 8 mg. The doctor determines the duration of therapy. In elderly patients and in patients with impaired renal function, no dose adjustment is necessary, but the dose should be as low as possible and the dose should be increased under strict control. Doxazosin does not undergo dialysis. Special care should be taken in patients with hepatic impairment; use in patients with severe hepatic impairment is not recommended. There are no studies on the effectiveness and safety of the medicine in children and adolescents <18 years - not recommended.Table. modified-release (XL) 4 mg. Hypertension and benign prostatic hyperplasia: the starting dose is 4 mg once a day. A daily dose of 4 mg is effective in most patients. If the expected pressure reduction after 4 weekstreatment is unsatisfactory and if the patient tolerates the treatment well, the dose can be increased to 8 mg once a day. The maximum recommended daily dose is 8 mg administered once a day. No dosage adjustment is necessary in elderly patients or patients with renal impairment. Doxazosin does not undergo dialysis. Special care should be taken in patients with hepatic impairment; use in patients with severe hepatic impairment is not recommended. There are no studies on the effectiveness and safety of the medicine in children and adolescents <18 years - not recommended. The tablets should be swallowed whole with water. Table. XL should not be chewed, divided or crushed; Table. 2 mg, 4 mg can be divided into halves.