Product info: Blood Pressure - Diovan
Diovan: Diovan (Valsartan) is used for treating high blood pressure alone or with other medicines. It is also used for treating heart failure in patients who do not tolerate angiotensin-converting enzyme (ACE) inhibitors.
Diovan is an angiotensin II receptor blocker. It works by blocking a hormone that tightens blood vessels. This causes blood vessels to relax (dilate), which lowers blood pressure and decreases the workload on the heart.
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Diovan HCT
Generic Name: valsartan and hydrochlorothiazide
Dosage Form: Combination TabletsHIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DIOVAN HCT safely and effectively. See full prescribing information for DIOVAN HCT.
DIOVAN HCT (valsartan and hydrochlorothiazide) tablet, film coated for oral use
Initial U.S. Approval: 1998
WARNING: AVOID USE IN PREGNANCY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue Diovan HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1) 7/2008
Dosage and Administration, Initial Therapy (2.4) 7/2008
Warnings and Precautions: Avoid Use in Pregnancy 9/2007
Indications and Usage for Diovan HCT
Diovan HCT is the combination tablet of valsartan (Diovan), an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic. Diovan HCT is indicated for the treatment of hypertension:
In patients not adequately controlled with monotherapy (1)
As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1)
Diovan HCT Dosage and Administration
General considerations:
Maximum effects within 2 to 4 weeks after dose change (2.1)
Renal impairment: Not recommended for patients with severe renal impairment (creatinine clearance ?30 mL/min) (2.1, 5.8)
Diovan HCT may be administered with or without food.
Add-on therapy OR Initial therapy: Initiate with 160/12.5 mg. Titrate upwards as needed to a maximum dose of 320/25 mg. One tablet daily (2.2, 2.4)
Replacement therapy: may be substituted for titrated components (2.3)
Hypertension
Dosage Forms and Strengths
Tablets (valsartan/HCTZ mg): 80/12.5, 160/12.5, 160/25, 320/12.5, 320/25
Contraindications
Anuria; Hypersensitivity to any sulfonamide-derived drugs (4)
Warnings and Precautions
Avoid fetal or neonatal exposure (5.1)
Symptomatic hypotension with volume- and/or salt-depletion. Correct volume-depletion prior to administration. Not recommended as initial therapy in volume-depleted patients (2.4, 5.2)
Use with caution in patients with impaired hepatic (5.3) or renal (5.8) function
Observe for signs of fluid or electrolyte imbalance (5.7)
Thiazide diuretics may cause an exacerbation or activation of systemic lupus erythematosus (5.5)
Adverse Reactions
The most common reasons for discontinuation of therapy with Diovan HCT were headache and dizziness. The only adverse experience that occurred in ?2% of patients treated with Diovan HCT and at a higher incidence than placebo was nasopharyngitis (2.4% vs. 1.9%) (6.1)
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