Extor™

Indications

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

Contraindications

 Hypersensitivity to any component of Extor. Pregnancy.

Recommended dose is one film-coated tablet per day (5mg amlodipine and 80mg valsartan, or 5mg amlodipine and 160mg valsartan, or 10mg amlodipine and 160mg valsartan).

Warning and Precautions

Risk of hypotension in sodium-and/or volume-depleted patients. Beta-blocker withdrawal should be gradual. Severe renal impairment(creatinine cleareance <10mL/min) and dialysis. No data available in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation. Caution in patients with hepatic impairment or biliary obstructive disorders. As with all other vasodilators, special caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Caution when driving or operating machines. Avoid use in women planning to become pregnant and while breast-feeding. Not recommended in patients below 18 years of age. Dosage & Administration

The recommended dosage of Axtend is two capsules at night after meals for at least 8-12 weeks. The dosage and duration of treatment may be adjusted according to the severity of problem.

 
Interactions

Caution and monitoring of serum potassium levels when used concomitantly with potassium supplements, potassium sparing diuretics, salt substitutes containing potassium supplements, potassium sparing diuretics, salt substitutes containing potassium, or other drugs that may increase potassium level. Adverse reactions: The most common adverse reactions are: Nasopharyngitis, influenza, headache, oedema peripheral, oedema, fatigue, flushing, asthenia, vertigo, tachycardia, palpitations, orthostatic hypotension, cough, pharyngolaryngeal pain, diarrhoea, nausea, abdominal pain, constipation, rash, erythema, join swelling, back pain, arthralgia. Rare adverse reactions but potentially serious are:Hypersensitivity. Additional potentially serious adverse experiences reported in clinical trails with amlodipine monotherapy are: Gastritis, gingival hyperplasia, gynaecomastia, leucopenia, myalgia, pancreatitis, thrombocytopenia, vasculitis, In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema compared to lacebo.• Additional potentially serious adverse experiences reported in clinical trails with valsartan monotherapy are: Neutropenia. Heart failure patients: >50% increases in creatinine in 3.9% of valsartan-treated patients compared to 0.9% of placebo-treated patients. > 20% increases in serum potassium in 10% of valsartan-treated patients compared to 5.1% of placebo-treated patients. >50% increases in BUN in 16.6% of valsartan-treated patients compared to 6.3% of placebo-treated patients. Post-myocardial infarction patients: doubling of serum creatinine in 4.2% of valsartan-treated patients and 3.4% of captopril-treated patients.

Note: Before prescribing, please read full prescribing information.

Presentations Available

Extor: Amlodipine and valsartan 5mg/80mg, 5mg/160mg and 10mg/160mg film-coated tablets.

 

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