中文药名: 典必殊（地塞米松妥布霉素）

药品名称
【别名】妥布霉素-地塞米松滴眼剂,点必舒,典必殊

生产厂家
Alcon Labratories Inc. 爱尔康

规格
滴眼剂:0.3%妥布霉素 0.1%地塞米松;
眼膏剂:每克含妥布霉素3.0mg 地塞米松1.0mg.

药理作用
妥布霉素具有广谱抗菌作用，能够有效地杀灭细菌、控制感染，并具有极佳的角膜安全性和更为持久的PAE（抗菌素后续作用时间）；地塞米松具有抗炎效果显著、角膜穿透力好等优点。妥布霉素和地塞米松的结合充分发挥了各自的优点，能够非常安全有效地控制眼部感染及炎症。

适应症
*术前、术后预防、治疗感染与炎症反应
*结膜炎、外周角膜炎、泪囊炎与化学灼伤
*RK、PRK术前、术后

用法用量
*混悬液：1-2滴/4-6小时，最初1-2天可增至2小时一次
*眼药膏：取1-1.5cm长的药膏点入结膜囊中，3-4次/日，或仅睡前用
*术后用药方法：　　
术后第1、2天，每两小时一次，每次2滴；第3-14天，每日四次，每次1滴；以后逐减（注：注意监测眼压）。
任何疑问，请遵医嘱！

不良反应
有过敏反应,如眼睑发痒与红肿,结膜红斑.

禁忌症　　
树枝状角膜炎。牛痘、水痘及其它因滤过性病毒引起的角膜炎、结膜炎。眼睛分枝杆菌感染。眼结构的真菌感染；对本品任何成份过敏者及角膜上异物未完全去除者。

【原产地英文商品名】TOBRADEX EYE DROPS 5mls/bottle
【原产地英文药品名】TOBRAMYCIN SULFATE/DEXAMETHASONE
【中文参考商品译名】
注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
·典必殊滴眼液 10毫升/瓶
·典必殊滴眼液 2.5毫升/瓶
·典必殊滴眼液 5毫升/瓶
·典必殊ST滴眼液 5毫升/瓶
【中文参考药品译名】硫酸妥布霉素/地塞米松
【生产厂家中文参考译名】爱尔康
【生产厂家英文名】ALCON

TobraDex®
(tobramycin and dexamethasone ophthalmic ointment)
Sterile
DESCRIPTION
TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone are presented below:

Each gram of TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) contains: Actives : tobramycin 0.3% (3mg) and dexamethasone 0.1% (1mg). Preservative : chlorobutanol 0.5%. Inactives : mineral oil and white petrolatum.

CLINICAL PHARMACOLOGY

Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. Dexamethasone is a potent corticoid.

The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms:

Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Bacterial susceptibility studies demonstrate that in some cases microorganisms resistant to gentamicin remain sus ceptible to tobramycin.

No data are available on the extent of systemic absorption from TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment); however, it is known that some systemic absorption can occur with ocularly applied drugs. The usual physiologic replacement dose is 0.75 mg daily. The administered dose for TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) in both eyes four times daily would be 0.4 mg of dexamethasone daily.

INDICATIONS AND USAGE

TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) is indicated for steroidresponsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:

Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillinresistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

CONTRAINDICATIONS

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

WARNINGS

NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction does occur, discontinue use.

Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, ste roids may mask infection or enhance existing infection.

PRECAUTIONS

General

The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. When multiple prescriptions are required, or whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Ophthalmic ointment may retard corneal wound healing.

Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.

Information for Patients

Do not touch tube tip to any surface, as this may contaminate the contents. Contact lenses should not be worn during the use of this product.

Do not use the product if the imprinted carton seals have been damaged, or removed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted to evaluate the carcinogenic or mutagenic potential. No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at doses of 50 and 100 mg/kg/day.

Pregnancy Category C

Corticosteroids have been found to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy. Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well controlled studies in pregnant women. TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

ADVERSE REACTIONS

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available. The most frequent adverse reactions to topical ocular tobramycin (TOBREX® tobramycin ophthalmic ointment) are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration. The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection. The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

OVERDOSAGE

Clinically apparent signs and symptoms of an overdose of TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

DOSAGE AND ADMINISTRATION

Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac(s) up to three or four times daily.

How to apply TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) :

1. Tilt your head back.

2. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid.

3. Place a small amount (about 1/2 inch) of TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) in the "V" pocket. Do not let the tip of the tube touch your eye.

4. Look downward before closing your eye.

Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

HOW SUPPLIED

3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35).

STORAGE: Store at 2°- 25°C (36°- 77°F).