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Uperio

Uperio Dosage/Direction for Use

sacubitril + valsartan

Manufacturer:

Novartis Indonesia
Full Prescribing Info
Dosage/Direction for Use
The target dose of UPERIO is 200 mg twice daily.
The recommended starting dose of UPERIO is 100 mg twice daily. A starting dose of 50 mg twice daily is recommended for patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), and should be considered for patients previously taking low doses of these agents (see Pharmacology: Pharmacodynamics: Clinical studies under Actions).
The dose of UPERIO should be doubled every 2-4 weeks to the target dose of 200 mg twice daily, as tolerated by the patient.
Due to the potential risk of angioedema when used concomitantly with an ACE inhibitor, UPERIO must not be started until 36 hours after discontinuing ACE inhibitor therapy (see Contraindications).
Treatment should not be initiated in patients with serum potassium level >5.4 mmol/l or with SBP <100 mmHg (see Precautions). A starting dose of 50 mg twice daily should be considered for patients with SBP ≥100 to 110 mmHg.
UPERIO should not be co-administered with an ARB due to the angiotensin II receptor blocking activity of UPERIO (see Precautions and Interactions).
If patients experience tolerability issues (symptomatic hypotension, hyperkalemia, renal dysfunction), consideration should be given to adjustment of concomitant medications, or to temporary down-titration of UPERIO.
Special populations: Renal impairment: A starting dose of 50 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 Pharmacology: Pharmacodynamics (PD) under Actions) UPERIO should be used with caution and a starting dose of 50 mg twice daily is recommended. There is no experience in patients with end-stage renal disease and use of UPERIO is not recommended.
No dose adjustment is required in patients with mild (Estimated Glomerular Filtration Rate [eGFR] 60-90 mL/min/1.73 m2) renal impairment.
Hepatic impairment: No dose adjustment is required when administering UPERIO 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. UPERIO should be used with caution in these patients and the recommended starting dose is 50 mg twice daily (see Precautions and Pharmacology: Pharmacokinetics (PK) under Actions). UPERIO is contraindicated in patients with severe hepatic impairment, biliary cirrhosis or cholestasis (Child-Pugh C classification) (see Contraindications).
Pediatric patients: The safety and efficacy of UPERIO in pediatric patients aged below 18 years has not been established.
Geriatric patients (older than 65 years): No dosage adjustment is required in patients over 65 years.
Method of administration: For oral use. UPERIO may be administered with or without food (see Pharmacology under Actions). The tablets must be swallowed with a glass of water.
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