Duration of its actions is over 24 hours. The medication in particular is prescribed after heart attacks. Dosage and direction Once a day together with food or before a meal.
Maximal daily dose is mg, usual dose is 80 mg daily. Depending on your condition dosage may change. Do not take this medication if it was not administered to you. Follow all directions of your doctor. Precautions FDA pregnancy category D. Valsartan may be harmful to an unborn baby. Continue treatment with this medication even if you feel fine unless your doctor told you different. In rare cases, Valsartan can cause a condition that results in the breakdown of skeletal muscle tissue, which then leads to kidney failure.
In this case such symptoms as fever, nausea, dark colored urine, muscle pain appear and you should inform your doctor immediately about it to avoid further complications.
Contraindications Hypersensitivity, pregnancy, breastfeeding. The medication should be administered cautiously in patients with a biliary cirrhosis, bile duct obstruction, kidney failure, stenosis of kidney artery. In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed. A total of 33, hypertensive patients aged 55 or older were randomised and followed for a mean of 4.
The patients had at least one additional coronary heart disease risk factor, including: The primary endpoint was a composite of fatal coronary heart disease or non-fatal myocardial infarction. There was no significant difference in the primary endpoint between amlodipine-based therapy and chlorthalidone-based therapy: Among secondary endpoints, the incidence of heart failure component of a composite combined cardiovascular endpoint was significantly higher in the amlodipine group as compared to the chlorthalidone group However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidone-based therapy RR 0.
Valsartan Valsartan is an orally active, potent and specific angiotensin II receptor antagonist. It acts selectively on the receptor subtype AT1, which is responsible for the known actions of angiotensin II. The increased plasma levels of angiotensin II following AT1 receptor blockade with valsartan may stimulate the unblocked receptor subtype AT2, which appears to counterbalance the effect of the AT1 receptor. Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much about 20,fold greater affinity for the AT1 receptor than for the AT2 receptor.
Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing. In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate.
In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs within 2 hours, and the peak drop in blood pressure is achieved within 4—6 hours. The antihypertensive effect persists over 24 hours after administration. During repeated administration, the maximum reduction in blood pressure with any dose is generally attained within 2—4 weeks and is sustained during long-term therapy. Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events.
ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. ACE inhibitors and ARBs should therefore not be used concomitantly in patients with diabetic nephropathy see section 4.
The study was terminated early because of an increased risk of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest hyperkalaemia, hypotension and renal dysfunction were more frequently reported in the aliskiren group than in the placebo group. The rate and extent of absorption of Exforge are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
After oral administration of therapeutic doses of amlodipine alone, peak plasma concentrations of amlodipine are reached in 6—12 hours. Amlodipine bioavailability is unaffected by food ingestion. In vitro studies with amlodipine have shown that approximately Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours.
Steady-state plasma levels are reached after continuous administration for 7—8 days. Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2—4 hours. This reduction in AUC is not, however, accompanied by a clinically significant reduction in the therapeutic effect, and valsartan can therefore be given either with or without food.
The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively. This metabolite is pharmacologically inactive. The half-life of valsartan is 6 hours.
Special populations Paediatric population age below 18 years No pharmacokinetic data are available in the paediatric population. Elderly age 65 years or over Time to peak plasma amlodipine concentrations is similar in young and elderly patients. In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve AUC and elimination half-life.
Renal impairment The pharmacokinetics of amlodipine are not significantly influenced by renal impairment. Hepatic impairment Very limited clinical data are available regarding amlodipine administration in patients with hepatic impairment.
On average, in patients with mild to moderate chronic liver disease exposure measured by AUC values to valsartan is twice that found in healthy volunteers matched by age, sex and weight. Caution should be exercised in patients with liver disease see section 4.
Histopathological signs of inflammation of the glandular stomach was seen in male rats at an exposure of about 1. At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males. Similar changes were also seen in the valsartan alone group exposure 8. Similar changes were found in the valsartan alone group exposure 8. In an embryo-foetal development study in the rat, increased incidences of dilated ureters, malformed sternebrae, and unossified forepaw phalanges were noticed at exposures of about 12 valsartan and 10 amlodipine times the clinical doses of mg valsartan and 10 mg amlodipine.
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