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:

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 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 PHARMACO

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 dose pack of 30 tablets. Unit of Use Bottles of 30:  25mg (NDC 68645-407-54) 50 mg - green, oval-shaped, film-coated tablets. On one side of the tablet debossed with "7365", on the other side of the tablet debossed with "9" on one side of the breakline and "3" on the other side of the breakline, in dose pack of 30 tablets. Unit of Use Bottles of 30:  50mg (NDC 68645-409-54) 100 mg - dark green, oval-shaped, film-coated tablets, debossed with “93” on one side and “7366” on the other side, in dose pack of 30 tablets.  Unit of Use Bottles of 30:  100mg (NDC 68645-411-54) 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). 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 Distributed By Wal-Mart Bentonville, AR 72716 Packaged By Legacy Pharmaceutical Packaging, LLC Earth City, MO 63045

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
LEGACY PHARMACEUTICAL PACKAGING, LLC
----------
LOSARTAN POTASSIUM TABLETS USP
7364
7365
7366
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DIS CONTINUE 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 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.
Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain
potassium in the following amounts:
1
22
22
6
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 impor