Use of Tabuvan in Children
Children with an abnormality in the functioning of the kidney/liver, fever
, or dehydration
are at an increased risk when using Tabuvan. Tabuvan should not be used in children with creatinine
clearance less than 30 ml/min, severe abnormal functioning of the liver, and obstruction of bile flow (cholestasis
, and obstructive biliary disorders). Monitoring of the functioning of the kidney and potassium
levels should be considered. Also, patients with abnormal functioning of the kidney should not use angiotensin II receptor blocker or angiotensin converting enzyme inhibitors with aliskiren.
Dual Blockade of the Renin-Angiotensin-Aldosterone System
Patients using angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, ramipril or aliskiren are at an increased risk while using Tabuvan. Such patients are at an increased risk of low blood pressure, increased potassium
level, and decreased functioning of the kidneys. Avoid the combined use of angiotensin II receptor blockers, angiotensin-converting enzyme inhibitors, ramipril or aliskiren. Proper monitoring of the functioning of the kidney, blood pressure, and electrolytes should be considered.
Swelling in the Lower Layer of the Skin
Patients with a history of swelling of the lower layer of skin or taking Tabuvan are at an increased risk when using Tabuvan. These patients may experience swelling of the larynx, lips, face, tongue, pharynx, an opening between the vocal folds (glottis), and airway obstruction. Tabuvan should be discontinued immediately on the occurrence of swelling of the lower layer of the skin and should not be started again.
Abnormality in the Functioning of the Liver
Patients with an abnormality in the functioning of the liver or in the bile flow (cholestasis
) are at increased risk when using Tabuvan. Take necessary precautions in such patients.
Precaution should be taken in patients with obstruction in the blood flow of the heart (aortic and mitral valve stenosis
) and thickening of the heart muscles (Hypertrophic cardiomyopathy
Increased Production of Aldosterone
These patients do not respond to blood pressure lowering drugs. Tabuvan should not be used in patients with increased production of aldosterone (primary hyperaldosteronism
Increased Levels of Potassium
Patients with heart failure or abnormality in the functioning of the kidney taking Tabuvan are at increased risk. These patients may experience increased levels of potassium
in the blood. Discontinuation of Tabuvan or dose reduction should be considered in such patients. Patients should not use Tabuvan with potassium-sparing diuretics
, potassium supplements, agents increasing potassium levels (heparin), and salt
substitutes containing potassium.
Abnormality in the Functioning of the Kidney
Patients with an abnormality in the functioning of the kidney, narrowing of kidney arteries (renal artery stenosis
), heart failure or volume-depleted patients are at increased risk when using Tabuvan. Use of Tabuvan may cause kidney failure in these patients. Precaution along with monitoring should be considered in such patients. Tabuvan should not be used with angiotensin-converting enzyme inhibitors and aliskiren in patients with an abnormality in the functioning of the kidney.
Low Blood Pressure
Patients with high blood pressure, heart diseases, and sodium
or volume-depleted patients taking Tabuvan are at increased risk. Symptomatic low blood pressure, increased level of potassium
and decreased functioning of the kidney, and fatality may occur in these patients when taking Tabuvan alone or in combination with angiotensin-converting enzyme inhibitors. The condition of the patient should be corrected and monitored before starting Tabuvan therapy. Take necessary precautions while starting Tabuvan therapy. On the occurrence of severe low blood pressure, the patient should be placed in the supine position or infusion of normal saline in the veins should be given to the patients.
Increased Mortality in Infants
A fetus is at increased risk when pregnant women use this medicine. The use of Tabuvan during the second and third trimesters of pregnancy
may lead to fetal and neonatal injury, including reduced functioning of the kidney, low blood pressure, deficiency of amniotic fluid, abnormalities of the skull and lung, insufficiency to produce urine, kidney failure, or other fatal conditions. Discontinue the use of Tabuvan immediately after diagnosis of pregnancy.
This medicine should not be used in patients with rare genetic problems of galactose intolerance, the Lapp lactase deficiency or disturbed absorption of glucose-galactose.
Tabuvan should not be used in patients allergic to peanut or soya.