Medicinal Products

ALTEIS 10 mg

Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Olmesartan medoxomil
laboratory: Menarini Inter OP Luxemb

Coated tablet
Box of 90
All forms

Indication

Treatment of essential hypertension.

Dosage ALTEIS 10 mg Film-coated tablet Box of 90

adults

The initial dosage of olmesartan is 10 mg once daily. In patients inadequately controlled at this dose, the dosage of olmesartan may be increased to the optimal dose of 20 mg once daily.

If a greater decrease in blood pressure is required, the dosage of olmesartan may be increased to 40 mg once daily or the combination with hydrochlorothiazide (diuretic) may be considered.

The antihypertensive action appears within 2 weeks after initiation of treatment and reaches its maximum in about 8 weeks. Take this into account when adjusting each patient's dosage.

To promote adherence to treatment, it is recommended to take ALTEIS every day at the same time, during or after meals.

Elderly

In most cases, no dosage adjustment is required in the elderly (see below for dose adjustments in renal impairment). If the maximum dosage of 40 mg per day is required, blood pressure should be closely monitored.

Renal failure

In patients with mild to moderate renal impairment (creatinine clearance 20-60 ml / min), the maximum dose of olmesartan is 20 mg once daily. In patients with severe renal impairment (creatinine clearance <20 ml / min), the use of olmesartan is not recommended (see sections 4.4 and 5.2 ).

Hepatic insufficiency

No dose adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment, the recommended starting dose of olmesartan is 10 mg once daily and the maximum dosage is 20 mg once daily. Close monitoring of blood pressure and renal function is recommended in patients with hepatic impairment treated with diuretics and / or other antihypertensives. There is no experience of using olmesartan in patients with severe hepatic impairment, so the use of olmesartan is not recommended in this population (see sections 4.4 Special warnings and precautions for use of olmesartan in patients with severe hepatic impairment ). use and pharmacokinetic properties ). Olmesartan should not be used in patients with biliary obstruction (see section 4.3 ).

Children and adolescents

The use of ALTEIS is not recommended for children under the age of 18, given the lack of data concerning their safety and effectiveness in this population.

Against indications

Hypersensitivity to the active substance or to any of the excipients of ALTEIS (see section List of excipients );

· 2nd and 3rd trimesters of pregnancy (see sections Special warnings and precautions for use and Pregnancy and lactation );

· Breastfeeding (see section on Pregnancy and lactation )

· Biliary obstruction (see section Pharmacokinetic properties ).

Alteis side effects

The following side effects have been reported during the post-marketing experience. They are classified by organ type and order of frequency: very common (≥1 / 10), frequent (≥1 / 100, <1/10), uncommon (≥1 / 1000, <1/100), rare (≥1 / 10000, <1/1000) and very rare (<1/10000) including isolated cases.

organs

Very rare

Blood and lymphatic system disorders

thrombocytopenia

Metabolism and nutrition disorders

hyperkalemia

Nervous system disorders

Dizziness, headache

Respiratory, thoracic and mediastinal disorders

Cough

Gastrointestinal disorders

Abdominal pain, nausea, vomiting

Skin and subcutaneous disorders

Pruritus, rash, skin rash

Allergic manifestations such as angioneurotic edema, allergic dermatitis, edema of the face and urticaria

Musculoskeletal and Connective Tissue Disorders

Muscle cramps, myalgia

Renal and urinary disorders

Acute renal failure and renal insufficiency (see also Explorations)

General disorders

Asthenic states such as asthenia, fatigue, lethargy, malaise

explorations

Abnormal renal function results such as increased creatinine and uremia

Increased liver enzymes

Isolated cases of rhabdomyolysis have been reported with combinations of angiotensin II receptor antagonists. A causal relationship has not been established.

Clinical studies

Clinical trials in monotherapy, double-blind, versus placebo, showed that the total incidence of adverse events was 42.4% under olmesartan and 40.9% under placebo. In these trials, the only unambiguous adverse event attributable to treatment was dizziness (2.5% olmesartan and 0.9% placebo).

The percentage of treatment discontinuations for adverse events during long-term treatment (2 years) was 3.7% in patients treated with 10 to 20 mg / day of olmesartan taken once.

The following adverse events have been observed in clinical trials with olmesartan versus reference or placebo, regardless of the causality or incidence of these effects compared to placebo. They are listed below, classified by type of organ and in order of frequency, according to the same criteria as before:

Central nervous system disorders

Frequent: dizziness

Uncommon: dizziness

Cardiovascular system disorders

Rare: hypotension

Uncommon: angina pectoris

Respiratory system disorders

Frequent: bronchitis, cough, pharyngitis, rhinitis

Gastrointestinal disorders

Common: abdominal pain, diarrhea, dyspepsia, gastroenteritis, nausea

Skin disorders

Uncommon: rash

Musculoskeletal problems

Frequent: arthritis, back pain, bone pain

Urinary tract disorders

Frequent: hematuria, urinary tract infection

General disorders

Frequent: chest pain, fatigue, flu syndrome, peripheral edema, pain

Biological parameters

In placebo-controlled clinical trials, the incidence of hypertriglyceridemia (2.0% versus 1.1%) and creatine phosphokinase increase (1.3% versus 0.7%) was slightly higher on olmesartan than on placebo.

Undesirable effects on the biological endpoints observed in clinical trials with olmesartan (including trials without placebo), regardless of the causality or incidence of these effects compared to placebo, included:

Metabolic and nutritional disorders

Frequent: elevation of creatine phosphokinase, hypertriglyceridemia, hyperuricemia

Rare: hyperkalemia

Hepatic and biliary disorders

Frequent: elevation of liver enzymes

Other information on particular populations

In the elderly, the frequency of hypotension is slightly increased from "rare" to "infrequent".

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