Reference ID: 4197373

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: 1 9 9 6

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 40 or 80 mg

(2.1)

twice daily

40 -160 mg twice daily

---

Hypertension-- a g e 6 to16 years (2.2)

Heart Failure (2.3)

Post-Myocardial Infarction (2.4)

0.65 mg/kg twice daily (up to 40 mg total)

40 mg twice daily

20 mg twice daily

0.65-1.35 mg/kg twice daily (up to 40 mg-160 mg total)

40 mg-160 mg twice daily

20 mg-160 mg twice daily

---

160 mg twice daily 160 mg twice daily

*as tolerated by patient

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: FETAL TOXICITY

1 INDICATIONS AND USAGE 1.1 Hypertension 1.2 Heart Failure 1.3 Post-Myocardial Infarction

2 DOSAGE AND ADMINISTRATION 2.1 General Considerations 2.2 Adult Hypertension 2.3 Pediatric Hypertension 6 to 16 Years of Age 2.4 Heart Failure 2.5 Post-Myocardial Infarction

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS 5.1 Fetal Toxicity 5.2 Hypotension 5.3 Impaired Renal Function 5.4 Hyperkalemia

6 ADVERSE REACTIONS 6.1 Clinical Studies Experience 6.2 Postmarketing Experience

7 DRUG INTERACTIONS 7.1 Agents Increasing Serum Potassium 7.2 Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) 7.3 Dual Blockade of the Renin-Angiotensin System (RAS) 7.4 Lithium

Reference ID: 4197373

--------------------- DOSAGE FORMS AND STRENGTHS --------------------Oral Solution, 4 mg /mL

------------------------------ 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 potassium in susceptible patients (5.3, 5.4)

------------------------------ ADVERSE REACTIONS -----------------------------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 Carmel Biosciences, Inc. at 1-855-462-3186 or FDA at 1-800-FDA-1088 or medwatch.

------------------------------ DRUGINTERACTIONS------------------------------ 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 ................
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