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:

Mylan Pharmaceuticals Inc.

INN (International Name):

INDAPAMIDE

Composition:

INDAPAMIDE 1.25 mg

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. 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 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 venous return by the expanded uterus, is properly treated through elevation of the lower extremities

Product summary:

Indapamide Tablets, USP are available containing 1.25 mg or 2.5 mg of indapamide, USP. The 1.25 mg tablets are pink film-coated, unscored, round tablets debossed with M on one side of the tablet and 69 on the other side. They are available as follows: NDC 0378-0069-01 bottles of 100 tablets NDC 0378-0069-05 bottles of 500 tablets 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 0378-0080-77 bottles of 90 tablets NDC 0378-0080-01 bottles of 100 tablets NDC 0378-0080-10 bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Revise: 07/2022 INDAP:R6

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

INDAPAMIDE- INDAPAMIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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INDAPAMIDE TABLETS, USP
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
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