VALSARTAN — valsartan solution
ANI Pharmaceuticals, Inc.
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue Valsartan Oral Solution as soon as possible. (5.1)
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
Valsartan is indicated for the treatment of hypertension in adults and children six years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Valsartan may be used alone or in combination with other antihypertensive agents.
Valsartan Oral Solution is indicated for the treatment of heart failure (NYHA class II-IV) to reduce the risk of hospitalization for heart failure in patients who are unable to swallow valsartan tablets. There is no evidence that valsartan provides added benefits when it is used with an adequate dose of an ACE inhibitor [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3) and Clinical Studies (14.2) ].
Valsartan Oral Solution is indicated to reduce the risk of cardiovascular death in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction who are unable to swallow valsartan tablets [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3) and Clinical Studies (14.3) ].
Valsartan Oral Solution is not therapeutically equivalent to the tablet formulation of Diovan. The peak concentration of valsartan with Valsartan Oral Solution is higher than with Diovan [see Warnings and Precautions (5.2) , Clinical Pharmacology (12.3) ]. Follow dosing instructions given here.
The recommended starting dose of Valsartan Oral Solution is 40 mg or 80 mg twice daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions in blood pressure may be started at 80 mg administered twice a day. Valsartan Oral Solution may be used over a total daily dose range of 80 mg to 320 mg.
The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the total daily dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.
No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Monitor closely patients with severe hepatic or renal impairment.
Valsartan Oral Solution may be administered with other antihypertensive agents.
The recommended starting dose is 0.65 mg/kg twice daily (up to 40 mg total daily dose). The dosage should be adjusted according to blood pressure response. Doses higher than 1.35 mg/kg twice daily (or >160 mg total daily dose) have not been studied in pediatric patients 6 to 16 years old.
No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73 m2 [see Use in Specific Populations (8.4) ].
Valsartan Oral Solution is not recommended for patients under 6 years of age [see Adverse Reactions (6.1) , Use in Specific Populations (8.4) , Clinical Studies (14.1) ].
The recommended starting dose of Valsartan Oral Solution is 40 mg twice daily. Titrate to 80 mg and 160 mg twice daily, as tolerated by the patient. Consider reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Valsartan Oral Solution may be initiated as early as 12 hours after a myocardial infarction. The recommended starting dose of Valsartan Oral Solution is 20 mg twice daily. Patients may be up titrated within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consider dosage reduction. Valsartan Oral Solution may be given with other standard post-myocardial infarction treatment, including thrombolytics, aspirin, beta-blockers, and statins.
4 mg/mL aqueous solution
Do not use in patients with known hypersensitivity to any component.
Do not coadminister aliskiren with Valsartan Oral Solution in patients with diabetes [see Drug Interactions (7)].
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 can be 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 Oral Solution as soon as possible [see Use in Specific Populations (8.1)].
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.
Peak plasma concentrations of valsartan are higher following administration of Valsartan Oral Solution and may result in increased risk of hypotension as compared to administration of valsartan tablets [see Clinical Pharmacology (12.3)]. Patients with heart failure or post-myocardial infarction patients given valsartan tablets in clinical trials commonly had some reduction in blood pressure. Only use Valsartan Oral Solution in heart failure or post-myocardial infarction patients who are unable to swallow valsartan tablets. In clinical trials of valsartan tablets, discontinuation of therapy because of continuing symptomatic hypotension usually was not necessary. In 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 the Valsartan in Acute Myocardial Infarction Trial (VALIANT), 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 symptomatic hypotension occurs, place the patient in the supine position and, if necessary, give 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.
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