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英文药名: Ocufen(flurbiprofen drops 0.03%)
中文药名: 氟比洛芬钠 0.03%滴眼液
生产厂家: Allergan
药品简介
通用名：氟比洛芬钠滴眼液
英文名：Flurbiprofen Sodium Eye Drops
主要成份
本品主要成份为：氟比洛芬钠。其化学名称为：消旋-2-(2-氟-4-联苯基)-丙酸钠。
性状
无色澄明液体。
药理作用
氟比洛芬为非甾体消炎药，动物研究证明具有镇痛、解热和消炎作用，其作用机制是抑制环氧化酶活性阻断前列腺素合成。前列腺素是某些眼内炎症的介质，可致血-房水屏障崩溃、血管扩张、血管通透性增加、白细胞趋化，引起与胆碱能机制无关的瞳孔缩小。临床研究表明，本品可抑制白内障手术时的瞳孔缩小，对眼内压无明显影响。非临床毒理研究 在小鼠或大鼠的长期研究中，没有发现氟比洛芬有致癌性及导致不育症。长期的致突变研究尚未进行。
药代动力学
人眼滴入0.03%氟比洛芬钠50ml后30分钟，在房水中可检测到药物，2小时达到峰值(60ng/ml)；平均滞留时间约3.7小时。
适应症
用于术后抗炎，治疗激光小梁成形术后的炎症反应和其他眼前段炎症。预防和治疗白内障人工晶状体植入术后的黄斑囊样水肿。也用于治疗巨乳头性结膜炎。抑制内眼手术中的瞳孔缩小。
用法用量
抑制内眼手术时的瞳孔缩小 术前2小时开始滴眼，每半小时点1滴，共4次。消炎和术后消炎 一日3～4次，一次1滴；用药2～3周。激光小梁成形术后 一日3～4次，一次1滴；用药1～2周。
不良反应
有短暂烧灼、刺痛或其他轻微刺激症状。
禁忌
对本品过敏者禁用。
注意事项
（1）该药可能影响血小板凝聚而延长出血时间，因此有出血倾向或服用其他使出血时间延长药物者要慎用。
（2）该药可能与乙酰水杨酸或其他非甾体消炎药存在交叉过敏，因此，对这些药物过敏者应慎用。
（3）急性眼部感染疾病在局部使用抗炎药时，可能掩盖病情。
（4）本品无抗菌作用，对眼部感染性疾病，应同时应用抗生素。
（5）有单纯疱疹病毒性角膜炎病史者，慎用本药。
孕妇及哺乳期妇女用药
已经发现，给大鼠每天口服氟比洛芬0.4mg/kg以上（约相当于人每日局部用量的67倍）时，可引起胚胎损害、分娩延长、妊娠延长、体重下降、胎儿生长轻度受阻。但尚无人体研究报道，因此孕妇应慎用。尚不清楚氟比洛芬是否可通过母乳分泌，考虑到许多药物可经乳汁分泌，而且氟比洛芬对哺乳期婴儿有严重不良反应，因此，或停止哺乳或停止用药，须选择其一。
儿童用药
本药对儿童的安全性和疗效尚未考察。
药物相互作用
虽然临床及动物实验显示氟比洛芬与氯化乙酰胆碱及卡巴胆碱无相互影响，也无相互影响的药理基础，但有报告指出，外科病人在使用氟比洛芬时氯化乙酰胆碱及卡巴胆碱失去作用。
药物过量
过量使用通常不引起急症，意外食入可饮水稀释。
贮藏
贮存于15～25℃，远离儿童存放。
Ocufen 0.03%(flurbiprofen sodium ophthalmic solution, USP)
SPL UNCLASSIFIED SECTION
sterile
DESCRIPTION
OCUFEN® (flurbiprofen sodium ophthalmic solution, USP) 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use.
Chemical Name:
Sodium (±)-2-(2-fluoro-4-biphenylyl) propionate dihydrate.
Structural Formula:
C15H12FNaO2•2H2O Mol. Wt. 302.27
Contains: Active: flurbiprofen sodium 0.03% (0.3 mg/mL). Preservative: thimerosal 0.005%. Inactives: citric acid; edetate disodium; polyvinyl alcohol 1.4%; potassium chloride; purified water; sodium chloride; and sodium citrate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. The pH of OCUFEN® ophthalmic solution is 6.0 to 7.0. It has an osmolality of 260 - 330 mOsm/kg.
CLINICAL PHARMACOLOGY
Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins.
Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, OCUFEN® ophthalmic solution has been shown to inhibit the miosis induced during the course of cataract surgery. Results from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure.
INDICATIONS AND USAGE
OCUFEN® ophthalmic solution is indicated for the inhibition of intraoperative miosis.
CONTRAINDICATIONS
OCUFEN® ophthalmic solution is contraindicated in individuals who are hypersensitive to any components of the medication.
WARNINGS
With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that OCUFEN® ophthalmic solution may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
There is the potential for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
PRECAUTIONS
General Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
It is recommended that OCUFEN® ophthalmic solution be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
Information for Patients Patients should be instructed to avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
To avoid the potential for cross-contamination, the patient should be advised to use one bottle for each eye with bilateral ocular surgery. The use of the same bottle of eye drops for both eyes is not recommended with ocular surgery.
Drug Interactions Interaction of OCUFEN® ophthalmic solution with other topical ophthalmic medications has not been fully investigated.
Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with OCUFEN® ophthalmic solution.
Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in mice and/or rats have shown no evidence of carcinogenicity with flurbiprofen. Long-term mutagenicity studies in animals have not been performed.
Pregnancy
Pregnancy Category C
Flurbiprofen has been shown to be embryocidal, delay parturition, prolong gestation, reduce weight, and/or slightly retard growth of fetuses when given to rats in daily oral doses of 0.4 mg/kg (approximately 300 times the human daily topical dose) and above.
There are no adequate and well-controlled studies in pregnant women. OCUFEN® ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from flurbiprofen sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
ADVERSE REACTIONS
Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of OCUFEN® ophthalmic solution. Other adverse reactions reported with the use of OCUFEN® ophthalmic solution include: fibrosis, hyphema, miosis, mydriasis, and ocular hyperemia.
Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported (see Warnings).
OVERDOSAGE
Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.
DOSAGE AND ADMINISTRATION
A total of four (4) drops of OCUFEN® ophthalmic solution should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery.
HOW SUPPLIED
OCUFEN® (flurbiprofen sodium ophthalmic solution, USP) is available for topical ophthalmic administration as a 0.03% sterile solution, and is supplied in a white opaque low density polyethylene bottle with a controlled dropper tip and a gray high impact polystyrene cap in the following size:
2.5 mL in 5 mL bottle - NDC 11980-801-03
Storage: Store at 15°-25°C (59°-77°F).
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产地国家: 美国
原产地英文商品名:
OCUFEN sodium ophthalmic 0.03% 2.5mL/5mL/bottle
原产地英文药品名:
flurbiprofen sodium ophthalmic
中文参考商品译名:
欧可芬0.03%滴眼液 2.5毫升/5毫升/瓶
中文参考药品译名:
氟比洛芬钠
生产厂家中文参考译名:
ALLERGAN
生产厂家英文名:
ALLERGAN
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