Amlife Special Precautions

Losartan potassium: Fetal Toxicity: Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces 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 losartan as soon as possible. These adverse outcomes are usualy associated with the use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, the mother should be informed of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue losartan, unless it is considered life-saving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. However, patients and physicians should be aware that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Infants with history of in utero exposure to losartan should be closely observed for hypotension, oliguria and hyperkalemia. If oliguria or hypotension occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.
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.
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.
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.
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 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.