Cozaar/Cozaar XQ

Cozaar/Cozaar XQ Special Precautions

losartan

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
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.)
Liver function impairment: 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).
Cozaar XQ: Because amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine to patients with severe hepatic impairment.
Renal Function Impairment: 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.
Cozaar: No initial dosage adjustment is necessary in patients with mild renal impairment (i.e. creatinine clearance 20-50 mL/min). For patients with moderate to severe renal impairment (i.e. creatinine clearance <20 ml/min) or patients on dialysis, a lower starting dose of 25 mg once daily is recommended.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see INTERACTIONS).
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Use in Children: Safety and effectiveness in children have not been established (Cozaar); in children ≤ 18 years of age has not been established, administration of COZAAR XQ is not recommended (Cozaar XQ).
Neonates with a history of in utero exposure to COZAAR/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.
Cozaar: Presently there is limited clinical experience in patients above 75 years of age; a lower starting dose of 25 mg once daily is recommended.
Cozaar XQ: 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.
Cozaar: Hypotension and Electrolyte/Fluid Imbalance: In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. These conditions should be corrected prior to administration of COZAAR, or a lower starting dose should be used (see DOSAGE & ADMINISTRATION).
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 COZAAR 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).
Race: Based on the LIFE (Losartan Intervention For Endpoint reduction in hypertension) study, the benefits of COZAAR on cardiovascular morbidity and mortality compared to atenolol do not apply to Black patients with hypertension and left ventricular hypertrophy although both treatment regimens effectively lowered blood pressure in Black patients. In the overall LIFE study population (n=9193), treatment with COZAAR resulted in a 13.0% risk reduction (p=0.021) as compared to atenolol for patients reaching the primary composite endpoint of the combined incidence of cardiovascular death, stroke, and myocardial infarction. In this study, COZAAR decreased the risk of cardiovascular morbidity and mortality compared to atenolol in non-Black, hypertensive patients with left ventricular hypertrophy (n=8660) as measured by the primary endpoint of the combined incidence of cardiovascular death, stroke, and myocardial infarction (p=0.003). In this study, however, Black patients treated with atenolol were at lower risk of experiencing the primary composite endpoint compared with Black patients treated with COZAAR (p=0.03). In the subgroup of Black patients (n=533; 6% of the LIFE study patients), there were 29 primary endpoints among 263 patients on atenolol (11%, 25.9 per 1000 patient-years) and 46 primary endpoints among 270 patients (17%, 41.8 per 1000 patient-years) on COZAAR.
Cozaar XQ: Volume-depleted patients (e.g., those treated with diuretics).
Patients having strictly limited salt diet.
Patients with moderate to severe renal impairment (i.e. creatinine clearance <20 mL/min) or patients on dialysis.
Patients with hyperkalaemia.
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.
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.
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