Doxazosin - instructions for use, analogs, reviews and release forms (1 mg, 2 mg and 4 mg Zentiva, FPO, Teva) drugs for the treatment of BPH or benign prostatic hyperplasia and hypertension in men. Composition

In this article, you can read the instructions for using the drug Doxazosin. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Doxazosin in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of doxazosin in the presence of existing structural analogs.Use for the treatment of BPH or benign prostatic hyperplasia and hypertension in men. Composition of the preparation.

Doxazosin - selective competitive blocker of postsynaptic alpha 1-adrenergic receptors. Causes the expansion of peripheral vessels, which leads to a decrease in OPSS and a decrease in blood pressure. Promotes an increase in the ratio of HDL / total cholesterol, a decrease in the total level of triglycerides and cholesterol.

With long-term use, regression of left ventricular hypertrophy is observed, suppression of platelet aggregation and an increase in the content of plasminogen activator in tissues. The blockade of alpha1-adrenergic receptors located in the stroma and capsule of the prostate gland in the neck of the bladder leads to a decrease in resistance and pressure in the urethra, a decrease in resistance in its internal opening. Improves urodynamics and reduces the manifestations of benign prostatic hyperplasia.

Composition

Doxazosin + excipients.

Doxazosin mesylate + excipients (Doxazosin Zentiva).

Pharmacokinetics

After oral administration, it is well absorbed from the digestive tract.Cmax in plasma is reached after 1.5-3.6 hours. Binding to plasma proteins is 98-99%. Intensively metabolized in the liver. It is excreted primarily through the intestines in the form of metabolites, 5% - in unchanged form; 9% is excreted by the kidneys.

Indications

• BPH or benign prostatic hyperplasia (symptomatic treatment);
• arterial hypertension (as part of combination therapy).

Forms of release

Tablets 1 mg, 2 mg and 4 mg.

Instructions for use and dosing regimen

Doxazosin is administered indoors regardless of food intake and can be taken both in the morning and in the evening. The tablet should be swallowed without chewing, squeezed with enough water.

Benign prostatic hyperplasia

The recommended initial dose of Doxazosin is 1 mg 1 time per day in order to minimize the possibility of postural hypotension and / or syncope (syncope). 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 up to a maximum recommended dose of 8 mg. The recommended interval for increasing the dose is 1-2 weeks. Usually the recommended maintenance dose is 2-4 mg once a day.

Arterial hypertension

The dose varies from 1 mg per day to 16 mg per day. It is recommended to start treatment with 1 mg once a day for 1 or 2 weeks in order to minimize the possibility of postural hypotension and / or syncope (fainting) phenomenon (the "first dose" phenomenon). After taking the first dose, the patient needs to monitor the blood pressure within 6-8 hours. This is required in connection with the possibility of developing the phenomenon of a "first dose", especially pronounced against the background of previous intake of diuretics.

For the next 1 or 2 weeks, the dose may be increased to 2 mg once a day.

To achieve the desired reduction in blood pressure, if necessary, the daily dose should be increased gradually, observing uniform intervals up to 4 mg, 8 mg and up to a maximum of 16 mg, depending on the severity of the patient's reaction to taking the drug. Usually the dose is 2-4 mg once a day.

If a diuretic or other antihypertensive drug is added to the therapy, the dosage of Doxazosin should be adjusted depending on the patient's condition with further titration under the supervision of the doctor.

In the event that therapy with Doxazosin was interrupted for several days, the use of the drug should be resumed from the initial dose.

In elderly patients, dose adjustment is not required.

The pharmacokinetics of doxazosin in patients with renal insufficiency does not change, and the drug itself does not worsen the existing renal dysfunction, so in such patients it is used in usual doses.

In patients with hepatic insufficiency, the drug should be used with caution.

Side effect

• respiratory tract infections;
• urinary tract infections;
• thrombocytopenia, leukopenia;
• allergic drug reactions;
• anaphylactic reactions;
• anorexia;
• increased appetite;
• increase in body weight;
• gout;
• excitation;
• anxiety;
• insomnia;
• anxiety;
• depression;
• drowsiness;
• headache;
• dizziness;
• tremor;
• fainting;
• impaired cerebral circulation;
• paresthesia;
• blurred vision;
• intraoperative syndrome of atonic iris (variant of narrow pupil syndrome);
• vertigo;
• noise in ears;
• a feeling of palpitations;
• tachycardia;
• angina pectoris;
• myocardial infarction;
• bradycardia;
• arrhythmia;
• marked decrease in blood pressure;
• postural hypotension;
• flushes of blood to the skin of the face;
• dyspnea;
• rhinitis;
• cough;
• bronchitis;
• nose bleed;
• bronchospasm;
• abdominal pain;
• dyspepsia;
• dryness of the oral mucosa;
• nausea, vomiting;
• flatulence;
• diarrhea, constipation;
• gastroenteritis;
• cholestasis;
• hepatitis;
• jaundice;
• increased activity of hepatic transaminases;
• itching;
• skin rash;
• purpura;
• alopecia;
• hives;
• backache;
• myalgia;
• arthralgia;
• muscle spasms;
• muscle weakness;
• cystitis;
• urinary incontinence;
• increased frequency of urination;
• dysuria;
• hematuria (blood in the urine);
• polyuria;
• nocturia;
• an increase in daily diuresis;
• erectile disfunction;
• gynecomastia;
• priapism;
• retrograde ejaculation;
• asthenia;
• peripheral edema;
• chest pain;
• influenza-like syndrome;
• swelling of the face;
• pain of different localization;
• fatigue;
• malaise.

Contraindications

• severe hepatic insufficiency (lack of experience in this category of patients);
• urinary tract infections;
• anuria;
• progressive renal failure;
• arterial hypotension with orthostatic disorders (including in the anamnesis);
• hypotension (refers only to the indication of benign prostatic hyperplasia);
• concomitant obstruction of the upper urinary tract;
• chronic urinary tract infections;
• stones in the bladder;
• obstructive disorders of the digestive tract;
• esophageal obstruction;
• decrease in the diameter of the lumen of the digestive system of any degree;
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption (due to the presence of lactose in the formulation);
• age to 18 years;
• the period of breastfeeding (for the treatment of hypertension);
• hypersensitivity to quinazoline derivatives (eg, to prazosin, terazosin, doxazosin), or to any of the auxiliary components of the preparation.

As a monotherapy:

• patients with bladder overflow;
• anuria with or without progressive renal failure.

Application in pregnancy and lactation

Although Doxazosin did not have a teratogenic effect in animal experiments, but when used in extremely high doses, a decrease in fetal survival was observed. These doses are about 300 times greater than the maximum recommended dose for a person.

Because of the lack of adequate, well-controlled studies in pregnant women, the safety of the drug during pregnancy has not yet been established.In connection with this, during pregnancy, the drug can be prescribed only in cases where the intended benefit to the mother exceeds the potential risk to the fetus.

Doxazosin is contraindicated in the period of breastfeeding. Experimental studies in animals have shown that doxazosin accumulates in the milk of lactating rats. There is no information on the isolation of the drug into breast milk.

If you need to use the drug should stop breastfeeding.

Use in children

Doxazosin is contraindicated in children under 18 years of age due to a lack of sufficient data on efficacy and safety.

Application in elderly patients

In elderly patients, dose adjustment is not required, but the drug should be used with caution in connection with the possibility of developing orthostatic hypotension. With age, the risk of dizziness, visual impairment and fainting increases.

special instructions

As with any alpha 1-blockers, especially at the beginning of therapy, in the treatment of Doxazosin, a very small percentage of patients may experience postural hypotension, manifested by dizziness and weakness or loss of consciousness (fainting).Before starting treatment with Doxazosin, the patient should be warned how to avoid symptoms of postural hypotension, in particular, it is necessary to refrain from rapid changes in body position. At the beginning of treatment with Doxazosin, the patient should be advised that care should be taken in case of weakness or dizziness.

Doxazosin should be used with caution in elderly patients due to the possibility of developing orthostatic hypotension. With age, the risk of dizziness, visual impairment and fainting increases. The patient should be informed of the increased risk of developing orthostatic hypotension with alcohol, prolonged standing or exercise, and in hot weather.

Benign prostatic hyperplasia (BPH)

Before starting BPH therapy, it is necessary to exclude the malignant neoplasm of the prostate. In patients with BPH, the drug can be prescribed both in the presence of arterial hypertension, and at normal BP.When the drug is used in patients with BPH with normal BP, the change in the latter is not significant. In this case, the use of Doxazosin in patients with a combination of arterial hypertension and BPH is possible as a monotherapy.

Doxazosin does not affect the concentration of prostate-specific antigen (PSA) in the blood plasma.

Intraoperative syndrome of atonic iris

Intraoperative syndrome of atonic iris (variant of narrow pupil syndrome) was observed in some patients during the operation for the removal of cataracts that received or received treatment with alpha 1-adrenoblockers. Since the intraoperative syndrome of atonic iris can lead to more complications during surgical interventions, it is necessary to alert the operating surgeon that alpha1-adrenoblockers are being taken at this time or taken before surgery.

Co-administration with PDE-5 inhibitors

With simultaneous use of doxazosin with PDE-5 inhibitors (for example, with sildenafil, Tadalafil and vardenafil), care should be taken, since both drugs have vasodilating effects and may lead to the development of symptomatic arterial hypotension in some patients.To reduce the risk of orthostatic hypotension, treatment with PDE-5 inhibitors is recommended to start only if the patient's hemodynamics has stabilized against the background of the use of alpha-blockers. In addition, treatment with PDE5 inhibitors is recommended starting at the lowest possible dose and maintaining a 6-hour interval from taking doxazosin. Studies of drugs with prolonged release of doxazosin have not been conducted.

Impaired liver function

Care should be taken when prescribing Doxazosin, as well as other drugs completely exposed to biotransformation in the liver, to patients with impaired liver function, avoiding the appointment of maximum doses. Do not use Doxazosin in patients with severe hepatic insufficiency due to lack of sufficient experience.

The preparation contains lactose. Patients with hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption drug is contraindicated.

Impact on the ability to drive vehicles and manage mechanisms

BecauseDuring the period of Doxazosin treatment, drowsiness, dizziness and fainting may occur on the part of the nervous system, care should be taken when driving vehicles and engaging in other potentially dangerous activities requiring increased attention and speed of psychomotor reactions.

Drug Interactions

The combined use of Doxazosin with PDE-5 inhibitors (sildenafil, tadalafil, tardenafil, vardenafil) in some patients can lead to symptomatic arterial hypotension.

It is not recommended to take doxazosin concomitantly with other alpha 1-adrenoreceptor blockers.

Doxazosin enhances the antihypertensive effect of other antihypertensive drugs.

Doxazosin binds highly to plasma proteins (98%). Studies have shown that doxazosin does not interfere with protein binding of the following drugs: digoxin, phenytoin, warfarin, or indomethacin.

Undesirable drug interactions were not observed in clinical studies with thiazide diuretics,furosemide, beta-blockers, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, oral hypoglycemic drugs, with funds for uric acid and anticoagulants.

There was no adverse interaction with simultaneous use of doxazosin with slow calcium channel blockers and ACE inhibitors.

With simultaneous use with induction of microsomal oxidation in the liver, it is possible to increase the effectiveness of doxazosin, with inhibitors - decrease. Estrogens and sympathomimetic agents can reduce the hypotensive effect of doxazosin. Eliminating the alpha-adrenostimulating effects of adrenaline, doxazosin can lead to tachycardia and arterial hypotension.

In an open, randomized, placebo-controlled study in 22 healthy male volunteers, the administration of a single doxazosin dose of 1 mg per day on the first day of the four-day administration of cimetidine (400 mg orally twice daily) resulted in an increase of 10% in mean AUC of doxazosin without statistically significant changes in the mean values ​​of Cmax and the half-life of doxazosin.A 10% increase in the mean AUC for doxazosin with cimetidine is within the inter-individual variability (27%) of the mean AUC for doxazosin with placebo.

Analogues of the drug Doxazosin

Structural analogs for the active substance:

• Artesine;
• Artesine retard;
• Doxazosin Belupo;
• Doxazosin Zentiva;
• Doxazosin Sandoz;
• Doxazosin Teva;
• Doxazosin FPO;
• Doxazosin ratopharm;
• Doxazosin mesylate;
• Zooxon;
• Camyrin;
• Camirin HL;
• Cardura;
• Cardura Neo;
• Tonicardin;
• Urocardia.

Analogues on the curative effect (remedies for the treatment of benign prostatic hyperplasia):

• Avodart;
• Adenostop;
• Akineton;
• Alfinal;
• Alfuzosin;
• Afala;
• Afalase;
• Vezielut;
• Vitaprost;
• Vitaprost forte;
• Gentos;
• Glansin;
• Dalfaz;
• Dalfaz retard;
• Depostat;
• Grain;
• Indigal;
• Ipertrophane 40;
• Kornam;
• Longidase;
• Metovit;
• Nitroxoline;
• Omnik;
• Omnik Okas;
• Omsulosin;
• Penester;
• Peponen;
• Permikson;
• Polipressin;
• Populus composite;
• Proscar;
• Prostavern Urtika;
• They will prostate;
• Prostagut forte;
• Prostamine;
• Prostamol Uno;
• Prostaplant;
• Prosteride;
• Simpletons;
• Raveron;
• Serpens;
• Setegis;
• Cialis;
• Sinestrol;
• Sonizine;
• Sounirid Duo;
• Tadenan;
• Tamsulosin;
• Tamsulon;
• Terazosin;
• Trianol;
• Tulosin;
• Urorek;
• Finasteride;
• Finast;
• Focussin;
• Haytrin;
• Cernilton;
• Cernilton forte.

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