HYZAAR Film-coated tablet Ref.[10571] Active ingredients: Hydrochlorothiazide Losartan

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

HYZAAR 50/12.5 (losartan potassium-hydrochlorothiazide), HYZAAR 100/12.5 (losartan potassium-hydrochlorothiazide) and HYZAAR 100/25 (losartan potassium-hydrochlorothiazide) tablets combine an angiotensin II receptor blocker acting on the AT1 receptor subtype and a diuretic, hydrochlorothiazide.

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 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.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

HYZAAR is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. HYZAAR 50/12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. HYZAAR 100/12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. HYZAAR 100/25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are microcrystalline cellulose, lactose hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. HYZAAR 50/12.5 and HYZAAR 100/25 also contain D&C yellow No. 10 aluminum lake. HYZAAR 50/12.5, HYZAAR 100/12.5, and HYZAAR 100/25 may also contain carnauba wax.

HYZAAR 50/12.5 contains 4.24 mg (0.108 mEq) of potassium, HYZAAR 100/12.5 contains 8.48 mg (0.216 mEq) of potassium, and HYZAAR 100/25 contains 8.48 mg (0.216 mEq) of potassium.

Dosage Forms and Strengths
  • HYZAAR 50/12.5 are yellow, oval, film-coated tablets, with code 717 on one side.
  • HYZAAR 100/12.5 are white, oval, film-coated tablets, with code 745 on one side.
  • HYZAAR 100/25 are light yellow, oval, film-coated tablets, with code 747 on one side.
How Supplied

HYZAAR is supplied as a film-coated tablet.

Losartan/Hydrochlorothiazide Color Shape Engraving NDC 0006-xxxx-xx
Bottle/ 30 Bottle/ 90 Bottle/ 1000
50/12.5 mg yellow oval 717 0717-31 0717-54 0717-82
100/12.5 mg white oval 745 0745-31 0745-54 0745-82
100/25 mg light yellow oval 747 0747-31 0747-54 n/a

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Drugs

Drug Countries
HYZAAR Brazil, Canada, Ecuador, France, Hong Kong, Croatia, Mexico, Netherlands, Poland, Singapore, Turkey, United States

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