Medicinal Products

APROVEL 150 mg

Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Irbesartan
laboratory: Sanofi Pharma Bms Snc

Coated tablet
Box of 56 Pre-cut platelets of 1
All forms

Indication

Aprovel is indicated in adults for the treatment of essential hypertension. It is also indicated for the treatment of renal impairment in adult hypertensive patients with type 2 diabetes, in the context of management with an antihypertensive drug (see section 5.1 ).

Dosage APROVEL 150 mg Film-coated tablet Box of 56 Pre-cut packs of 1

Dosage The recommended starting and usual maintenance dose is 150 mg given as a single dose once daily during or after meals. Aprovel at a dose of 150 mg once a day usually provides better control of blood pressure over 24 hours than the 75 mg dose. However, initiation of treatment with 75 mg daily may be considered particularly in hemodialysis patients or patients over 75 years of age.

In patients inadequately controlled at 150 mg once daily, the dosage may be increased to 300 mg or another antihypertensive agent may be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Aprovel (see section Interactions with other medicinal products and other forms of interaction ).

In hypertensive patients with type 2 diabetes, treatment should be initiated at a dose of 150 mg irbesartan once daily and increased to 300 mg once daily, a preferable maintenance dose for the treatment of renal impairment. . The demonstration of the renal benefit of Aprovel in hypertensive patients with type 2 diabetes is based on studies in which irbesartan was used, if necessary, in addition to other antihypertensive agents to achieve a blood pressure goal (see section 5.1). Special populations

Renal Insufficiency: No dose adjustment is required in patients with renal impairment. A lower starting dose (75 mg) should be considered in patients undergoing hemodialysis (see section 4.4 Special warnings and precautions for use ).

Hepatic impairment: No dose adjustment is required in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.

Elderly: Apart from subjects over 75 years of age, in whom treatment may be initiated at 75 mg / day, no dose adjustment is usually necessary in the elderly.

Pediatric population: The efficacy and safety of Aprovel in children aged 0 to 18 years has not been established. The available data are described in the Adverse Reactions, Pharmacodynamic Properties and Pharmacokinetic Properties sections, but no dosage recommendations can be made.

Administration mode

Oral way.

Against indications

Hypersensitivity to the active substance or to any of the excipients (see section Composition ).
Second and third trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

Aprovel side effects

In placebo-controlled trials in hypertensive patients, the overall incidence of adverse events was not different between the irbesartan group (56.2%) and the placebo group (56.5%). . Treatment interruptions due to clinical or laboratory adverse events were less frequent in patients treated with irbesartan (3.3%) than in placebo-treated patients (4.5%). The incidence of adverse events was independent of dosage (within recommended dose range), sex, age, race or duration of treatment.

In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic vertigo and orthostatic hypotension were reported in 0.5% (ie, infrequently) patients, but in excess of placebo.

The following adverse events have been reported in placebo-controlled clinical studies in which 1965 patients received irbesartan. In diabetic hypertensive patients with chronic renal failure and overt proteinuria, the marked adverse effects of (*) were reported in more than 2% of patients and in excess of placebo.

The frequency of adverse reactions listed below is defined according to the following convention: very common (≥ 1/10); frequent (≥ 1/100 to <1/10); uncommon (≥1 / 1, 000 to <1/100); rare (≥ 1 / 10, 000 to <1 / 1, 000); very rare (<1 / 10, 000). In each frequency group, adverse effects are presented in order of decreasing severity.

Additional adverse reactions reported after marketing are also listed. These side effects come from spontaneous reports.

Immune system disorders:

Not known: hypersensitivity reactions, such as angioedema, rash, urticaria

Metabolism and nutrition disorders:

Not known: hyperkalemia

Nervous system disorders

Common: dizziness, orthostatic vertigo *

Not known: dizziness, headache

Affections of the ear and labyrinth:

Not known: tinnitus

Heart conditions

Uncommon: tachycardia

Vascular disorders

Common: orthostatic hypotension *

Uncommon: Vasomotor flush

Respiratory, thoracic and mediastinal disorders

Uncommon: cough

Gastrointestinal disorders

Common: nausea / vomiting

Uncommon: diarrhea, dyspepsia / heartburn

Not known: dysgeusia

Hepatobiliary disorders

Uncommon: jaundice

Not known: hepatitis, abnormal liver function

Skin and subcutaneous tissue disorders:

Not known: leukocytoclastic vasculitis

Musculoskeletal and systemic disorders

Frequent: musculoskeletal pain *

Not known: arthralgia, myalgia (associated in some cases with increased creatine kinase levels), muscle cramp

Renal and urinary disorders:

Not known: alteration of renal function, including renal failure in patients at risk (see Warnings and Precautions section )

Disorders of reproductive organs and breast

Uncommon: Sexual dysfunction

General disorders and administration site conditions

Frequency: tiredness

Uncommon: chest pain

investigations:

Very common: hyperkalemia * occurred more often in diabetic patients treated with irbesartan than in those treated with placebo. In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalemia (≥ 5.5 mEq / l) occurred in 29.4% (ie, very frequently) patients in the irbesartan 300 mg group. and in 22% of patients in the placebo group. In diabetic hypertensive patients with chronic renal failure and overt proteinuria, hyperkalemia (≥ 5.5 mEq / l) occurred in 46.3% of patients in the irbesartan group and 26.3% of patients in the placebo group.

Frequent: Significant increases in plasma creatine kinase have been observed frequently (1.7%) in subjects treated with irbesartan. None of these increases were associated with clinically identifiable musculoskeletal events.

In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a non-clinically significant decrease in hemoglobin * was observed.

Pediatric population:

In a randomized study that included 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse events were reported during the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), vertigo (1.9%), cough (0.9%). In the 26-week open-label period of this study, the most frequently observed laboratory abnormalities were increases in creatinine (6.5%) and increased CK values ​​in 2% of children receiving the product.

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