LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Aidarex Pharmaceuticals LLC

INN (nemzetközi neve):

LOSARTAN POTASSIUM

Összetétel:

LOSARTAN POTASSIUM 100 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin­angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, losartan potassium and hydrochlorothiazide should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality . 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 t

Termék összefoglaló:

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100-25 mg are supplied as round, yellow film coated, biconvex, beveled-edge tablets. The 100-25 mg tablets are debossed with product identification "54 557" on one side and plain on the other side. Store at 20º to 25ºC (68º to 77ºF) (See USP controlled room temperature). Keep container tightly closed. Protect from light.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET
AIDAREX PHARMACEUTICALS LLC
----------
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS USP
USE IN PREGNANCY
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, DRUGS
THAT ACT DIRECTLY ON
THE RENINANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN DEATH TO THE
DEVELOPING FETUS. When
pregnancy is detected, losartan potassium and hydrochlorothiazide
should be discontinued as soon
as possible. See WARNINGS: FETAL/NEONATAL MORBIDITY AND MORTALITY.
DESCRIPTION
Losartan Potassium and Hydrochlorothiazide Tablets USP combine an
angiotensin II receptor (type
AT ) antagonist and a diuretic, hydrochlorothiazide.
Losartan potassium, a nonpeptide molecule, is chemically described as
2butyl4chloro1[_p_(o1_H_tetrazol-
5ylphenyl)benzyl]imidazole5methanol monopotassium salt. Its molecular
formula is C
H ClKN O,
and its structural formula is:
Losartan potassium is a white to offwhite freeflowing 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 5hydroxymethyl group on the imidazole ring results in
the active metabolite of
losartan.
Hydrochlorothiazide is
6chloro3,4dihydro2_H_1,2,4benzothiadiazine7sulfonamide 1,1dioxide. Its
molecular formula is C H ClN O S and its structural formula is:
1
22
22
6
7
8
3
4
2
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.
Losartan Potassium and Hydrochlorothiazide Tablets USP are available
for oral administration in three
tablet combinations of losartan and hydrochlorothiazide. Losartan
Potassium and Hydrochlorothiazide
Tablets USP 5012.5 contains 50 mg of losartan potassium USP and 12.5
mg of hydrochlorothiazide
USP. Losartan Potassium and Hydrochlorothiazide Tablets USP 1001