Neofloxin D is a solution for auricular (in the Eye & Ear) and ocular (in the eye) use. It contains: Ciprofloxacin, an antibiotic belonging to the group known as the fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections, and Dexamethasone , a corticosteroid with anti-inflammatory and analgesic properties for treatment of swelling and pain.

Product information

THERAPEUTIC INDICATIONS

Neofloxin D Eye & Ear drops is used for the treatment of certain Eye & Ear infections caused by bacteria that are sensitive to it, such as:

for Eye:

• Bacterial conjunctivitis: (bacterial pink eye) is a bacterial infection of the eye which causes inflammation or swelling of the conjunctiva, Neofloxin D eye drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, Streptococcus pneumoniae and others.
• Bacterial keratitis: is an infection of the cornea (the clear dome covering the colored part of the eye) that is caused by bacteria.
• Corneal ulcers.
• superfacial infections of the eye.
• After eye surgeries to prevent infections or inflammations.

for Ear:

• It is used in adults and in children aged 6 months and older to treat Acute otitis externa (infection of the outer Eye & Ear).
• It is used in adults and in children aged 6 months and older to treat Otitis media (infection of the middle Eye & Ear) with draining Eye & Ear tubes (tympanostomy tubes) of bacterial origin.
• After Eye & Ear surgeries to prevent infections or inflammations.

You must talk to a doctor if you do not feel better or if you feel worse.

COMPOSITION

Neofloxin D Eye & Ear drops (5 ml container) , Each 1 ml contains:

• (Ciprofloxacin) 3 mg.
• Dexamethasone 1 mg.

• Preserved with benzalkonium chloride 0.1 mg / ml

What you need to know before you take Neofloxin D Eye & Ear drops?

Do not take Neofloxin D Eye & Ear drops if:

• Hypersensitivity to quinolones: (Ciprofloxacin) is contraindicated in persons with a history of hypersensitivity to (Ciprofloxacin), any member of the quinolone class of antimicrobial agents, or any of the product components.
• Hypersensitivity to Dexamethasone or any of the other ingredients of this medicine 
• Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.

Warnings and precautions

• This preparation should only be applied to the Eye & Ear. It should not be swallowed, injected or inhaled. 
• Once treatment has begun, if you develop urticaria (hives), skin rash or any other allergic symptoms (e.g. sudden swelling of face, throat or eyelids, respiratory difficulty), you must stop treatment immediately and you should consult with your doctor. Serious hypersensitivity reactions may need immediate emergency treatment.
• Tell your doctor if the symptoms do not improve before the end of the treatment. As with other antibiotic preparations, sometimes additional infections may occur caused by organisms which are not affected by Ciprofloxacin. In case of such infection, appropriate treatment should be started by your doctor.
• Patients wearing contact lenses must not use the drops during the time the lenses are worn.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Inform your doctor about all the medications you’re taking.

Other medicines and Neofloxin D Eye & Ear drops

• Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines, including medicines obtained without a prescription.
• Use in conjunction with other Eye & Ear medicines is not recommended.

Children

There is insufficient clinical experience available on the use of Neofloxin D Eye & Ear drops in children below 6 months, so talk to your doctor before giving this medicine if your child is this age.

Pregnancy, breast-feeding 

• It is a drug of pregnancy category-C.
• There are no adequate and well-controlled studies with Neofloxin D in pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• Caution should be exercised when Neofloxin D is used during breast-feeding since it is not known whether Neofloxin D is excreted in human milk.

 what is the recommended dose of  Neofloxin D Eye & Ear drops?

Eye:

• One or two drops to be instilled into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one to two drops every two hours. Frequency should be decreased gradually or warranted in clinical signs. Care should be taken not to discontinue therapy prematurely.

Ear:

• For all infections two to three drops every two to three hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs.

Method of administration

Eye:

1. 1. Wash your hands properly before using the medication.
   2. Turn the closed bottle upside down and shake to move the medicine into the tip of the bottle.
   3. Continue holding the bottle upside down and remove the cap.
   4. Tilt your head back and slightly pull your lower lid down.
   5. Hold the bottle over your eye and gently squeeze the bottle. Instill the number of drops required for both eyes. If a drop misses the eye, do it again.
   6. Put back the cap and close tightly. Keep in a cool, dry place.

Ear:

1. The person giving Neofloxin D should wash his or her hands with soap and water.

2. Gently clean any discharge that can be removed easily from the outer Eye & Ear. Do not insert any object or swab into the Eye & Ear canal.

4. Warm the Eye & Ear drops by holding the container in your hands for 1 or 2 minutes to avoid dizziness.

5. Twist off the container cap.

6. Tilt your/your child’s head to one side to keep the affected Eye & Ear up.

7. Place 1 2 drops  in the Eye & Ear.

8a. For patients with outer Eye & Ear canal infection, gently pull the outer Eye & Ear lobe upward and outward. This will allow the Eye & Ear drops to flow down into the Eye & Ear canal.

8b. For patients with middle Eye & Ear infection, pump the tragus (the small piece of cartilage found in front of the Eye & Ear canal) 4 times by pushing inward to allow the medicine to penetrate the middle Eye & Ear. This will allow the drops to pass through the tube in the Eye & Eardrum and into the middle Eye & Ear.

9. Keep the patient’s head tilted sideways for approximately 1 minute to allow the medicine time to penetrate the Eye & Ear. When instilling Eye & Ear drops, raising the head to the vertical position or moving too rapidly may cause some of the medicine to leak out of the Eye & Ear canal. This should be avoided as it may prevent the medicine from reaching the full depth of the Eye & Ear canal.

10. Repeat all steps, if necessary, for the opposite Eye & Ear.

It is important to follow these instructions to make sure this medicine works.

• Avoid touching the applicator tip with your fingers and ensure that it doesn’t touch the Eye & Ear when used.
• If any sign of allergic reaction occurs, immediately discontinue use and contact your doctor.
• Take the medication exactly as prescribed. Avoid missing doses and do not discontinue until full course of treatment has been completed.
• If you are using any other eye medications such as drops or ointments, give at least 5 minutes interval between the medications.
• Once opened, the medication can be stored in room temperature for up to 28 days.
• Unopened bottles can be stored in the fridge. Do not freeze the medication.

Properties

Dexamethasone

is glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. The potency of the compound is accomplished by the addition of a methyl radical and a fluorine atom to the prednisolone radical. Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects.

Ciprofloxacin

has cidal and inhibitory activities against bacteria which result from an interference with DNA gyrase, an enzyme needed by the bacterium for the synthesis of DNA. Thus, vital information from the bacterial chromosomes cannot be transcribed, which causes a break-down of bacterial metabolism. Ciprofloxacin has a very high in vitro activity against almost all gram negative microorganisms including Pseudomonas aeruginosa. It is also effective against gram positive bacteria, such as Staphylococci and Streptococci. Anaerobes are in general less susceptible.

If you forget to take Neofloxin D Eye & Ear drops

• If you forget to take Neofloxin D Eye & Ear drops, take your dose as soon as possible. If it is almost time for the next dose, just skip that dose and take the next one when it is due. If in doubt, please contact your doctor or pharmacist. If you have to skip a dose, still take all of your dose. This means that you will finish your course a day later.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Neofloxin D Eye & Ear drops

• Never stop the treatment with Neofloxin D Eye & Ear drops on your own, but first discuss this with your doctor. If the prescribed treatment is not completely finished, the infection may come back again.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• The most frequently reported drug-related adverse reactions seen with Ciprofloxacin are:  transient ocular burning or discomfort.
• Other reported reactions include:  stinging, redness, itching, conjunctivitis/keratitis, periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain.
• Rare reports of dizziness have been received.
• The reactions due to the steroid component are:  elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage, posterior sub capsular cataract formation, and delayed wound healing.
• If you consider that any of the side effects you suffer are serious, or if you notice any side effects
  not listed in this leaflet, please tell your doctor or pharmacist.

overdose

Symptoms of overdose are unknown. In case of overdose, or if the medicine is accidentally swallowed, contact your doctor or pharmacist immediately or go to the nearst hospital.

How to store Neofloxin D Eye & Ear drops?

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Store in a cool and dry place.
• Do not use longer than 30 days after first opening.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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