Prescription Drug Information: ATACAND HCT (Page 4 of 4)

DOSAGE AND ADMINISTRATION

The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. ATACAND can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Patients requiring further reduction in blood pressure should be titrated to 32 mg. Doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.

Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.

Use in Renal Impairment: Dosing recommendations for ATACAND HCT in patients with creatinine clearance < 30 mg/min cannot be provided (see SPECIAL POPULATIONS, Renal Insufficiency).

Use in moderate to severe Hepatic Impairment: ATACAND HCT is not recommended for initiation because the appropriate starting dose, 8 mg, cannot be given (see SPECIAL POPULATIONS, Hepatic Insufficiency).

Replacement Therapy: The combination may be substituted for the titrated components.

Dose Titration by Clinical Effect: A patient whose blood pressure is not controlled on 25 mg of hydrochlorothiazide once daily can expect an incremental effect from ATACAND HCT 16-12.5 mg. A patient whose blood pressure is controlled on 25 mg of hydrochlorothiazide but is experiencing decreases in serum potassium can expect the same or incremental blood pressure effects from ATACAND HCT 16-12.5 mg and serum potassium may improve.

A patient whose blood pressure is not controlled on 32 mg of ATACAND can expect incremental blood pressure effects from ATACAND HCT 32-12.5 mg and then 32-25 mg. The maximal antihypertensive effect of any dose of ATACAND HCT can be expected within 4 weeks of initiating that dose.

ATACAND HCT may be administered with other antihypertensive agents.

ATACAND HCT may be administered with or without food.

HOW SUPPLIED

ATACAND HCT 16-12.5 mg Tablets are peach, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACS on one side. They are supplied in bottles of 90 tablets (NDC 62559-650-90).

ATACAND HCT 32-12.5 mg Tablets are yellow, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACJ on one side. They are supplied in bottles of 90 tablets (NDC 62559-651-90).

ATACAND HCT 32-25 mg Tablets are pink, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACD on one side. They are supplied in bottles of 90 tablets (NDC 62559-652-90).

Storage:

Store at 20° to 25°C (68° to 77°F); excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

Manufactured under the license from Takeda Pharmaceutical Company, Ltd.

Manufactured by:
AstraZeneca AB, SE-151 85
Södertälje, Sweden

Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
logo

ATACAND HCT is a registered trademark of the AstraZeneca group of companies and is licensed to ANI Pharmaceuticals.

10114 Rev 05/20

PRINCIPAL DISPLAY PANEL – 16 mg/12.5 mg

NDC 62559-650-90
ATACAND HCT® (candesartan cilexetil-hydrochlorothiazide) Tablets
16 mg/12.5 mg
Rx only
90 Tablets

Label_16-12
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 32 mg/12.5 mg

NDC 62559-651-90
ATACAND HCT® (candesartan cilexetil-hydrochlorothiazide) Tablets
32 mg/12.5 mg
Rx only
90 Tablets

Label_32-12
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 32 mg/25 mg

NDC 62559-652-90
ATACAND HCT® (candesartan cilexetil-hydrochlorothiazide) Tablets
32 mg/25 mg
Rx only
90 Tablets

Label_32-25
(click image for full-size original)

ATACAND HCT candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-650
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 16 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
POLYETHYLENE GLYCOL 8000
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color PINK (peach) Score 2 pieces
Shape OVAL (biconvex) Size 10mm
Flavor Imprint Code ACS
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-650-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021093 10/01/2018
ATACAND HCT candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-651
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 32 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
POLYETHYLENE GLYCOL 8000
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL (biconvex) Size 11mm
Flavor Imprint Code ACJ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-651-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021093 10/01/2018
ATACAND HCT candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-652
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 32 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
POLYETHYLENE GLYCOL 8000
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL (biconvex) Size 11mm
Flavor Imprint Code ACD
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-652-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021093 10/01/2018
Labeler — ANI Pharmaceuticals, Inc. (145588013)

Revised: 05/2020 ANI Pharmaceuticals, Inc.

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