Ciprodex (Ciprofloxacin/Dexamethasone)

When antimicrobial treatment is used

Ciprodex is a combined liquid medicine with 2 active ingredients. It is used only to treat ear infections caused by bacteria. The medicine (sterile solution, 7.5 mL) is put into the ear and must not be swallowed, injected or used in any other way.

The aims of treatment are to clear the infection, ease pain or swelling, and help prevent complications. In the UK, the choice of treatment is usually based on the clinician's assessment of the infection and how severe the symptoms are.

Unless your doctor tells you otherwise, this medicine 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 eardrum).

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

How it works

Ciprodex is a combined anti-infective medicine. 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 give the product its dosage form.

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

This substance has strong bactericidal activity against most susceptible pathogens. Because of its properties, it is used to treat infectious diseases of different severity, 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 biosynthesis is disrupted and the microorganism's genetic code is damaged.
• The pathogen dies (bactericidal effect).

Pathogens are destroyed with minimal release of bacterial structural components (endotoxins), which may help reduce the risk of complications.

Dexamethasone is a synthetic corticosteroid with anti-inflammatory effects, similar to a natural hormone produced by the adrenal glands. It was first synthesised 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 formulation to help reduce this inflammatory response.

Dosage guide

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

In most cases, Ciprodex is used in the same way for all patients. The dose does not depend on age, the type of illness, how severe the infection is, or the type of microorganism causing it.

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

Important: read the instructions for putting in the drops and using the DROP-TAINER bottle correctly. After using the drops, patients with AOE should press gently on the tragus (the small cartilaginous flap on the outer ear). This helps the medicine enter the middle ear.

Treatment works best when the drops are used at the same times each day. It is best to plan a dosing schedule in advance and stick to it throughout the course.

How safe is Ciprodex?

The effectiveness and safety of Ciprodex have been studied in clinical trials. The results showed that the medicine provided 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 possible risks. As with any treatment for infection, Ciprodex ear drops can cause side effects and are not suitable for everyone in the UK.

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

Side effects reported with 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 linked to irritability
• Dysgeusia (distortion of taste)
• Redness (flushing)
• Fungal infection
• Vomiting or nausea

If your body tolerates Ciprodex well, the risk of these reactions is low. Even if they do happen, they are usually mild, generally well tolerated and pass quickly. Side effects are not a reason to stop treatment on your own.

Allergic reactions may occur if Ciprodex comes into contact with the skin or if 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 the drops in

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

Read the instructions for Ciprodex ear drops before giving this medicine to children or adults.

• To remove the protective cap, twist 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 greatly on following these recommendations:

• Keep good hygiene habits to help prevent infection.
• Make sure the hands of the person putting in the drops are clean.
• If you keep the drops in a cool place, warm the bottle in your hands or place it in warm, clean water. Cold drops can cause discomfort and dizziness.
• Help young children stay calm. A favourite toy can be a useful distraction.
• 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, tip down, a few centimetres above the ear.
• Do not let the dropper tip touch anything.
• Put the drops into 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, allow any excess drops to drain out.

Important information to know

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

It is also not known whether the active ingredients can be absorbed in amounts that would be detectable in breast milk and passed to a breastfed baby.

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

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

Long-term antibiotic use increases the risk of fungal infections. Broad-spectrum antibiotics should not be used for longer than prescribed.

Who should not use it

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

• Hypersensitivity to the active substances or any other ingredient in the solution.
• Allergy to any corticosteroid or quinolone medicine.
• 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 medicine in a damaged bottle.

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

Do not use Ciprodex after the expiry date.

Store Ciprodex ear suspension (7.5 mL) in a dark place to protect it from daylight and UV rays. Exposure can degrade the active ingredients.

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

Keep this medicine out of the reach of children and pets.