CETRAXAL PLUS 0.25 mg/mL + 3 mg/mL ear drops – fluocinolone acetonide and ciprofloxacin, 10 mL

When is CETRAXAL PLUS used and how should the ear drops be administered? CETRAXAL PLUS 0.25 mg/mL + 3 mg/mL contains fluocinolone acetonide, a co..

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When is CETRAXAL PLUS used and how should the ear drops be administered?

CETRAXAL PLUS 0.25 mg/mL + 3 mg/mL contains fluocinolone acetonide, a corticosteroid with anti-inflammatory activity, and ciprofloxacin, a fluoroquinolone antibiotic.

It is indicated in adults and children aged 6 months and older for acute otitis externa and acute otitis media in patients with tympanostomy tubes when caused by bacteria susceptible to ciprofloxacin.

Important warning
CETRAXAL PLUS is a prescription medicine intended only for use in the ear. It must not be used for viral or fungal ear infections. Do not discontinue the prescribed antibiotic treatment simply because symptoms improve.

Active substances	Fluocinolone acetonide + ciprofloxacin
Strength	0.25 mg/mL + 3 mg/mL
Dosage form	Ear drops, solution
Pack	10 mL dropper bottle
Age	Adults and children aged 6 months and older
Supply	Prescription medicine

What is CETRAXAL PLUS used for?

It is used for acute inflammation of the outer ear and acute middle-ear inflammation in patients with tympanostomy tubes when caused by bacteria susceptible to ciprofloxacin.

Ciprofloxacin acts against susceptible bacteria while fluocinolone acetonide reduces inflammation.

Dosage

The recommended dose for adults and children is 6 to 8 drops into the affected ear twice daily for 7 days, approximately every 12 hours.

How to administer CETRAXAL PLUS

Wash your hands.
Warm the bottle in your hand for several minutes.
Tilt the head so the affected ear faces upwards.
Instil 6–8 drops without touching the ear or fingers with the dropper.
For patients with tympanostomy tubes, gently press the tragus four times using a pumping motion.
For otitis externa, gently pull the earlobe forwards and backwards.
Remain in this position for approximately 1 minute.

Who should not use CETRAXAL PLUS?

Do not use the medicine in patients allergic to ciprofloxacin, other quinolones, fluocinolone acetonide or any ingredient. It must not be used for viral or fungal ear infections.

Warnings and precautions

Contact the doctor if symptoms do not resolve after one week or become worse. Medical advice is also required if blurred vision or another visual disturbance occurs.

The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions, including delayed reactions.

When should urgent medical help be sought?
Stop treatment and seek medical help immediately if swelling of the face, lips, mouth or throat, difficulty breathing or swallowing, hives, a severe rash, sores or another sign of serious hypersensitivity occurs.

Other medicines

Tell the doctor or pharmacist about all medicines being used. Concomitant administration with other ear preparations is not recommended.

Pregnancy and breast-feeding

There are no adequate controlled studies in pregnant women. The doctor assesses the expected benefit against potential risk. Caution is advised during breast-feeding because it is not known whether the medicine is excreted in breast milk.

Driving and using machines

Because of its properties and route of administration, CETRAXAL PLUS does not affect the ability to drive or use machines.

Possible side effects

Common effects include ear discomfort, ear pain, itching and taste disturbance. Uncommon effects may include tinnitus, burning, blocked-ear sensation, reduced hearing, redness, discharge, swelling of the outer ear, fungal infection, dizziness, headache, vomiting or fatigue. Blurred vision has been reported with unknown frequency.

Missed dose

Do not use a double dose. Continue with the next dose according to the prescribed schedule.

Overdose or accidental ingestion

In the event of overdose or accidental swallowing, contact a doctor, pharmacist or the nearest healthcare facility.

Pharmacist's advice
Warm the bottle in your hand for several minutes before use and do not touch the ear or fingers with the dropper. Remain with the affected ear facing upwards for about one minute after administration and complete the prescribed 7-day course even if symptoms improve sooner.

Ljubica Barbulović, Master of Pharmacy

Availability and price
CETRAXAL PLUS is supplied on prescription and is not available for purchase through the online store. Please contact the pharmacy directly for current availability and price.

Related category

For ear hygiene and care products, see Ear problems. Hygiene products, supplements and medical devices are not substitutes for prescribed antibiotic therapy.

Composition

Each millilitre contains 0.25 mg fluocinolone acetonide and 3 mg ciprofloxacin as ciprofloxacin hydrochloride.

The formulation contains, among other ingredients, methyl parahydroxybenzoate, propyl parahydroxybenzoate, povidone K90-F and purified water.

Pack

CETRAXAL PLUS is supplied in a dropper bottle containing 10 mL of solution.

Marketing authorisation holder and manufacturer

Marketing authorisation holder: AMICUS SRB D.O.O., Belgrade.
Manufacturer: LABORATORIOS SALVAT, S.A., Spain.

Storage

Store according to the conditions stated on the original package and keep out of the sight and reach of children. Use the bottle only for the prescribed treatment and do not save it for a future self-initiated course.

Frequently asked questions

How many CETRAXAL PLUS drops are used?
The recommended dose is 6–8 drops into the affected ear twice daily.

How long does treatment last?
The recommended course is 7 days.

Can CETRAXAL PLUS be used in children?
According to the official leaflet, it is used from 6 months of age.

Can it be used in patients with tympanostomy tubes?
Yes. Acute otitis media in patients with tympanostomy tubes is an approved indication.

Can it be used for viral or fungal infections?
No. The medicine must not be used in these situations.

Should the bottle be warmed?
Yes. Hold it in the hand for several minutes before administration.

What if a dose is missed?
Do not use a double dose. Continue with the next scheduled dose.

When should the doctor be contacted again?
If symptoms do not resolve after treatment, worsen or signs of serious hypersensitivity occur, contact a doctor.

Official sources

ALIMS – CETRAXAL PLUS Patient Information Leaflet
ALIMS – CETRAXAL PLUS Summary of Product Characteristics

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For all orders received up to 12h from Monday to Friday, the approximate delivery time is 2-4 business days for the whole territory of the Republic of Serbia. In case the order is placed on weekends (Saturdays and Sundays), the delivery is done as well as for the orders received on Monday - so next business day.

Deliveries are not made on Saturdays and Sundays.

Additional information

The items will be packed so that they cannot be damaged by normal handling of the goods in transit. When picking up the product, the buyer is obliged to check for any damage and immediately advertise it to the courier who delivered the goods, or refuse to take over the shipment, which shows the external damage. Any subsequent product claims for shipping damage will not be considered.

When picking up the product, the customer is required to sign the delivery note taken by the Daily Express delivery worker. The delivery note is considered to be a receipt and delivery note.

The courier service delivers the goods to the address, ie. does not bring into the living space.

Delivery restrictions on goods

Delivery of items purchased on the site www.apotekaonline.rs is made exclusively through the Daily Express courier service in the territory of the Republic of Serbia. Delivery outside the territory of the Republic of Serbia, ie export of goods, is done exclusively through the service of DHL and PostExport Post of Serbia.

Shipping cost

For the territory of the Republic of Serbia:

For goods ordered up to 5.000,00 RSD, delivery charge is 260.00 RSD (VAT included). For goods over 5.000,00 RSD, shipping is free of charge.

For international delivery:

For the export of goods abroad through the PostExport service of Post of Serbia, the shipping price is for:

Zone I (Slovenia, Croatia, Bosnia and Herzegovina, Montenegro, Northern Macedonia) - 1,280.00 RSD
Zone II (Other European countries) - 1,790.00 RSD
Zone III (Asia, Africa, America, Australia and other countries) - 2,650.00 RSD

Delivery time is 15 days or more (depending on the country of delivery)

For export of goods abroad through DHL service, the shipping price is 2,700.00 RSD. Delivery time is 1-5 business days (depending on the country of delivery)

Shipping cost is with tax. The price includes the delivery of the parcel to the buyer's address with the associated tax and customs at the seller's expense. A possible additional cost may be a customs charge against the buyer, depending on the country to which the package is being shipped.

For any additional questions, complaints or checking the current location of your shipment, please contact us at the following e-mail address: info@apotekaonline.rs