LOSARTAN 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:

Proficient Rx LP

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. They 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 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 PH

Product summary:

Losartan potassium tablets USP are available as follows: 25 mg - light green, oval-shaped, film-coated tablets, debossed with “93” on one side and “7364” on the other side, in bottles of 30, 60 and 90. 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 as defined in the USP, with a child-resistant closure (as required). All trademarks are the property of their respective owners. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. J 10/2014 Repackaged by: PROFICIENT RX LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
PROFICIENT RX LP
----------
LOSARTAN POTASSIUM TABLETS USP
7364
RX ONLY
WARNING: FETAL TOXICITY
•
•
DESCRIPTION
Losartan potassium tablets USP are an angiotensin II receptor (type AT
) antagonist. Losartan potassium,
USP, 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 structural formula is:
C
H ClKN O M.W. 461.01
Losartan potassium, USP is a white to off-white free-flowing
crystalline powder. 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, USP and the following inactive
ingredients: D&C Yellow #10
aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,
pregelatinized starch, talc, and
titanium dioxide. Additionally, 50 mg and 100 mg tablets contain FD&C
Yellow #6/sunset yellow FCF
aluminum lake.
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.
1
22
22
6
Losartan potassium tablets USP, 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.
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 pa