Excessive production of the hormone aldosterone from the adrenal glands (primary aldosteronism)
The patients who are on treatment with Safetelmi and who have primary aldosteronism are not responsive to treatment with medicinal products which act through blockade of the renin-angiotensin system. The use of Safetelmi in such patients is not recommended.
Reduction in volume of extracellular fluid (intravascular hypovolemia)
The patients after taking the first dose of Safetelmi may experience symptomatic reduced blood pressure who are volume and sodium
depleted by therapy with diuretics
, restriction of salt
, or vomiting. These conditions in such patients should be treated before starting the treatment with Safetelmi. Volume and sodium loss should be corrected before giving Safetelmi.
Patients with kidney failure and kidney transplantation
The use of Safetelmi in patients who have abnormal functioning of kidneys, frequent monitoring of potassium
levels in the blood is recommended. The information about the use of Safetelmi in patients with kidney transplantation is not available.
High blood pressure caused by the kidney response to narrowing of the arteries that supply the kidneys
The patients in whom narrowing of one of the arteries of kidneys (bilateral kidney artery stenosis
or stenosis of the artery to a single functioning of kidneys) are at an increased risk of severe low blood pressure and kidney insufficiency who are being treated with medicines that affect the renin-angiotensin-aldosterone system.
Dual blockade of the renin-angiotensin-aldosterone system
Patients who are undergoing therapy with renin-angiotensin system blockers are at an increased risk to experience changes in the functioning of kidneys including kidney failure. These patients may suffer from dual blockade of the renin-angiotensin-aldosterone system by adding an ACE-inhibitor
to an angiotensin II receptor blocker, and therefore, such patients should be closely monitored of the functioning of kidneys. Patients taking the combination of Safetelmi with ramipril did not obtain any extra advantage as compared to those who received monotherapy but experienced an increased incidence of kidney dysfunctioning compared with groups receiving Safetelmi alone or ramipril alone. Such patients should not use Safetelmi and ramipril in combination.
Patients with kidney dysfunction and heart problems and who are on treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers are at an increased risk when using Safetelmi. The use of angiotensin-converting enzyme (ACE) blockers and angiotensin receptor blockers in such patients have been related to decreased production of urine, abnormally high levels of nitrogen-containing compounds (azotemia), acute kidney failure, and fatalities. Studies with ACE inhibitors in patients suffering from narrowing of one of the arteries of kidneys (unilateral or bilateral kidney artery stenosis
), increases in the level of creatinine
in blood or blood urea nitrogen have been observed. In such patients, as a result of blockade of the renin-angiotensin-aldosterone system, the changes in the functioning of kidneys in susceptible individuals should be predicted.
Patients who have biliary obstructive disorders or liver dysfunctioning are at an increased risk to have reduced clearance because major amounts of Safetelmi are cleared by biliary excretion. In such patients, the therapy with Safetelmi should be started at low doses and the dose should be increased slowly.
High levels of potassium in the blood
Patients who are on treatment with angiotensin receptor blockers, particularly who have kidney dysfunctioning, heart failure, who are on kidney replacement therapy, or potassium
supplements, potassium-containing salt
substitutes, potassium-sparing diuretics
, or other drugs that increase the levels of potassium are at an increased risk when using this medicine. In such patients, consideration of determination of blood levels of electrolytes should be done to detect the possible electrolyte imbalances, particularly in patients who are at risk.
Low blood pressure
Patients who are on treatment with diuretics
with an activated renin-angiotensin system are at an increased risk to experience symptomatic low blood pressure after the therapy with Safetelmi has been started. Such patients should be advised to correct this condition before the beginning of treatment with Safetelmi or start the treatment under closed monitoring with a low dose. If low blood pressure occurs, the patient should be made to lie down and, if necessary, should be given an intravenous infusion with normal saline.
Patients who become pregnant during the second and third trimesters while using this medicine are at an increased risk because the medicines acting on the renin-angiotensin system can result in harmful effects on the fetus as well as can result in the fatality of the unborn baby (fetus). Pregnant women who take Safetelmi may pose a risk of low blood pressure, skull hypoplasia, failure of the kidneys to produce urine (anuria), reversible or irreversible kidney failure, and can even result in fatalities in the fetus or an unborn child. There may also be a risk of deficiency of amniotic fluid (oligohydramnios
) that may result from decreased functioning of kidneys of an unborn child; oligohydramnios has also been related to shortening of muscles of the unborn (fetal limb contractures), deformity in the growth of facial bones (craniofacial deformation), and underdevelopment of lungs. Other conditions reported are prematurity and a condition during which a baby does not grow to a healthy weight (intrauterine growth retardation). Such patients should discontinue the use of Safetelmi as soon as pregnancy
Narrowing of large blood vessel and abnormal thickening of the heart muscles (aortic and mitral valve stenosis and obstructive hypertrophic cardiomyopathy)
Special caution should be used in patients who are suffering from aortic or mitral stenosis
, or obstructive hypertrophic cardiomyopathy
Patients with high blood sugar on treatment with insulin or agents that lower blood sugar level
The patients with high levels of sugar in blood who are on treatment with insulin
or blood sugar lowering agents in combination with Safetelmi are at an increased risk to suffer from low blood sugar. Such patients should undergo regular monitoring of blood sugar levels and adjustment of the dose of insulin or antidiabetic agent may also be required.
Patients with a family history of absorbing fructose (fructose intolerance)
Safetelmi contains sorbitol, therefore patients who have a family history of fructose intolerance should not use Safetelmi.
Angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists such as Safetelmi are less effective in lowering the blood pressure in black people than in non-blacks due to the reason that black people have low-renin states.