Ciprodex (Ciprofloxacin/Dexamethasone)

When antimicrobial treatment is used

Ciprodex is a combination liquid medication with 2 active ingredients, used only to treat ear infections caused by bacteria. This medicine (sterile solution, 7.5 mL) is placed in the ears. Do not swallow it, inject it, or use it in any other way.

The aims of treatment are to clear the infection, ease pain or swelling, and help prevent complications. Treatment is usually chosen by a doctor based on the type and severity of the infection.

Unless a doctor tells you otherwise, this medication may be suitable for:

• Patients with acute otitis externa (AOE).
• Children with acute otitis externa (AOE) after surgical re-aeration of the middle ear cavity (with a tympanostomy/myringotomy tube inserted into the tympanic membrane).

This solution is not intended for children under 6 months of age.

How it works

Ciprodex is a combination anti-infective medication. It contains two active ingredients that work together at the site of infection.

The active ingredients in Ciprodex are:

• Ciprofloxacin hydrochloride (HCl)
• Dexamethasone

The standard dose of 4 drops corresponds to 0.42/0.14 mg of ciprofloxacin/dexamethasone.

The solution also contains inactive ingredients that help create the final dosage form.

Ciprofloxacin HCl is an antimicrobial agent (a second-generation fluoroquinolone antibiotic). It has been used since the mid-1980s to treat a wide range of infections in different parts of the body and from different causes.

This ingredient has strong bactericidal activity against many susceptible bacteria. Because of these properties, it is used to treat infections of different types and severities, including severe infections.

When Ciprodex ear drops and their active ingredient ciprofloxacin HCl enter a bacterial cell through the outer membrane, the following happens:

• DNA synthesis is disrupted and the microorganism's genetic code is damaged.
• The pathogen dies (bactericidal effect).

This destroys the bacteria with minimal release of bacterial structural components (endotoxins), which helps reduce the risk of complications.

Dexamethasone is a synthetic corticosteroid with anti-inflammatory activity, similar to a naturally occurring hormone made by the adrenal glands. It was synthesized in the 1960s and is used to treat a range of conditions, including skin, eye, and ear conditions.

Bacterial infections are often linked with inflammation, especially in children. Dexamethasone is included in the formula to help reduce this inflammatory response.

Dosage guide

This medication comes in plastic bottles (DROP-TAINER) designed to make ear drops easier to use. The dropper bottle helps deliver drops of a consistent size.

In most cases, Ciprodex dosing is the same for all patients. It does not depend on age, the type of disease, the severity of the infection, or the type of microorganism causing the infection.

• Initial/optimal dose: 4 drops
• Dosing frequency: approximately every 12 hours

Important: read the instructions for putting in the drops and using the DROP-TAINER bottle correctly. After the drops are placed, patients with AOE should apply light pressure to the tragus (the small cartilaginous bump on the outer ear). This helps the medication enter the middle ear.

Treatment works best when the medication is used at the same times each day. It helps to set a schedule in advance and follow it for the full course.

How safe is Ciprodex?

The effectiveness and safety of Ciprodex have been studied in clinical trials. The results showed that the medication provides the expected effect regardless of the severity of the patient's condition, age, and other factors.

In most cases, the benefits of Ciprodex outweigh the potential risks. Like any treatment for an infection, Ciprodex ear drops can cause side effects and may not be right for everyone.

The drops mainly work on the surface of the ear and only very small amounts are absorbed into the bloodstream. Systemic exposure is negligible, so most side effects are local.

Reported side effects of Ciprodex include:

• Otalgia (ear pain)
• Unpleasant sensations in the ear
• Precipitate formation in the ear canal
• A feeling of blockage in the ear
• Behaviour changes associated with irritability
• Dysgeusia (distortion of taste perception)
• Redness (flushing)
• Fungal infection
• Vomiting or nausea

If your body tolerates Ciprodex well, the risk of these reactions is low. If they do happen, they are usually temporary and generally pass quickly. Do not stop treatment on your own just because side effects appear.

Allergic reactions may occur if Ciprodex comes into contact with the skin or if any of the ingredients are absorbed into the body. Signs of hypersensitivity, such as shortness of breath or a rash, should not be ignored. These reactions can be severe and need immediate medical attention.

How to put in the drops

The dose of Ciprodex is the same for children and adults. In young children, the ear canals are narrower than in adults, which can make the drops harder to use. Children may also be afraid of unfamiliar procedures and may resist.

Read the instructions for Ciprodex ear drops before giving this medication to a child or an adult.

• To open the protective cap on the bottle, turn it to the left.
• To dispense the drops, turn the open plastic bottle upside down.
• When the bottle is squeezed, the drops are released into the ear canal as directed.
• After use, close the bottle and store it as recommended.

The effectiveness and safety of antibacterial treatment depend a lot on following these recommendations:

• Follow good hygiene practices to help prevent infection.
• Make sure the hands of the person giving the drops are clean.
• If you keep the drops in a cool place, warm the bottle between your palms or place it in warm, clean water. Cold drops can cause discomfort and dizziness.
• Help young children stay calm. A toy or another distraction may help.
• Explain to older children that the procedure should not be painful.
• The patient should lie on their side on a flat surface with the affected ear facing up.
• Hold the open bottle with the tip pointing down a few centimetres above the ear.
• Do not let the dropper tip touch anything.
• Place the drops in the ear.
• For patients with AOE, press on the tragus to help the solution enter the middle ear.
• The patient should not sit up or turn their head for 1 minute.
• Repeat for the other ear if prescribed.
• After the procedure, let any extra drops drain out.

Important information you should know

Special studies on the effects of Ciprodex in pregnant women have not been carried out. It is not known whether this medication may harm the fetus.

It is also not known whether the active ingredients can be absorbed in amounts high enough to be detected in breast milk and passed to a nursing infant.

Ciprodex is used topically, but no medication is completely risk-free. Discuss your situation with your doctor. The benefits for the mother should outweigh any potential risks to the fetus or baby.

Ciprodex should only be used when needed. Always complete the full course of treatment.

Using antibiotics for a long time increases the risk of fungal infections. Do not use broad-spectrum antibiotics for longer than prescribed.

Contraindications

Ciprodex is contraindicated or should be delayed in the following cases:

• Hypersensitivity to the active ingredients or any component of the solution.
• Allergy to any corticosteroid or quinolone medication.
• Fungal, parasitic, or viral ear infections.

Driving

Based on clinical trials and post-marketing reports, Ciprodex has not been shown to affect the ability to:

• Drive.
• Do activities that require increased attention.

Storage

Do not store this medication in a damaged bottle.

Do not store this medication without the screw cap. This can change the properties of the solution or lead to contamination. The dropper tip must remain sterile. Keep the bottle tightly closed when you are not using the ear drops.

Do not use Ciprodex after the expiry date.

Store Ciprodex otic suspension (7.5 mL) in a dark place, protected from daylight and UV rays. Exposure can break down the active ingredients.

The best storage temperature is between 15°C (59°F) and 30°C (86°F). Do not freeze.

Keep this medication out of reach of children and pets.