Dexamethasone Ciprofloxacin

Dexamethasone/Ciprofloxacin is a combination medicine used to treat otitis media (infections inside the ear) and otitis externa (infections of the ear canal). 

• Dexamethasone/Ciprofloxacin is available under the following different brand names: Ciprodex

Common side effects of Dexamethasone/Ciprofloxacin include:

• ear itching or pain, 
• ear discomfort or fullness,
• unusual taste in the mouth,
• feeling irritable,
• rash, and
• a buildup of debris in the ear canal.

Serious side effects of Dexamethasone/Ciprofloxacin include:

• severe pain, and
• hearing problems.

Rare side effects of Dexamethasone/Ciprofloxacin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Otic suspension

• 0.3%/0.1%

Acute Otitis Externa

Adult dosage

• 4 drops in the affected ear every 12hours for 7 days
• Acute Otitis Media with Tympanostomy Tubes, Acute Otitis Externa

Pediatric dosage

• Children below 6 months: Not recommended
• Children above 6 months: 4 drops in the affected ear every 12hours for 7 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Dexamethasone/Ciprofloxacin has no noted severe interactions with any other drugs.
• Dexamethasone/Ciprofloxacin has no noted serious interactions with any other drugs.
• Dexamethasone/Ciprofloxacin has no noted moderate interactions with any other drugs.
• Dexamethasone/Ciprofloxacin has no noted minor interactions with any other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to any component (contains benzalkonium chloride)
• Fungal or viral infections of the external canal, including varicella and herpes simplex virus infections

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dexamethasone/Ciprofloxacin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dexamethasone/Ciprofloxacin?”

Cautions

• Discontinue if hypersensitivity or superinfection occurs
• Reevaluate if no improvement is noted after 1 week
• Prolonged use may result in overgrowth of non-susceptible bacteria and fungi
• Otorrhea may occur; if it persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor
• Tendon inflammation and/or rupture reported with systemic fluoroquinolones; exposure resulting from otic administration is substantially lower than systemic therapy; discontinue at the first sign of tendon inflammation or pain

Pregnancy and Lactation

• There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; because of minimal systemic absorption of ciprofloxacin and dexamethasone following topical otic administration, the product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women
• Animal reproduction studies have not been conducted; oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits not reported to cause fetal malformations; these doses were at least 200 times the recommended otic human dose (ROHD in mice, rats, and rabbits, respectively, based on body surface area (BSA); with dexamethasone, malformations have been observed in animal studies after ocular and systemic administration
• Lactation
  • Not known whether ciprofloxacin and dexamethasone are present in human milk following topical otic administration
  • Published literature reports the presence of ciprofloxacin in human milk after oral administration to lactating women; however, because of minimal systemic absorption of ciprofloxacin following topical otic administration, breastfeeding is not expected to result in the exposure of the infant to ciprofloxacin
  • Systemically administered corticosteroids appear in human milk; dexamethasone in breast milk could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects; however, not known whether topical otic administration of drug could result in systemic absorption that is sufficient to produce detectable quantities of dexamethasone in human milk
  • There are no data on the effects of ciprofloxacin or dexamethasone on milk production
  • Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for drug combination and any potential adverse effects on the breast-fed child from therapy