Generic Name and Formulations:
Triamcinolone acetonide ext-rel 32mg; per vial; susp for intra-articular inj after dilution.
Flexion Therapeutics, Inc.
Indications for ZILRETTA:
Osteoarthritis pain of the knee.
Limitations Of use:
Not intended for repeat administration.
Give 32mg (5mL) as a single intra-articular inj.
Not interchangeable with other injectable triamcinolone acetonide formulations. For intra-articular injection only. Not for epidural or intrathecal use; serious neurologic events may occur. Not suitable for use in small joints (eg, hand). Previously infected or unstable joints: not recommended. Increased risk of infections (viral, bacterial, fungal, protozoan, or helminthic). May mask signs of current infection. Avoid exposure to chickenpox or measles if unvaccinated. HPA axis suppression. Adrenal insufficiency. Supplement with additional corticosteroids in physiologic stress (eg, trauma, surgery, illness). Hypo- or hyperthyroidism. Patients with CHF, hypertension, renal insufficiency: monitor; dietary salt restriction and K+ supplementation may be necessary. Elevated intraocular pressure (monitor). Increased GI perforation risk in those with active or latent peptic ulcers, diverticulosis, diverticulitis, ulcerative colitis, intestinal anastomoses; avoid. Increased osteoporosis risk (eg, postmenopausal women). Emotional instability or psychiatric disorder; monitor for new or worsening behavior or mood disturbances. Pregnancy. Nursing mothers.
Potentiated by CYP3A4 inhibitors (eg, ketoconazole), cyclosporine, estrogens, macrolide antibiotics. Antagonized by CYP3A4 inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin), cholestyramine. May potentiate cyclosporine (seizure risk). May antagonize oral anticoagulants (monitor), isoniazid. Aminoglutethimide may lead to loss of corticosteroid-induced adrenal suppression. Increased risk of arrhythmias with digitalis. May need to adjust dose of antidiabetic agents. Increased GI effects with aspirin or other NSAIDs. Caution with aspirin in hypoprothrombinemia. Monitor for hypokalemia with K+-depleting drugs (eg, amphotericin B, diuretics). Withdraw anticholinesterase agents at least 24hrs before initiating corticosteroid therapy. May suppress reactions to skin tests. Defer routine vaccine or toxoid administration until corticosteroid is discontinued.
Sinusitis, cough, contusions; joint tissue damage, infection, cardiovascular effects, renal effects, GI perforation, endocrine function or bone density alterations, behavioral and mood disturbances; rare: anaphylaxis.
Single-dose kit—1 (vial + diluent + adapter)
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