Cetraxal drug information: Ingredients, uses, safe doses

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Posted by Pharmacist Nguyen Thi Bich Phuong - Clinical Pharmacist - Faculty of Pharmacy - Vinmec Ha Long International Hospital
Cetraxal is a sterile solution for ear drops. For the effective use of the drug, users need to follow the instructions of the doctor or pharmacist.

1. Composition and indications for use of Cetraxal

Cetraxal is a sterile solution of ear drops containing ciprofloxacin. This is a fluoroquinolone antibiotic with bactericidal action. Each ml of solution contains 2 mg of ciprofloxacin as the hydrochloride salt. Each single-dose tube contains 0.25 ml of solution, containing 0.5 mg of ciprofloxacin (as the hydrochloride salt).
The drug is officially indicated in adults and children ≥1 year of age with acute otitis externa caused by bacteria sensitive to ciprofloxacin. However, Cetraxal is also contraindicated in people who are hypersensitive to ciprofloxacin, quinolone antibiotics and any of its ingredients.
Objects to be used with caution are:
Children under 1 year old. Cetraxal is not for eye drops, inhalation, or injection. Discontinue if skin rash or hypersensitivity reaction occurs.

2. Dosage and how to use Cetraxal

Dosage of Cetraxal: Instill 1 tube/time x 2 times/day into the inflamed ear. The recommended duration of treatment is: 7 days. Accordingly, users should note: The expiry date after opening the package containing the ampoules is 8 days (It is recommended that the doctor prescribes the number of boxes of 15 tubes for 1 course of treatment).
How to use the medicine as follows:
Hold the vial in your hand for a few minutes before using it to warm it up (To reduce the feeling of dizziness when cold drops are put into the ear canal). The patient lies with the inflamed ear facing up and drops the medicine into the ear, done several times. Hold the position for 5 minutes to allow the medicine to penetrate into the ear. Discard single dose ampoules after administration, should not be reused. If an instrument is used to deliver medication to the ear, the first dose should be doubled (2 tubes instead of 1 tube).

3. Some notes when using Cetraxal

Side effects when using Cetraxal to pay attention:
Common: Ear itching, headache and pain in the ear drops Uncommon: Dizziness, headache, dermatitis, tinnitus. Rare: Skin rash, toxic epidermal detachment, exfoliative dermatitis, Stevens-Johnson syndrome and urticaria During use, users should pay attention to skin symptoms, risk of perforation of the eardrum. To avoid drug interactions, patients should not use other ear drops concurrently. Cetraxal is a topical drug, so systemic absorption is negligible, so it can be used in pregnant women. It is not known whether Cetraxal is excreted in breast milk after ear drops, because systemic absorption is negligible, so it can be used in lactating women.
Cetraxal can cause dizziness, headache. Although this undesirable effect is uncommon, caution should be exercised when driving or operating machinery while taking the drug. Store Cetraxal at a temperature below 30°C, in the original packaging to protect from light.
Cetraxal is an antibiotic prescribed by doctors to treat inflammation of the outer ear canal. To ensure effective treatment, patients need to take prescription drugs, in case of serious side effects, patients need to go to medical centers for examination and treatment.

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References: SPC product information sheet, Update accessed on July 21, 2020.