Diovan or Valsartan is an angiotensin receptor blocker that is indicated for the treatment of the following conditions:

• Heart failure (NYHA Class II to IV).

  • The American College of Cardiology/ AHA recommends the use of ARBs in patients with heart failure with a reduced ejection fraction to reduce mortality who cannot tolerate ACE inhibitors.

• Hypertension: ACE inhibitors and ARBs like Diovan (valsartan) may be preferred for the management of hypertension in patients who have

  • Diabetes,
  • Stable chronic kidney disease,
  • as a combination therapy in stage 2 hypertension or
  • those with ASCVD risk of more than 10%.

• Left ventricular dysfunction or failure after MI:

  • Valsartan is associated with a reduction of cardiovascular mortality in patients impaired left a ventricular function or heart failure after myocardial infarction.

• It is also used (off-label) in patients with acute coronary syndrome for the prevention of  cardiovascular events.

Valsartan (Diovan) Dose in Adults

Diovan (Valsartan) dosage:

• Dose in Hypertension:

  • Oral solution: 40 to 80 mg two times a day to a maximum of 320 mg daily in two divided doses.
  • Tablet: 80 mg or 160 mg once daily to a maximum of 320 mg daily.

• Dose in Heart failure:

  • 20 to 40 mg twice daily.
  • Titrate the dose in increments of 40 mg twice daily to a maximum of 320 mg/day.

• Dose in Left ventricular dysfunction or failure after MI:

  • 20 mg twice daily. Increase the dose at weekly intervals by 20 mg twice daily to a maximum of 160 mg twice daily.

Valsartan (Diovan) Dose in Childrens

Valsartan for Hypertension in children and adolescents:

Initiate therapy with oral solution or tablet of 0.65 mg/kg to 1.3 mg/kg twice daily to a maximum of 1.35 mg/kg to 2.7 mg/kg once daily or 160 mg/day. 

Pregnancy Risk Factor D

• [US Boxed Warning]Diovan, like other drugs that act on the RAAS system, can cause injury or death for the developing fetus. 
• Once pregnancy has been confirmed, it should be stopped immediately.
• Drugs that act in the RAAS system can be associated with oligohydramnios, resulting in fetal lungs hypoplasia or skeletal malformations.
• Hypotension, anuria and skull hypoplasia may occur in infants/neonates. 
• Exchange transfusions may be necessary for infants who are exposed in utero. 
• The second and third trimesters are when most complications occur in neonates.

Diovan (Valsartan) use during breastfeeding

• It is unknown whether Diovan can be excreted into breast milk. The benefits of Valsartan in breast milk should be weighed by the clinician.    

Valsartan (Diovan) dose in Renal disease:

• Patients with a CrCl of 30 mL/minute or more:

  • No dose adjustment is necessary.

• CrCl of 30 mL/minute or less:

  • Use with caution. Monitor for rising creatinine levels. The manufacturer has not recommended any dosage adjustment in severe renal disease.

Diovan dose in liver disease:

• Patients with mild to moderate hepatic impairment:

  • No dose adjustment required.

• In severe hepatic impairment (Child class C):

  • Use with caution. The manufacturer has not recommended any dose adjustment in severe hepatic impairment.

Common side effects of Diovan (valsartan):

• Central nervous system:

  • Dizziness and hypertension

• Renal:

  • Increased BUN

Less common side effects of Valsartan:

• Cardiovascular:

  • Hypotension,
  • orthostatic hypotension, and
  • syncope.

• Central nervous system:

  • Fatigue,
  • orthostatic dizziness,
  • headache, and
  • vertigo

• Endocrine & metabolic:

  • Hyperkalemia

• Gastrointestinal:

  • Diarrhea,
  • abdominal pain, and
  • nausea

• Hematologic & oncologic:

  • Neutropenia

• Infection:

  • Viral infection

• Neuromuscular & skeletal:

  • Arthralgia,
  • back pain

• Ophthalmic:

  • Blurred vision

• Renal:

  • Increased serum creatinine and
  • renal insufficiency

• Respiratory:

  • Dry cough

Contraindications to Diovan (Valsartan) include:

• Severe allergic reactions, whether to valsartan itself or to any component of its formulation
• Concomitant use of direct renin inhibitors - Aliskiren
• Pregnancy
• Breastfeeding

Warnings and Precautions

• Angioedema:
  • Angioedema can occur at any stage of treatment.
  • Patients who have angioedema that is associated with ACE inhibitors, idiopathic or hereditary may be at greater risk.
  • If patients experience swelling in the larynx, glottis or face, it is important to monitor them.
  • The drug should be stopped immediately and not restarted.
• Aggressive management of the airway and Intramuscular epinephrine should be part of the resuscitation.
• Hyperkalemia:
  • Hyperkalemia is a risk for the following:
  • Patients with impaired renal function
  • Diabetes mellitus
  • Use potassium-sparing diuretics in conjunction
  • Patients taking potassium-containing or potassium-supplementing salts.
• Hypotension:
  • Hypotension is a risk factor for patients who are salt- and volume-depleted (e.g. Patients taking high-dose diuretics. 
  • The patient must be well hydrated before initiating treatment.
• Renal function deterioration:
  • Patients suffering from low renal blood flow (e.g. Acute renal impairment may occur in patients with heart disease and renal artery narrowing.
  • If there is a marked decline in renal function, therapy should be stopped.
• Cirrhosis can cause ascites:
  • Patients with cirrhosis should not be given Diovan as they may experience rapid decline in their renal function.
• Pregnancy:[US Boxed Warning]
  • If the drug is administered to pregnant women, it may cause the death of the foetus or severe damage to the foetus. 
  • You should stop using it as soon as you are sure that your pregnancy has been confirmed.
• Patients undergoing surgery:
  • With the induction or maintenance of general anesthesia, intraoperative hypotension can occur.

Valsartan: Drug Interaction

Monitor:

Monitor Blood pressure before and after the start of therapy, electrolytes, and renal functions. The dose should be adjusted to achieve the target blood pressure of:

• Less than 130/80 mmHg in hypertensive patients with known cardiovascular disease or a 10-year ASCVD risk of more than 10%
• Less than 130/80 mmHg may be reasonable in hypertensive patients without markers of ASCVD risk.

Blood Pressure Targets in Diabetes patients (ADA 2018 recommendations):

• Less than 140/90 in patients with co-morbid diabetes and hypertension and age less than 65 years

• Less than 130/80 in patients less than 65 years of age with diabetes and at high risk of cardiovascular disease.

• Less than 140/90 mmHg in patients older than 65 years of age with Diabetes.

• Less than 150/90 mmHg in patients older than 65 years of age with Diabetes and poor health status.

Diovan for heart failure:

• 1 - 2 weeks after the initiation of therapy, check the blood pressure (both lying and standing - postural drop), renal functions, and serum potassium levels.

How to administer:

• Valsartan (Diovan) may be taken with or without food. 

Mechanism of action of Valsartan (Diovan):

  Valsartan (Diovan), is a direct antagonist of the angiotensin-2 receptors. Inhibition of angiotensin II's binding to its receptors can be done by blocking it.

The following mechanisms can be used to lower blood pressure:

• Vasodilation
• Inhibition of aldosterone production
• Catecholamine inhibition
• Blocking the release of arginine vasopressin
• Hypertrophic and water intake can be inhibited.

Diovan blocks angiotensin 2 in a more effective manner than ACE inhibitors.

The onset of action is around 2 hours

Duration of action is 24 hours It is 95%

Protein bound (primarily to albumin)

Bioavailability ranges from 10 to 35%

Half-life elimination is 4 - 5 hours.

Time to peak plasma concentrations is 2 - 4 hours which is reduced by a high-fat and a high-calorie diet.

Excretion is primarily via feces (83%).    

International brands of Valsartan:

• Adwivalsar
• Anginet
• Arbiten
• Arovan
• Balsartec-160
• Balsartec-80
• Bespres
• Cardival
• Cardovaldon
• Diokor
• Diopass
• Dioten
• Diotens
• Diovan
• Diovane
• Diqvan
• Disartan
• Disys
• Dizantin
• Exvan
• Hapresval
• Hiperval
• Hyvalor
• Idisartan
• Kovan
• Maxdio
• Nisis
• Provas
• Rusartin 80
• Starval
• Sui Yue
• Tabuvan
• Tareg
• Torval
• Valazyd
• Valcap
• Valcard
• Valeza
• Valor
• Valosartan
• Valsaone
• Valsar
• Valsarect
• Valt
• Valtan
• Valtensin
• Valvex
• Varcor
• Vasar
• Vasblock
• Vector

Valsartan Brands in Pakistan: