Cozaar XQ Special Precautions

COZAAR XQ: Hypotension: In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics) or with severe aortic stenosis, symptomatic hypotension may occur. Intravascular volume depletion should be corrected prior to administration of COZAAR XQ, or a lower starting dose should be used (see DOSAGE & ADMINISTRATION). Because of the gradual onset of action, acute hypotension is unlikely.
Losartan: Fetal Toxicity: 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 XQ as soon as possible. (See PREGNANCY under Use in Pregnancy & Lactation).
Hypersensitivity: Angioedema. (See SIDE EFFECTS.)
Electrolyte/Fluid Imbalance: Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. In a clinical study conducted in type 2 diabetic patients with proteinuria, the incidence of hyperkalemia was higher in the group treated with losartan as compared to the placebo group; however, few patients discontinued therapy due to hyperkalemia (see Laboratory Test Findings under SIDE EFFECTS).
Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia (see INTERACTIONS).
Amlodipine: Increased Angina or Myocardial Infarction: Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
Use in Patients with Heart Failure: In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischaemic etiology, amlodipine was associated with increased reports of pulmonary edema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Effects on Ability to Drive and Use Machines: No studies of the effects of COZAAR XQ on the ability to drive and operate machines have been performed. However, certain side effects that have been reported with COZAAR XQ may affect some patients' ability to drive or operate machinery. Individual responses to COZAAR XQ may vary. (See SIDE EFFECTS.)
Liver function impairment: COZAAR XQ: Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose of losartan should be considered for patients with a history of hepatic impairment (see DOSAGE & ADMINISTRATION and Pharmacology: PHARMACOKINETICS under Actions).
Because amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t_½) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine to patients with severe hepatic impairment.
Renal Function Impairment: Losartan: As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported in susceptible individuals; these changes in renal function may be reversible upon discontinuation of therapy.
Other drugs that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Similar effects have been reported with losartan; these changes in renal function may be reversible upon discontinuation of therapy.
Use in Children: Since safety and efficacy of COZAAR XQ in children ≤18 years of age has not been established, administration of COZAAR XQ is not recommended.
Neonates with a history of in utero exposure to COZAAR XQ: If oliguria or hypotension occur, 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 renal function.
Use in the Elderly: In clinical studies there was no age-related difference in the efficacy or safety profile of losartan. Because of decreased clearance of amlodipine in the elderly, with a resulting increase of AUC of approximately 40-60% amlodipine therapy should usually be initiated at 2.5 mg daily. Since a 2.5 mg dose of amlodipine is not available with COZAAR XQ, this dose should be achieved with amlodipine monotherapy.