INDAPAMIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ). 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 and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate. Anuria. Known hypersensitivity to indapamide or to other sulfonamide-derived drugs.

Product summary:

Indapamide Tablets USP are available containing 2.5 mg of indapamide USP. The 2.5 mg tablets are white, round, film coated tablets debossed ‘ANI’ over ‘511’ on one side and plain on the other side. They are available in bottles of 100 tablets (NDC 63629-1954-1). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Avoid excessive heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

INDAPAMIDE- INDAPAMIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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.
C
H
CLN O S
C
H
CLN O S
Each tablet, for oral administration, contains 1.25 mg or 2.5 mg of
indapamide USP and
the following inactive ingredients: corn starch, hypromellose, lactose
monohydrate,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
polysorbate 80, talc,
and titanium dioxide. Additionally, the 1.25 mg product contains FD&C
yellow #6
aluminum 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
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
a
16 16
3
3
16 16
3
3
blood. The whole blood/plasma ratio is approximately 6:1 at the time
of peak
concentration and decreases to 3.5:1 at 8 hours. From 71% to 79% of
the