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Monodox (doxycycline monohydrate) capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- 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.
- Other: Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines
- Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported
- Hepatotoxicity has been reported.
- serum sickness