Indapamide (Page 3 of 3)

OVERDOSAGE

Symptoms of overdosage include nausea, vomiting, weakness, gastrointestinal disorders, and disturbances of electrolyte balance. In severe instances, hypotension and depressed respiration may be observed. If this occurs, support of respiration and cardiac circulation should be instituted. There is no specific antidote. An evacuation of the stomach is recommended by emesis and gastric lavage after which the electrolyte and fluid balance should be evaluated carefully.

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 4 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 4 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 containing 1.25 mg or 2.5 mg of indapamide USP.

The 1.25 mg tablets are orange, round, film coated tablets debossed ‘ANI’ over ‘510’ on one side and plain on the other side. They are available in bottles of 100 tablets (NDC 51407-024-01).

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 51407-025-01).

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.

Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623

9957 Rev 03/21

Marketed/Packaged by:
GSMS, Inc.

Camarillo, CA USA 93012

Package/Label Display Panel

Indapamide Tablets USP, 1.25 mg
NDC 51407-024-01
Rx only
100 Tablets

Package/Label Display Panel

Indapamide Tablets USP, 2.5 mg
NDC 51407-025-01
Rx only
100 Tablets

INDAPAMIDE indapamide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-024(NDC:62559-510) 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 HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TALC TITANIUM DIOXIDE FD&C YELLOW NO. 6

Product Characteristics Color orange Score no score Shape ROUND Size 7mm Flavor Imprint Code ANI;510 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51407-024-01 100 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074299 04/29/1996

INDAPAMIDE indapamide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-025(NDC:62559-511) 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 STARCH, CORN HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TALC TITANIUM DIOXIDE

Product Characteristics Color white Score no score Shape ROUND Size 7mm Flavor Imprint Code ANI;511 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51407-025-01 100 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074299 07/27/1995

Labeler — Golden State Medical Supply, Inc. (603184490)

Establishment
Name	Address	ID/FEI	Operations
Golden State Medical Supply, Inc.		603184490	relabel (51407-025), repack (51407-025), relabel (51407-024), repack (51407-024)

Revised: 05/2021 Golden State Medical Supply, Inc.