LOSORTAN POTASSIUM- losartan potassium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Losartan potassium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. Losartan potassium tablets 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 are contraindicated in patients who are hypersensitive to any component of this product.

Product summary:

Losartan Potassium Tablets USP, 50 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z16" on one side and lip type breakline on other side and are supplied as follows: NDC 21695-714-30in bottle of 30 tablets NDC 21695-714-90 in bottle of 90 tablets Losartan Potassium Tablets USP, 100 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z18" on one side and plain on other side and are supplied as follows: NDC 21695-717-90 in bottle of 90 tablets NDC 21695-717-30 in bottle of 30 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Dispense in a tight, light-resistant container. *** Trademark of Paddock Laboratories, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSORTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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LOSARTAN POTASSIUM TABLETS, USP
USE IN PREGNANCY
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
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 molecular formula is C
H ClKN O, and its structural formula is:
Losartan potassium USP, is off-white to creamish-yellow powder with a
molecular weight of 461.01. It
is soluble in water. Oxidation of the 5-hydroxymethyl group on the
imidazole ring results in the active
metabolite of losartan.
Each losartan potassium tablet intended for oral administration
contains 25 mg or 50 mg or 100 mg of
losartan potassium. In addition, each tablet contains the following
inactive ingredients: colloidal silica
anhydrous, hydroxypropyl cellulose (low substituted), hypromellose,
lactose monohydrate, magnesium
stearate, maize starch (corn starch), microcrystalline cellulose,
polyethylene glycol, sodium starch
glycolate, talc 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.
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
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aldosterone secretion by the adrenal cortex. Losart