For: Hypertension, Congestive Heart Failure, Left Ventricular Dysfunction
Marketing Status: Discontinued
Prexxartan (valsartan) is an angiotensin II receptor blocker (ARB) oral solution formulation indicated for the treatment of hypertension, heart failure, and left ventricular dysfunction following myocardial infarction. PREXXARTAN (valsartan) Oral Solution contains 4 mg/mL valsartan for oral administration. PREXXARTAN is packaged in bottles containing 473 mL, bottles containing 120 mL and unit dose cups containing 20 mL.
White HDPE bottles of 473 mL: NDC 25208-100-08
White HDPE bottles of 120 mL: NDC 25208-100-07
Unit Dose Cups of 20 mL: NDC 25208-100-06
Store at 20 °C-25 °C (68 °F-77 °F); excursions permitted to 15 °C -30 °C (59 °F -86 °F) [see USP Controlled Room Temperature].
Dispense in tight container (USP). These highlights do not include all the information needed to use PREXXARTANTM safely and effectively. See full prescribing information for PREXXARTANTM.
PREXXARTANTM (valsartan) oral solution
Initial U.S. Approval: 1996
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue PREXXARTAN 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)
INDICATIONS AND USAGE
PREXXARTAN is an angiotensin II receptor blocker (ARB) indicated for:
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 (1.1)
Heart failure (NYHA class II-IV); PREXXARTAN significantly reduces hospitalization for heart failure in patients who are unable to swallow valsartan tablets (1.2)
Stable left ventricular failure or left ventricular dysfunction following myocardial infarction; PREXXARTAN reduces cardiovascular mortality in patients who are unable to swallow valsartan tablets (1.3)
DOSAGE AND ADMINISTRATION
Indication Starting Dose Dose Range Target Maintenance Dose*
Hypertension - adults(2.1) 40 or 80 mg twice daily 40 -160 mg twice daily ---
Hypertension—age 6 to16 years (2.2) 0.65 mg/kg twice daily (up to 40 mg total) 0.65-1.35 mg/kg twice daily (up to 40 mg-160 mg total) ---
Heart Failure (2.3) 40 mg twice daily 40 mg-160 mg twice daily 160 mg twice daily
Post-Myocardial Infarction (2.4) 20 mg twice daily 20 mg to 160 mg twice daily 160 mg twice daily
* as tolerated by patient
DOSAGE FORMS AND STRENGTHS
Oral Solution, 4 mg/mL (3)
Known hypersensitivity (4)
Patients with diabetes on aliskiren (4)
WARNINGS AND PRECAUTIONS
Observe for signs and symptoms of hypotension (5.2)
Monitor renal function and potassium in susceptible patients (5.3, 5.4)
Hypertension: Most common adverse reactions are headache, dizziness, fatigue and abdominal pain (6.1)
Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia (6.1)
Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Medicure at 1-800-509-0544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Potassium-sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, increases in serum creatinine (7)
NSAIDs increase risk of renal impairment and loss of antihypertensive effect (7)
Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia (7)
Lithium: Increases in serum lithium concentrations and lithium toxicity (7)
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding not recommended. (8.2).
Pediatrics: Efficacy and safety data support use in 6-16 year old patients; use is not recommended in patients <6 years old (6.1, 8.4)
See 17 for PATIENT COUNSELING INFORMATION.