صيدلية اونلاين

ENTRESTO 50MG

$412.84 $111.58
1. Name of the medicinal product

Entresto® 24 mg/26 mg film-coated tablets

Entresto® 49 mg/51 mg film-coated tablets

Entresto® 97 mg/103 mg film-coated tablets

2. Qualitative and quantitative composition

Entresto 24 mg/26 mg film-coated tablets

Each film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex).

Entresto 49 mg/51 mg film-coated tablets

Each film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex).

Entresto 97 mg/103 mg film-coated tablets

Each film-coated tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex).

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet (tablet)

Entresto 24 mg/26 mg film-coated tablets

Violet white ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “LZ” on the other side. Approximate tablet dimensions 13.1 mm x 5.2 mm.

Entresto 49 mg/51 mg film-coated tablets

Pale yellow ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L1” on the other side. Approximate tablet dimensions 13.1 mm x 5.2 mm.

Entresto 97 mg/103 mg film-coated tablets

Light pink ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L11” on the other side. Approximate tablet dimensions 15.1 mm x 6.0 mm.

4. Clinical particulars
4.1 Therapeutic indications

Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction .

4.2 Posology and method of administration

Posology

The recommended starting dose of Entresto is one tablet of 49 mg/51 mg twice daily, except in the situations described below. The dose should be doubled at 2-4 weeks to the target dose of one tablet of 97 mg/103 mg twice daily, as tolerated by the patient (see section 5.1).

If patients experience tolerability issues (systolic blood pressure [SBP] ≤95 mmHg, symptomatic hypotension, hyperkalaemia, renal dysfunction), adjustment of concomitant medicinal products, temporary down–titration or discontinuation of Entresto is recommended (see section 4.4).

In PARADIGM-HF study, Entresto was administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin II receptor blocker (ARB) (see section 5.1). There is limited experience in patients not currently taking an ACE inhibitor or an ARB or taking low doses of these medicinal products, therefore a starting dose of 24 mg/26 mg twice daily and slow dose titration (doubling every 3-4 weeks) are recommended in these patients (see “Titration” in section 5.1).

Treatment should not be initiated in patients with serum potassium level >5.4 mmol/l or with SBP <100 mmHg (see section 4.4). A starting dose of 24 mg/26 mg twice daily should be considered for patients with SBP ≥100 to 110 mmHg.

Entresto should not be co-administered with an ACE inhibitor or an ARB. Due to the potential risk of angioedema when used concomitantly with an ACE inhibitor, it must not be started for at least 36 hours after discontinuing ACE inhibitor therapy (see sections 4.3, 4.4 and 4.5).

The valsartan contained within Entresto is more bioavailable than the valsartan in other marketed tablet formulations (see section 5.2).

If a dose is missed, the patient should take the next dose at the scheduled time.

Special populations

Elderly population

The dose should be in line with the renal function of the elderly patient.

Renal impairment

No dose adjustment is required in patients with mild (Estimated Glomerular Filtration Rate [eGFR] 60-90 ml/min/1.73 m2) renal impairment. A starting dose of 24 mg/26 mg twice daily should be considered in patients with moderate renal impairment (eGFR 30-60 ml/min/1.73 m2). As there is very limited clinical experience in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) (see section 5.1) Entresto should be used with caution and a starting dose of 24 mg/26 mg twice daily is recommended. There is no experience in patients with end-stage renal disease and use of Entresto is not recommended.

Hepatic impairment

No dose adjustment is required when administering Entresto to patients with mild hepatic impairment (Child-Pugh A classification). There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh B classification) or with AST/ALT values more than twice the upper limit of the normal range. Entresto should be used with caution in these patients and the recommended starting dose is 24 mg/26 mg twice daily (see sections 4.4 and 5.2). Entresto is contraindicated in patients with severe hepatic impairment, biliary cirrhosis or cholestasis (Child-Pugh C classification) ).

Paediatric population

The safety and efficacy of Entresto in children and adolescents aged below 18 years have not been established. No data are available.

Method of administration

Oral use.

Entresto may be administered with or without food . The tablets must be swallowed with a glass of water.

4.3 Contraindications

• Hypersensitivity to the active substances or to any of the excipients 

• Concomitant use with ACE inhibitors . Entresto must not be administered until 36 hours after discontinuing ACE inhibitor therapy.

• Known history of angioedema related to previous ACE inhibitor or ARB therapy 

• Hereditary or idiopathic angioedema 

• Concomitant use with aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2

• Severe hepatic impairment, biliary cirrhosis and cholestasis \.

• Second and third trimester of pregnancy


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