CETRAXAL PLUS ear (otic) drops … Ciprofloxacin+Fluocinolone  .. treatment of bacterial ear infectionotic

CETRAXAL PLUS is a solution for auricular use (in the ear). It contains: Ciprofloxacin, an antibiotic belonging to the group known as the fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections, and fluocinolone acetonide, a corticosteroid with anti-inflammatory and analgesic properties for treatment of swelling and pain.

Product information

Product CETRAXAL PLUS ear drops – single-dose container
Available concentrations   3 mg/ml + 0.25 mg/ml 
Arabic Content- click the name CETRAXAL PLUS ear drops -Arabic-Information
Company   LABORATORIOS NORMON ,S.A – SPAIN.
Agent in UAE   LUNATUS DRUG STORE
Agent in Lebanon   Pharma Group – Spephal
Active Ingredients Ciprofloxacin+ Fluocinolone 
Anatomical main group SENSORY ORGANS
Therapeutic subgroup OTOLOGICALS
Pharmacological subgroup   CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION
Chemical subgroup Corticosteroids (Fluocinolone ) and antiinfectives (Fluoroquinolones ) in combination
ATC code S02CA05
Legal status Prescription only

THERAPEUTIC INDICATIONS

CETRAXAL PLUS ear drops is used for the treatment of certain ear infections caused by bacteria that are sensitive to it, such as:

  • It is used in adults and in children aged 6 months and older to treat Acute otitis externa (infection of the outer ear).
  • It is used in adults and in children aged 6 months and older to treat Otitis media (infection of the middle ear) with draining ear tubes (tympanostomy tubes) of bacterial origin.
  • After 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

CETRAXAL PLUS  ear  drops (single-dose container) , Each 1 ml contains:

  • (Ciprofloxacin) 3.5 mg 
  • Fluocinolone 0.25mg
  • The other ingredients are polysorbate 80, glycerin, povidone and purified water.

What you need to know before you take CETRAXAL PLUS ear drops?

Do not take CETRAXAL PLUS 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 fluocinolone acetonide or any of the other ingredients of this medicine 
  • if you have an ear infection caused by a virus or fungus.

Warnings and precautions

  • This preparation should only be applied to the ear. It should not be swallowed, injected or inhaled. It should not be used in the eye.
  • 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.
  • 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 CETRAXAL PLUS 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 ear medicines is not recommended.

Children

There is insufficient clinical experience available on the use of CETRAXAL PLUS 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 CETRAXAL PLUS 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 CETRAXAL PLUS is used during breast-feeding since it is not known whether CETRAXAL PLUS is excreted in human milk.

 what is the recommended dose of  CETRAXAL PLUS ear drops?

  • Children of one year of age and adults: Instill 1- 2  drop in the affected ear(s) twice a day for 7 days.
  • Children less than one year of age: Not recommended.
  • CETRAXAL PLUS is intended to be administered into the ear only (auricular use).
  • Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
  • Only use CETRAXAL PLUS in both ears if your doctor told you to do so.
  • Your doctor will tell you how long your treatment with CETRAXAL PLUS will last. To make sure that the infection does not return, do not stop treatment early even if your ear(s) feel better.

Method of administration

  • How to use:

1. The person giving Cetraxal Plus should wash his or her hands with soap and water.

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

3. Detach the single-dose container from the pack.

4. Warm the ear drops by holding the single-dose container in your hands for 1 or 2 minutes.

5. Twist off the single-dose container cap.

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

7. Place all the content of 1 single-dose container in the ear.

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

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

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

Discard the single-dose container after the administration.

10. Repeat all steps, if necessary, for the opposite 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 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.
  • 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.

If you forget to take CETRAXAL PLUS ear drops

  • If you forget to take CETRAXAL PLUS 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 CETRAXAL PLUS ear drops

  • Never stop the treatment with CETRAXAL PLUS 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.

Uncommon: may affect up to 1 in 100 people:

  • Ear pruritus (itching), ringing in the ears.
  • Headache.
  • Dizziness.
  • Local skin reactions or irritation (Dermatitis).
  • Pain in the application site.

Very rare: may affect up to 1 in 10,000 people:

  • Rash.
  • Blistering and tissue break down (Toxic epidermolysis).
  • Redness and scaling of the skin (Exfoliative dermatitis).
  •  Serious allergic reaction with fever, red patches, joint pain and/or eye problems
    (Stevens-Johnson syndrome).
  •  Skin allergy with development of itchiness and wheals (Urticaria).

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 nearest hospital.

How to store CETRAXAL PLUS 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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