Ciprodex - Consumer Medicine Information
|Condition:||Otitis Media, Otitis Externa|
|Class:||Otic steroids with anti-infectives|
|Form:||Ear drops (otic)|
|Ingredients:||ciprofloxacin, dexamethasone, boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodium, purified water, sodium hydroxide and/or hydrochloric acid|
CIPRODEX (CI-PRO-DEX) Otic Suspension
(ciprofloxacin 0.3% and dexamethasone 0.1%)
What is CIPRODEX ?
CIPRODEX is an antibiotic/steroid combination product in a sterile suspension used to treat:
- Middle Ear Infection with Drainage Through a Tube in Children 6 months and older: A middle ear infection is a bacterial infection behind the eardrum. People with a tube in the eardrum may notice drainage from the ear canal.
- Outer Ear Canal Infection in Patients 1 year and older: An outer ear canal infection, also known as "Swimmer's Ear", is a bacterial infection of the outer ear canal. The ear canal and the outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal.
Who should NOT use CIPRODEX ?
- Do not use this product if allergic to ciprofloxacin or to other quinolone antibiotics, including nalidixic acid or to any of the components in this medication (See “What does CIPRODEX contain?”).
- Do not use this product if allergic to dexamethasone or to other steroids.
- Do not use this product if you have a viral infection of the external canal including herpes simplex infections.
- Do not give this product to pediatric patients who are less than 6 months old.
What does CIPRODEX contain?
CIPRODEX contains ciprofloxacin hydrochloride and dexamethasone as well as a preservative called benzalkonium chloride. CIPRODEX also contains: boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodium, purified water, sodium hydroxide and/or hydrochloric acid.
How should CIPRODEX be given?
- Wash hands
The person giving CIPRODEX Otic Suspension should wash his/her hands with soap and water.
- Warm & shake bottle
Hold the bottle of CIPRODEX in the hand for one or two minutes to warm the solution, then shake well.
- Add drops
The person receiving CIPRODEX should lie on his/her side with the infected ear up.
Patients should have 4 drops of CIPRODEX put into the infected ear. The tip of the bottle should not touch the fingers or the ear or any other surfaces.
- For Patients with Middle Ear Infection with Tubes: While the person receiving CIPRODEX lies on his/her side, the person giving the drops should gently press the tragus (see diagram) 5 times in a pumping motion. This will allow the drops to pass through the tube in the eardrum and into the middle ear.
- For Patients with Outer Ear Infection ("Swimmer's Ear"): While the person receiving the drops lies on his/her side, the person giving the drops should gently pull the outer ear lobe upward and backward. This will allow the ear drops to flow down into the ear canal.
- Stay on side
The person who received the ear drops should remain on his/her side for at least 60 seconds. Repeat Steps 2-5 for the other ear if both ears are infected.
BE SURE TO FOLLOW INSTRUCTIONS BELOW FOR THE PATIENT'S SPECIFIC EAR INFECTION.
How often should CIPRODEX be given?
CIPRODEX ear drops should be given 2 times each day (about 12 hours apart, for example, 8 AM in the morning and 8 PM in the evening) in each infected ear unless the doctor has instructed otherwise. It is very important to use the ear drops for as long as the doctor has instructed, even if the symptoms improve.
What if a dose is missed?
If a dose of CIPRODEX is missed, it should be given as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not use a double dose unless the doctor has instructed you to do so. If the infection is not improved after one week, you should consult your doctor. If you have two or more episodes of drainage within six months, it is recommended you see your doctor for further evaluation.
What activities should be avoided while using CIPRODEX ?
It is important that the infected ear(s) remain clean and dry. When bathing, avoid getting the infected ear(s) wet. Avoid swimming unless the doctor has instructed otherwise.
What are the possible side effects of CIPRODEX ?
During the testing of CIPRODEX Otic Suspension for middle ear infections, the most common side effect related to CIPRODEX was ear discomfort or ear pain that occurred in up to 3 out of 100 patients. Other common side effects were: white, flaking, scaling material in the ear; irritability; and abnormal taste. During the testing of CIPRODEX for ear canal infections, the most common side effect related to CIPRODEX was itching of the ear that occurred in 1 to 2 out of 100 patients. Other common side effects were: flaking and scaling material in the ear; fungus infection in the treated ear; feeling of fullness or plugging in the ear; ear pain; and skin rash. If any of these side effects continue, call the doctor. If an allergic reaction to CIPRODEX occurs, stop using the product and contact your doctor.
DO NOT TAKE BY MOUTH
If CIPRODEX is accidentally swallowed or overdose occurs, immediately contact your doctor or pharmacist for advice on how to proceed. Emergency care may be required. This medicine is available only with a doctor's prescription. Use only as directed. Do not use this medicine if the expiry date printed on the label has past. If you wish to learn more about CIPRODEX, call your doctor or pharmacist.
Store at room temperature, 15°C to 30°C. Avoid freezing. Store in carton.
Alcon Canada Inc.
Mississauga, Ontario L5N 8C7