Jane S. Ricciuti, RPh, MS

Disclosures

October 21, 2003

In This Article

Cardiovascular Agents

Lopressor
(metoprolol tartrate) Injection & Tablets

Manufacturer: Novartis

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 9/12/03)

Precautions: This supplemental approval for Lopressor (metoprolol) is for the addition of the following geriatric use section:

  • Geriatric Use

    • Clinical trials of metoprolol in hypertension did not include sufficient numbers of elderly patients to determine whether patients older than 65 years differ from younger subjects in their response to metoprolol. Other reported clinical experience in elderly, hypertensive patients has not identified any difference in response from younger patients.

    • In worldwide clinical trials of metoprolol in myocardial infarction, where approximately 478 patients were older than 65 years (0 older than 75 years), no age-related differences in safety and effectiveness were found. Other reported clinical experience in myocardial infarction has not identified differences in response between the elderly and younger patients. However, greater sensitivity of some elderly individuals taking Lopressor cannot be categorically ruled out. Therefore, in general, it is recommended that dosing proceed with caution in this population.

Lopressor (metoprolol tartrate) Injection & Tablets Letter

Lopressor (metoprolol tartrate) Injection & Tablets

Lotrel (amlodipine and benazepril HCl) Capsules

Manufacturer: Novartis

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 8/29/03)

Precautions: This supplemental approval for Lotrel (amlodipine and benazepril) is for the addition of the following under the geriatric use subsection:

  • Benazepril and benazeprilat are substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

  • Amlodipine is extensively metabolized in the liver. In elderly patients, clearance of amlodipine is decreased with resulting increases in peak plasma levels, elimination half-life, and area under the plasma concentration curve. Thus, a lower starting dose may be required in older patients.

Lotrel (amlodipine and benazepril HCl) Capsules Letter

Lotrel (amlodipine and benazepril HCl) Capsules

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