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
ani

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

//medlibrary.org/lib/images-rx/indapamide-12/51407-024ol-300x125.jpg
(click image for full-size original)

Package/Label Display Panel

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

//medlibrary.org/lib/images-rx/indapamide-12/51407-025-01lb-300x223.jpg
(click image for full-size original)

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.

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