Ramipril (Page 7 of 7)
14.3 Heart Failure Post-Myocardial Infarction
Ramipril was studied in the AIRE trial. This was a multinational (mainly European) 161-center, 2006-patient, double-blind, randomized, parallel-group study comparing ramipril to placebo in stable patients, 2 to 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 ramipril 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 ramipril) 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 ramipril 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 ramipril 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
Ramipril capsules USP are available in 2.5 mg, 5 mg, and 10 mg hard gelatin capsules. Descriptions of Ramipril capsules USP are summarized below.
Ramipril capsules USP, 2.5 mg are: Size “4” capsules with orange cap, imprinted with ‘LUPIN’ in black ink and orange body imprinted with ‘RAMIPRIL 2.5 mg’ in black ink, containing white to off-white powder.
NDC 68180-589-09 bottles of 90
NDC 68180-589-01 bottles of 100
NDC 68180-589-02 bottles of 500
Ramipril capsules USP, 5 mg are: Size “4” capsules with red cap, imprinted with ‘LUPIN’ in black ink and red body imprinted with ‘RAMIPRIL 5 mg’ in black ink, containing white to off-white powder.
NDC 68180-590-09 bottles of 90
NDC 68180-590-01 bottles of 100
NDC 68180-590-02 bottles of 500
Ramipril capsules USP, 10 mg are: Size “4” capsules with light blue cap, imprinted with ‘LUPIN’ in black ink and light blue body imprinted with ‘RAMIPRIL 10 mg’ in black ink, containing white to off-white powder.
NDC 68180-591-09 bottles of 90
NDC 68180-591-01 bottles of 100
NDC 68180-591-02 bottles of 500
Dispense in light-resistant, tight container with child-resistant closure.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
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 ramipril 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 ramipril 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 ramipril 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.
Manufactured for:
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States
MADE IN INDIA
Revised: March 2021 ID#: 266878
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
2.5 mg – Bottle of 90s
NDC 68180-589-09 bottles of 90
5 mg – Bottle of 90s
NDC 68180-590-09 bottles of 90
10 mg – Bottle of 90s
NDC 68180-591-09 bottles of 90
2.5 mg – Bottle of 90s
NDC 68180-589-09 bottles of 90
5 mg – Bottle of 90s
NDC 68180-590-09 bottles of 90
10 mg – Bottle of 90s
NDC 68180-591-09 bottles of 90
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| Labeler — Lupin Pharmaceuticals, Inc. (089153071) |
| Registrant — LUPIN LIMITED (675923163) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| LUPIN LIMITED | 677600414 | MANUFACTURE (68180-589), MANUFACTURE (68180-590), MANUFACTURE (68180-591), PACK (68180-589), PACK (68180-590), PACK (68180-591) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| LUPIN LIMITED | 862272739 | MANUFACTURE (68180-589), MANUFACTURE (68180-590), MANUFACTURE (68180-591), PACK (68180-589), PACK (68180-590), PACK (68180-591) | |
Revised: 03/2021 Lupin Pharmaceuticals, Inc.
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