Indications for antimicrobial therapy
Ciprodex is a combined liquid preparation (2 active ingredients) intended only for the treatment of ear infections caused by bacterial pathogens. The drug (sterile solution 7.5ml) is instilled into the ears, it must not be swallowed, injected or used in any other way.
The goals of treatment are to fight infection, relieve pain or swelling, and prevent complications of infection.
Unless otherwise indicated by a physician, suitable candidates for medication use are:
- Patients with acute otitis externa (AOE).
- Children with acute otitis externa (AOE) after surgical re-aeration of the middle ear cavity (with tympanostomy/myringotomy tube inserted into the tympanic membrane).
The solution is not intended for children under 6 months of age.
Pharmacologic effect
Ciprodex is a combined anti-infective drug. It contains two active ingredients for a complex effect on the focus of infection.
Ciprodex ingredients that provide the pharmacological effect:
- Ciprofloxacin Hydrochloride (HCL)
- Dexamethasone
Standard dose of 4 drops of solution corresponds to 0.42/0.14 mg of Ciprofloxacin/Dexamethasone.
The solution also contains inert ingredients that combine with medicinal substances to create a product with a special dosage.
Ciprofloxacin HCL is an antimicrobial agent (2nd generation antibiotic from the fluoroquinolone class). It appeared on the pharmaceutical market in the mid-80s of the last century and is widely used to treat a wide variety of infections with different localization and etiology.
This substance has an extremely high degree of bactericidal activity against most pathogens susceptible to it. Due to its properties, it is suitable for the treatment of infectious diseases of any degree, including severe forms.
When Ciprodex otic solution and its active ingredient Ciprofloxacin HCL enter the bacterial cell through the outer membrane, the following occurs:
- The biosynthesis of DNA is disrupted and the genetic code of the microorganism is destroyed.
- The pathogen dies (bactericidal effect).
The destruction of pathogens of infectious diseases occurs with a minimum release of the structural components of the bacterial cell (endotoxins), which minimizes the risk of complications.
Dexamethasone is a synthetic corticosteroid with anti-inflammatory activity, similar to a naturally occurring hormone produced by the adrenal glands. It was synthesized in the 1960s and is used to treat a range of conditions, including skin, eye, and ear infections.
Bacterial infections are often associated with inflammatory reactions, especially in pediatric patients. Dexamethasone has been added to the drug formulation to help reduce the inflammatory response.
Dosage guide
This medication comes in plastic bottles (DROP-TAINER), especially designed for easy administration of liquid medication. Dropper bottles allow receiving drops (doses) of the same size.
Typically, Ciprodex drops dosage is the same for all patients. It does not depend on the age of the patients, the type of disease, the severity of the infection and the type of pathogenic microorganisms that caused the infection.
- Initial/optimal dose – 4 drops
- Dosing frequency – 1 time approximately every 12 hours
Important: read the recommendations for instillation of drops and the correct use of the DROP-TAINER dropper bottle. After instillation of the solution, patients with AOE should apply light pressure to the part of the ear known as the tragus. This will allow the medication to enter the middle ear.
Treatment is more effective when dosed at the same time. It is better to develop a specific dosing schedule in advance and adhere to it throughout the entire treatment course.
How safe is Ciprodex
The level of effectiveness and safety of Ciprodex has been extensively studied and examined during long-term medical trials. The test results showed that the drug provides the expected effect, regardless of the severity of the patient’s condition, age and other factors.
Usually, the benefits of Ciprodex outweigh the potential risks of treatment. As with any treatment for infectious diseases, Ciprodex ear drops can cause side effects and are not suitable for absolutely everyone.
Drops fall on the surface of the ear and weakly penetrate into the blood plasma. Systemic exposure to the solution is negligible, so most of the common side effects are local.
List of adverse reactions associated with the pharmacological activity of Ciprodex:
- Otalgia (ear pain)
- Unpleasant sensations in the ear area
- Formation of a precipitate of solution in the ear canal
- Feeling of blockage in the ear
- Changes in behavior associated with increased irritability
- Dysgeusia (distortion of the perception of the taste of food)
- Redness caused by blood flow to the capillaries of the skin
- Fungal infection
- Vomiting, urge to vomit
If the body adapts well to the action of Ciprodex, the risk of such reactions is minimal. Even if they occur, as a rule, they are not hazardous to health, are relatively easily tolerated by the patient and pass quickly. Adverse reactions are not a reason for stopping treatment on your own.
Allergic reactions may occur if Ciprodex suspension comes in contact with the skin surface or after the ingredients have entered the bloodstream. Signs of hypersensitivity (shortness of breath, rash, etc.) should not be ignored. These reactions can be severe and require immediate medical attention.
Drops instillation technique
Dosage of Ciprodex for kids is the same as it is for adults. An age-related feature of young children is narrower auditory canals compared to adults. This can complicate the procedure. In addition, children are often afraid of unfamiliar procedures and are often naughty during their implementation.
Read Ciprodex ear drops instructions before administering this medication to children or adults.
- To open the protective cap on the bottle, it must be turned to the left.
- To drip drops, an open plastic bottle must be turned upside down.
- When the bottle is squeezed, the drops are instilled into the ear canal according to the instructions.
- After use, bottle is closed and stored as recommended.
The effectiveness and safety of antibacterial treatment for children and adults largely depends on adherence to a number of recommendations:
- Practice good hygiene to prevent any infection.
- It is important that the hands of the person who instills the solution are absolutely clean.
- If you store drops in a cool place, warm them between the palms of your hands or place the bottle in warm, clean water. Cold drops can cause discomfort and dizziness.
- Young children need to be set up to be positive. They shouldn’t be naughty or cry. Suggest a distraction toy.
- An older child can be told everything and explained that the procedure does not cause pain.
- The patient should lie on his side on a horizontal surface with the ear facing up.
- An open bottle (bottom up) should be positioned a few centimeters above the patient’s ear.
- It must be remembered that the tip of the pipette must not come into contact with anything.
- Place the drops in your ear.
- Press on the tragus of patients with AOE (small cartilaginous protuberance on the outer ear) to allow the solution to enter the middle ear.
- The patient should not stand up or turn his head for 1 minute.
- Repeat the procedure for the other ear, if prescribed by the treatment.
- After the procedure, the patient must sit down. Let the extra drops leak out of the ear.
Important information you should know
Special studies on the effect of the active substances of Ciprodex on pregnant women have not been carried out. It is not known if this medicine may harm the fetus.
It is not known whether the active ingredients of the drug can penetrate the skin in sufficient quantities to be detected in breast milk and passed from mother to child through breast milk.
Ciprodex is used topically, but there are no completely safe and completely harmless drugs out there. Discuss this situation with your doctor. Benefits for women must justify the potential risks to the fetus or baby.
Ciprodex should only be used when really needed. Always complete the course of treatment.
Long-term antibiotic treatment is one of the risk factors for the onset and progression of a fungal infection. Do not use broad-spectrum antibiotics for longer than prescribed by treatment.
Contraindications
There are several categories of patients for whom Ciprodex treatment is contraindicated or should be delayed. An antibacterial agent should not be used in the following cases:
- Hypersensitivity to active substances or to any of the solution components.
- Allergy to any drugs of the corticosteroid or quinolone class.
- Fungal, parasitic, or viral ear infections.
Driving a car
According to the results of clinical trials and post-marketing studies, no cases were detected of the influence of Ciprodex over the ability to:
- Drive a car.
- Engage in 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 lead to a change in the properties of the solution or to contamination. The pipette tip must remain sterile. Keep the bottle tightly closed when not using ear drops.
Do not use Ciprodex for ears after the expiration date.
Store Ciprodex otic suspension 7.5ml in a dark place to protect from daylight and UV rays. Under their influence, the active ingredients can be destroyed.
The optimum storage temperature is between 15°C and 30°C. Avoid freezing.
This may seem obvious, but you must make sure that the medicine is stored out of reach of children or pets.