Medication info

Ciprofloxacin HCl Suspension

Prescription medicationApproval withdrawn
Ingredient · strength
Ciprofloxacin Hydrochloride Hydrate›Strength being verifiedHydrocortisone›Strength being verified
Manufacturer / importer
한림제약(주)
Appearance
A slightly viscous opaque suspension that is white to pale yellow, contained in a white plastic bottle, with a vinegar smell.
Packaging
7mL/bottle
Approval status
Approval withdrawn

MFDS item code 200611348 · Notified 2006.11.29

This product's status changed to Approval withdrawn on 2023.04.25. 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
Instill 3 drops of this medication into the infected ear twice daily for 7 days. Shake well before use. Instilling a cold solution into the ear can cause dizziness; therefore, warm the container by holding it for about 1-2 minutes before administering. The patient should lie down with the infected ear facing up to instill the medication, and this position should be maintained for about 30-60 seconds to allow for better absorption.
Children's dosage
Instill 3 drops of this medication into the infected ear twice daily for 7 days. Shake well before use. Instilling a cold solution into the ear can cause dizziness, so it is advised to warm the container by holding it for 1-2 minutes.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Treatment of acute otitis externa

  • Acute otitis externa
View approved original text

This medicine is used for the treatment of acute otitis externa caused by various bacteria, including Staphylococcus aureus, Proteus mirabilis, and Pseudomonas aeruginosa.

Dosage and Administration

Adult dosage

Instill 3 drops of this medication into the infected ear twice daily for 7 days. Shake well before use. Instilling a cold solution into the ear can cause dizziness; therefore, warm the container by holding it for about 1-2 minutes before administering. The patient should lie down with the infected ear facing up to instill the medication, and this position should be maintained for about 30-60 seconds to allow for better absorption.

Children's dosage

Instill 3 drops of this medication into the infected ear twice daily for 7 days. Shake well before use. Instilling a cold solution into the ear can cause dizziness, so it is advised to warm the container by holding it for 1-2 minutes.

Precautions

This medication should not be used in patients allergic to hydrocortisone or ciprofloxacin, or any other quinolone antibacterial agents. It is also unsafe for patients with a perforated eardrum or viral infections around the ear such as chickenpox or herpes simplex. During use, side effects such as headache, sensory disturbances, skin fungal infections, cough, rash, and hair loss may occur; if these symptoms develop, consult a physician immediately. Be cautious as the medication may remain in the ear, leading to decreased hearing or pain. If any skin redness or allergic reactions occur while using this drug, promptly discontinue its use and consult medical personnel. Other germs such as fungi may grow excessively; therefore, if symptoms persist after treatment for more than a week, a culture test should be performed. Vision disturbances may arise due to the corticosteroid component; if blurred vision or other visual disturbances occur, seek ophthalmological treatment. It is advisable to avoid using this medication alongside other otic medications, and research on drug interactions has not been conducted yet. Pregnant or breastfeeding women should exercise caution when using this medication; especially during breastfeeding, consult with a doctor regarding whether or not to discontinue breastfeeding as side effects may occur in the infant. It is safe for children over 2 years old; however, there is insufficient data for children under 2, so caution is advised. This medication should not be placed in the eyes or used as an injection; ensure the container does not become contaminated. Any remaining medication after treatment should be discarded, and it is not used for treating otitis media. Store out of reach of children, do not transfer to another container, and keep in a cool place away from direct sunlight and moisture.

Side effects and when to seek care immediately

Mild side effects

  • Migraine
  • sensory impairment
  • abnormal sensation
  • skin fungal infection
  • cough
  • rash
  • urticaria
  • hair loss
  • headache
  • itching
Show 6 more
  • decreased sensation 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 and light. Additionally, care must be taken to prevent the medication from freezing, and it is important to maintain a storage temperature of below 25 degrees.

Appearance and packaging

Appearance

A slightly viscous opaque suspension that is white to pale yellow, contained in a white plastic bottle, with a vinegar smell.

Package unit

7mL/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.