RiteMED Losartan potassium + Amlodipine besilate Special Precautions

Losartan potassium: Hypotension and Electrolyte/Fluid Imbalance: Symptomatic hypotension may be observed in patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics). These conditions should be corrected before starting losartan therapy, or a lower starting dose should be used.
Monitor serum potassium levels in type 2 diabetic patients with nephropathy treated with an angiotensin II antagonist. Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed.
The concomitant use of potassium-sparing diuretics, potassium supplements and potassium-containing salt substitutes with losartan is not recommended.
Primary Hyperaldosteronism: Patients with primary hyperaldosteronism will not generally respond to antihypertensive drugs acting through inhibition of the renin-angiotensin-aldosterone system. Therefore, the use of losartan is not recommended.
Coronary Heart Disease and Cerebrovascular Disease: As with any antihypertensive agent, excessive hypotension in patients with ischemic cardiovascular and cerebrovascular disease could result in a myocardial infarction or stroke.
Heart Failure: There is a risk of severe arterial hypotension and (often acute) renal impairment in patients with heart failure with or without renal impairment.
Aortic and Mitral Valve Stenosis, Obstructive Hypertrophic Cardiomyopathy: Special caution is indicated in patients with aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Hypersensitivity: Angioedema. Patients with a history of angioedema (swelling of the face, lips, throat, and/or tongue) should be closely monitored.
Renal Impairment: Due to inhibition of the renin-angiotensin-aldosterone system, changes in renal function including renal failure have been seen in susceptible patients (e.g., patients whose renal function is dependent on the renin-angiotensin-aldosterone system such as those with severe cardiac insufficiency or pre-existing renal dysfunction) treated with losartan; these changes in renal function may be reversible upon discontinuation of therapy in some patients.
Treatment with ACE inhibitors has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death in patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure). Similar outcomes have been observed with losartan.
In studies, ACE inhibitors may increase blood urea nitrogen (BUN) and serum creatinine in patients with unilateral or bilateral renal artery stenosis. Similar effects have been observed with losartan; these effects may be reversible upon discontinuation of therapy in some patients.
The concomitant use of losartan and ACE inhibitors has shown to impair renal function. Therefore, concomitant use is not recommended.
There is no experience with losartan in patients with recent kidney transplantation.
Hepatic Impairment: In patients with a history of hepatic impairment, a lower dose of losartan should be given since significantly increased plasma concentrations of the drug in cirrhotic patients has been observed in pharmacokinetic studies. There is no therapeutic experience with losartan in patients with severe hepatic impairment; thus, losartan should not be administered in patients with severe hepatic impairment.
Amlodipine besilate: Increased Angina or Myocardial Infarction: After initiating or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease, worsening angina and acute myocardial infarction may develop.
Hypotension: Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely because of the gradual onset of action of amlodipine.
Heart Failure: In general, calcium channel blockers should be used with caution in patients with heart failure. In a controlled trial on amlodipine in patients with severe heart failure (NYHA III and IV), amlodipine was associated with increased reports of pulmonary edema.
Hepatic Impairment: Amlodipine should be used with caution and in reduced dosage in patients with hepatic impairment. Titrate slowly in patients with severe hepatic impairment.
Effects on ability to drive and use machine: No studies on the effects on the ability to drive and use machines have been performed. However, when driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, in particular during initiation of treatment or when the dose is increased.
Amlodipine may have minor or moderate influence on the ability to drive and use machines. If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea, the ability to react may be impaired. Caution is recommended.
Use in Pregnancy & Lactation: Fetal Toxicity: See Use in Pregnancy & Lactation for further information.
Use in Children: The safety and efficacy of losartan + amlodipine FDC in pediatric patients have not been established.
Use in the Elderly: There were no age-related differences in efficacy or safety profile of losartan. Observe caution in amlodipine dose selection for an elderly. Elderly patients are more likely to experience delayed clearance of amlodipine and can be at greater risk for toxicity.