HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useDiovanHCTsafely and effectively. See full prescribing information forDiovanHCT.
DiovanHCT (valsartan and hydrochlorothiazide USP) Tablets
Initial U.S. Approval: 1998
WARNING:AVOID USE IN PREGNANCY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue DiovanHCT 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
Warnings and Precautions: Acute Angle-Closure Glaucoma (5.9)2/2011
INDICATIONS AND USAGE
DiovanHCT is the combination tablet of valsartan (Diovan), an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic. DiovanHCT 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)
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 ≤30mL/min)(2.1, 5.8)
DiovanHCT may be administered with or without food.
Hypertension
Add-on therapy OR Initial therapy: Initiate with 160/12.5mg. Titrate upwards as needed to a maximum dose of 320/25mg. One tablet daily (2.2, 2.4)
Replacement therapy: may be substituted for titrated components (2.3)
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 withvolume- 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)
Hydrochlorothiazide has been associated with acute angle-closure glaucoma (5.9)
ADVERSE REACTIONS
The most common reasons for discontinuation of therapy with DiovanHCT were headache and dizziness. The only adverse experience that occurred in ≥2% of patients treated with DiovanHCT and at a higher incidence than placebo was nasopharyngitis (2.4% vs. 1.9%)(6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Hydrochlorothiazide(7):
Alcohol, barbiturates, narcotics: Potentiation of orthostatic hypotension
Antidiabetic drugs: Dosage adjustment of antidiabetic may be required
Cholestyramine and colestipol: Reduced absorption of thiazides
Corticosteroids, Adrenocorticotrophic Hormone (ACTH): Hypokalemia, electrolyte depletion
Lithium: Reduced renal clearance and high risk of lithium toxicity when used with diuretics. Should not be given with diuretics.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Can reduce diuretic, natriuretic and antihypertensive effects o