EXFORGE 5 MG/160 MG / 12.5 MG14 TAB; valsartan, amlodipine, hydrochlorothiazide, cardiovascular agents .
ACTIVE-INGREDIENT OF EXFORGE 5 MG/160 MG / 12.5 MG14 TAB
5 mg of amlodipine ( as amlodipine besylate ) and 160 mg of valsartan and 12.5 mg hydrochlorothiazide.
INDICATION OF EXFORGE 5 MG/160 MG / 12.5 MG14 TAB
Treatment of essential hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension.
DOSAGE OF EXFORGE 5 MG/160 MG / 12.5 MG14 TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
The recommended dose is one tablet per day. Apatient whose blood pressure is not adequately controlled on dual therapy may be directly switched to combination therapy with Exforge HCT. For convenience, patients receiving valsartan, amlodipine and HCTZ from separate tablets may be switched to Exforge HCT containing the same component doses. A patient who experiences dose limiting adverse reactions on any dual combination of the components of Exforge HCT may be switched to Exforge HCT containing a lower dose of that component to acheive similar blood pressure reductions. Dosage may be increased after two wekks. The maximum antihypertensive effect of Exforge HCT is reached within two weeks after a change in dose. The maximum recommended dose of Exforge HCT is 10/320/25 mg. Special populations: Geriatric patients ( aged 65 years or above): No dose adjustment of the starting dose is required for elderly patients aged 65 years or above. Starting with the lowest ava lable dose of amlodipine should be considered. The lowest strenght of Exforge HCT contains 5 mg of amlodipine. Pediatric patients ( below 18 years): Exforge HCT is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy. Renal impairment: Due to hydrochlorothiazide component, Exforge HCT is contraindicated in patients with anuria and should be used with caution in patients with severe kidney disease ( GFR OVER-DOSAGE OF EXFORGE 5 MG/160 MG / 12.5 MG14 TAB
There is no experience of overdosage with Exforge HCT. The major symptom of overdose with valsartan is possibly pronounced hypotension with dizziness. Overdosage with amlodipine may result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and otentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported. Overdosage with amlodipine may result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and otentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported. Clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extermities and attention to circulating fluid volume and urine output. A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. If the ingestion is recent, induction of vomiting or gastric lavage may be considered. Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade. Both valsartan and amlodipine are unlikely to be removed by haemodialysis whereas clearance of HCTZ will be achieved by dialysis.
CONTRA-INDICATION OF EXFORGE 5 MG/160 MG / 12.5 MG14 TAB
Known hypersensitivity to amlodipine, valsartan, HCTZ, other sulfonamide derived medicinal products or to any of the excipients. Pregnancy. Because of hydrochlorothiazide, Exforge HCT is contraindicated in patients with anuria. Concomitant use of angiotensin receptor antagonists (ARBs) – including valsartan – or of angiotensin – converting enzyme inhibitors (ACEIs) with aliskiren in patients with diabetes or Renal impairment.
STORAGE OF EXFORGE 5 MG/160 MG / 12.5 MG14 TAB
Do not store above 30°C,protect from moisture. Store in the original package. Keep out of the reach and sight of children.
PACK OF EXFORGE 5 MG/160 MG / 12.5 MG14 TAB
14 film-coated tablets.
EXFORGE 5 MG/160 MG / 12.5 MG14 TAB MANUFACTURED BY
Novartis Farmaceutica S.A., Spain for Novartis Pharma AG, Basal, Switzerland.