Medicinal Products

ALTEISDUO 20 mg / 25 mg

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

Coated tablet
Box of 90
All forms

Indication

Treatment of essential hypertension.

ALTEISDUO is a fixed combination indicated in adult patients whose blood pressure is not sufficiently controlled by olmesartan medoxomil alone.

Dosage ALTEISDUO 20 mg / 25 mg Film-coated tablet Box of 90

adults

ALTEISDUO should not be used as first-line therapy but should be used in patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil alone. ALTEISDUO will be given once daily, during or after meals.

Switching from 20 mg olmesartan medoxomil to this fixed combination can be considered depending on the clinical situation, taking into account that the antihypertensive action of olmesartan medoxomil peaks after 8 weeks of treatment. approximately (see section Pharmacodynamic properties ). The gradual adaptation of the doses of each individual component is recommended:

ALTEISDUO 20 mg / 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by olmesartan medoxomil monotherapy at the optimal dose of 20 mg.

ALTEISDUO 20 mg / 25 mg may be administered in patients whose blood pressure is not adequately controlled by olmesartan medoxomil 20 mg / hydrochlorothiazide 12.5 mg.

Elderly (65 years old and over)

No dosage adjustment is necessary in the elderly.

Renal failure

In patients with mild to moderate renal impairment (creatinine clearance between 30 and 60 ml / min) periodic monitoring of renal function is recommended (see Warnings and Precautions ). ALTEISDUO is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml / min) (see section 4.3 ).

Hepatic insufficiency

In patients with mild to moderate hepatic impairment, ALTEISDUO should be used with caution (see Warnings and Precautions and Pharmacokinetic Properties sections). In patients with moderate hepatic impairment, the recommended starting dose of olmesartan medoxomil is 10 mg once daily and the maximum dosage should not exceed 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 antihypertensive agents. There is no experience of using olmesartan medoxomil in patients with severe hepatic impairment.

ALTEISDUO should not be used in patients with severe hepatic impairment (see sections Contraindications and Pharmacokinetic Properties ), cholestasis or biliary obstruction (see section 4.3 ).

Pediatric population

The safety and efficacy of ALTEISDUO in children and adolescents under 18 years of age have not been established. No data available.

Administration mode

The tablet should be swallowed with a sufficient amount of liquid (eg a glass of water). The tablet should not be chewed and should be taken at the same time each day.

Against indications

· Hypersensitivity to any of the active substances, to any of the excipients (see section Composition ) or to other substances derived from sulfonamides (hydrochlorothiazide being a substance derived from sulphonamides);

· Severe renal insufficiency (creatinine clearance <30 ml / min);

· Refractory hypokalemia, hypercalcemia, hyponatremia and symptomatic hyperuricemia;

· Severe hepatic insufficiency, cholestasis and obstruction of the bile ducts;

· 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

Alteisduo side effects

The most common side effects reported with ALTEISDUO are headache (2.9%), dizziness (1.9%) and fatigue (1.0%).

Hydrochlorothiazide may induce or exacerbate hypovolemia causing electrolyte disturbances (see Warnings and Precautions ).

In clinical trials involving 1155 patients treated with olmesartan medoxomil / hydrochlorothizide at 20 mg / 12.5 mg or 20 mg / 25 mg and 466 placebo-treated patients for up to 21 months, The total frequency of adverse reactions found for this combination was comparable to placebo. Olmesartan medoxomil / hydrochlorothiazide 20 mg / 12.5 mg and 20 mg / 25 mg (2%) treatment discontinuations for adverse reactions were comparable to those treated with placebo (3%). Compared with placebo, the frequency of treatment-related adverse events with age (<65 years vs. ≥ 65 years), sex, or race did not occur, although the frequency of dizziness was somewhat slightly increased in patients aged 75 years or older.

In addition, the safety of ALTEISDUO as a high-dose combination was evaluated in clinical trials in 3709 patients receiving olmesartan medoxomil in combination with hydrochlorothiazide at 40 mg / 12.5 mg and 40 mg / 25 mg.

Adverse effects observed under ALTEISDUO in clinical trials, tolerance studies after marketing authorization and spontaneous reports are summarized in the table below, as well as adverse effects reported with one of the components, olmesartan medoxomil and hydrochlorothiazide, taking into account the known safety profiles of these substances.

The following definitions were used to rank the adverse events in order of frequency: very common (≥ 1/10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1000 to < 1/100), rare (≥1 / 10000 to <1/1000), very rare (<1/10000).

Classes of MedDRA Organ Systems

Side effects

Frequency

Olmesartan Medoxomil / Hydrochlorothiazide Association

Olmesartan medoxomil

hydrochlorothiazide

Infections and infestations

sialadenitis

Rare

Blood and lymphatic system disorders

Aplastic anemia

Rare

Myelosuppression

Rare

Hemolytic anemia

Rare

leukopenia

Rare

Neutropenia / agranulocytosis

Rare

thrombocytopenia

Rare

Rare

Immune system disorder

Anaphylactic reactions

Rare

Rare

Metabolism and nutrition disorders

Anorexia

Rare

glycosuria

Frequent

hypercalcemia

Frequent

hypercholesterolaemia

Rare

Very common

hyperglycemia

Frequent

hyperkalemia

Rare

hypertriglyceridemia

Rare

Frequent

Very common

hyperuricemia

Rare

Frequent

Very common

hypochloraemia

Frequent

Hypochloremic alkalosis

Very rare

hypokalemia

Frequent

hypomagnesemia

Frequent

hyponatremia

Frequent

hyperamylasemia

Frequent

Psychiatric disorders

Apathy

Rare

Depression

Rare

agitation

Rare

Sleeping troubles

Rare

Nervous system disorders

Confusional state

Frequent

convulsions

Rare

Disorders of consciousness (such as loss of consciousness)

Rare

Dizziness / lightheadedness

Frequent

Frequent

Frequent

Headache

Frequent

Frequent

Rare

Loss of appetite

Rare

paresthesia

Rare

Postural dizziness

Rare

Drowsiness

Rare

Syncope

Rare

Eye disorders

Decrease of lacrimal secretions

Rare

Transient impairment of vision

Rare

Aggravation of pre-existing myopia

Rare

xanthopsia

Rare

Affections of the ear and labyrinth

Dizziness

Rare

Rare

Rare

Heart conditions

Angina pectoris

Rare

Heart arrhythmias

Rare

palpitations

Rare

Vascular disorders

embolisms

Rare

hypotension

Rare

Rare

Necrotizing vasculitis (vasculitis, cutaneous vasculitis)

Rare

Orthostatic hypotension

Rare

Rare

Thrombosis

Rare

Respiratory, thoracic and mediastinal disorders

Bronchitis

Frequent

Cough

Rare

Frequent

Dyspnea

Rare

Interstitial pneumonia

Rare

Pharyngitis

Frequent

Pulmonary edema

Rare

Respiratory distress

Rare

rhinitis

Frequent

Gastrointestinal disorders

Abdominal pain

Rare

Frequent

Frequent

Constipation

Frequent

diarrhea

Rare

Frequent

Frequent

Dyspepsia

Rare

Frequent

Gastric irritation

Frequent

Gastroenteritis

Frequent

meteorism

Frequent

nausea

Rare

Frequent

Frequent

pancreatitis

Rare

Paralytic ileus

Very rare

vomiting

Rare

Rare

Frequent

Hepatobiliary disorders

Acute cholecystitis

Rare

Jaundice (intrahepatic cholestatic jaundice)

Rare

Skin and subcutaneous tissue disorders

Allergic dermatitis

Rare

Cutaneous anaphylactic reactions

Rare

Angioneurotic edema

Rare

Rare

Lupus erythematous reactions

Rare

Eczema

Rare

Erythema

Rare

Exanthema

Rare

Photosensitivity reactions

Rare

itching

Rare

Rare

purpura

Rare

rash

Rare

Rare

Rare

Reactivation of cutaneous lupus erythematosus

Rare

Toxic epidermal necrosis

Rare

Urticaria

Rare

Rare

Rare

Musculoskeletal and systemic disorders

arthralgia

Rare

Arthritis

Frequent

Back pain

Rare

Frequent

Muscle spasms

Rare

Rare

Muscular weakness

Rare

myalgia

Rare

Rare

Pain at the extremities

Rare

paresis

Rare

Bone pain

Frequent

Renal and urinary disorders

Acute renal failure

Rare

Rare

hematuria

Rare

Frequent

Interstitial nephritis

Rare

Renal failure

Rare

Abnormalities of renal function

Rare

Urinary tract infection

Frequent

Disorders of reproductive organs and breast

Erectile dysfunction

Rare

Rare

General disorders and administration site conditions

Asthenia

Frequent

Rare

Chest pains

Frequent

Frequent

Edema of the face

Rare

Tired

Frequent

Frequent

Fever

Rare

Flu syndrome

Frequent

Lethargy

Rare

Discomfort

Rare

Rare

pains

Frequent

Peripheral edema

Frequent

Frequent

Weakness

Rare

investigations

Increase in ALT

Rare

Increase in ASAT

Rare

hypercalcemia

Rare

elevated serum creatinine concentrations

Rare

Rare

Frequent

Increased blood creatine phosphokinase

Frequent

hyperglycemia

Rare

Decreased hematocrit

Rare

Decreased hemoglobin level

Rare

hyperlipidemia

Rare

hypokalemia

Rare

hyperkalemia

Rare

Increased blood urea level

Rare

Frequent

Frequent

Increase in blood nitrogen

Rare

Increased blood uric acid level

Rare

Increase in gamma-GT

Rare

Increased liver enzymes

Frequent

Isolated cases of rhabdomyolysis have been reported with combinations of angiotensin II receptor antagonists.

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