INDAPAMIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Mylan Institutional Inc.

INN (Algemene Internationale Benaming):

INDAPAMIDE

Samenstelling:

INDAPAMIDE 2.5 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. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS below). 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 below). Dependent edema in pregnancy, resulting from restriction of ve

Product samenvatting:

Indapamide Tablets, USP are available containing 2.5 mg of indapamide, USP. The 2.5 mg tablets are white film-coated, unscored, round tablets debossed with M on one side of the tablet and 80 on the other side. They are available as follows: NDC 51079-868-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12293 1/16

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

INDAPAMIDE- INDAPAMIDE TABLET, FILM COATED
MYLAN INSTITUTIONAL INC.
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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.
Each tablet, for oral administration, contains 1.25 mg or 2.5 mg of
indapamide, USP and the following
inactive ingredients: anhydrous lactose, colloidal silicon dioxide,
hypromellose, magnesium stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol,
pregelatinized starch, sodium lauryl
sulfate, and titanium dioxide. Additionally, the 1.25 mg product
contains glyceryl triacetate and D&C
Red No. 30 Aluminum Lake and the 2.5 mg product contains triacetin.
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 the blood
within 2 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 2 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