英文药名: Tobi (Tobramycin Nebule)

中文药名: 妥布霉素吸入剂

品牌药生产厂家: Novartis

药品简介

妥布霉素(tobramycin)吸入液剂(TOBI)获欧盟许可，用于长期治疗囊性纤维化病人铜绿假单胞菌引起的慢性肺部感染，并获得许可用于6岁以上儿童。另据美国研究报道，本品可有效用于支气管扩张的病人。在这一II期临床研究中，78例这类病人随机接受本品喷雾剂一日2次(37例)或安慰剂，用药4周。此后病人再随访2周。4周治疗后，与安慰剂组相比，本品组痰中铜绿假单胞菌密度较基础水平有明显较大的减少(平均为-4.54对+0.02菌落对数单位/g痰)。本品组和安慰剂组痰中铜绿假单胞菌根除率分别为35%和0%。6周时，本品组和安慰剂组分别有62%和38%病人评定为身体情况改善。逻辑学回归分析显示，2、4和6周时铜绿假单胞菌密度的减低显然是身体情况改善的预示因子。妥布霉素喷雾剂溶液，商品名为Tobi。每安瓿含妥布霉素300mg/5ml，为无防腐剂喷雾剂水溶液。本品用于长期治疗5岁以上纤维囊泡症儿童由绿脓杆菌引起的肺部慢性感染。对氨基糖苷类药高敏病人禁用。

【剂量与用法】成人与儿童（5岁以上），推荐剂量为1月2次，每次1安瓿，一个疗程为28日。用药间隔尽可能达12小时，至少不小于6小时。一个疗程后，应休息28日。Tobi给药时手持PariLc Plus重复使用喷雾器，约吸15分钟。

【别名】妥布拉霉素，尼拉霉素因子6，抗普霉素，Distobram，Gernebcin，Obracin，Tobracin，Tobradistin，Tobrasix，Tobre,Tobrmycin Sulfate; Tobi (inhalation) 。等

【适应症】
1.主要用于假单孢菌（包括绿脓杆菌）以及其他革兰阴性杆菌所致的呼吸系统、皮肤、软组织、骨、腹腔感染及败血症等。
2.用于尿路感染治愈率可达79%，有效率为87.5%，尤其对单纯性尿路感染，疗效明显。对复杂性尿路感染的治愈率低，且易复发等。　　

【不良反应】
1.本品可引起耳毒性和肾毒性，但比庆大霉素低。耳毒性易发生在肾功能不良者或用药剂量大、疗程长时。其肾毒性主要表现是血肌酐值升高、蛋白尿、少尿或多尿。
2.偶见胃肠道反应，如恶心、呕吐等。此外，尚有皮疹、头痛、血清转氨酶升高、白细胞降低等。　　

【注意事项】
1.早产儿、新生儿及孕妇慎用。
2.对本品或其他氨基糖甙类抗生素过敏者禁用。
3.不应与强效利尿药、神经肌肉阻滞剂同时使用，肾功能减退者应酌情减量。

【原产地英文商品名】TOBI 300mg/5ml/ampule 56ampules/box
【原产地英文药品名】TOBRAMYCIN/0.25 NORMAL SALINE
【中文参考商品译名】TOBI 300毫克/5毫升/安瓿 56安瓿/盒
【中文参考药品译名】妥布霉素/0.25生理盐水
【生产厂家中文参考译名】诺华
【生产厂家英文名】NOVARTIS PHARMS

Tobramycin And 0.25 Normal Saline Inhalation
Important Note:
The Following Information Is Intended To Supplement, Not Substitute For, The Expertise And Judgment Of Your Physician, Pharmacist Or Other Healthcare Professional. It Should Not Be Construed To Indicate That Use Of The Drug Is Safe, Appropriate, Or Effective For You. Consult Your Healthcare Professional Before Using This Drug.

tobramycin Inhalation Solution - Oral
(toe-bruh-my-sin)
Common Brand Name(s): Tobi
Warning: This Drug Has Caused Kidney Problems, Nerve Damage Or Permanent Hearing Loss, Even At Usual Doses. Hearing Loss Can Occur Even After The Drug Is Stopped. If You Already Have Kidney Problems Or Hearing Difficulty, Tell Your Doctor. Notify Your Doctor Immediately If Any Of The Following Occur: Ringing In Your Ears, Hearing Loss, Unusual Change In Amount Of Urine, Dizziness, Numbness, Skin Tingling, Muscle Twitching Or Seizures. This Drug May Be Stopped If You Develop Kidney Or Hearing Problems. Your Doctor Will Monitor Your Progress To Minimize The Possibility Of These Effects Occurring And May Run Certain Tests (e.g., Hearing And/or Kidney Tests). Do Not Use This Medication With Other Drugs That Can Cause Nerve, Kidney Or Hearing Problems. Other Factors That Increase The Risk Of These Side Effects Occurring Include Advanced Age Or Dehydration (unusual Thirst).

Uses:
This Drug Is Used For Lung Infections (e.g., Pseudomonas) Occurring With Certain Lung Conditions (e.g., Cystic Fibrosis).

How To Use:
This Drug Is Inhaled Via A Nebulizer, Generally Twice Daily For 28 Days, Then 28 Days Off, Then Repeat The Cycle. It Is Advised To Inhale This Product Last If Other Inhalers Are Used At The Same Time Of Day. Follow All Directions And Learn Proper Use Of This Product (information Is In The Patient Guide Contained With The Product), And The Nebulizer (including Cleaning). Consult Your Pharmacist. Do Not Mix This Drug With Dornase Alfa In The Nebulizer. Antibiotics Work Best When The Amount Of Medicine In Your Body Is Kept At A Constant Level. Do This By Taking The Medication At Evenly Spaced 12 Hour Intervals Throughout The Day And Night. Stopping The Medication Too Early May Allow Bacteria To Continue To Grow Resulting In A Relapse Of The Infection. Continuing The Drug Beyond The Prescribed Period May Result In Increased Side Effects.

Side Effects:
Hoarseness Of Voice Might Occur. If This Effect Persists Or Worsens, Notify Your Doctor. Report Promptly: Wheezing, Trouble Breathing. Unlikely But Report Promptly: Ringing In The Ears, Hearing Trouble, Dizziness Or Unsteadiness. Very Unlikely But Report Promptly: A Major Change In Urine Amount, Muscle Weakness. In The Unlikely Event You Have An Allergic Reaction To This Drug, Seek Immediate Medical Attention. Symptoms Of An Allergic Reaction Include: Rash, Itching, Swelling, Dizziness, Trouble Breathing. If You Notice Other Effects Not Listed Above, Contact Your Doctor Or Pharmacist.

Precautions:
Before Using This Drug, Tell Your Doctor Your Entire Medical History, Including: Allergies, Hearing Or Balance (ear) Problems, Kidney Problems, Muscle Diseases (e.g., Parkinson's Disease), Asthma. This Drug Is Not Recommended For Use During Pregnancy. Consult Your Doctor Before Using This Drug. It Is Not Known Whether This Drug Is Excreted Into Breast Milk. Because Of The Potential Risk To The Infant, Breast-feeding While Using This Drug Is Not Recommended. Consult Your Doctor Before Breast-feeding.

Drug Interactions:
Tell Your Doctor Of All Nonprescription And Prescription Medication You May Use, Especially Of: Other Antibiotics (e.g., Other Aminoglycosides; Vancomycin, Minocycline), Dornase Alfa, "platin"-type Cancer Drugs (e.g., Cisplatin), Urea, Certain "water Pills" (e.g., Ethacrynic Acid, Furosemide), Mannitol. Do Not Start Or Stop Any Medicine Without Doctor Or Pharmacist Approval.

Overdose:
If Overdose Is Suspected, Contact Your Local Poison Control Center Or Emergency Room Immediately. This Medicine May Be Harmful If Swallowed.

Notes:
This Medication Has Been Prescribed For Your Current Condition Only. Do Not Share This With Others. Medical Tests Will Be Performed To Monitor Your Treatment.

Missed Dose:
If You Miss A Dose, Use It As Soon As You Remember. If It Is Less Than Six Hours Before The Next Dose, Skip The Missed Dose And Resume Your Usual Dosing Schedule. Do Not "double-up" The Dose To Catch Up.

Storage:
Store This Product In The Refrigerator Between 36 And 46 Degrees F (2-8 Degrees C) Away From Light And Moisture. However, If Necessary (e.g., Transporting This Drug) You May Store The Foil Pouches (opened Or Unopened) At Room Temperature Up To 77 Degrees F (25 Degrees C) For Up To 28 Days. Do Not Freeze.