LOSARTAN POTASSIUM- losartan potassium tablet tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Direct RX

INN (International namn):

LOSARTAN POTASSIUM

Sammansättning:

LOSARTAN POTASSIUM 50 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

- Hypertension Losartan potassium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. Hypertensive Patients with Left Ventricular Hypertrophy 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.) Nephropathy in Type 2 Diabetic Patients Losartan potassium tablets 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 reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine

Produktsammanfattning:

Losartan potassium tablets, USP 25 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "25" on one side and "113" on the other side. Losartan potassium tablets, USP 50 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "114" on one side and breakline on the other side. Losartan potassium tablets, USP 100 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "100" on one side and "115" on the other side. Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA. For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. 8051805                                                                                        Revised October 2014

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET TABLET
DIRECT RX
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LOSARTAN POTASSIUM
BOXED WARNING
DESCRIPTION
Losartan potassium 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, USP 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:
colloidal silicon dioxide,
hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium
stearate, microcrystalline
cellulose, pregelatinized starch, 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 aldosterone secretion by the adrenal cortex. Losartan and
its principal active metabolite
block the vasoconstrictor and aldosterone-secreting effects of
angiotensin II by selectively
blocking the binding of angiotensin II to the AT1 receptor found in
many tissues, (e.g., vascular
smooth muscle, adrenal gland). There is also an AT2 receptor found in
many tissues but it is not
kn