Prescription Drug Information: Indapamide (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Hypertension: The adult starting indapamide dose for hypertension is 1.25 mg as a single daily dose taken in the morning. If the response to 1.25 mg is not satisfactory after four weeks, the daily dose may be increased to 2.5 mg taken once daily. If the response to 2.5 mg is not satisfactory after four weeks, the daily dose may be increased to 5 mg taken once daily, but adding another antihypertensive should be considered.

Edema Of Congestive Heart Failure: The adult starting indapamide dose for edema of congestive heart failure is 2.5 mg as a single daily dose taken in the morning. If the response to 2.5 mg is not satisfactory after one week, the daily dose may be increased to 5 mg taken once daily.

If the antihypertensive response to indapamide is insufficient, indapamide may be combined with other antihypertensive drugs, with careful monitoring of blood pressure. It is recommended that the usual dose of other agents be reduced by 50% during initial combination therapy. As the blood pressure response becomes evident, further dosage adjustments may be necessary.

In general, doses of 5 mg and larger have not appeared to provide additional effects on blood pressure or heart failure, but are associated with a greater degree of hypokalemia. There is minimal clinical trial experience in patients with doses greater than 5 mg once a day.

HOW SUPPLIED

Indapamide Tablets, USP are available as follows:

1.25 mg — Each orange, round, compound cup, film-coated tablet imprinted with c8144390-figure-02on 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 Imprint Image 2 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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE
NDC 42291-348-90
Indapamide Tablets, USP
1.25 mg
90 Tablets Rx Only

1.25 mg label
(click image for full-size original)

AvKARE

NDC 42291-349-90
Indapamide Tablets, USP
2.5 mg

90 Tablets Rx Only

2.5 mg label
(click image for full-size original)
INDAPAMIDE
indapamide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-348(NDC:0228-2597)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDAPAMIDE (INDAPAMIDE) INDAPAMIDE 1.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
TALC
TITANIUM DIOXIDE
TRIACETIN
FD&C YELLOW NO. 6
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color orange Score no score
Shape ROUND (compound cup) Size 7mm
Flavor Imprint Code R;597
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-348-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074722 02/09/2016
INDAPAMIDE
indapamide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-349(NDC:0228-2571)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDAPAMIDE (INDAPAMIDE) INDAPAMIDE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white Score no score
Shape ROUND (compound cup) Size 7mm
Flavor Imprint Code R;571
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-349-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074722 02/09/2016
Labeler — AvKARE, Inc. (796560394)

Revised: 01/2020 AvKARE, Inc.

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