Triamcinolone Acetonide 40 mg/mL · injectable suspension
Steroid, Injections & Implants
XIPERE ® is a corticosteroid indicated for the treatment of macular edema associated with uveitis.
Contraindications
- Active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases
- Known hypersensitivity to triamcinolone acetonide or any other components of this product
40 mg/mL injectable suspension in a single-dose glass vial, with SCS Microinjector and 900-µm and 1100-µm needles
Triamcinolone acetonide is a synthetic glucocorticoid (glucocorticoids are often referred to as corticosteroids) with immunosuppressive and anti-inflammatory activity. The primary mechanism of action for triamcinolone acetonide is as a corticosteroid hormone receptor agonist.
The recommended dosage is 4 mg (0.1 mL) administered as a suprachoroidal injection.
Warnings & Precautions
- Potential Corticosteroid-Related Effects: Use of corticosteroids may produce cataracts, increased intraocular pressure, and glaucoma. Use of corticosteroids 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. Corticosteroids should not be used in patients with active ocular herpes simplex.
- Alterations in Endocrine Function: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia can occur following administration of a corticosteroid. Monitor patients for these conditions with chronic use. Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.
- Secondary adrenocortical insufficiency: Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.
- Changes in thyroid status: Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.
Common Side Effects
The most common adverse reactions reported by ≥ 10% of patients and at a rate greater than control included elevated intraocular pressure and eye pain.
Pregnancy: There are no adequate and well-controlled studies with XIPERE ® in pregnant women to inform drug-associated risks. In animal reproductive studies from the published literature, topical ocular administration of corticosteroids has been shown to produce teratogenicity at clinically relevant doses. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: 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. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XIPERE ® and any potential adverse effects on the breastfed infant from XIPERE ®.
Safety and effectiveness of XIPERE ® in pediatric patients have not been established.