ciprofloxacin/fluocinolone acetonide, otic (Rx)

Brand and Other Names:Otovel
  • Print

Dosing & Uses

AdultPediatric

Not indicated

Dosage Forms & Strengths

ciprofloxacin/fluocinolone acetonide

otic suspension

  • 0.3%/0.025% (0.75mg/0.0625mg)/2.5mL

Otitis Media

Indicated for acute otitis media with tympanostomy tubes (AOMT) in children aged ≥6 months caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa

<6 months: Safety and efficacy not established

≥6 months: Instill contents of 1 single-dose vial (0.25 mL) into affected ear canal BID for 7 days

Next:

Adverse Effects

1-10%

Otorrhea (5.4%)

Excessive granulation tissue (1.3%)

<1%

Ear infection (0.9%)

Ear pruritus (0.9%)

Tympanic membrane disorder (0.9%)

Auricular swelling (0.4%)

Balance disorder (0.4%)

Postmarketing Reports

Immune system disorders: Allergic reaction

Infections and infestations: Candidiasis

Nervous system disorders: Dysgeusia, paresthesia (tingling in ears), dizziness, headache

Ear and labyrinth disorders: Ear discomfort, hypoacusis, tinnitus, ear congestion

Vascular disorders: Flushing

Skin and subcutaneous tissue disorders: Skin exfoliation

Injury, poisoning and procedural complications: Device occlusion (tympanostomy tube obstruction)

Previous
Next:

Warnings

Contraindications

Known hypersensitivity to drug or components

Viral infections of the external ear canal, including varicella and herpes simplex infections, and fungal otic infections

Cautions

Hypersensitivity; discontinue at first appearance of skin rash or other hypersensitivity; serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported with systemic quinolones (see Contraindications)

Prolonged use may result in microbial overgrowth of nonsusceptible bacteria and fungi; discontinue therapy if it occurs; institute alternative therapy

If otorrhea persists after a full course of therapy, or if ≥2 episodes occur within 6 months, further evaluate to exclude other conditions (eg, cholesteatoma, foreign body, tumor)

Tendon inflammation and/or rupture reported with systemic fluoroquinolones; exposure is substantially lower with otic administration; discontinue at first sign of tendon inflammation or pain

Previous
Next:

Pregnancy

Pregnancy

Negligible systemic absorption following otic administration; not expected to result in fetal exposure if used during pregnancy

Lactation

Exposure to infant from mother not expected during breastfeeding

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Previous
Next:

Pharmacology

Mechanism of Action

Ciprofloxacin: Fluoroquinolone antibiotic, exerts anti-bacterial effects through DNA gyrase inhibition

Fluocinolone acetonide: Corticosteroid which inhibits local biosynthesis of prostaglandins; and thus, decreasing inflammation

Absorption

Negligible systemic absorption

Detectible plasma concentration (eg, 3 mcg/mL) at 7 days in one patient with bilateral administration

Previous
Next:

Administration

Otic Administration

For otic use only; not for ophthalmic use, or for injection

Wash hands with soap and water

Gently clean any fluid (discharge) from outer ear using a clean cloth or tissue; do not put a cotton swab or any other object in ear canal

Warm 1 vial by holding in hand for 1-2 minutes; this is to avoid dizziness, which may result from the instillation of a cold solution into the ear canal

Instruct patient to lie with affected ear upward, and then instill medication

Pump tragus 4 times by pushing inward to facilitate penetration of the medication intomiddle ear

Maintain this position for 1 minute; repeat, if necessary, for opposite ear

Storage

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

Protect from light; store unused vials in pouch and discard 7 days after opening the pouch

Do not open until ready to use

Discard vial after use

Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.