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Cozaar

Generic Name: Losartan Potassium
Drug Category: ARB
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 6 years old for a maximum duration of 5 years.

Approved Uses

Indicated for:

Hypertension:

• The treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. COZAAR may be administered with other antihypertensive agents.

Hypertensive Patients with Left Ventricular Hypertrophy:

• To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients.

Nephropathy in Type 2 Diabetic Patients:

• The treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, COZAAR reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation).

COZAAR is not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m2.

Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on COZAAR. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on COZAAR.

COZAAR has not been studied in patients with severe hepatic impairment.

Monitor serum potassium periodically and treat appropriately. Dosage reduction or discontinuation of COZAAR may be required.

Cases of cough, including positive re-challenges, have been reported with the use of losartan in  postmarketing experience.

In patients with an activated renin-angiotensin system, such as volume-or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with COZAAR. Correct volume or salt depletion prior to administration of COZAAR.

Do not co-administer aliskiren with COZAAR in patients with diabetes.

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.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including losartan) may result in deterioration of renal function, including possible acute renal failure.

In most patients no benefit has been associated with using two RAS inhibitors concomitantly. In general, avoid combined use of RAS inhibitors.

The antihypertensive effect of angiotensin II receptor antagonists, including losartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors.

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.

When pregnancy is detected, discontinue COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue COZAAR as soon as possible.

It is not known whether losartan is excreted in human milk, but significant levels of losartan and its active metabolite were shown to be present in rat milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

Off-label Uses

• Use in patients under the age of 6. GoToSource

• Congestive heart failure. GoToSource

• Marfan syndrome. GoToSource

• Gout. GoToSource

• Congenital muscular dystrophy to reduce fibrosis and restore skeletal muscle. GoToSource

• Acute lung injury and acute respiratory distress syndrome. GoToSource

• Mitigate radiation-induced renal injury. GoToSource

• Prevention of neointimal hyperplasia after balloon angioplasty. GoToSource

• Prevention of exercise-induced myocardial ischemia. GoToSource

• Prevention and progression of early diabetic nephropathy. GoToSource

• Diabetic maculopathy in type 2 diabetic patients. GoToSource

• Portal pressure in cirrhosis. GoToSource

• Nonalcoholic steatohepatitis. GoToSource

• Reduce proteinuria and to preserve GFR in children with chronic proteinuric disorders. GoToSource

• Treatment and prevention of chronic allograft nephropathy. GoToSource

Adverse Events

Hepatotoxicity (liver damage). GoToSource

Anaphylaxis (life-threatening allergic reaction) and angioedema (swelling in deep layers of skin). GoToSource

Anuria (failure of kidneys to produce urine) and acute pulmonary edema. GoToSource

Headache and upper respiratory tract infection. GoToSource

Increased mortality in patients with heart failure compared with other ARBs. GoToSource

Increased serum lithium concentrations and lithium toxicity. GoToSource

Fetal toxicity including incomplete ossification of skull bones, transient oliguria and feed intolerance. GoToSource

Use of angiotensin-converting enzyme inhibitors and calcium channel blockers is associated with increased rate of lung cancer. GoToSource

Litigation

Lawsuits filed for birth defects and cancer from NDEA and NDMA contamination.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 28, 2024