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U.S. Department of Health and Human Services

Safety

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Kaletra (lopinavir and ritonavir) Solution for Oral Use


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Initial Statement
  • Table 3: Drugs That Are Contraindicated With Kaletra

ADVERSE REACTIONS

  • Pediatric Patients - Clinical Trials Experience

DRUG INTERACTIONS

  • Table 9
    • Benzodiazepines:
      Parenterally
      Administered
      Midazolam

USE IN SPECIFIC POPULATIONS

  • Pediatric Use

PATIENT PACKAGE INSERT

  • What is Kaletra and how does it work?
    • ...Kaletra is for adults and for children age 14 days and older.
  • How should I take Kaletra?
    • Dosing in children greater than 14 days of age...

CONTRAINDICATIONS

Kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir.

Table 3: Drugs That Are Contraindicated With Kaletra

Sedative/Hyponotics:

  • Orally Administered Midazolam (added)