ALTACE (Page 7 of 7)

14.3 Heart Failure Post-Myocardial Infarction

ALTACE was studied in the AIRE trial. This was a multinational (mainly European) 161-center, 2006-patient, double-blind, randomized, parallel-group study comparing ALTACE to placebo in stable patients, 2–9 days after an acute myocardial infarction, who had shown clinical signs of congestive heart failure at any time after the myocardial infarction. Patients in severe (NYHA class IV) heart failure, patients with unstable angina, patients with heart failure of congenital or valvular etiology, and patients with contraindications to ACE inhibitors were all excluded. The majority of patients had received thrombolytic therapy at the time of the index infarction, and the average time between infarction and initiation of treatment was 5 days.

Patients randomized to ALTACE treatment were given an initial dose of 2.5 mg twice daily. If the initial regimen caused undue hypotension, the dose was reduced to 1.25 mg, but in either event doses were titrated upward (as tolerated) to a target regimen (achieved in 77% of patients randomized to ALTACE) of 5 mg twice daily. Patients were then followed for an average of 15 months, with the range of follow-up between 6 and 46 months.

The use of ALTACE was associated with a 27% reduction (p=0.002) in the risk of death from any cause; about 90% of the deaths that occurred were cardiovascular, mainly sudden death. The risks of progression to severe heart failure and of congestive heart failure-related hospitalization were also reduced, by 23% (p=0.017) and 26% (p=0.011), respectively. The benefits of ALTACE therapy were seen in both genders, and they were not affected by the exact timing of the initiation of therapy, but older patients may have had a greater benefit than those under 65. The benefits were seen in patients on (and not on) various concomitant medications. At the time of randomization these included aspirin (about 80% of patients), diuretics (about 60%), organic nitrates (about 55%), beta-blockers (about 20%), calcium channel blockers (about 15%), and digoxin (about 12%).

16 HOW SUPPLIED/STORAGE AND HANDLING

ALTACE is available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules. Descriptions of ALTACE capsules are summarized below.

Capsule Strength Capsule Color Package Configuration NDC#
1.25 mg yellow Bottle of 100 61570-110-01
2.5 mg orange Bottle of 100 61570-111-01
5 mg red Bottle of 100 61570-112-01
10 mg Process Blue Bottle of 100 61570-120-01

Dispense in well-closed container with safety closure.

Store at controlled room temperature (59°–86°F).

17 PATIENT COUNSELING INFORMATION

Angioedema

Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially following the first dose. Advise patients to immediately report any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to temporarily discontinue drug until they have consulted with the prescribing physician.

Neutropenia

Advise patients to promptly report any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia.

Symptomatic Hypotension

Inform patients that light-headedness can occur, especially during the first days of therapy, and it should be reported. Advise patients to discontinue ALTACE if syncope (fainting) occurs, and to follow up with their health care providers.

Inform patients that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting while taking ALTACE can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Pregnancy

Tell female patients of childbearing age about the consequences of exposure to Altace during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physicians as soon as possible.

Hyperkalemia

Advise patients not to use salt substitutes containing potassium without consulting their physician.

Logo

LAB-0581-8.0

PRINCIPAL DISPLAY PANEL — 1.25 mg Capsule Bottle Label

NDC 61570-110-01

Pfizer

Altace ®
(ramipril) capsules, for oral use

1.25 mg

100 CapsulesRx only

PRINCIPAL DISPLAY PANEL -- 1.25 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2.5 mg Capsule Bottle Label

NDC 61570-111-01

Pfizer

Altace ®
(ramipril) capsules, for oral use

2.5 mg

100 CapsulesRx only

PRINCIPAL DISPLAY PANEL -- 2.5 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mg Capsule Bottle Label

NDC 61570-112-01

Pfizer

Altace ®
(ramipril) capsules, for oral use

5 mg

100 CapsulesRx only

PRINCIPAL DISPLAY PANEL -- 5 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Capsule Bottle Label

NDC 61570-120-01

Pfizer

Altace ®
(ramipril) capsules, for oral use

10 mg

100 CapsulesRx only

PRINCIPAL DISPLAY PANEL -- 10 mg Capsule Bottle Label
(click image for full-size original)
ALTACE ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61570-110
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAMIPRIL (RAMIPRILAT) RAMIPRIL 1.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Altace;1;25;mg;MP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61570-110-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019901 01/28/1991
ALTACE ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61570-111
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAMIPRIL (RAMIPRILAT) RAMIPRIL 2.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C RED NO. 40
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Altace;2;5;mg;MP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61570-111-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019901 01/28/1991
ALTACE ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61570-112
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAMIPRIL (RAMIPRILAT) RAMIPRIL 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Altace;5;mg;MP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61570-112-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019901 01/28/1991
ALTACE ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61570-120
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAMIPRIL (RAMIPRILAT) RAMIPRIL 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FD&C BLUE NO. 1
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Altace;10;mg;MP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61570-120-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019901 01/28/1991
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
UPM Pharmaceuticals 032125469 ANALYSIS (61570-110), ANALYSIS (61570-111), ANALYSIS (61570-112), ANALYSIS (61570-120), LABEL (61570-110), LABEL (61570-111), LABEL (61570-112), LABEL (61570-120), MANUFACTURE (61570-110), MANUFACTURE (61570-111), MANUFACTURE (61570-112), MANUFACTURE (61570-120), PACK (61570-110), PACK (61570-111), PACK (61570-112), PACK (61570-120)

Revised: 06/2020 Pfizer Laboratories Div Pfizer Inc

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