Exforge HCT

Exforge HCT Dosage/Direction for Use

Manufacturer:

Novartis

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
The recommended dose of Exforge HCT is one tablet per day, to be taken preferably in the morning.
Before switching to Exforge HCT patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Exforge HCT should be based on the doses of the individual components of the combination at the time of switching.
The maximum recommended dose of Exforge HCT is 10 mg/320 mg/25 mg.
Special populations: Renal impairment: No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions). Due to the hydrochlorothiazide component, Exforge HCT is contraindicated for use in patients with anuria (see Contraindications) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2) (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
The concomitant use of Exforge HCT with aliskiren is contraindicated in patients with renal impairment (GFR <60 ml/min/1.73 m2) (see Contraindications).
Diabetes mellitus: The concomitant use of Exforge HCT with aliskiren is contraindicated in patients with diabetes mellitus (see Contraindications).
Hepatic impairment: Due to the valsartan component, Exforge HCT is contraindicated in patients with severe hepatic impairment (see Contraindications). In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan and therefore Exforge HCT is not suitable in this group of patients (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions). Amlodipine dosage recommendations have not been established in patients with mild to moderate hepatic impairment. When switching eligible hypertensive patients (see Indications) with hepatic impairment to Exforge HCT, the lowest available dose of the amlodipine component should be used.
Heart failure and coronary artery disease: There is limited experience with the use of Exforge HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease. Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Exforge HCT, 10 mg/320 mg/25 mg.
Elderly (age 65 years or over): Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Exforge HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited. When switching eligible elderly hypertensive patients (see Indications) to Exforge HCT, the lowest available dose of the amlodipine component should be used.
Paediatric population: There is no relevant use of Exforge HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.
Method of administration: Exforge HCT can be taken with or without food. The tablets should be swallowed whole with some water, at the same time of the day and preferably in the morning.
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