Valsartan

Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

If you have diabetes, do not use valsartan together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take valsartan with or without food. Take the medicine at the same time each day.

If a child taking valsartan cannot swallow a capsule whole, your pharmacist can mix the medicine into a liquid. Shake this liquid well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may have very low blood pressure while taking valsartan. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

It may take 2 to 4 weeks of using this medicine before your blood pressure is under control. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Diovan: 40 mg [scored]

Diovan: 80 mg, 160 mg, 320 mg

Generic: 40 mg, 80 mg, 160 mg, 320 mg

• Angiotensin II Receptor Blocker
• Antihypertensive

Heart failure: Treatment of heart failure (NYHA Class II to IV).

Hypertension: Management of hypertension (monotherapy or in combination with other antihypertensives).

Left ventricular dysfunction or failure after MI: Reduction of cardiovascular mortality in patients with left ventricular dysfunction or failure postmyocardial infarction.

Guideline recommendations:

Hypertension: The 2014 guideline for the management of high blood pressure in adults (Eighth Joint National Committee [JNC 8; James 2013]) recommends initiation of pharmacologic treatment to lower blood pressure for the following patients:

• Patients ≥60 years with systolic blood pressure (SBP) ≥150 mm Hg or diastolic blood pressure (DBP) ≥90 mm Hg.

• Patients <60 years with SBP ≥140 mm Hg or DBP ≥90 mm Hg.

• Patients ≥18 years with diabetes and SBP ≥140 mm Hg or DBP ≥90 mm Hg.

• Patients ≥18 years with chronic kidney disease (CKD) and SBP ≥140 mm Hg or DBP ≥90 mm Hg.

Coronary artery disease and hypertension: The American Heart Association, American College of Cardiology and American Society of Hypertension (AHA/ACC/ASH) 2015 scientific statement for the treatment of hypertension in patients with coronary artery disease (CAD) recommends the use of an ARB (or ACE inhibitor) as part of a regimen in patients with hypertension and chronic stable angina if there is prior MI, LV systolic dysfunction, diabetes mellitus, or CKD. A BP target of <140/90 mm Hg is reasonable for the secondary prevention of cardiovascular events. A lower target BP (<130/80 mm Hg) may be appropriate in some individuals with CAD, previous MI, stroke or transient ischemic attack, or CAD risk equivalents (AHA/ACC/ASH [Rosendorff 2015]).

Diabetes and hypertension: The American Diabetes Association (ADA) guidelines recommend an ARB (or an ACE inhibitor) for patients with hypertension and diabetes with albuminuria (urinary albumin-to-creatinine ratio [UACR] ≥30 mg/g). For patients with hypertension and diabetes without albuminuria, any of the 4 classes of blood pressure medications (eg, ACE inhibitors, ARBs, thiazide-like diuretics, dihydropyridine calcium channel blockers) may be used and have shown beneficial cardiovascular outcomes (ADA 2017a).

Heart failure: The ACCF/AHA 2013 heart failure guidelines recommend the use of ARBs (ie, candesartan, losartan, and valsartan) in patients with HF with reduced ejection fraction who cannot tolerate ACE inhibitors (due to cough) to reduce morbidity and mortality. They also suggest that ARBs are reasonable first-line alternatives to ACE inhibitors in patients already maintained on an ARB for other indications (ACCF/AHA [Yancy 2013]).

Children and Adolescents 6 to 16 years of age:

Glomerular filtration rate (GFR) ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.

GFR <30 mL/minute/1.73m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dialysis: Has not been studied.

Adults:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dialysis: Not significantly removed.

Mild-to-moderate impairment: No dosage adjustment necessary; use with caution.

Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Baseline and periodic blood pressure, electrolyte panels, renal function; in HF, serum potassium during dose escalation and periodically thereafter

2013 ACCF/AHA Heart Failure guideline recommendations: Within 1 to 2 weeks after initiation, reassess blood pressure (including postural blood pressure changes), renal function, and serum potassium; follow closely after dose changes. Patients with systolic blood pressure <80 mm Hg, low serum sodium, diabetes mellitus, and impaired renal function should be closely monitored (Yancy 2013)

[US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected. The use of drugs which act on the renin-angiotensin system are associated with oligohydramnios. Oligohydramnios, due to decreased fetal renal function, may lead to fetal lung hypoplasia and skeletal malformations. Use is also associated with anuria, hypotension, renal failure, skull hypoplasia, and death in the fetus/neonate. in The exposed fetus should be monitored for fetal growth, amniotic fluid volume, and organ formation. Infants exposed in utero should be monitored for hyperkalemia, hypotension, and oliguria (exchange transfusions or dialysis may be needed). These adverse events are generally associated with maternal use in the second and third trimesters.

Untreated chronic maternal hypertension is also associated with adverse events in the fetus, infant, and mother. The use of angiotensin II receptor blockers is not recommended to treat chronic uncomplicated hypertension in pregnant women and should generally be avoided in women of reproductive potential (ACOG, 2013).

Commonly reported side effects of valsartan include: dizziness and increased serum potassium. Other side effects include: hypotension. See below for a comprehensive list of adverse effects.

Applies to valsartan: oral capsule, oral tablet

Along with its needed effects, valsartan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking valsartan:

• Bloody urine
• cold sweats
• confusion
• decreased frequency or amount of urine
• difficult breathing
• dizziness, faintness, or lightheadedness when getting up from a lying position
• fainting
• increased thirst
• irregular heartbeat
• loss of appetite
• lower back or side pain
• nausea
• nervousness
• numbness or tingling in the hands, feet, or lips
• swelling of the face, fingers, or lower legs
• unusual tiredness or weakness
• vomiting
• weight gain

• Chills
• fever
• hoarseness
• sore throat
• swelling of the mouth, hands, or feet
• trouble with swallowing or breathing (sudden)

• Dark urine
• general tiredness and weakness
• light-colored stools
• upper right abdominal or stomach pain
• yellow eyes and skin

Some side effects of valsartan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• back pain
• blurred vision
• cold or flu-like symptoms
• coughing
• diarrhea
• difficulty with moving
• headache
• muscle pain or stiffness
• pain, swelling, or redness in the joints

• Hair loss
• thinning of the hair

Initial dose: 40 mg orally twice a day
Maintenance dose: 80 to 160 mg twice a day. The dose should be increased to the highest dose tolerated by the patient.

Initial dose: 20 mg orally twice a day
Maintenance dose: The initial dosage may be titrated upward within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice a day as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction.

Comment: Valsartan may be initiated as early as 12 hours after a myocardial infarction, and may be given with other standard postmyocardial infarction treatment, including thrombolytics, aspirin, beta blockers, and statins.

Valsartan is used for the treatment of heart failure or high blood pressure. The effectiveness of valsartan does not appear to be influenced by race, unlike some other medications used for high blood pressure.