美国 FDA批准Alcon公司的合成糖皮质激素曲安奈德40mg/mL无防腐剂注射混悬液(triamcinolone acetonide,Triesence)上市,用于玻璃体摘除术的视觉恢复和治疗对局部使用糖皮质激素类药物无效的交感性眼炎、颞动脉炎、眼色素层炎及眼炎症。
本品中的曲安奈德治疗视网膜疾病已使用了多年。此次新批准的药品为眼科医生提供了专门治疗各种视网膜炎症的无防腐剂无菌眼用制剂。推荐除恢复视觉外的所有适应证初始剂量为4 mg(0.1 m L的40 mg/mL的混悬液);推荐除恢复视觉外的初始治疗剂量为玻璃体内给予1~4 mg(0.025~0.1 m L的40 mg/mL的混悬液)。
TRIESENCE® Ophthalmic Suspension
TRIESENCE® (triamcinoline acetonaide injectable suspension) 40 mg/ml is a preservative-free injectable suspension designed and approved for intraocular use in the United States, for treatment of uveitis, certain types of eye inflammation unresponsive to topical corticosteroids, sympathetic ophthalmia, and temporal arteritis. The drug is also approved for use in assisting with visualization of the retina during surgery. For more information on surgical indications, see surgical products.
TRIESENCE® suspension is contraindicated in patients with systemic fungal infection and those with hypersensitivity to triamcinolone or any component of this product. Ophthalmic side effects may include cataracts, infections, and glaucoma.
曲安奈德注射混悬液(TRIESENCE,TRIAMCINOLONE ACETONIDE INJ)
玻璃体内注射曲安奈德
TRIESENCE
Last Updated: March 27, 2008
Manufacturer:
Alcon Laboratories, Inc.
Pharmacological Class:
Glucocorticoid
Active Ingredient(s):
Triamcinolone acetonide 40mg/mL; susp for intravitreal inj.
Indication(s):
Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Visualization during vitrectomy.
Pharmacology:
Triesence is a synthetic corticosteroid analog primarily used as an anti-inflammatory agent. It possesses glucocorticoid activity typical of this class of drug, but with little or no mineralocorticoid activity. Corticosteroids have been shown to depress the production of eosinophils and lymphocytes, while stimulating erythropoiesis and production of polymorphonuclear leukocytes. Inflammatory processes (eg, edema, fibrin deposition, capillary dilatation, migration of leukocytes, and phagocytosis) and the later stages of wound healing (eg, capillary proliferation, deposition of collagen, cicatrization) are inhibited.
Legal Classification:
Rx
Contraindication(s):
Systemic fungal infections. Live vaccination.
Adults & Children:
Give anesthesia and broad-spectrum microbicide prior to use. Ophthalmic diseases: initially 4mg (100microliters); may repeat if needed. Visualization: 1–4mg (25–100microliters) intravitreally.
Warnings/Precautions:
Not for IV administration. Ocular herpes simplex. Cerebral malaria: not recommended. Tuberculosis. If exposed to chickenpox or measles, consider prophylactic passive immune therapy. Strongyloides infestation. Latent amebiasis. Thyroid disorders. Diabetes. CHF. Hypertension. Recent MI. Renal insufficiency. GI perforation. Diverticulitis. Intestinal anastomoses. Peptic ulcer. Myasthenia gravis. Hypoprothrombinemia. Monitor for osteoporosis (esp. postmenopausal women) if on long-term therapy; do bone density tests. Supplement with additional steroids in physiologic stress. Monitor growth, weight, blood pressure, fluid and electrolyte balance. Avoid abrupt cessation. Pregnancy (Cat.D); (avoid in 1st trimester). Nursing mothers.
Interaction(s):
Potentiated by CYP3A4 inhibitors (eg, ketoconazole, macrolides), cyclosporine, estrogens. Antagonized by CYP3A4 inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin), ephedrine, cholestyramine. May potentiate cyclosporine. May antagonize anticoagulants (monitor), isoniazid. Increased risk of arrhythmias with digitalis. May need to adjust dose of antidiabetic agents. Increased GI effects with aspirin, other NSAIDs. Monitor for hypokalemia with potassium-depleting drugs (eg, amphotericin B, diuretics). Withdraw anticholinesterase agents at least 24 hours before starting corticosteroid therapy. May suppress reactions to skin tests.
Adverse Reaction(s):
Elevated intraocular pressure (monitor), cataracts, endophthalmitis, hypopyon, inj site reactions, glaucoma, vitreous floaters, retinal pigment epithelium detachment, optic disc vascular disorder, eye inflammation, conjunctival hemorrhage, reduced visual acuity, HPA axis suppression, masks infection, increased susceptibility to infection, hypertension, hypokalemia, weight gain, osteoporosis, behavioral or mood disturbances, myopathy, Kaposi’s sarcoma.
How Supplied:
Single-use vial (1mL)—1
Last Updated:
1/14/2009
TRIESENCE
最后更新:2008年3月27日,
制造商:
爱尔康公司
类药物:
糖皮质激素
活性成分(S):
玻璃体内注射曲安奈德40mg/mL; SUSP。
指示(S):
交感性眼炎,颞动脉炎,葡萄膜炎,眼反应迟钝外用皮质类固醇消炎条件。在玻璃体切割手术的可视化。