Ciprodex

DRUG DESCRIPTION

CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension contains the synthetic broad-spectrum antibacterial agent, ciprofloxacin hydrochloride, combined with the anti-inflammatory corticosteroid, dexamethasone, in a sterile, preserved suspension for otic use. Each mL of CIPRODEX® (ciprofloxacin and dexamethasone ) Otic contains ciprofloxacin hydrochloride (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodium, and purified water. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH.

Ciprofloxacin, a fluoroquinolone is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. The empirical formula is C17H18FN3O3•HCl•H2O and the structural formula is:

CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Structural Formula Illustration

Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione, is an anti-inflammatory corticosteroid. The empirical formula is C22H29FO5 and the structural formula is:

What are the possible side effects of ciprofloxacin and dexamethasone otic (Ciprodex)?

Stop using ciprofloxacin and dexamethasone otic and seek emergency medical attention or notify your doctor if you experience:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • skin rash; or
  • ear drainage, discharge, or worsening pain.

Other less serious side effects may also occur such as ear discomfort or itching or an unusual taste in the mouth. Continue to use the medication and talk to your doctor if...

Read All Potential Side Effects and See Pictures of Ciprodex »

What are the precautions when taking ciprofloxacin and dexamethasone (Ciprodex)?

Before using this medication, tell your doctor or pharmacist if you are allergic to quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), or to corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an ear infection caused by a virus (e.g., herpes simplex).

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only when clearly...

Read All Potential Precautions of Ciprodex »


Ciprodex Consumer (continued)

SIDE EFFECTS: Discomfort, pain, or itching in the ear may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged or repeated periods may result in a new fungal ear infection. Do not use this medication for longer than prescribed. Contact your doctor if you notice new or worsening symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), or to corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an ear infection caused by a virus (e.g., herpes simplex).

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Ciprodex Patient Information Including Side Effects

Brand Names: Ciprodex

Generic Name: ciprofloxacin and dexamethasone otic (Pronunciation: sih pro FLOCK sah sin and dex ah MEH thah sone)

  • What is ciprofloxacin and dexamethasone otic (Ciprodex)?
  • What are the possible side effects of ciprofloxacin and dexamethasone otic (Ciprodex)?
  • What is the most important information I should know about ciprofloxacin and dexamethasone otic (Ciprodex)?
  • What should I discuss with my healthcare provider before using ciprofloxacin and dexamethasone otic (Ciprodex)?
  • How should I use ciprofloxacin and dexamethasone otic (Ciprodex)?
  • What happens if I miss a dose (Ciprodex)?
  • What happens if I overdose (Ciprodex)?
  • What should I avoid while using ciprofloxacin and dexamethasone (Ciprodex)?
  • What other drugs will affect my ciprofloxacin and dexamethasone otic (Ciprodex)?
  • Where can I get more information?

What is ciprofloxacin and dexamethasone otic (Ciprodex)?

Ciprofloxacin is a fluoroquinolone antibiotic. Ciprofloxacin fights bacteria in the body.

Dexamethasone is a steroid. It is used with ciprofloxacin to reduce inflammation caused by an infection.

Together, ciprofloxacin and dexamethasone are used to treat ear infections.

Ciprofloxacin and dexamethasone otic may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ciprofloxacin and dexamethasone otic (Ciprodex)?

Stop using ciprofloxacin and dexamethasone otic and seek emergency medical attention or notify your doctor if you experience:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • skin rash; or
  • ear drainage, discharge, or worsening pain.

Other less serious side effects may also occur such as ear discomfort or itching or an unusual taste in the mouth. Continue to use the medication and talk to your doctor if these side effects seem excessive or unusual.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ciprofloxacin and dexamethasone otic (Ciprodex)?

Do not use this medication in the eyes or take it by mouth. Ciprofloxacin and dexamethasone otic is intended for use in the ears only.

Do not touch the dropper opening to any surface, including the ears or hands. The dropper opening is sterile. If it becomes contaminated, it could cause another infection in the ear.

Notify your doctor if the condition does not improve or appears to worsen.

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