ARBLI (losartan potassium)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Pregnancy

There are 7 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Child-pugh class B hepatic impairment
Disease of liver
Hyperkalemia
Hyponatremia
Hypotension
Hypovolemia
Renal artery stenosis

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Kidney disease with reduction in glomerular filtration rate (GFr)

There are 12 severe adverse reactions.

More Frequent	Less Frequent
None.	Chest pain

Rare/Very Rare
Abnormal hepatic function tests Anaphylaxis Angioedema Hepatitis Hyperkalemia Hyponatremia IgA vasculitis Interstitial nephritis Rhabdomyolysis Thrombocytopenic disorder Vasculitis

There are 27 less severe adverse reactions.

More Frequent	Less Frequent
Back pain Dizziness Headache disorder Muscle weakness Nasal congestion Upper respiratory infection	Anorexia Diarrhea Dyspepsia Edema Fatigue Hypoglycemic disorder Hypotension Nausea Orthostatic hypotension Pharyngitis Urinary tract infection

Rare/Very Rare
Acute abdominal pain Cough Cramps Dysgeusia Erythema Insomnia Malaise Myalgia Sialoadenitis Sinusitis

Losartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the RAS during the second or third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Oligohydramnios in pregnant women who use drugs affecting the RAS in the second or third trimester of pregnancy can result in reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations (including skull hypoplasia), hypotension, and death.

Discontinue losartan immediately when pregnancy is detected. In the rare case that there is no appropriate alternative therapy, apprise the mother of the potential risk to the fetus. If losartan is taken during pregnancy, 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.

Oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe neonates who have been exposed to losartan in utero for signs of hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required.

Losartan is distributed into milk in rats; it is not known whether the drug is distributed into human breast milk. A decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the potential risk in breastfeeding infants and the importance of the drug to the mother.

In controlled clinical trials evaluating losartan for hypertension, 19% of patients were >=65 years of age and 2% were >=75 years of age. In controlled clinical trials evaluating losartan for renal protection in type 2 diabetes, 33% of patients were >=65 years of age. In controlled clinical trials evaluating losartan for the reduction of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy, 62% of patients were >=65 years of age and 18% were >=75 years of age. No overall differences in pharmacokinetics, safety, or efficacy of losartan have been observed between geriatric patients and younger adults, but increased sensitivity in some older individuals cannot be ruled out.