Expiration date: 03/2025

Structure and Composition: 

The modified-release tablets. One tablet contains doxazosin mesylate 4.85 mg

(Equivalent to 4mg doxazosin)

excipients: hypromellose, anhydrous calcium hydrogen phosphate lactose monohydrate magnesium stearate

shell - dye Opadry white (hypromellose, titanium dioxide E171) macrogol 400

in blister 10 pcs. a stack of cardboard 1, 3 or 9 blisters.

Also available as a standard Camiri (1, 2 and 4 mg, 30 tab. In the package).

Description pharmaceutical form:

Round, slightly biconvex tablets, film-coated white.

Pharmacokinetics:

Once inside Camiri CL is well absorbed.

Absorption - 80-90% (simultaneous reception of food slows the absorption of 1 hour). Tmax plasma -. 8.9 h Cmax level when assigning modified release tablets is only 1/3 compared with the conventional tablets, and Cmin is the same level in both forms of the drug. In this regard, the profile in plasma of doxazosin using modified release tablet smoother and the ratio between the maximum and the minimum concentration is 2 times lower than that of conventional tablets. Bioavailability - 60-70% (first pass metabolism). Binding to plasma proteins - about 98%. Excretion of plasma takes place in two phases with the end T1 / 2 - 9-22 hours, allowing the drug to assign 1 time per day.

Intensively metabolized in the liver by on-demethylation and hydroxylation. In patients with impaired liver function, as well as when taking drugs that may alter the hepatic metabolism of the drug biotransformation process can not be observed. Main removing - through the intestine, mainly in the form of metabolites, only 5% excreted in the urine in unchanged form. The kidneys remove 10%. Pharmacokinetic studies with doxazosin in the elderly and patients with kidney disease showed no significant pharmacokinetic differences.

Description of the pharmacological actions:

Doxazosin is a selective competitive blocker of postsynaptic alpha1-adrenergic receptors. By reducing vascular muscle tone doxazosin reduces round, resulting in a decrease in blood pressure. After a single dose of the drug the maximum hypotensive effect observed in the period from 2 to 6 hours, and anti-hypertensive effect lasts for 24 hours. During treatment with doxazosin in hypertensive patients with no differences in blood pressure values ??in the "standing" and "lying."

Effective with hypertension, including accompanied by metabolic disorders (obesity, impaired glucose tolerance).

It reduces the risk of developing coronary heart disease.

Acceptance of the drug in people with normal blood pressure are not accompanied by a decrease in blood pressure. With prolonged use of doxazosin in patients with no observed change in tolerance to the therapeutic antihypertensive effect.

During treatment doxazosin observed decrease in plasma levels of triglycerides, total cholesterol. At the same time there is some (by 4-13%) increase in the coefficient of HDL / total cholesterol.

Prolonged treatment doxazosin observed left ventricular hypertrophy regression, inhibition of platelet aggregation and the elevation of tissue plasminogen active.

Due to the fact that the blocks doxazosin alpha1-adrenergic receptors located in the stroma and prostatic capsule and bladder neck, there is a decrease of resistance and pressure in the urethra, internal sphincter resistance decrease. Therefore, the appointment of doxazosin to patients with symptomatic benign prostatic hyperplasia results in a significant improvement in urodynamics and reduce symptoms of the disease symptoms. Has effect in 66-71% of patients, onset of action - within 1-2 weeks of treatment, maximum - after 14 weeks, and the effect lasts for a long time. Compared with tablets dosage form - tablets with modified release have a ratio efficacy / safety.

Indications:

hypertension mild to moderate severity (in combination with other antihypertensive agents - thiazide diuretics, beta-blockers, CCBs, ACE inhibitors)

benign prostatic hyperplasia (symptomatic treatment).

Contraindications:

Hypersensitivity to other derivatives of doxazosin and quinazoline (prazosin, terazosin) or to other components of the preparation

age of 18 years (effectiveness and safety have been established).

Carefully:

• aortic or mitral stenosis
  
• liver and / or kidney disease
  
• orthostatic hypotension.
  

Application of pregnancy and breastfeeding:

Pregnant women can be given the drug only for health reasons, when benefit to the mother outweighs the potential risk to the fetus / baby. Safety of the drug in infants has not been established, therefore, nursing mothers should stop breast-feeding during treatment with doxazosin.

Side effect:

• In the treatment of hypertension
  
• In clinical studies, the most frequently observed, especially at the beginning of treatment, orthostatic hypotension, which in rare cases may cause fainting.
  

General reaction: asthenia, fatigue, malaise.

Cardio-vascular system: edema, fainting.

Eliminating alpha adrenostimuliruyuschee effects of epinephrine may cause tachycardia and hypotension.

Dosage and administration:

Inside, 1 time a day, morning or evening, regardless of prima food without chewing and drinking plenty of water.

Hypertension: The usual dose Camiri CL - 4 mg (1 tab.) Per day.

The drug can be shown on the first day of treatment, the therapeutic effect occurs within 4 weeks after starting treatment. After 4 weeks, in case of good tolerability and lack of effectiveness, may increase the dose. The maximum recommended daily dose of Camiri CL - 8 mg (2 tab.) In 1 reception. If the therapeutic effect is not sufficient, it is possible to simultaneously assign other antihypertensive agents: beta-blockers, diuretics, CCBs, ACE inhibitors. After reaching a stable dose of a therapeutic effect is usually somewhat lower (average therapeutic dose for maintenance therapy is usually 2-4 mg / day) can also be taken in pill form Camiri at 2 or 4 mg.

Benign prostatic hyperplasia in patients with normal blood pressure: the usual dose is 1 tablet. (4 mg) per day Camiri CL. The first dose should be taken in the evening before bedtime. Depending on the effectiveness of treatment dose can be gradually increased at intervals of 1-2 weeks 1 to 8 mg once daily. Typically, the average daily dose is from 2 to 4 mg. Can also be taken in the form of tablets Camiri 2 or 4 mg. The maximum daily dose - 8 mg.

Benign prostatic hyperplasia in hypertensive patients: the dose is the same as in hypertension patients without BPH.

The drug is used for a long time. The duration of treatment, the doctor sets individually. Dose should be adjusted according to the efficiency or possible adverse reactions in certain patients.

Patients with hepatic impairment require lower doses of the drug due to slow metabolism.

If the patient has forgotten to take Camiri CL at the usual time, the medication should be taken as soon as possible in the appropriate dose. When the time comes for the next dose, then it should be taken, not doubling. It is important to take the drug regularly. If the patient is taking the drug for several days, then a new therapeutic course should start with the lowest dose.

Special instructions:

Particular caution should be exercised in the appointment of the drug to patients with impaired liver function, especially in those cases where both are used drugs that can affect the liver. In case of deterioration of the functional state of the liver drug overturned immediately.

In order to prevent orthostatic reactions, patients should avoid unexpected and sudden shifts in body position (transition from the "lying" in the "standing" position).

Drinking alcohol can increase adverse reactions.

Safety and efficacy of doxazosin in children has not been established, so the drug is not recommended for children.

The effect of the "first" of the drug is especially pronounced against the background of previous diuretic therapy and diet sodium restriction.

Before therapy is necessary to exclude the malignant degeneration of the prostate gland.

Due to the fact that doxazosin can cause orthostatic reactions at the beginning of treatment or during the period of increasing dosages to patients it is advisable to refrain from any potentially dangerous activities, in particular from road transport management and other vehicles and machinery.