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Exforge 5/80 mg

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3.33 Grams
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Cardiovascular System-Anti-Hypertensives
Cardiovascular System

= Additional active ingredients
Valsartan, amlodipine besylate.
TABS: 28 X 160/5 mg.
TABS: 28 x 80/5 mg.
TABS: 28 x 160/10 mg.

Treatment of essential hypertension, in patients whose blood pressure is not adequately controlled on monotherapy.

Known hypersensitivity to amlodopine, valsartan, to dihydropyridine derivatives, or to any of the excipients. Severe hepatic impairment, biliary chirrhosis or cholestasis. Severe renal impairment (GFR < 30 ml/min/1.73 m2) and patients undergoing dialysis. Pregnancy. Concomitant use of this product with aliskiren containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2).  

Patients with sodium- and/or volume depletion: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Exforge in placebo-controlled studies. In patients with an activated renin-angiotensin system (such as volume- and/or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin receptor blockers, symptomatic hypotension may occur. Correction of this condition prior to administration of Exforge or close medical supervision at the start of treatment is recommended. If hypotension occurs with Exforge, the patient should be placed in the supine position and, if necessary, given an i.v. infusion of normal saline. Treatment can be continued once blood pressure has been stabilized.
Hyperkalaemia: Concomitant use with potassium supplements, potassium sparing diuretics, salt substitutes containing potassium, or other drugs that may increase potassium levels (heparin, etc.) should be used with caution and with frequent monitoring of potassium.
Patients with renal artery stenosis: Should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Patients with renal impairment: No data is available for severe cases (creatinine clearance < 10 mL/min.) and caution is therefore advised. Monitoring of potassium levels and creatinine is advised in moderate renal impairment. No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR> 30 ml/min/1.73 m2). The use of ARBs – including valsartan – or of ACEIs with aliskiren is contraindicated in patients with renal impairment (GFR < 60 mL/min).
Patients with kidney transplantation: To date there is no experience of the safe use of Exforge in patients who have had a recent kidney transplantation.
Patients with hepatic impairment: Valsartan is mostly eliminated unchanged via the bile whereas amlodipine is extensively metabolized by the liver. Particular caution should be exercised when administering Exforge to patients with hepatic impairment or biliary obstructive disorders. In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
Primary hyperaldosteronism: Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
Angioedema: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with valsartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Exforge should be immediately discontinued in patients who develop angioedema, and Exforge should not be re-administered. Patients with heart failure/post myocardial infraction As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe congestive heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death. Evaluation of patients with heart failure or postmyocardial infarction should always include assessment of renal function Similar outcomes have been reported with valsartan. In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic etiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo. In general, calcium channel blockers including amlodipine should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV).
Patients with acute myocardial infarction: Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease. Patients with aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is required when using amlodipine in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. This Drug has not been studied in any patient population other than hypertension.
Dual Blockade of the Renin-Angiotensin System RAS): Hypotension, syncope, stroke, hyperkalaemia, and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system . Dual blockade of the renin-angiotensin aldosterone system by combining valsartan with aliskiren is therefore not recommended. Caution is required while co-administering ARBs, including valsartan, with other agents blocking the RAS such as ACEIs.

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Simvastatin: Co-administration of multiple doses of 10 mg of amlodipine with 80 mg. simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. It is recommended to limit the dose of simvastatin to 20 mg daily in patients on amlodipine.
CYP3A4 inhibitors: Co-administration of a 180 mg daily dose of diltiazem with 5 mg. amlodipine in elderly hypertensive patients resulted in a 1.6 fold increase in amlodipine systemic exposure. However, strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir) may increase the plasma concentrations of amlodipine to a greater extent than diltiazem. Caution should therefore be exercised when co-administering amlodipine with CYP3A4 inhibitors.
Grapefruit Juice: The exposure of amlodipine may be increased when co-administered with grapefruit juice due to CYP3A4 inhibition. However, co-administration of 240 mL of grapefruit juice with a single oral dose of amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of amlodipine.
CYP3A4 inducers: No information is available on the quantitative effects of CYP3A4 inducers on amlodipine. Patients should be monitored for adequate clinical effect when amlodipine is coadministered with CYP3A4 inducer (anticonvulsant agents [e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum). In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, maalox® (Aluminium hydroxide gel, Magnesium hydroxide and Simeticone), cimetidine, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
Valsartan: Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren: Clinical trial data have shown that dual blockade of the RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent. It is recommended to monitor blood pressure, renal function and electrolytes in patients on this drug and other agents that affect the RAAS.
Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors or angiotensin II receptor antagonists. If the combination proves necessary, careful monitoring of serum lithium levels is recommended during concomitant use. If a diuretic is also used, the risk of lithium toxicity may presumably be increased further with this drug.
Potassium: Concomitant use with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (heparin ect.) requires caution and frequent monitoring of potassium levels. If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised. The combination of valsartan with Alsikeran is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m2) and is not recommended in other patients.
Non-steroidal anti-inflammatory Agents (NSAIDs) including Selective Cyclooxygenase-2 Inhibitors (COX-2 inhibitors), acetylsalicylic acid >3 g/day, and non-selective NSAIDs: When angiotensin II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. Furthermore, in patients who are elderly, volume-depleted (including those on duretic therapy), or have compromised renal function, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium. Therefore, monitoring of renal function is recommended when initiation or modifying the treatment in patients on valsartan who are taking NSAIDs concomitantly, as well as adequate hydration of the patient.
Transporters:The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2. Co-administration of inhibitors of the uptake transporter (e.g., rifampin, ciclosporin) or efflux transporter (e.g., ritonavir) may increase the systemic exposure to valsartan. In monotherapy with valsartan, no drug interactions of clinical significance have been found with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide.
Interactions common to the combination: No drug interaction studies were performed with This drug and other medicinal products. To be taken into account with concomitant use.
Other antihypertensive agents: Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers for treatment of benign prostate hyperplasia) may increase the antihypertensive effect of the combination.

General Target Population: A patient whose blood pressure is not adequately controlled on monotherapy may be switched to combination therapy with Exforge. The recommended dose is one tablet per day (the 3 strengths are listed in section 2 Description and composition). Individual dose titration with the components (i.e. amlodipine and valsartan) is recommended before changing to the fixed dose combination. When clinically appropriate direct change from monotherapy to the fixed-dose combination may be considered. For convenience, patients receiving valsartan and amlodipine from separate tablets may be switched to Exforge containing the same component doses. The maximum dose is 10/320 mg. Both amlodipine and valsartan monotherapy can be taken with or without food. It is recommended to take this drug with some water. Must not be used in combination with aliskiren in patients with diabetes mellitus.
Special Population: Geriatric patients (aged 65 years or above) Since both components of the combination are equally well tolerated when used at similar doses in elderly (aged 65 years or above) or younger patients, no dose adjustment of the starting dose is required. In elderly patients, caution is required when increasing the dosage.
Pediatric Patients (below 18 years): Not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Renal Impairment:  No dose adjustment is required for patients with mild to moderate renal impairment. Monitoring of potassium levels and creatinine is advised in moderate renal impairment.
Concomitant use of Exforge with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2).
Hepatic Impairment: Due to amlodipine and valsartan, caution should be exercised when administering this drug to patients with hepatic impairment or biliary obstructive disorders . In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.

There is no experience of overdosage with Exforge yet. The major symptom of overdosage with valsartan is possibly pronounced hypotension with dizziness. Overdosage with amlodipine may result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and potentially 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 potentially 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 extremities 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.
Both valsartan and amlodipine are unlikely to be removed by haemodialysis.

Pregnancy: As for any drug that also acts directly on the RAAS, this drug must not be used during pregnancy. If pregnancy is detected during therapy, this drug must be discontinued as soon as possible. 
Lactation: It is not known whether valsartan and/or amlodipine are excreted in human milk. Valsartan was excreted in the milk of lactating rats. It is therefore not advisable for women who are breastfeeding to use this drug.

Effects on ability to drive and use machines: Patients taking this drug and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur. Amlodipine can have mild or moderate influence on the ability to drive and use machines. If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.

Manufacturer: Novartis Pharma Stein AG Switzerland
License Holder: Novartis Pharma3

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