LOSARTAN POTASSIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)

Available from:

Legacy Pharmaceutical Packaging, LLC

INN (International Name):

LOSARTAN POTASSIUM

Composition:

LOSARTAN POTASSIUM 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Losartan potassium tablets USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. Losartan potassium tablets USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See PRECAUTIONS, Race    and  CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race ). Losartan potassium tablets USP are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets USP reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMAC

Product summary:

Losartan Potassium Tablets USP, 25 mg are white, capsule shaped, biconvex, film-coated tablets, debossed with 'LU' on one side and 'P21' on the other side. They are supplied as follows: NDC 68645-524-70 – Unit of Dose of 30 Losartan Potassium Tablets USP, 50 mg are white, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of breakline on one side and 'P22' on the other side. They are supplied as follows: NDC 68645-525-70 – Unit of Dose of 30 Losartan Potassium Tablets USP, 100 mg are white, capsule shaped, biconvex, film-coated tablets, debossed with 'LU' on one side and 'P23' on the other side. They are supplied as follows: NDC 68645-526-70 – Unit of Dose of 30 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET
LEGACY PHARMACEUTICAL PACKAGING, LLC
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LOSARTAN POTASSIUM TABLETS USP
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE LOSARTAN POTASSIUM TABLETS AS
SOON AS
POS S IBLE
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO
THE DEVELOPING FETUS. SEE WARNINGS, FETAL TOXICITY.
DESCRIPTION
Losartan potassium is an angiotensin II receptor (type AT )
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 C
H ClKN O, and its structural formula is:
Losartan potassium is a white to off-white 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 tablets USP are available as tablets for oral
administration containing either 25 mg,
50 mg or 100 mg of losartan potassium and the following inactive
ingredients: anhydrous lactose,
colloidal silicon dioxide, magnesium stearate, microcrystalline
cellulose, pregelatinized starch and
opadry white. The opadry white contains hydroxypropyl cellulose,
hypromellose and titanium dioxide.
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.
USP dissolution test for losartan potassium tablets USP is pending.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Angiotensin II [formed from angiotensin I in a reaction catalyzed by
angiotensin converting enzyme
(ACE, kininase II)], is a potent vasoconstrictor, the primary
vasoactive hormone of the renin-angiotensin
system and an important component in the pathophysiology of
hypertension. It also stimulates
aldosterone secretio