Ciprofloxacin is used in pediatrics to treat children during a tympanostomy surgery—insertion of ear tubes. This surgical procedure is done in children with the condition bilateral otitis media with effusion. The condition occurs when thick or sticky fluid builds up behind the ear drum in the middle ear and causes an infection.
The ear suspension is given via the intratympanic route, which is into the middle ear through the ear drum. The single-dose treatment is injected into each ear, following suction of the effusion (fluid). Ear tubes are then inserted through the ears drums.
The medicine is safe and effective for use in pediatrics. It attacks and kills the bacteria present and prevent further growth in the middle ear. Treatment with this suspension in children younger than 6 months of age is not recommended.
Any decision to use this drug should be made after the risks and benefits were carefully assessed and it was determined safe for the patient.
This medicine may interact with other prescription drugs, over-the-counter (OTC’s) medicines, and vitamin or herbal supplements. Tell your doctor of all medications and products your child is taking or plans to take.
To determine whether the medication is safe for your child, consider the following:
Allergies: Patients allergic to Ciprofloxacin should not use it. Tell your child’s doctor or healthcare professional if your child is allergic to it. The medicine may also have inactive ingredients that may trigger an allergic reaction. Any allergy to foods, preservatives, dyes, or animals should be disclosed.
Pediatrics: The suspension medicine is proven to be safe and effective for use in children 6 months of age and older. It should not be used in children younger than 6 months old because its safety and efficacy have not yet been established.
Side effects are common with the use of most medicines. Some of them are needed and expected. Others are unwanted and can become bothersome or serious. Not all side effects may occur in one patient, and if any does it may or may not require medical attention.
The following is a list of side effects that may require medical attention. Since your child will be at a hospital or medical center when this medicine is administered, speak with the doctor or nurse immediately if you notice the following symptoms:
• Ear pain or discomfort (felt where the medicine was injected)
• Soreness of the throat
• Stuffy or runny nose
• Muscle pain or aches
• Feeling unusually tired or weak
Side effects that do not require medical attention usually go away on their own. If any of them become bothersome or gets worse, tell your doctor or healthcare professional. You may also ask about ways to prevent or reduce these effects.
Other side effects that are not listed here may occur. If you notice any other effects, speak with your child’s doctor or healthcare professional.
Side effects may be reported to the FDA by calling 1-800-FDA-1088.
Ciprofloxacin ear suspension will be given to your child at the hospital or medical center during the surgical procedure. A doctor or other healthcare professional will administer the medication. This medicine will be injected into your child's middle ear.
For treating bilateral otitis media with effusion
Children (6 months of age and older): A single dose of 0.1 mL (6 mg) suspension should be injected into each affected ear, following suctioning of the fluid backed up in the middle ear.
Your child’s doctor will determine the dose best suited to your child.
The medicine is given as a single-dose injection.
This medicine is given directly to the patient by a doctor or healthcare professional. No risk of patient-induced overdose.
Other drugs may interact with Ciprofloxacin when they are used together during treatment. Certain combinations of medicines should not be used at all. But the use of other medicines may be required for the health of the patient. If it becomes necessary to do so, caution should be taken to avoid serious adverse reactions.
In such cases, your doctor may change any of the medicines you are taking or may change the dose. Other precautions may also be taken, such as changing how often you take any of the medicines.
The medication is not recommended to be used with any of the medicines mentioned in the list below. They were selected based on their potential to cause significant interaction with the antibiotic suspension.
Tell your doctor if your child is using or plan to use any of them. Your doctor may decide against treatment with this medication or change one or more of the other medicines your child takes.
Using Ciprofloxacin with any of the medicines on the following list is usually not recommended. In cases where it is necessary to do so, your child’s doctor may change the dose of one or more of the medicines and how often any of them should be taken.
• Arsenic Trioxide
• Insulin Bovine
• Insulin Lispro, Recombinant
• Insulin Glargine, Recombinant
• Perflutren Lipid Microsphere
• Cholera Vaccine, Live
• Insulin Detemir
• Doxorubicin Hydrochloride Liposome
• Insulin Degludec
• Insulin Aspart, Recombinant
• Insulin Glulisine
• Sodium Phosphate
• Sodium Phosphate, Monobasic
• Sodium Phosphate, Dibasic
An increased risk of serious side effects may occur if Ciprofloxacin is used with any of the following medicines. However, using one or more of them during treatment with this antibiotic medicine may be best for your child. If any of the medicines is prescribed together, your child’s doctor may change the dose or how often any of them should be taken.
• Lanthanum Carbonate
• Mycophenolate Mofetil
Your child’s doctor may tell you if the use of alcohol, tobacco, and certain foods may cause interaction with this medicine. The substance mentioned below was selected based on its potential to cause a significant interaction. Using it during treatment may cause an increased risk of certain side effects. If it is necessary to be used together, your doctor may change the dose or how often you use it.
Other medications or substances not listed in this guide may also cause adverse interaction when used together with this medicine.
• Your child should not use Ciprofloxacin ear suspension if he or she is allergic to it or any of its ingredients.
• Call your child’s doctor if your child’s ear becomes painful or fluid continues to drain from the ear past the first few days of the ear tube procedure.
• Keep all follow-up appointments so your child’s doctor can examine your child to see if he or she is recovering well.
Patients are not required to store this medicine since it is administered on site by a doctor or other healthcare professional during the tympanostomy surgery.
The use of Ciprofloxacin (Otiprio) during surgery for removal of middle ear effusion and placement of ear tubes into a patient’s ears is safe and effective.
There are few known side effects and no known interaction with other medical problems. This makes the antibiotic ear suspension a preferred medicine for treating children undergoing a tympanostomy operation.
The administration of the medicine does not present any challenges for patients as this is done by a doctor or healthcare professional. A single dose is administered then the surgical procedure is carried out.
Children under 6 months of age should not be given this medication because its safety and efficacy have not been established.