Medicinal Products

ATACAND 8 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Candesartan cilexetil
laboratory: Astrazeneca

Tablet breackable
Box of 98
All forms

Indication

ATACAND is indicated in:

· Treatment of essential hypertension in adults.

· The treatment in adults of heart failure with left ventricular systolic dysfunction (left ventricular ejection fraction ≤ 40%) in combination with angiotensin converting enzyme inhibitors (ACE inhibitors) or intolerant to inhibitors of the conversion enzyme (IEC) (see section 5.1 Pharmacodynamic properties ).

Dosage ATACAND 8 mg scored tablet Box of 98

Dosage in high blood pressure

The usual recommended starting and maintenance dose of ATACAND is 8 mg once daily. The antihypertensive effect is largely achieved within 4 weeks. In some patients for whom blood pressure is not properly controlled, the dose may be increased up to 16 mg once daily and up to a maximum of 32 mg once daily. The treatment should be adjusted according to the blood pressure response.

ATACAND may also be used in combination with other antihypertensive medications. The addition of hydrochlorothiazide showed an additive antihypertensive effect with different doses of ATACAND.

Elderly patient

No initial dose adjustment is required in elderly patients.

Patient with intravascular volume depletion

An initial dose of 4 mg may be considered in patients at risk of hypotension, such as patients who may have volume depletion (see Warnings and Precautions section ).

Renal failure patient

The initial dose is 4 mg in patients with renal impairment, including hemodialysis patients. The dose should be adjusted according to the response. Experience is limited in patients with very severe or terminal renal impairment (creatinine clearance <15 ml / min) (see Warnings and Precautions ).

Hepatic insufficiency patient

An initial dose of 4 mg once daily is recommended in patients with mild to moderate hepatic impairment. The dose can be adjusted depending on the response. ATACAND is contraindicated in patients with severe hepatic impairment and / or cholestasis (see sections Contraindications and Pharmacokinetic Properties ).

Black patient

The antihypertensive effect of candesartan is less important in black patients than in other patients. As a result, increased doses of ATACAND and associated therapy may be needed more frequently to control blood pressure in black patients compared to other patients (see section 5.1 ).

Dosage in heart failure

The usual starting dose is 4 mg once daily. The dosage will be increased to the target dose of 32 mg once daily (maximum dosage) or up to the highest tolerated dose by doubling the dose at intervals of at least 2 weeks (see Warnings and Precautions section). of employment ). Assessment of heart failure patients should always include renal function assessments including serum creatinine and potassium monitoring. ATACAND may be used in combination with other heart failure therapies, including ACE inhibitors, beta-blockers, diuretics, digitalis, or a combination of these drugs. The combination of ACE inhibitor, hyperkalaemic diuretic (eg spironolactone) and ATACAND is not recommended and should be considered only after a careful assessment of the potential benefits and risks (see sections Warnings and precautions for use, adverse effects and pharmacodynamic properties ).

Special populations

No adjustment of the initial dose is required for elderly patients or patients with intravascular volume depletion, renal impairment, or mild to moderate hepatic impairment.

Pediatric population

The safety and efficacy of ATACAND in children under 18 years of age have not been evaluated for the treatment of high blood pressure and heart failure. No data available.

Administration mode

Oral administration.

ATACAND should be administered once daily during or after meals.

The bioavailability of candesartan is not affected by diet.

Against indications

Hypersensitivity to candesartan cilexetil or to any of the excipients.

Second and third trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

Severe hepatic insufficiency and / or cholestasis.

Atacand side effects

Treatment of high blood pressure

In controlled clinical trials, adverse events were transient and mild. The overall frequency of adverse events was not correlated with dosage or age. Treatment discontinuations due to adverse events were comparable with candesartan cilexetil (3.1%) or placebo (3.2%)

In a pooled analysis of clinical trial data in hypertensive patients, adverse effects with candesartan cilexetil were defined by an incidence of events at least 1% greater than that observed with placebo. According to this definition, the most commonly reported adverse reactions were dizziness / vertigo, headache and respiratory infections.

The table below presents adverse effects in clinical and post-marketing trials.

The frequencies used in the tables in the Adverse Reactions section are as follows: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100) ), rare (≥ 1/10 000 to <1/1000) and very rare (<1/10 000):

Class of organ system

Frequency

Undesirable effect

Infections and infestations

Frequent

Respiratory infection

Blood and lymphatic system disorders

Very rare

Leukopenia, neutropenia and agranulocytosis

Metabolism and nutrition disorders

Very rare

Hyperkalemia, hyponatremia

Nervous system disorders

Frequent

Dizziness / vertigo, headache

Respiratory, thoracic and mediastinal disorders

Very rare

Cough

Gastrointestinal disorders

Very rare

nausea

Hepatobiliary disorders

Very rare

Elevated liver enzymes, abnormal liver function or hepatitis

Skin and subcutaneous tissue disorders

Very rare

Angioedema, rash, urticaria, pruritus

Musculoskeletal disorders, connective tissues

Very rare

Dorsalgia, arthralgia, myalgia

Renal and urinary disorders

Very rare

Impairment of renal function, including renal failure in at-risk patients
(see section Warnings and precautions for use )

Biology

In general, administration of A tacand did not result in a clinically significant change in the usual biological data. As with other inhibitors of the renin-angiotensin-aldosterone system, slight decreases in hemoglobin have been observed with prolonged use. Regular monitoring of biological parameters is generally not required for patients receiving ATACAND However, in patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended.

Treatment of heart failure

The profile of Atacand adverse events in patients with heart failure was consistent with the pharmacology of the drug and the patients' state of health. In the CHARM clinical program, comparing Atacand at doses up to 32 mg (n = 3, 803) to placebo (n = 3, 796), 21.0% of patients in the candesartan cilexetil group and 16.1% of patients in the placebo group discontinued treatment due to adverse events. The most commonly reported adverse events were hyperkalemia, hypotension and renal failure.

These events are more common in patients over 70 years of age, diabetics, or subjects who have received other treatments that affect the renin-angiotensin-aldosterone system, particularly ACE inhibitors and / or spironolactone.

The table below presents adverse effects in clinical and post-marketing trials.

Class of organ system

Frequency

Undesirable effect

Blood and lymphatic system disorders

Very rare

Leukopenia, neutropenia and agranulocytosis

Metabolism and nutrition disorders

Frequent

hyperkalemia

Very rare

hyponatremia

Nervous system disorders

Very rare

Dizziness, headache

Vascular disorders

Frequent

hypotension

Respiratory, thoracic and mediastinal disorders

Very rare

Cough

Gastrointestinal disorders

Very rare

nausea

Hepatobiliary disorders

Very rare

Elevated liver enzymes, abnormal liver function or hepatitis

Skin and subcutaneous tissue disorders

Very rare

Angioedema, rash, urticaria, pruritus

Musculoskeletal disorders, connective tissues

Very rare

Dorsalgia, arthralgia, myalgia

Renal and urinary disorders

Frequent

Impairment of renal function including renal failure in patients at risk (see Warnings and Precautions section )

Biology

Hyperkalaemia and impaired renal function are common in patients treated with ATACAND for heart failure. Periodic monitoring of serum creatinine and potassium levels is recommended (see Warnings and Precautions section ).

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