LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

STAT RX USA LLC

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 contraindi

Product samenvatting:

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg are light yellow colored, oval shaped, biconvex film coated tablets, debossed with "116" on one side and plain on other side. Bottles of 30                                           NDC 13668-116-30 Bottles of 90                                           NDC 13668-116-90 Bottles of 1000                                       NDC 13668-116-10 100 Unit Dose Tablets                          NDC 13668-116-74 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 13668-117-30 Bottles of 90                                           NDC 13668-117-90 Bottles of 1000                                       NDC 13668-117-10 100 Unit Dose Tablets                          NDC 13668-117-74 Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg are yellow colored, oval shaped, biconvex film coated tablets, debossed with "1118" on one side and plain on other side. Bottles of 30                                           NDC 13668-118-30 Bottles of 90                                           NDC 13668-118-90 Bottles of 1000                                       NDC 13668-118-10 100 Unit Dose Tablets                          NDC 13668-118-74   Storage     Store at 20° to 25°C (68° to 77°F) (See USP controlled room temperature). Protect from light. Keep container tightly closed.   Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA. For: TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40, Kalamazoo, Michigan 49009.    8025591                                                                                                         Revised September 2010

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE - LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
STAT RX USA LLC
----------
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:
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
1
22
22
6
7
8
3
4
2
Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg contain 50 mg of
losartan potassi