Alanboss XL 10 Hasan treats symptoms of benign prostatic hypertrophy (3 blisters x 10 tablets)

ATC code: G04CA01

Mechanism of action

alfuzosin is a derivative of quinazolin oral, has a selective antagonistic effect on Alpha, -adrenergic receptors.

Alfuzosin has structure and pharmacology related to prazosin, doxazosin, terazosin and pharmacy related to tamsulosin.

Alfuzosin has a selective effect with alpha, -adrenergic receptors in the lower urinary tract, prostate, prostate cover, bottom, bladder neck and urethra. The drug directly acts on the prostate smooth muscle, reduces the obstruction in the bladder neck and reduces urethral pressure, so the drug reduces the urine flow.

In vivo research shows that alfuzosin has a more selective effect than prazosin or terazosin for alpha receptors, in the lower urinary tract compared to the circuit system. Alfuzosin can reduce the effectiveness of the urethra with a dose that does not affect blood pressure. On the isolated human tissue, alfuzosin compared to Tamsulosin, Doxazosin and Terazosin have the highest selective rate for prostate tissue on vascular tissue. In clinical, the selective properties for the lower urinary tract of alfuzosin are not affected by the patient's age. The effect of reducing the urethra pressure of the drug is much larger than lowering blood pressure.

In patients with benign prostatic hypertrophy with urine flow below 15 ml/sec, alfuzosin increases the flow of about 30%.

This effect appears immediately after the first dose; Significant reducing the pressure of the bladder muscle contraction and increasing the volume of urine causing urination, as well as reducing the volume of urine out of the bladder after urinating. These effects alleviate the irritant and obstruction symptoms.

For cardiovascular, alfuzosin lower blood pressure.

Pharmacokinetics

absorption

The average value of relative bioavailability of the release type lasts about 104.4% of the instant release (2.5 mg x 3 times/day) in middle -aged volunteers. The peak concentration in plasma is 9 hours after drinking compared to 1 hour for instant release.

Studies show that the bioavailability of the drug increases when used after meals.

In the NO state, the average CMAX and CTRough values ​​are 13.6 (sd = 5.6) and 3.2 (sd = 1.6). The average AUC0-24 value is 194 (sd = 75) ng.h/ml. Stable concentration is observed from 3 hours to 14 hours with a concentration of> 8.1 ng/ml (CAV) for 11 hours.

Distribution

Alfuzosin binds about 90% to plasma proteins.

Metabolism

Alfuzosin is strongly metabolized in the liver. The main enzyme in the liver is related to the metabolism of alfuzosin is CYP3A4.

Elimination

Sell waste time is 9.1 hours. The majority of non -active metabolites are eliminated through feces (75 - 91%), only 11% in the form of unproven metabolism are eliminated through urine.

Pharmacokinetics in some special clinical subjects:

Elderly: Pharmacokinetics parameters (CMAX and AUC) do not increase in elderly patients compared to healthy middle -aged volunteers. Sell ​​waste time does not change.

Renal failure: Increased integral and increased clearance when the kidney function is impaired, possibly due to a decrease in the rate of binding with plasma proteins. However, the sale time does not change. This pharmacokinetic change does not have clinical significance, so it is not necessary to adjust the dose on patients with renal impairment mild to moderate.

Hepatic failure: Prolonged sale time in patients with severe liver failure.

The peak concentration in plasma doubled and increased bioavailability compared to young, healthy volunteers. ALANBOSS XL 10 extended release tablet is contraindicated for patients with liver failure.

Chronic heart failure: Alfuzosin pharmacokinetic properties are not affected by chronic heart failure.

Caution when using

is like other alpha receptor blockers, alfuzosin can cause hypotension with or no symptoms (dizziness, fatigue, sweat), which occurs in a few hours after drinking. In this case, the patient needs to lie until the symptoms completely disappear. These symptoms are often transient, occurring in the early stages of the treatment process and often does not hinder the continued treatment. Clear hypotension usually occurs in patients with risk factors (cardiovascular disease or being treated with other anti -hypertension drugs). The risk of hypotension and unexpected effects is abnormally higher in the elderly, patients need to be warned of the risk of the above events.

Be cautious when using alfuzosin in patients with acute heart failure and a history of hypotension clearly with other alpha blockers; Patients are using other anti -hypertension drugs, nitrate groups, and need special blood pressure monitoring in the beginning of treatment.

Because the symptoms of cancer and benign prostatic hypertrophy are the same, it is necessary to eliminate cancer before starting treatment.

Soft pupil syndrome during surgery has been encountered in cataract surgery by emulsifier in some patients currently used or previously used Alpha receptor blockers. Men before cataract surgery should notify the current medical doctor or previously treated with alpha receptor blockers, including alfuzosin. If the patient has taken this medicine, the eye doctor needs to replace other techniques.

When using alfuzosin is higher than the recommended dose, the QT range may last. However, up to now, there has not been a twisted appearance in people using alfuzosin. Some reports suggest that the extended QT interval in users the alfuzosin dose is higher than the recommended dose, which should be considered when using alfuzosin for people who know that there is a long -term QT ​​or the person who is using drugs has known to cause a long QT range.

Do not use lone alfuzosin in patients with coronary artery disease. Need to continue treating coronary coronary insufficient disease for patients. If angina occurs or worse, it is necessary to stop using alfuzosin.

Because there is no data proving safety in patients with severe renal impairment (plasma creatinine clearance

Patients need to be warned of not being chewed, grinded or broken by pills because it can lead to inappropriate release and absorption.

The effect of the drug on the ability to drive and operate machinery

There is no data on the effect of the drug on the ability to drive train, operate machinery. Unwanted effects such as dizziness, dizziness, dizziness, weakness can occur, especially when starting treatment. Be careful when driving a train, operating machinery.

Use drugs for women during pregnancy and lactation

Not applicable (due to the indication for treatment of Alfuzosin is not related to women).

Drug interaction

Combining drugs:

Alpha-1 receptor blockers: contraindicated use in combination with alfuzosin because it can cause very severe posture lowering.

Caution should be careful:

Other anti -hypertension drugs: Be cautious when combining alfuzosin with other anti -hypertension drugs because of the increased risk of excessive hypotension.

Products containing nitrate: Be careful because of the increased risk of hypotension.

Active inhibitors of CYP3A4 (Ketoconazole, Itraconazole, Protease inhibitors (Ritonavir), Clarithromycin, Erythromycin), Telithromycin and Nefazodon: increase the concentration of alfuzosin in soy sauce and increase the risk of desirable effects.

Ketoconazole: Coordinate with ketoconazole to 200 mg/day repeated for 7 days, increasing the value of CMAX and AUC of Alfuzosin 2.1 times and 2.5 times when taking a single dose in a full state (a meal rich in fat). Other parameters such as Tmax and T12 do not change. CMAX and AUC of alfuzosin when taking a single dose in a state, increasing 2.3 times and 3.0 times when taken in combination with ketoconazole 400 mg/day repeated for 8 days.

Anesthesia: Using systemic anesthesia in patients being treated with alfuzosin can cause deep hypotension. Therefore, it is recommended to stop using the drug 24 hours before surgery.

Other interactions: warfarin, digoxin, hydrochlorothiazid and atenolol: no pharmacokinetic and pharmacokinetics interactions between alfuzosin and the above drugs are observed in healthy volunteers.