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U.S. Department of Health and Human Services

Safety

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Hyzaar (losartan potassium hydrochlorothiazide) 50-12.5 mg, 100-12.5 mg, and 100-25 mg Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

September 2014

Summary View

WARNINGS

Lithium Toxicity
  • added ..... Monitor serum lithium levels in patients receiving lithium and hydrochlorothiazide (see PRECAUTIONS, Drug Interactions, Hydrochlorothiazide, Lithium)

PRECAUTIONS

Drug Interactions, Losartan Potassium
  • Lithium  ..... Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use.
Dual Blockade of the Renin-Angiotensin System (RAS)
  • ......The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinaryalbumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. Closely monitor blood pressure, renal function and electrolytes in patients on HYZAAR and other agents that affect the RAS.
Drug Interactions, Hydrochlorothiazide
  • Lithium - should not generally be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Monitor serum lithium levels during concomitant use. Refer to the package insert for lithium preparations before use of such preparations with HYZAAR.

 

January 2014

Summary View

BOXED WARNING

Warning: fetal toxicity
  • When pregnancy is detected, discontinue Hyzaar as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity

WARNINGS

Fetal Toxicity

Pregnancy Category D

  • Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy  reduces renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be  associated ..... (section extensively revised - see PI)

PRECAUTIONS

  • Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to Hyzaar during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
  • Neonates with a history of in utero exposure to Hyzaar: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for  disordered  renalfunction.

PPI

What is the most important information I should know about Hyzaar?

  • Hyzaar can cause harm or death to an unborn baby
  • Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
  • If you get pregnant while taking Hyzaar, tell your doctor right away. 

 

June 2009

Summary View

 

ADVERSE REACTIONS

Losartan Potassium
  • General disorders and administration site conditions: Malaise
Hydrochlorothiazide/Post-Marketing Experience
  • Hemic: Thrombocytopenia (reworded)