Otovel
- Generic Name: ciprofloxacin and fluocinolone acetonide otic solution
- Brand Name: Otovel
Otovel (Ciprofloxacin and Fluocinolone Acetonide Otic Solution) side effects drug center
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- ear discharge (otorrhea
- excessive granulation tissue
- ear infection
- ear itching
- tympanic membrane disorder
- auricular swelling, and
- balance disorder.
- the first sign of any skin rash, no matter how mild;
- new or worsening symptoms of infection; or
- ear drainage that continues for up to 6 months after you have finished all doses of this medicine.
- ear pain, swelling, or itching;
- problems with balance; or
- scar tissue on part of the ear.
- 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).
Otovel (ciprofloxacin and fluocinolone acetonide) otic solution is a combination of a fluoroquinolone antibacterialand a corticosteroid indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa. Common side effects of Otovel include:
Instill the contents of one single-dose vial (0.25mL) of Otovel into the affected ear canal twice daily for 7 days. Otovel may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or become pregnant while using Otovel. Otovel is not expected to be harmful to a fetus. Otovel is only minimally absorbed by the mother and is not expected to be harmful to a nursing infant. Consult your doctor before breastfeeding.
Our Otovel (ciprofloxacin and fluocinolone acetonide) otic solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching; dizziness; fast or pounding heartbeat; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Otovel (Ciprofloxacin and Fluocinolone Acetonide Otic Solution)
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, 224 patients with AOMT were treated with OTOVEL for a median duration of 7 days. All the patients received at least one dose of OTOVEL. There were 220 patients who received at least one dose of ciprofloxacin (CIPRO) and 213 patients received at least one dose of fluocinolone acetonide (FLUO).
The most common adverse reactions that occurred in 1 or more patients are as follows:
Table 1: Selected Adverse Reactions that Occurred in 1
or more Patients in the OTOVEL Group
| A Adverse Reactions1 | Number (%) of Patients | ||
| OTOVEL N=224 |
CIPRO N=220 |
FLUO N=213 |
|
| Otorrhea | 12 (5.4%) | 9 (4.1%) | 12 (5.6%) |
| Excessive granulation tissue | 3 (1.3%) | 0 (0.0%) | 2 (0.9%) |
| Ear infection | 2 (0.9%) | 3 (1.4%) | 1 (0.5%) |
| Ear pruritus | 2 (0.9%) | 1 (0.5%) | 1 (0.5%) |
| Tympanic membrane disorder | 2 (0.9%) | 0 (0.0%) | 0 (0.0%) |
| Auricular swelling | 1 (0.4%) | 1 (0.5%) | 0 (0.0%) |
| Balance disorder | 1 (0.4%) | 0 (0.0%) | 0 (0.0%) |
| 1Selected adverse reactions that occurred in ≥ 1 patient in the OTOVEL group derived from all reported adverse events that could be related to the study drug or the drug class. | |||
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of ciprofloxacin and fluocinolone acetonide otic solution, 0.3% / 0.025% outside the US. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the entire FDA prescribing information for Otovel (Ciprofloxacin and Fluocinolone Acetonide Otic Solution)
© Otovel Patient Information is supplied by Cerner Multum, Inc. and Otovel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.