Valsartan

Valsartan is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks (myocardial infarctions, or MI).

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.

Valsartan is indicated for the treatment of heart failure (NYHA class II-IV).

Valsartan is indicated to reduce cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction.

Valsartan is available under the following different brand names: Diovan.

Adult and Pediatric Dosage Forms and Strengths

Tablet

• 40 mg
• 80 mg
• 160 mg
• 320 mg

Dosage Considerations – Should be Given as Follows:

Hypertension

• Adult: 80-160 mg/day orally
• Adult Maintenance: 80-320 mg/day orally
• Children under 6 years: Safety and efficacy not established
• Children 6 years and older: 1.3 mg/kg/day orally (not to exceed 40 mg/day); maintenance: 1.3-2.7 mg/kg/day orally (not to exceed 160 mg/day)

Congestive Heart Failure

• 40 mg orally every 12 hours
• Maintenance: 40-160 mg orally every 12 hours; not to exceed 320 mg/day

Post-MI Therapy in Left Ventricular Dysfunction

• May be initiated more than 12 hours after myocardial infarction (MI)
• 20 mg orally every 12 hours initially, 12 hours after MI, then increased to 40 mg orally every 12 hours within 7 days
• Maintenance: Titrated to 160 mg orally every 12 hours as tolerated

Administration

• Although food may decrease absorption (by 40%), manufacturer states drug may be administered without regard to meals
• Drug may also be given in combination with hydrochlorothiazide (Diovan HCT) or amlodipine (Exforge)

Dose Modification

Renal Impairment

• CrCl 30 mL/min or greater: No dose adjustment necessary in adults
• CrCl less than 30 mL/min: Use with caution in adults; not studied in children

Hepatic Impairment

• Mild to moderate liver impairment: No adjustment necessary; use with caution in liver disease
• Severe liver impairment: Not studied

Dosing Considerations

• Generally, adjust dosage monthly (maximal reduction of blood pressure attained after 4 weeks); adjust more aggressively in high-risk patients and patients with comorbidities

Adult and Pediatric Dosage Forms and Strengths

Tablet

• 40 mg
• 80 mg
• 160 mg
• 320 mg

Dosage Considerations – Should be Given as Follows:

Hypertension

• Adult: 80-160 mg/day orally
• Adult Maintenance: 80-320 mg/day orally
• Children under 6 years: Safety and efficacy not established
• Children 6 years and older: 1.3 mg/kg/day orally (not to exceed 40 mg/day); maintenance: 1.3-2.7 mg/kg/day orally (not to exceed 160 mg/day)

Congestive Heart Failure

• 40 mg orally every 12 hours
• Maintenance: 40-160 mg orally every 12 hours; not to exceed 320 mg/day

Post-MI Therapy in Left Ventricular Dysfunction

• May be initiated more than 12 hours after myocardial infarction (MI)
• 20 mg orally every 12 hours initially, 12 hours after MI, then increased to 40 mg orally every 12 hours within 7 days
• Maintenance: Titrated to 160 mg orally every 12 hours as tolerated

Administration

• Although food may decrease absorption (by 40%), manufacturer states drug may be administered without regard to meals
• Drug may also be given in combination with hydrochlorothiazide (Diovan HCT) or amlodipine (Exforge)

Dose Modification

Renal Impairment

• CrCl 30 mL/min or greater: No dose adjustment necessary in adults
• CrCl less than 30 mL/min: Use with caution in adults; not studied in children

Hepatic Impairment

• Mild to moderate liver impairment: No adjustment necessary; use with caution in liver disease
• Severe liver impairment: Not studied

Dosing Considerations

• Generally, adjust dosage monthly (maximal reduction of blood pressure attained after 4 weeks); adjust more aggressively in high-risk patients and patients with comorbidities

Side effects associated with use of Valsartan, include the following:

• Dizziness
• Increased blood urea nitrogen (BUN)
• High blood potassium
• Low blood pressure (hypotension)
• Fatigue
• Viral infection
• Low white blood cell count (neutropenia)
• Fainting and lightheadedness
• Upper abdominal pain
• Spinning sensation (vertigo)

Other side effects of valsartan include:

• Headache
• Cough (rare)

Postmarketing side effects of valsartan reported include:

• Hypersensitivity: Skin swelling (rare)
• Digestive: Elevated liver enzymes, hepatitis (rare)
• Renal: Impaired renal function, renal failure
• Clinical laboratory tests: High blood potassium
• Dermatologic: Hair loss, bullous dermatitis
• Blood and lymphatic: Low blood platelet count (thrombocytopenia) (rare)
• Vascular: Vasculitis

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of valsartan include:
  • aliskiren
• Serious interactions of valsartan include:
  • benazepril
  • captopril
  • eluxadoline
  • enalapril
  • fosinopril
  • lisinopril
  • lithium
  • moexipril
  • perindopril
  • potassium phosphates, IV
  • quinapril
  • ramipril
  • trandolapril
• Valsartan has moderate interactions with at least 150 different drugs.
• Mild Interactions of valsartan include:
  • agrimony
  • cornsilk
  • food
  • lofexidine
  • noni juice
  • octacosanol
  • ombitasvir/paritaprevir/ritonavir and dasabuvir
  • reishi
  • Shepherd's purse
  • simvastatin

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

• Discontinue as soon as possible when pregnancy is detected; drug affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury or death
• This medication contains valsartan.
• Do not take Diovan if you are allergic to valsartan or any ingredients contained in this drug
• Keep out of reach of children.
• In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Hypersensitivity
• Do not co-administer with aliskiren in patients with diabetes mellitus

Effects of Drug Abuse

• No information provided

Short-Term Effects

• See "What Are Side Effects Associated with Using Valsartan?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Valsartan:"

Cautions

• Use caution in hereditary angioedema, volume depletion, severe congestive heart failure (CHF), hyperkalemia, hepatic or renal impairment, aortic or mitral valve stenosis, surgery, anesthesia
• Discontinue immediately if patient is pregnant; potential risk of congenital abnormalities
• Concomitant use with angiotensin-converting enzyme (ACE) inhibitor and beta-blockers is not recommended in CHF patients
• Post-heart attack (myocardial infarction, or MI) treatment: Consider dosage reduction if hypotension or renal dysfunction occurs after MI
• Angioedema, hypotension, hyperkalemia, and renal function deterioration may occur; monitor
• Dosage reduction or discontinuance may be required if hyperkalemia or increased serum creatinine occurs
• Use with caution in renal artery stenosis; avoid in bilateral renal artery stenosis
• Dual blockade of the renin-angiotensin system with angiotensin-receptor blockers (ARBs), ACE inhibitors, or aliskiren is associated with increased risk of hypotension, hyperkalemia, and altered renal function (including acute renal failure) in comparison with monotherapy; closely monitor blood pressure
• Avoid co-administration with aliskiren in patients with renal impairment (i.e,., GFR less than 60 mL/min/1.73 m²)

Pregnancy and Lactation

• Use valsartan during pregnancy only in LIFE-THREATENING emergencies when no safer drug is available
• There is positive evidence of human fetal risk
• Discontinue valsartan as soon as pregnancy detected; during the second and third trimesters of pregnancy, resulting oligohydramnios may cause fetal injury (e.g., hypotension, neonatal skull hypoplasia, anuria, reversible and irreversible renal failure) and death
• Neonates with a history of in utero exposure: Direct attention toward support of blood pressure and renal perfusion; exchange transfusions or dialysis may be required
• There is no human data on use of valsartan while lactating; use with caution if breastfeeding