Label Changes for:
Hyzaar (losartan/hydrochlorothiazide) Tablets
November 2011
Changes have been made to the PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2011
PRECAUTIONS
- Dual blockade of the renin-angiotensin-aldosterone system: Dual blockade of the renin-angiotensin-aldosterone system is associated with increased risk of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure). Closely monitor blood pressure, renal function and electrolytes in patients.
PATIENT PACKAGE INSERT
What should I tell my doctor before taking?
Especially tell your doctor if you are taking:
- other medicines to reduce blood pressure
August 2011
WARNINGS
Acute Myopia and Secondary Angle-Closure Glaucoma
- Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Patient Package Insert
What are the possible side effects of Hyzaar?
- Eye problems. One of the medicines in HYZAAR can cause eye problems that, if left untreated, may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting HYZAAR. Tell your doctor right away if you have:
- decrease in vision
PRECAUTIONS
- or glycyrrhizin (found in liquorice) – intensified electrolyte depletion, particularly hypokalemia.
