Drugplain

Xipere 40 mg/mL

triamcinolone acetonide · INJECTION, SUSPENSION · Bausch & Lomb Incorporated

No Recall HistoryCurrently in Shortage
Plain English

Xipere is a injection, suspension containing triamcinolone acetonide at 40 mg/mL, taken ophthalmic. Manufactured by Bausch & Lomb Incorporated.

Key Facts

Brand Name
Xipere
Generic Name
triamcinolone acetonide
NDC Code (Product)
24208-040
Manufacturer
Bausch & Lomb Incorporated
Strength
40 mg/mL
Dosage Form
INJECTION, SUSPENSION
Route
OPHTHALMIC
Marketing Status
Application #
NDA211950
Drug Class
Corticosteroid [EPC]
Marketing Start
12/17/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective3,520 reports
off label use2,615 reports
pruritus2,255 reports
rash2,230 reports
pain1,932 reports
fatigue1,845 reports
nausea1,763 reports
product use in unapproved indication1,571 reports
vomiting1,544 reports
condition aggravated1,532 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE XIPERE ® (triamcinolone acetonide injectable suspension) 40 mg/mL is indicated for the treatment of macular edema associated with uveitis. XIPERE ® is a corticosteroid indicated for the treatment of macular edema associated with uveitis. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dosage is 4 mg (0.1 mL) administered as a suprachoroidal injection. ( 2.1 ) 2.1 Dosing Information For suprachoroidal injection using the SCS Microinjector ® . The recommended dose of XIPERE ® is 4 mg (0.1 mL of the 40 mg/mL injectable suspension). 2.2 Preparation for Administration Suprachoroidal injection is performed under aseptic conditions. The components for administration include: One single-dose glass vial of triamcinolone acetonide injectable suspension 40 mg/mL One SCS Microinjector ® syringe with vial adapter attached One 30-G x 900-µm needle One 30-G x 1100-µm needle Step 1 Figure A Remove the tray from the carton (see Figure A). The tray consists of two compartments: An open, non-sterile compartment that holds the vial A sealed compartment that contains a sterile tray Step 2 Figure B Examine the tray for damage (see Figure B). Ensure that the sealed compartment cover is intact and that there is no evidence of damage. If damage is present, do not use. Step 3 Figure C Remove the vial from the tray (see Figure C). Examine the vial and ensure there is no evidence of damage. Set aside for use in Step 6. Step 4 Figure D Peel off th…

Contraindications

4 CONTRAINDICATIONS Ocular or periocular infections ( 4.1 ) Hypersensitivity to triamcinolone or any component of this product ( 4.2 ) 4.1 Ocular or Periocular Infections XIPERE ® is contraindicated in patients with 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. 4.2 Hypersensitivity XIPERE ® is contraindicated in patients with known hypersensitivity to triamcinolone acetonide or any other components of this product.

Adverse Reactions

6 ADVERSE REACTIONS In controlled studies, the most common adverse reactions reported by ≥ 10% of patients and at a rate greater than control included elevated intraocular pressure and eye pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. XIPERE ® was studied in a multicenter, randomized, sham-controlled, double-masked study in patients with macular edema associated with uveitis. Table 1 summarizes data available from the clinical trial for XIPERE ® treated patients and control patients. The most common ocular (study eye) adverse reactions occurring in ≥ 2% of patients and non-ocular adverse reactions occurring in ≥ 5% of patients are shown in Table 1. Table 1: Ocular Adverse Reactions Reported in ≥ 2% of Patients and Non-ocular Adverse Reactions Reported in ≥ 5% of Patients a Includes in…

Frequently Asked Questions

What is Xipere used for?

Xipere contains triamcinolone acetonide. It is a injection, suspension taken ophthalmic. Consult your doctor for specific uses.

Is Xipere a controlled substance?

Xipere is not classified as a controlled substance by the DEA.

What is the generic name for Xipere?

The generic name for Xipere is triamcinolone acetonide. There are 12 other brand versions of triamcinolone acetonide.

What is the NDC code for Xipere 40 mg/mL?

The NDC (National Drug Code) for Xipere 40 mg/mL is 24208-040, listed by Bausch & Lomb Incorporated.

Product NDC

24208-040

Package NDC

24208-040-01

Other Triamcinolone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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