Safety

Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension, Vibramycin Hyclate (doxycycline hyclate capsules, USP), Vibramycin Calcium (doxycycline calcium oral suspension) Syrup, Vibra-Tabs (doxycycline hyclate tablets, USP)

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

April 2016

Summary View

WARNINGS

  • Use doxycycline in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever), particularly when there are no alternative therapies.

PRECAUTIONS

Pediatric Use
  • Because of the effects of drugs of the tetracycline-class on tooth development and growth, use doxycycline in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever), particularly when there are no alternative therapies.
     

September 2014

Summary View

WARNINGS

  • ... Clinical manifestations of IH include headache, blurred vision, diplopia,and vision loss; papilledema can be found on fundoscopy ... Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize.
     

 

September 2013

Summary View

PRECAUTIONS

General
  • Revisions to the language related to benign intracranial hypertension

ADVERSE REACTIONS

Immune
  • Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)
     

 

Page Last Updated: 05/13/2016
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