LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

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Download Productkenmerken (SPC)
13-09-2011

Werkstoffen:

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

Beschikbaar vanaf:

Rebel Distributors Corp

INN (Algemene Internationale Benaming):

LOSARTAN POTASSIUM

Samenstelling:

LOSARTAN POTASSIUM 100 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Hypertension      Losartan Potassium and Hydrochlorothiazide Tablets 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). Hypertensive Patients with Left Ventricular Hypertrophy      Losartan Potassium and Hydrochlorothiazide 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, 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 patie

Product samenvatting:

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg are white to off white colored, oval shaped, biconvex film coated tablets, debossed with "1117" on one side and plain on other side. Bottles of 30                                           NDC 21695-966-30   Storage     Store at 20° to 25°C (68° to 77°F) (See USP controlled room temperature). Protect from light. Keep container tightly closed.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

                                LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET
REBEL DISTRIBUTORS CORP
----------
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP 100 MG/12.5 MG
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 and Hydrochlorothiazide
Tablets should be
discontinued as soon as possible. See WARNINGS, _Fetal/Neonatal
Morbidity and Mortality._
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_-_1H_-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol
monopotassium salt. Its empirical formula is
C
H ClKN O, and its structural formula is:
Losartan potassium, USP 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 C H ClN O S and its structural formula is:
1
22
22
6
7
8
3
4
2
Hydrochlorothiazide, USP 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.
Losartan Potassium and Hydrochlorothiazide Tablets, USP are available
for oral administration in
three tablet combinations of losartan and hydrochlorothiazide.
Losartan Potassium and
Hydrochlorothia
                                
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