Important Information about CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) sterile otic suspension
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.
Ciprodex® Otic is by prescription only.
IMPORTANT SAFETY INFORMATION
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.
Click here for full prescribing information for CIPRODEX® Otic
Important information about VIGAMOX® (moxifloxacin HCI ophthalmic solution) 0.5% as base
What is VIGAMOX® Solution?
VIGAMOX® Solution is an antibiotic eye drop used to treat bacterial conjunctivitis, (eye infection) caused by susceptible bacteria. VIGAMOX® Solution is available by prescription only.
The recommended dose of VIGAMOX® Solution for patients 1 year of age and older is 1 drop in the affected eye(s) 3 times a day for 7 days.
IMPORTANT SAFETY INFORMATION
Who should not use VIGAMOX® Solution?
Do not use VIGAMOX® Solution if you are allergic to moxifloxacin, the active ingredient of VIGAMOX® Solution, or medications in the same antibiotic class (quinolone antibiotics), or to any component in VIGAMOX® Solution.
What should I tell my healthcare provider before using VIGAMOX® Solution?
- Tell your healthcare provider about all your medical conditions, including:
- Any allergies, especially to quinolone antibiotics or any of the ingredients in VIGAMOX® Solution
- If you are pregnant, planning to become pregnant, or nursing
- Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines
- Tell your healthcare provider if you wear contact lenses. Contact lenses should not be worn in you have eye redness or other signs and symptoms of bacterial conjunctivis.
What the most common side effects of VIGAMOX® Solution?
The most common side effects of the eye reported with the use of VIGAMOX® Solution are eye inflammation, decreased vision, dry eye, eye discomfort, eye redness, eye pain, eye itching, and watery eyes. These side effects have occurred in approximately 1-6% of patients.
What are other possible side effects of VIGAMOX® Solution?
- Severe allergic reactions have been reported with other uses of moxifloxacin, the active ingredient of VIGAMOX® Solution. If a rash or allergic reaction to VIGAMOX® Solution occurs, immediately discontinue use and contact a doctor.
- Do not use VIGAMOX® Solution for longer than instructed by your doctor. Prolonged use may result in overgrowth of some organisms that are not susceptible to VIGAMOX® Solution.
- These are not all of the possible side effects of VIGAMOX® Solution. For more information about side effects, see the full Prescribing Information and speak with your healthcare provider or pharmacist.
What other information should I know while using VIGAMOX® Solution?
- VIGAMOX® Solution is for topical eye use only and should not be injected or swallowed.
- Do not wear contact lenses if you are experiencing eye redness or other signs or symptoms of bacterial conjunctivis.
- To prevent contamination of the dropper tip and solution, avoid touching the dropper tip to any surface.
For additional information about VIGAMOX® Solution, please see the full Prescribing Information.
Click here for full prescribing information for VIGAMOX® Solution