【药品名称】
商品名：那特真Natacyn
通用名：那他霉素眼用混悬液
英文名：Natamycin Eye Drops
汉语拼音：Natameisu Yanyong Hunxuanye
【成分】
每毫升混悬液含有：活性成份：5%那他霉素50mg。保存剂：0.02%氯化苄烷胺。非活性成份：氢氧化钠和/或盐酸（作为中和剂来调定pH值），蒸馏水。
15毫升玻璃瓶装，并附有消毒滴管。
【简介】
美国药典认可的唯一眼用抗真菌滴眼剂， 众多专家一致推荐的一线眼部抗真菌药物； 杀灭眼部念珠菌、曲霉菌、镰刀菌的首选治疗药物。
【临床药理学】
那特真-那他霉素是一种从NATALENSIS链霉菌中提取的四烯烃类抗菌素。在体外具有抗多种酵母菌和丝状真菌，包括念珠菌，曲霉菌，头孢子菌，镰刀霉菌和青霉菌的作用。其作用机制是通过药物分子与真菌细胞膜中的固醇部分结合，形成多烯固醇复合物，改变细胞膜的渗透性，使真菌细胞内的基本细胞成份衰竭。虽然这种抗真菌作用与药物剂量相关，但那他霉素仍是明显的抗真菌剂。那他霉素在体外对工地兰氏阳性菌和革兰氏阴性菌没有作用。局部应用那他霉素可以在角膜实质层内聚积压达到有效浓度但在眼内液中却不能达到。局部滴用5%那他霉素不可能全身吸收。如同其他多烯烃类抗生素，通过胃肠道吸收该药的量非常微小。免滴用那他霉素的研究结果表明，在房水和血清中测不出该药物，但测量的敏感度不超过2mg/ml。
【适应症】
5%的那他霉素适用于对本品敏感的微生物引起的真菌性睑炎、结膜炎和角膜炎，包括腐皮镰刀菌角膜炎。如同其他类型的溃疡性角膜炎那样，应根据临床诊断、涂片和角膜乔片培状等实验室检查，以及对药物的反应来确定真菌性角膜炎开始及持续治疗的时间。
【用法】
使用前请充分摇匀。应用5%那他霉素治疗真菌性角膜炎的最佳开始剂量为每次1滴，每1-2小时1次，滴入结膜囊内。3-4天后改为每次1滴，每天6-8次。治疗一般要持续14-21天，或者一直持续到活动性真菌性角膜炎消退。大多数病例，每隔4-7天逐渐减少药物剂量，对确保消除病原体的复制是非常必要的。治疗真菌性睑炎和结膜炎初始剂量可以小一些，为每次一滴，每天4-6次。
【禁忌症】
对那特真中任一成份有过敏史的患者禁用。
【注意事项】
1.一般：只限于眼部滴用，不能注射使用。使用本品7-10天后，若角膜炎没有好转，则提示引起感染的微生物对那他霉素不敏感。应根据临床再次检查和其他实验室检查结果决定是否继续治疗。
2.患者须知：勿触及药瓶瓶口，以防药液污染。
3.孕妇和哺乳妇女慎用。
【不良反应】
据报道出现过一例球结膜水促和充血的病例，但实际上是因为过敏引起的。
【贮存】
可于2-8℃（36-46℉）冰箱内保存。或在8-24℃（46-75℉）室温下保存，不宜冰冻。避免光照或过热。
【规格】
15ml:750mg
【批准文号】
注册证号H20080104
【生产企业】
企业名称：Alcon Laboratories, Inc
Generic Name: natamycin
Dosage Form: ophthalmic suspension
Natacyn®
(natamycin ophthalmic suspension) 5%
Sterile
DESCRIPTION:
Natacyn® (natamycin ophthalmic suspension) 5% is a sterile, antifungal drug for topical ophthalmic administration. Each mL of the suspension contains: Active: natamycin 5% (50 mg). Preservative: benzalkonium chloride 0.02%. Inactive: sodium hydroxide and/or hydrochloric acid (neutralized to adjust the pH), purified water.
The active ingredient is represented by the chemical structure:
Established name: Natamycin
Molecular Formula: C33H47NO13
Molecular Weight: 665.73
Chemical name: Stereoisomer of 22-[(3-amino-3,6-dideoxy- β-D-mannopyranosyl)oxy]-1,3,26- trihydroxy-12- methyl-10-oxo-6,11,28- trioxatricyclo[22.3.1.05,7] octacosa-8,14,16,18,20-pentaene-25- carboxylic acid.
Other: Pimaricin
The pH range is 5.0 - 7.5.
CLINICAL PHARMACOLOGY:
Natamycin is a tetraene polyene antibiotic derived from Streptomyces natalensis. It possesses in vitro activity against a variety of yeast and filamentous fungi, including Candida, Aspergillus, Cephalosporium, Fusarium and Penicillium. The mechanism of action appears to be through binding of the molecule to the sterol moiety of the fungal cell membrane. The polyenesterol complex alters the permeability of the membrane to produce depletion of essential cellular constituents. Although the activity against fungi is dose-related, natamycin is predominantly fungicidal. Natamycin is not effective in vitro against gram-positive or gram-negative bacteria. Topical administration appears to produce effective concentrations of natamycin within the corneal stroma but not in intraocular fluid. Systemic absorption should not be expected following topical administration of Natacyn® (natamycin ophthalmic suspension) 5%. As with other polyene antibiotics, absorption from the gastrointestinal tract is very poor. Studies in rabbits receiving topical natamycin revealed no measurable compound in the aqueous humor or sera, but the sensitivity of the measurement was no greater than 2 mg/mL.
INDICATIONS AND USAGE:
Natacyn® (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. Whenever possible the in vitro activity of natamycin against the responsible fungus should be determined. The effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established.
CONTRAINDICATIONS:
Natacyn® (natamycin ophthalmic suspension) 5% is contraindicated in individuals with a history of hypersensitivity to any of its components.
PRECAUTIONS: General.
FOR TOPICAL OPHTHALMIC USE ONLY — NOT FOR INJECTION. Failure of improvement of keratitis following 7-10 days of administration of the drug suggests that the infection may be caused by a microorganism not susceptible to natamycin.
Continuation of therapy should be based on clinical re-evaluation and additional laboratory studies.
Adherence of the suspension to areas of epithelial ulceration or retention of the suspension in the fornices occurs regularly. Use only if the container is undamaged.
Information for Patients:
Do not touch dropper tip to any surface, as this may contaminate the suspension. Patients should be advised not to wear contact lenses if they have signs and symptoms of fungal blepharitis, conjunctivitis, and keratitis.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
There have been no long term studies done using natamycin in animals to evaluate carcinogenesis, mutagenesis, or impairment of fertility.
Pregnancy:
Pregnancy Category C. Animal reproduction studies have not been conducted with natamycin. It is also not known whether natamycin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Natacyn® (natamycin ophthalmic suspension) 5% should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when natamycin is administered to a nursing woman.
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:
The following events have been identified during post-marketing use of Natacyn® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to their seriousness, frequency of reporting, possible causal connection to Natacyn®, or a combination of these factors include: allergic reaction, change in vision, chest pain, corneal opacity, dyspnea, eye discomfort, eye edema, eye hyperemia, eye irritation, eye pain, foreign body sensation, parethesia, and tearing.
DOSAGE AND ADMINISTRATION:
SHAKE WELL BEFORE USING. The preferred initial dosage in fungal keratitis is one drop of Natacyn® (natamycin ophthalmic suspension) 5% instilled in the conjunctival sac at hourly or two-hourly intervals. The frequency of application can usually be reduced to one drop 6 to 8 times daily after the first 3 to 4 days. Therapy should generally be continued for 14 to 21 days or until there is resolution of active fungal keratitis. In many cases, it may be helpful to reduce the dosage gradually at 4 to 7 day intervals to assure that the replicating organism has been eliminated. Less frequent initial dosage (4 to 6 daily applications) may be sufficient in fungal blepharitis and conjunctivitis.
HOW SUPPLIED:
Natacyn® (natamycin ophthalmic suspension 5%) is a 15mL fill packaged in a 15mL amber glass bottle with a black phenolic closure. A flint glass dropper with a red plastic closure and a black rubber bulb are packaged separately in a clear plastic blister with Tyvek backing.
NDC 0065-0645-15
STORAGE: Store between 2-24°C (36-75°F). Do not freeze. Avoid exposure to light and excessive heat.