LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Verfügbar ab:

Proficient Rx LP

INN (Internationale Bezeichnung):

LOSARTAN POTASSIUM

Zusammensetzung:

LOSARTAN POTASSIUM 50 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Losartan potassium and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects , and DOSAGE AND ADMINISTRATION ). Losartan potassium and hydrochlorothiazide 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, CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke, Race, and DOSAGE AND ADMINISTRATION ). Losartan potassium and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product. Beca

Produktbesonderheiten:

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘48’ on the other side.                   Bottles of 30                                                        NDC 63187-599-30                   Bottles of 60                                                        NDC 63187-599-60                   Bottles of 90                                                     NDC 63187-599-90 Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘49’ on the other side.                   Bottles of 30                                                        NDC 63187-602-30                   Bottles of 60                                                        NDC 63187-602-60                    Bottles of 90                                                     NDC 63187-602-90 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810  Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt) AP-509302, INDIA Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 10/2014

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
PROFICIENT RX LP
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LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP
WARNING: FETAL TOXICITY
•
•
DESCRIPTION
Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg, losartan
potassium and
hydrochlorothiazide 100 mg/12.5 mg and losartan potassium and
hydrochlorothiazide 100 mg/25 mg,
combine an angiotensin II receptor (type AT ) antagonist and a
diuretic, hydrochlorothiazide.
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 molecular formula is
C
H ClKN O, and its structural formula is:
Losartan potassium USP is a white to off-white 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-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
Its molecular formula is C H ClN O S and its structural formula is:
WHEN PREGNANCY IS DETECTED, DISCONTINUE LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE
AS SOON AS POSSIBLE.
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
7
8
3
4
2
Hydrochlorothiazide USP is a white or practically white, practically
odorless, crystalline powder with
a molecular weight of 297.74, which is slightly soluble in water, but
freely soluble in sodium
hydroxide solution.
Losartan potassium and hydrochlorothiazide is available for oral
administration in three tablet
combinations of losartan and hydrochlorothiazide. Losartan potassium
and hydrochlorothiazide tablets
USP, 50 mg/12.5 mg contain 50 mg of losartan potassium USP and 12.5 mg
of hydrochlorothiazide USP.
Losartan potas