Label Changes for:

Kaletra (lopinavir and ritonavir) Solution for Oral Use

June 2008

Changes have been made to the CONTRAINDICATIONS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.


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)
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