RiteMED Valsartan

RiteMED Valsartan Special Precautions

valsartan

Manufacturer:

Sun Pharma Industries

Distributor:

RiteMED
Full Prescribing Info
Special Precautions
Hypotension: Excessive hypotension is rarely reported in patients with uncomplicated hypertension treated with valsartan alone. In patients with an activated renin-angiotensin system, such as volume and/ or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of valsartan, or the treatment should start under close medical supervision.
Caution should be observed when initiating therapy in patients with heart failure or postmyocardial infarction patients. Patients with heart failure or post-myocardial infarction patients given valsartan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed. In reported controlled trials in heart failure patients, the incidence of hypotension in valsartan treated patients was 5.5% compared to 1.8% in placebo-treated patients. In a reported clinical study, hypotension in post-myocardial infarction patients led to permanent discontinuation of therapy in 1.4% of valsartan-treated patients and 0.8% of captopril-treated patients.
If excessive hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
Impaired Hepatic Function: Valsartan is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and cholestasis (see CONTRAINDICATIONS). In patients with mild to moderate hepatic impairment without cholestasis, it should be used with caution and the dose of valsartan should not exceed 80 mg.
Pediatrics with Impaired Hepatic Function:
As in adults, valsartan is contraindicated in pediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see CONTRAINDICATIONS). There is limited clinical experience with valsartan in pediatric patients with mild to moderate hepatic impairment. The dose of valsartan should not exceed 80 mg in these patients.
As in adults, valsartan is contraindicated in pediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see CONTRAINDICATIONS). There is limited clinical data reported with valsartan in pediatric patients with mild to moderate hepatic impairment. The dose of valsartan should not exceed 80 mg in these patients.
Valsartan is not recommended for treatment of children with glomerular filtration rates <30 ml/min/1.73 m2, as no data has been reported.
Impaired Renal Function / Other Conditions with Stimulation of the Renin-Angiotensin System: In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g. patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been reportedly associated with oliguria and/or progressive azotemia and in rare cases with acute renal failure and/or death. As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of valsartan may be associated with impairment of the renal function.
Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g. patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on valsartan. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on valsartan. Safety and effectiveness of valsartan in patients with severe renal impairment (CrCl ≤ 30 ml/min) have not been established.
Pediatrics with Impaired Renal Function: Use in pediatric patients with a creatinine clearance <30 ml/min and pediatric patients undergoing dialysis has not been reported, therefore valsartan is not recommended in these patients. No dose adjustment is required for pediatric patients with a creatinine clearance >30 ml/min. Renal function and serum potassium should be closely monitored This applies particularly when valsartan is given in the presence of other conditions (fever, dehydration) likely to impair renal function. (SPECIAL POPULATIONS under Actions).
Sodium and/or Volume Depleted Patients: In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with valsartan. Sodium and/or volume depletion should be corrected before starting treatment with valsartan, for example by reducing the diuretic dose.
Kidney Transplantation: There is currently no experience reported on the safe use of valsartan in patients who have recently undergone kidney transplantation.
Hyperkalemia: Some patients with heart failure reportedly developed increases in potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of valsartan may be required.
Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended. Monitoring of potassium should be undertaken as appropriate.
Primary Hyperaldosteronism: Patients with primary hyperaldosteronism should not be treated with valsartan as their renin-angiotensin system is not activated.
Aortic and Mitral Valve Stenosis, Obstructive Hypertrophic Cardiomyopathy: As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).
History of 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. Valsartan should be immediately discontinued in patients who develop angioedema, and valsartan should not be re-administered.
Recent Myocardial Infarction: The combination of captopril and valsartan has shown no additional clinical benefit, instead the risk for adverse events increased compared to treatment with the respective therapies. Therefore, the combination of valsartan with an ACE inhibitor is not recommended.
Caution should be observed when initiating therapy in post-myocardial infarction patients. Evaluation of post-myocardial infarction patients should always include assessment of renal function (see DOSAGE & ADMINISTRATION).
Use of valsartan in post-myocardial infarction patients reportedly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed.
Heart Failure: In patients with heart failure, the triple combination of an ACE inhibitor, a beta blocker and valsartan has not been reported to show any clinical benefit. This combination apparently increases the risk for adverse events and is therefore not recommended.
Caution should be observed when initiating therapy in patients with heart failure. Evaluation of patients with heart failure should always include assessment of renal function (see DOSAGE & ADMINISTRATION).
Use of valsartan in patients with heart failure reportedly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed.
In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g. patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotemia and in rare cases with acute renal failure and/or death. As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of valsartan may be associated with impairment of the renal function.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive have been reported. When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur.
Renal Impairment:
Safety and effectiveness of valsartan in patients with severe renal impairment (CrCl ≤ 30 ml/min) have not been established. No dose adjustment is required in patients with mild (CrCl 60 to 90 ml/min) or moderate (CrCl 30 to 60 ml/min) renal impairment.
Hepatic Impairment: Valsartan is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and cholestasis (see CONTRAINDICATIONS). In patients with mild to moderate hepatic impairment without cholestasis, should be used with caution and the dose of valsartan should not exceed 80 mg.
Use in Children:
Valsartan is not recommended for patients <6 years old.
Use in pediatric patients aged 6 to 18 years with renal impairment: (see as follows).
Use in pediatric patients aged 6 to 18 years with hepatic impairment: As in adults, valsartan is contraindicated in pediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see CONTRAINDICATIONS). There is limited clinical data reported with valsartan in pediatric patients with mild to moderate hepatic impairment. The dose of valsartan should not exceed 80 mg in these patients.
Valsartan is not recommended for treatment of children with glomerular filtration rates <30 ml/min/1.73 m2, as no data has been reported.
Pediatric patients with heart failure and recent myocardial infarction: Valsartan is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents below the age of 18 years due to the lack of safety and efficacy data reported.
The antihypertensive effects of valsartan have been reported in two randomized, double-blind clinical studies in pediatric patients from 1 to 5 years and 6 to 16 years of age. The pharmacokinetics of valsartan have been reported in pediatric patients 1 to 16 years of age (see PHARMACOLOGY: PHARMACODYNAMICS and PHARMACOKINETICS under ACTIONS). Valsartan was reported to be well tolerated in children 6 to 16 years and the adverse experience profile was similar to that described for adults.
Neonates with a history of in utero exposure to valsartan: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required for reversing hypotension and/or substituting for disordered renal function.
Use in the Elderly: In the reported controlled clinical trials of valsartan, no overall difference in the efficacy or safety of valsartan was reported in hypertensive patients ≥65 years of age patient population.
In two separate reported randomized studies for patients (65 years of age or older) with heart failure treated with valsartan and valsartan + captopril, no notable difference in efficacy or safety was reported between older and younger patients.
Use in Pregnancy: Fetal Toxicity: (See WARNINGS).
Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use during pregnancy.
US FDA Pregnancy Category D.
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios are reportedly associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue valsartan as soon as possible (see USE IN PREGNANCY & LACTATION).
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