Aprovel, 300 mg 28 pcs.

An antihypertensive drug, a specific angiotensin II receptor antagonist (type AT< sub>1). Eliminates the vasoconstrictor effect of angiotensin II and reduces the plasma concentration of aldosterone. Does not inhibit kinase II, an enzyme that degrades bradykinin.< br> Reduces ROS, reduces postload. It decreases BP (with minimal change in HR) and small circulatory pressure, and the decrease in BP is dose-dependent. < br> < br> < br> The maximum effect of the drug develops in 3-6 hours after a single dose. Hypotensive effect is maintained for 24 hours. Sustained clinical effect is achieved after 1-2 weeks of using the drug, the maximum effect is achieved by 4-6 weeks after the start of treatment. After discontinuation of the drug, BP gradually returns to the baseline value. No withdrawal syndrome (recoil hypertension effect) is noted.

Aprovel has no effect on the concentration of triglycerides, cholesterol, glucose, uric acid in plasma or on uric acid excretion with urine.

Indications

– Essential hypertension

– Nephropathy in arterial hypertension and type 2 diabetes mellitus (as part of combined hypotensive therapy).

Active ingredient

Composition

1 tablet contains irbesartan 300 mg;

excipients:

Lactose monohydrate,

corn starch pregelatinized,

croscarmellose sodium,

poloxamer 188,

colloidal silica aqueous,

microcrystalline cellulose,

magnesium stearate.

How to take, the dosage

The starting and maintenance doses are 150 mg once daily.

If necessary, the dose can be increased to 300 mg once daily.

Aprovel can be taken with food or on an empty stomach. The tablets should be swallowed whole with water.

Interaction

In concomitant use of Aprovelle and thiazide diuretics, the hypotensive effect of the drugs is additive.

The concomitant use of Aprovelle with potassium-saving diuretics, potassium preparations may lead to increased serum potassium levels.

Special Instructions

Patients with bilateral renal artery stenosis should be prescribed Aprovelle with caution because of the possible risk of severe arterial hypotension and acute renal failure.

Pre-treatment with high-dose diuretics prior to administration of Aprovelle may lead to dehydration and increase the risk of arterial hypotension at the beginning of treatment with Aprovelle. In dehydrated patients or patients with sodium ion deficiency as a result of intensive treatment with diuretics, restriction of salt intake with food, diarrhea or vomiting, as well as in patients undergoing hemodialysis the dose should be corrected towards its reduction.

The results of experimental studies

In studies conducted on laboratory animals no mutagenic, clastogenic or carcinogenic effects of Aprovelle were found.

Pediatric use

The safety and effectiveness of the drug in children have not been established.

Impact on driving and operating ability

There are no reports about the effect of taking Aprovel on driving and operating ability.

Contraindications

– pregnancy;
– lactation;
– childhood and adolescence under 18 years of age;
– hypersensitivity to the components of the drug Aprovel.

Side effects

In placebo-controlled studies (1965 patients received irbesartan) the following adverse reactions were noted.

CNS side effects: often – dizziness.

Cardiovascular system: sometimes – tachycardia, hot flashes.

Respiratory system: sometimes – cough.

The digestive system: often – nausea, vomiting; sometimes – diarrhea, dyspepsia, heartburn.

As to the sexual system: sometimes – sexual dysfunction.

The body in general: often – fatigue; sometimes – pain in the chest.

Laboratory findings: often – significant increase of CPK (1.7%), not accompanied by clinical manifestations of the musculoskeletal system.

In patients with arterial hypertension and type 2 diabetes mellitus and microalbuminuria with normal renal function, orthostatic dizziness and orthostatic hypotension were observed in 0.5% of patients (more frequently than in placebo). In diabetic patients with hypertension with microalbuminuria and normal renal function, hyperkalemia (over 5.5% mmol/l) occurred in 29.4% of patients in the group receiving irbesartan at a dose of 300 mg, and 22% of patients in the group receiving placebo.
In patients with arterial hypertension with diabetes mellitus, chronic renal insufficiency, and marked proteinuria, the following additional adverse reactions were noted in 2% of patients (more often than in placebo).

CNS side effects: often – orthostatic dizziness.

Cardiovascular system: often – orthostatic hypotension.

Muscular system disorders: often – bone and muscle pain.

Laboratory findings: hyperkalemia (more than 5.5% mmol/l) occurred in 46.3% of patients in the group of patients receiving irbesartan and 26.3% of patients in the placebo group. A decrease in hemoglobin levels that was not clinically significant was seen in 1.7% of patients receiving irbesartan.

The following adverse reactions were also identified in the post-marketing period:

Allergic reactions: rarely, rash, urticaria, angioedema (as with other angiotensin II receptor antagonists).

Metabolism disorders: very rare – hyperkalemia.

CNS disorders: very rare – headache, tinnitus.

Digestive system: very rarely – dyspepsia, liver dysfunction, hepatitis.

Muscular system: very rarely – myalgia, arthralgia.

Urinary system disorders: very rarely – renal function disorders (including individual cases of renal failure in predisposed patients).

Overdose

Taking the drug in a dose of up to 900 mg/day for 8 weeks did not reveal any toxicity.

Treatment: In case of accidental administration of the drug in high doses gastric lavage and symptomatic therapy are indicated.

Irbesartan is not eliminated from the body by hemodialysis.

Pregnancy use

Aprovel is contraindicated in pregnancy. If pregnancy occurs during treatment, the drug should be discontinued immediately.

If it is necessary to prescribe the drug during lactation, discontinuation of breastfeeding should be considered.

Similarities