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Ozurdex

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Ozurdex

Ozurdex

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Intravitreal Injection-Related Effects

Intravitreal injections, including those with OZURDEX® have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments.

Patients should be monitored regularly following the injection [see PATIENT INFORMATION].

Potential Steroid-Related Effects

Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.

Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex.

Risk Of Implant Migration

Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No adequate studies in animals have been conducted to determine whether OZURDEX® (dexamethasone intravitreal implant) has the potential for carcinogenesis.

Although no adequate studies have been conducted to determine the mutagenic potential of OZURDEX®, dexamethasone has been shown to have no mutagenic effects in bacterial and mammalian cells in vitro or in the in vivo mouse micronucleus test.

Use In Specific Populations

Pregnancy

Teratogenic Effects - Pregnancy Category C

Topical dexamethasone has been shown to be teratogenic in mice producing fetal resorptions and cleft palate. In the rabbit, dexamethasone produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc. Pregnant rhesus monkeys treated with dexamethasone sodium phosphate intramuscularly at 1 mg/kg/day every other day for 28 days or at 10 mg/kg/day once or every other day at 3 or 5 days between gestation days 23 and 49 had fetuses with minor cranial abnormalities. A 1 mg/kg/dose in pregnant rhesus monkeys would be approximately 85 times higher than an OZURDEX® injection in humans (assuming 60 kg body weight).

There are no adequate and well-controlled studies in pregnant women. OZURDEX® (dexamethasone intravitreal implant) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when corticosteroids are administered to a nursing woman.

Pediatric Use

Safety and effectiveness of OZURDEX® in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Last reviewed on RxList: 2/20/2014
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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