FDA批准治疗急性中耳炎的局部疗法Ciprodex Otic
7月21日，Alcon公司称，FDA已批准其上市Ciprodex Otic用于局部治疗6个月及以上儿童因鼓膜留置通气管造成的急性中耳炎（AOMT）。FDA也批准Ciprodex Otic用于常见于游泳爱好者的急性外耳炎（AOE）的治疗，AOE适应症的应用对象包括儿童，成人及老年人。这是目前为止FDA批准的第一种将环丙沙星有效的抗菌活性和地塞米松的抗炎特性相结合用于治疗耳部感染的局部用药。
由于可使更高浓度的药物直接作用于感染部位，靶向局部疗法对于耳部感染的治疗非常有效。感染引起的炎症能阻碍滴耳液到达病灶处，干扰药物抗菌作用的发挥。应用一种甾体炎药物就可以减少伴随感染发生的炎症反应。而Ciprodex Otic正是将抗炎药物地塞米松和广谱抗菌素环丙沙星充分结合，从而取得了更好的临床治愈率，更有效地达到了除菌效果。
复方环丙沙星/地塞米松滴耳液
每年中耳炎感染数以百万计的儿童，是仅次于普通感冒的第二大发病率高的疾病。阿尔康（Alcon）公司的复方环丙沙星/地塞米松耳用制剂（商品名：Ciprodex Otic），用于局部治疗≥6岁儿童用鼓膜穿刺术管引起的急性中耳炎的中耳感染。本品还可用于治疗急性外耳炎（这是一种常见的耳部感染，亦称为游泳者耳），适用于儿童、成人（包括老年患者）。Ciprodex Otic是首个将具有强效抗菌活性的环丙沙星与具有消炎作用的肾上腺皮质激素类药地塞米松结合治疗耳局部感染的制剂。
局部靶位治疗耳部感染是非常有效的，因直接作用于感染部位所形成的药物浓度高，滴入本品至患病部位以抗菌作用来防止感染造成的炎症。甾体激素可减少感染引起的炎症反应。Ciprodex
Otic结合消炎药地塞米松与广谱抗菌药环丙沙星提高了临床治愈率和细菌根除率。
CIPRODEX®* Otic Suspension
CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) is the only otic combination therapy that combines a steroid with a fluoroquinolone antibiotic, to reduce swelling and fight infection in both the middle and outer ear.
Patients should try to keep the treated area dry and clean and should avoid getting the infected ear wet. Patients should not touch the bottle tip to any surface including the hand to avoid the risk of contamination.
This product should not be taken by patients with a sensitivity or allergy to ciprofloxacin or any other of its ingredients. Safety and efficacy have not been determined in children under six months of age. Caution should be used when administering this drug to pregnant or nursing women. The most common side effect of CIPRODEX® Otic Suspension is ear discomfort. Other common side effects include itching of the ear and ear debris, as well as other effects. If you experience any of these symptoms contact your doctor. For full U.S. prescribing information, see the product insert below.
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Ciprodex
Generic Name: ciprofloxacin and dexamethasone otic (sih pro FLOCK sah sin and dex ah MEH thah sone)Brand Names: Ciprodex
What is Ciprodex?
Ciprodex ear drops contain ciprofloxacin and dexamethasone.
Ciprofloxacin is a fluoroquinolone antibiotic.
Ciprofloxacin fights bacteria in the body.
Dexamethasone is a steroid.
It is used to reduce inflammation caused by an infection.
Ciprodex is used to treat ear infections. It works by killing bacteria by stopping the production of essential proteins needed by the bacteria to survive.
Ciprodex may also be used for purposes other than those listed.
Important information about Ciprodex
Do not use this medication in the eyes or take it by mouth.
Ciprodex is intended for use in the ears only.
Do not touch the dropper opening to any surface, including the ears or hands.
The dropper opening is sterile.
If it becomes contaminated, it could cause another infection in the ear.
Notify your doctor if the condition does not improve or appears to worsen.
Before using Ciprodex
Do not use Ciprodex without first talking to your doctor if you have had a previous allergic reaction to it or to another similar oral or topical medication such as: a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), sparfloxacin (Zagam), or trovafloxacin (Trovan);an oral or injectable steroid such as cortisone (Cortef, Cortone), dexamethasone (Decadron), dexamethasone (Hydrocortone), methylprednisolone (Medrol), prednisolone (Prelone, Pediapred), prednisone (Orasone, Deltasone), and others; ora topical steroid such as betamethasone (Diprosone, Diprolene), clobetasol (Temovate, Olux), fluocinolone (Synalar, Synemol, Fluonid), fluocinonide (Lidex), fluticasone (Cutivate), halobetasol (Ultravate), mometasone (Elocon), triamcinolone (Aristocort), and others.
You may not be able to use Ciprodex, or you may require a dosage adjustment or special monitoring during treatment.
Ciprodex is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby.
Do not use Ciprodex without first talking to your doctor if you are pregnant or could become pregnant during treatment.
It is not known whether Ciprodex passes into breast milk. Do not use Ciprodex without first talking to your doctor if you are breast-feeding a baby.
How should I use Ciprodex?
Use Ciprodex exactly as directed by your doctor.
If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Do not use this medication in the eyes or take it by mouth. Ciprodex is intended for use in the ears only.
In general, Ciprodex should be used as follows:Warm the drops slightly by holding them in the hands for 1 or 2 minutes. Administration of cold drops into the ear may cause dizziness.
Have another person administer the drops whenever possible.
Have the affected person lie on their side or tilt the ear up to make administering a drop easier.
Gently shake the drops just before administration.
For adults, gently hold the earlobe up and back. For children, gently hold the earlobe down and back.
This will allow the drops to run into the ear canal. Carefully instill the prescribed number of drops in the first ear.
Keep the ear tilted for at least 60 seconds to allow the medication to penetrate the ear.
If the patient being treated has ear tubes, the doctor may recommend gently pressing the tragus (part of the ear in front of the opening of the ear canal) five times in a pumping
motion after administration of the drops. This may allow the drops to pass through the tubes into the middle ear. Follow the doctor's instructions.
Repeat the process in the other ear if prescribed.Ciprodex ear drops are usually used twice a day, about 12 hours apart. Follow your doctor's instructions.
Use all of the medication that has been prescribed. Symptoms may begin to improve before the condition is completely treated.
If you do not use all of the medication prescribed, the condition could return or worsen.
It is important to use Ciprodex regularly to get the most benefit.
Notify your doctor if the condition does not improve or appears to worsen.
Avoid getting water inside of the affected ear(s) during treatment with Ciprodex. Care should be used while bathing and swimming may not be recommended. Talk to your healthcare
provider.
Store Ciprodex at room temperature, away from moisture, heat, and direct light. Keep the bottle properly capped.
What happens if I miss a dose?
Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose. Do not use a double dose of Ciprodex unless otherwise directed by your doctor.
What happens if I overdose?
Seek emergency medical attention if an overdose is suspected or if the medication has been ingested.
Symptoms of a Ciprodex overdose are not known.
What should I avoid while using Ciprodex?
Ear infections may sometimes cause dizziness or a loss of balance. Use caution when driving, operating machinery, or performing other hazardous activities if you experience
dizziness or a loss of balance. Avoid getting water inside of the affected ear(s) during treatment with Ciprodex. Care should be used while bathing and swimming may not be recommended.
Talk to your healthcare provider.Ciprodex side effects
Stop using Ciprodex and seek emergency medical attention or notify your doctor if you experience: an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);skin rash; orear drainage, discharge, or worsening pain.
Other less serious side effects may also occur such as ear discomfort or itching or an unusual taste in the mouth.
Continue to use the medication and talk to your doctor if these side effects seem excessive or unusual.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect my Ciprodex?
Do not use other ear drops during treatment with Ciprodex without first talking to your doctor.
Drugs other than those listed here may also interact with Ciprodex. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including
vitamins, minerals, and herbal products.
附件：
201261301140840.pdf
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产地国家: 美国
原产地英文商品名:
CIPRODEX OTIC DROPS SUSPENSION 7.5ML/BOTTLE
原产地英文药品名:
CIPROFLOXACIN/DEXAMETHASONE
中文参考商品译名:
CIPRODEX OTIC混悬滴剂 7.5毫升/瓶
中文参考药品译名:
环丙沙星/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 PHARMS LTD 