CIPRODEX- ciprofloxacin and dexamethasone suspension
Rebel Distributors Corp
(ciprofloxacin 0.3% and dexamethasone 0.1%)
Sterile Otic Suspension
IMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE USE.
What is CIPRODEX® Otic?
CIPRODEX® Otic 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 6 months 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® Otic?
• Do not use this product if allergic to ciprofloxacin or to other quinolone antibiotics.
• Do not use this product if allergic to dexamethasone or to other steroids.
• Do not give this product to pediatric patients who are less than 6 months old.
How often should CIPRODEX® Otic be given?
CIPRODEX® Otic ear drops should be given 2 times each day (about 12 hours apart, for example, 8 AM and 8 PM) in each infected ear unless the doctor has instructed otherwise. The best times to use the ear drops are in the morning and at night. It is very important to use the ear drops for as long as the doctor has instructed, even if the symptoms improve. If CIPRODEX® Otic ear drops are not used for as long as the doctor has instructed, the infection may return.
What if a dose is missed?
If a dose of CIPRODEX® Otic 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® Otic?
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® Otic?
During the testing of CIPRODEX® Otic for middle ear infections, the most common side effect related to CIPRODEX® Otic was ear discomfort that occurred in up to 3 out of 100 patients. Other common side effects were: ear pain; ear precipitate (residue); irritability; and abnormal taste. During the testing of CIPRODEX® Otic for ear canal infections, the most common side effect related to CIPRODEX® Otic was itching of the ear that occurred in 1 to 2 out of 100 patients. Other common side effects were: ear debris; ear infection in the treated ear; ear congestion; ear pain; and rash.
If any of these side effects persist, call the doctor.
If an allergic reaction to CIPRODEX® Otic occurs, stop using the product and contact your doctor.
DO NOT TAKE BY MOUTH
If CIPRODEX® Otic is accidentally swallowed or overdose occurs, call the doctor immediately. This medicine is available only with a doctor's prescription. Use only as directed. Do not use this medicine if outdated. If you wish to learn more about CIPRODEX® Otic, call your doctor or pharmacist.
CIPRODEX® Otic is supplied as follows: 7.5 mL fill in a DROP-TAINER® system. The DROP-TAINER® system consists of a natural polyethylene bottle and natural plug, with a white polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.
NDC 21695-969-75, 7.5 mL fill
Store at controlled room temperature, 15°C to 30°C (59°F to 86°F). Avoid freezing. Protect from light.
U.S. Patent Nos. 6,284,804; 6,359,016
Licensed to Alcon, Inc. by Bayer Schering Pharma AG.
CIPRODEX is a registered trademark of Bayer AG, licensed to Alcon, Inc by Bayer AG.
©2003, 2004, 2008, 2009 Alcon, Inc.
Relabeled by: Rebel Distributors Corp
Thousand Oaks, CA 91320
How should CIPRODEX® Otic be given?
1. Wash hands
The person giving CIPRODEX® Otic should wash his/her hands with soap and water.
2. Warm & shake bottle
Hold the bottle of CIPRODEX® Otic in the hand for one or two minutes to warm the suspension, then shake well.
3. Add drops
The person receiving CIPRODEX® Otic should lie on his/her side with the infected ear up.
Patients should have 4 drops of CIPRODEX® Otic put into the infected ear. The tip of the bottle should not touch the fingers, or the ear, or any other surfaces.
BE SURE TO FOLLOW INSTRUCTIONS BELOW FOR THE PATIENT'S SPECIFIC EAR INFECTION.
4. For Patients with Middle Ear Infection with Tubes:
While the person receiving CIPRODEX® Otic 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.
5. 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.
6. 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.