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U.S. Department of Health and Human Services

Safety

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Monodox (doxycycline monohydrate) capsules

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

 

October 2013

Summary View

PRECAUTIONS

General
  • Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Monodox. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and Monodox should be avoided because isotretinoin is also known to cause pseudotumor cerebri.
  • 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.

ADVERSE REACTIONS

  • Other: Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines
     

  

March 2011

Summary View

ADVERSE REACTIONS

Skin
  • Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported
Gastrointestinal
  • Hepatotoxicity has been reported.
Hypersensitivity Reactions
  • serum sickness