PREXXARTAN solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)

Available from:

Medicure International Inc.

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 4 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PREXXARTAN 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

Product summary:

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).

Authorization status:

New Drug Application

Summary of Product characteristics

PREXXARTAN- PREXXARTAN SOLUTION
MEDICURE INTERNATIONAL INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREXXARTAN SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR PREXXARTAN
.
PREXXARTAN (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
INDIC ATIO N
STARTING DOSE
DOSE RANGE
T ARG E T
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)
CONTRAINDICATIONS
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 potassiu