Medication info

Ciprofloxacin and Hydrocortisone Otic Suspension

Prescription medicationSuspensionApproval revoked
Ingredient · strength
Ciprofloxacin Hydrochloride Hydrate›2.329mg / 1mLHydrocortisone›10mg / 1mL
Manufacturer / importer
제이더블유신약(주)
Appearance
A slightly viscous, opaque white-yellow suspension in a white plastic container with a vinegar smell.
Packaging
5mL/bottle, 7/mL/bottle
Approval status
Approval revoked

MFDS item code 200600486 · Notified 2006.02.06

This product's status changed to Approval revoked on 2023.11.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of acute otitis externa
Who uses it
Adults · Children
Adult dosage
Adults : Instill 3 drops of this medication into the infected ear twice a day for 7 days. Shake well before use. Instilling cold solution into the ear may cause dizziness, so warm the container by holding it in your hand for 1-2 minutes before administration. The patient should lie down with the infected ear facing up while instilling the medication, allowing it to be absorbed more easily into the ear.
Children's dosage
Children (over 1 year) : Instill 3 drops of this medication into the infected ear twice a day for 7 days. Shake well before use. Instilling cold solution into the ear may cause dizziness.

Ingredients

Manufacturer
제이더블유신약(주)

Efficacy & effects

Treatment of acute otitis externa

  • Acute otitis externa
View approved original text

This medication is used to treat acute otitis externa caused by Staphylococcus aureus, Proteus mirabilis, Pseudomonas aeruginosa, among others.

Dosage and Administration

Adult dosage

Adults : Instill 3 drops of this medication into the infected ear twice a day for 7 days. Shake well before use. Instilling cold solution into the ear may cause dizziness, so warm the container by holding it in your hand for 1-2 minutes before administration. The patient should lie down with the infected ear facing up while instilling the medication, allowing it to be absorbed more easily into the ear.

Children's dosage

Children (over 1 year) : Instill 3 drops of this medication into the infected ear twice a day for 7 days. Shake well before use. Instilling cold solution into the ear may cause dizziness.

Precautions

This medication should not be administered to certain patients. Patients who are allergic to hydrocortisone, ciprofloxacin, or other quinolone antibiotics should not use this medication. Additionally, patients with a perforated eardrum or viral infections in the external ear canal such as chickenpox or herpes simplex should also avoid using this medication. Using this medication may result in various side effects such as migraine, sensory abnormalities, skin fungal infections, cough, rash, alopecia, etc. Occasionally, headaches or itching may also occur, and rarely, reported cases of sensory dullness in the ear, hearing impairment, and ear pain have been noted. Symptoms of blurred vision may also appear, so caution is advised. If any redness or allergic reactions appear on the skin, use should be discontinued immediately, and a doctor should be consulted. Like other antibiotics, this medication can lead to excessive growth of resistant bacteria such as fungi, so if symptoms do not improve after one week of use, a culture test should be conducted. Additionally, if any visual disturbances occur while using this medication, an ophthalmologist should be consulted. It is advisable to avoid using this medication concurrently with other drugs, and specific studies on drug interactions have not yet been conducted. Pregnant women should exercise caution when using this medication. There is no information on reproductive toxicity from animal studies, and some components may be transmitted through breast milk, so the decision to use it while breastfeeding should be made carefully. Safety and efficacy have been proven for children over 2 years old, but there is insufficient data for children under 2 years, so caution is needed for their use. This medication should not be used for ophthalmic or intravenous purposes, and care should be taken to prevent contamination of the container. After treatment, any remaining medication should be discarded, and it should not be used for treating otitis media. This medication should be stored out of the reach of children, and transferring it to other containers may lead to degradation of quality or accidental risks, so it should be avoided. It is recommended to store it in a cool, dry place away from direct sunlight.

Side effects and when to seek care immediately

Mild side effects

  • Migraine
  • sensory impairment
  • sensory abnormalities
  • skin fungal infections
  • cough
  • rash
  • urticaria
  • alopecia
  • headache
  • pruritus
Show 6 more
  • sensory dullness in the ear
  • hearing impairment
  • ear pain
  • nausea
  • dizziness
  • blurred vision

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or light. Also, care should be taken to ensure the medication does not freeze, and it should be kept at temperatures below 25 degrees Celsius.

Appearance and packaging

Appearance

A slightly viscous, opaque white-yellow suspension in a white plastic container with a vinegar smell.

Package unit

5mL/bottle, 7/mL/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.