estinal tract by up to 85% and 43% respectively.
Corticosteroids, ACTH- Intensified electrolyte depletion, particularly hypokalemia.
Pressor Amines (e.g., norepinephrine) - Possible decreased response to pressor amines but not sufficient to preclude their use.
Skeletal Muscle Relaxants, Nondepolarizing (e.g., tubocurarine) - Possible increased responsiveness to the muscle relaxant.
Lithium- Should not generally be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with DiovanHCT.
Nonsteroidal Anti-inflammatory Drugs- In some patients, the administration of a nonsteroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when DiovanHCT and nonsteroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Carbamazepine – May lead to symptomatic hyponatremia.
7.3 Clinical Laboratory Test Findings
In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of DiovanHCT.
Creatinine/Blood Urea Nitrogen (BUN): Minor elevations in creatinine and BUN occurred in 2% and 15% respectively, of patients taking DiovanHCT and 0.4% and 6% respectively, given placebo in controlled clinical trials.
Hemoglobin and Hematocrit: Greater than 20% decreases in hemoglobin and hematocrit were observed in less than 0.1% of DiovanHCT patients, compared with 0.0% in placebo-treated patients.
Liver Function Tests: Occasional elevations (greater than 150%) of liver chemistries occurred in DiovanHCT-treated patients.
Neutropenia: Neutropenia was observed in 0.1% of patients treated with DiovanHCT and 0.4% of patients treated with placebo.
Serum Electrolytes: [see Warnings and Precautions(5.7)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category D[see Warnings and Precautions (5.1)]
DiovanHCT, like other drugs that act on the renin-angiotensin system, can cause fetal and neonatal morbidity and death when used during the second or third trimester of pregnancy. DiovanHCT can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Angiotensin II receptor antagonists, like valsartan, and angiotensin-converting enzyme (ACE) inhibitors exert similar effects on the renin-angiotensin system. In several dozen published cases, ACE inhibitor use during the second and third trimesters of pregnancy was associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios was also reported, presumably from decreased fetal renal function. In this setting, oligohydramnios was associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus were also reported, although it is not clear whether these occurrences were due to exposure to the drug. In a retrospective study, first trimester |
