USE IN PREGNANCY
id: 0798a0fc-f6be-8730-0ee8-ce4d1ad6aaff
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, losartan potassium tablets should be discontinued as soon as possible. See
WARNINGS
,
Fetal/Neonatal Morbidity and Mortality
.
DESCRIPTION
id: 6a5283c2-1617-4b00-d972-a302d2701181
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Losartan Potassium Tablets USP is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is:
Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.
Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium stearate, hypromellose 6 cp, hydroxy propyl cellulose, titanium dioxide and carnauba wax.
Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.
CONTRAINDICATIONS
id: bc29ce60-a83f-e62e-3049-ee00858cf5dc
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Losartan Potassium Tablets USP is contraindicated in patients who are hypersensitive to any component of this product.
OVERDOSAGE
id: cada41b6-7e8e-07a1-36fa-4773f9c9e200
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Significant lethality was observed in mice and rats after oral administration of 1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m2 basis.
Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.
Neither losartan nor its active metabolite can be removed by hemodialysis.
HOW SUPPLIED
id: 5b18fdd4-bf59-4536-b751-04d11ac88ab6
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Losartan Potassium Tablets
USP
25 mg
White, round, biconvex film-coated tablets with “APO” debossed on one side and “LS” over “25” on the other side. Supplied in the following presentations
Bottles of 30 (NDC 60505-3160-3)
Bottles of 90 (NDC 60505-3160-9)
Bottles of 1000 (NDC 60505-3160-8)
Unit dose Blisters of 100 (10x10s) (NDC 60505-3160-0)
Losartan Potassium Tablets
USP
50 mg
White to off white, round, biconvex, film-coated, scored tablets debossed “APO” on one side and “LS” bisect “50” on the other side. Supplied in the following presentations
Bottles of 30 (NDC 60505-3161-3)
Bottles of 90 (NDC 60505-3161-9)
Bottles of 1000 (NDC 60505-3161-8)
Unit dose Blisters of 100 (10x10s) (NDC 60505-3161-0)
Losartan Potassium Tablets
USP
100 mg
White, oval, biconvex film-coated tablets with “APO” debossed on one side and “LS100” on the other side. Supplied in the following presentations
Bottles of 30 (NDC 60505-3162-3)
Bottles of 90 (NDC 60505-3162-9)
Bottles of 1000 (NDC 60505-3162-8)
Unit dose Blisters of 100 (10x10s) (NDC 60505-3162-0)
PATIENT INFORMATION
id: 42d9dfcd-e12a-fb83-5c93-38632e6f0cc2
displayName: INFORMATION FOR PATIENTS SECTION
FDA Article Code: 34076-0
Losartan Potassium Tablets
USP
25 mg, 50 mg, 100 mg
Read the Patient Information that comes with Losartan Potassium Tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition and treatment.
