LOSARTAN POTASSIUM- losartan potassium tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

losartan potassium (UNII: 3ST302B24A) (losartan - UNII:JMS50MPO89)

Tersedia dari:

Sandoz Inc.

INN (Nama Internasional):

losartan potassium

Komposisi:

losartan potassium 25 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Losartan potassium tablets are indicated for the treatment of hypertension. They 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 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 or end stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY, Pharmacodynam

Ringkasan produk:

No. 8441 — Losartan Potassium 25 mg Tablets are white, oval, film-coated tablets with code 951 on one side and plain on the other. They are supplied as follows: NDC 0781-5805-92 unit of use bottles of 90 NDC 0781-5805-10 bottles of 1,000. No. 8442 — Losartan Potassium 50 mg Tablets are white, oval, film-coated tablets with code 952 on one side and scored on the other. They are supplied as follows: NDC 0781-5806-31 unit of use bottles of 30 NDC 0781-5806-92 unit of use bottles of 90 NDC 0781-5806-10 bottles of 1,000. No. 3849 — Losartan Potassium 100 mg Tablets are white, teardrop-shaped, film-coated tablets with code 960 on one side and plain on the other. They are supplied as follows: NDC 0781-5807-31 unit of use bottles of 30 NDC 0781-5807-92 unit of use bottles of 90 NDC 0781-5807-10 bottles of 1,000. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Manufactured by MERCK SHARP & DOHME LTD. Cramlington, Northumberland, UK NE23 3JU for Sandoz Inc. Princeton, NJ 08540 Issued June 2010 9937401 NDC 0781-5805-92 Losartan Potassium Tablets 25 mg Rx only 90 Tablets SANDOZ Each tablet contains 25 mg of losartan potassium. Usual Adult Dosage: See accompanying circular. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Manufactured by MERCK SHARP & DOHME LTD. Cramlington, Northumberland, UK NE23 3JU for Sandoz Inc., Princeton, NJ 08540 Losartan Potassium (active ingred.) Made in France. Formulated in UK 12-2009M 9972000 90 | No. 8441

Status otorisasi:

New Drug Application

Karakteristik produk

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
SANDOZ INC.
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SANDOZ
LOSARTAN POTASSIUM TABLETS
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_-1_H_-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 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 tablets are available for oral administration
containing either 25 mg, 50 mg or
100 mg of losartan potassium and the following inactive ingredients:
microcrystalline cellulose, lactose
hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl
cellulose, hypromellose, and
titanium dioxide.
Losartan potassium tablets 25 mg, 50 mg and 100 mg 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. Losartan potassium
tablets 25 mg, losartan potassium tablets 50 mg, and losartan
potassium tablets 100 mg may also contain
carnauba wax.
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
1
22
22
6
system a