INDAPAMIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

INDAPAMIDE (UNII: F089I0511L) (INDAPAMIDE - UNII:F089I0511L)

Beschikbaar vanaf:

AvKARE

INN (Algemene Internationale Benaming):

INDAPAMIDE

Samenstelling:

INDAPAMIDE 1.25 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS). Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Indapamide is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities

Product samenvatting:

Indapamide Tablets, USP are available as follows: 1.25 mg — Each orange, round, compound cup, film-coated tablet imprinted with on one side and 597 on the other side contains 1.25 mg of indapamide, USP. Tablets are supplied in bottles of 90 (NDC 42291-348-90). 2.5 mg — Each white, round, compound cup, film-coated tablet imprinted with on one side and 571 on the other side contains 2.5 mg of indapamide, USP. Tablets are supplied in bottles of 90 (NDC 42291-349-90). Keep tightly closed. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Avoid excessive heat. Dispense in a tight, light-resistant container as defined in the USP. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 06/12 AV 02/16 (P)

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

INDAPAMIDE- INDAPAMIDE TABLET, FILM COATED
AVKARE
----------
INDAPAMIDE TABLETS, USP
RX ONLY
DESCRIPTION
Indapamide is an oral antihypertensive/diuretic. Its molecule contains
both a polar
sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline
moiety. It differs
chemically from the thiazides in that it does not possess the thiazide
ring system and
contains only one sulfonamide group. The chemical name of indapamide
is 4-Chloro- _N_-
(2-methyl-1-indolinyl)-3-Sulfamoylbenzamide, and its molecular weight
is 365.84. The
compound is a weak acid, pK
=8.8, and is soluble in aqueous solutions of strong bases.
It is a white to yellow-white crystalline (tetragonal) powder, and has
the following
structural formula:
Each tablet, for oral administration, contains 1.25 mg or 2.5 mg of
indapamide. In
addition, each tablet contains the following inactive ingredients:
corn starch,
hypromellose, lactose monohydrate, magnesium stearate, maltodextrin,
microcrystalline
cellulose, polydextrose, polyethylene glycol, talc, titanium dioxide,
triacetin. The 1.25 mg
tablet also contains FD&C yellow #6 aluminum lake (sunset yellow
lake).
CLINICAL PHARMACOLOGY
Indapamide is the first of a new class of antihypertensive/diuretics,
the indolines. The
oral administration of 2.5 mg (two 1.25 mg tablets) of indapamide to
male subjects
produced peak concentrations of approximately 115 ng/mL of the drug in
blood within
two hours. The oral administration of 5 mg (two 2.5 mg tablets) of
indapamide to
healthy male subjects produced peak concentrations of approximately
260 ng/mL of the
drug in the blood within two hours. A minimum of 70% of a single oral
dose is eliminated
by the kidneys and an additional 23% by the gastrointestinal tract,
probably including the
biliary route. The half-life of indapamide in whole blood is
approximately 14 hours.
Indapamide is preferentially and reversibly taken up by the
erythrocytes in the peripheral
blood. The whole blood/plasma ratio is approximately 6:1 at the time
of peak
concentration and decreases to