EXFORGE PACKAGE INSERT PDF

  • July 9, 2019

controlled with amlodipine 10 mg or valsartan mg alone or with Exforge 5 mg / mg. Exforge . No drug-drug interaction studies have been performed with Exforge and other medicinal products. Read the package leaflet before use. Exforge 5 mg/ mg: 41 Exforge 10 mg/ mg: 42 SH EXF APL JUN15 CL V8 COR FEB17 CL. PATIENT PACKAGE INSERT. EXFORGE is a high blood pressure medication. Learn more about how to * EXFORGE is a CCB/ARB single-pill combination product. It contains 2 prescription.

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Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events. Amlodipine The amlodipine component of Exforge inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.

EXFORGE &amp EXFORGE HCT

Some of these patients previously experienced angioedema with other medicinal products, including ACE inhibitors.

Following oral administration of Exforge, peak exforye concentrations of valsartan and amlodipine are reached in 3 and 6—8 hours, respectively. Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function.

Co-administration of inhibitors of the uptake transporter rifampicin, ciclosporin or efflux transporter ritonavir may increase the systemic exposure to valsartan. Adverse reactions previously reported with one of the individual components amlodipine or valsartan exfodge be potential adverse reactions with Exforge as well, even if not observed in clinical trials or during the post-marketing period.

Exforge HCT is indicated ONLY as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level.

Each film-coated tablet contains 10 mg of amlodipine as amlodipine besylate and mg of valsartan. To bookmark a medicine you must sign up and log in. The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established.

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C09DB01 Exforge combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: Mutagenicity studies revealed no drug related effects at either the gene or chromosome levels. As with all exrorge vasodilators, special caution is indicated in patients suffering from mitral stenosis or significant aortic stenosis that is not high grade. Images are the copyright of the Pharmacy Guild of Australia.

Not known Toxic Epidermal Necrolysis.

High Blood Pressure Medication | EXFORGE & EXFORGE HCT

Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate.

It is recommended to limit the dose of simvastatin to 20 mg daily in patients on amlodipine. In elderly patients, caution is required when increasing the dosage. Valsartan is mostly eliminated unchanged via the bile. Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2—4 hours. Show table of contents Hide table of contents 1. To email a medicine you must sign up and log in. Exforge has not been studied in any patient population other than hypertension.

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 lnsert group. Histopathological signs of inflammation of the glandular stomach was seen in male rats at an exposure of about 1. They can help you balance the risks and the benefits of this medicine during pregnancy.

Xeforge, sometimes with purpura. The amlodipine component of Exforge inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle. Reproductive system and breast disorders. A total of 33, hypertensive patients aged 55 or older were randomised and followed for a mean of 4. Common Somnolence, dizziness, palpitations, abdominal pain, nausea, ankle swelling.

In monotherapy with valsartan, no exgorge of clinical significance have been found with the following substances: Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures.

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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.

In animal studies, reproductive toxicity was observed at high doses see section 5. Exforge combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient. Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.

Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.

Treatment can be continued once blood pressure has been stabilised. It is Schedule 4: The clinical translation of these pharmacokinetic variations may be more pronounced in the elderly.

Not a valid value. For the full list of excipients, see section 6.

In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve AUC and elimination half-life. 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 aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.

Excessive hypotension was seen in 0. Kidney transplantation To date there is no experience of the safe use of Exforge in patients who have had a recent kidney transplantation. Please ecforge and try again Agree to Terms required. If symptoms persist see your healthcare professional.