tablet , yellow , oval oblong
Diovan (valsartan) is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype.
Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water.
Diovan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides (yellow, black and/or red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide.
Diovan? (valsartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Diovan is indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, Diovan significantly reduced hospitalizations for heart failure. There is no evidence that Diovan provides added benefits when it is used with an adequate dose of an ACE inhibitor. [See Clinical Studies]
In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality.
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Diovan (valsartan) has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse reactions with Diovan was similar to placebo.
The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen. Discontinuation of therapy due to side effects was required in 2.3% of valsartan patients and 2.0% of placebo patients. The most common reasons for discontinuation of therapy with Diovan were headache and dizziness.
The adverse reactions that occurred in placebo-controlled clinical trials in at least 1% of patients treated with Diovan and at a higher incidence in valsartan (n=2,316) than placebo (n=888) patients included viral infection (3% vs. 2%), fatigue (2% vs. 1%), and abdominal pain (2% vs. 1%).
Headache, dizziness, upper respiratory infection, cough, diarrhea, rhinitis, sinusitis, nausea, pharyngitis, edema, and arthralgia occurred at a more than 1% rate but at about the same incidence in placebo and valsartan patients.
In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE-inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%). In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p < 0.001).
Dose-related orthostatic effects were seen in less than 1% of patients. An increase in the incidence of dizziness was observed in patients treated with Diovan 320 mg (8%) compared to 10 to 160 mg (2% to 4%).
Diovan has been used concomitantly with hydrochlorothiazide without evidence of clinically important adverse interactions.
Other adverse reactions that occurred in controlled clinical trials of patients treated with Diovan ( > 0.2% of valsartan patients) are listed below. It cannot be determined whether these events were causally related to Diovan.
Body as a Whole: Allergic reaction and asthenia Cardiovascular: Palpitations
Dermatologic: Pruritus and rash
Digestive: Constipation, dry mouth, dyspepsia, and flatulence
Musculoskeletal: Back pain, muscle cramps, and myalgia
Neurologic and Psychiatric: Anxiety, insomnia, paresthesia, and somnolence
Special Senses: Vertigo
Other reported events seen less frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.
No relevant differences were identified between the adverse experience profile for pediatric patients aged 6-16 years and that previously reported for adult patients.