ACEFLO Fluocinolone / Polymyxin B / Neomycin 250mcg / 10000IU / 3.5mg Otic Solution 5mL

Indications / Uses

ACEFLO Fluocinolone / Polymyxin B / Neomycin 250mcg / 10000IU / 3.5mg Otic Solution 5mL is used for treating bacterial ear infections with inflammation in the outer ear canal. It provides relief from swelling, redness, and discomfort caused by acute otitis externa. This solution also addresses superficial infections involving the external auditory canal.

Formulation / Ingredients
ACEFLO Fluocinolone / Polymyxin B / Neomycin 250mcg / 10000IU / 3.5mg Otic Solution 5mL contains: Fluocinolone Acetonide 250mcg + Polymyxin B Sulfate 10000IU + Neomycin Sulfate 3.5mg

Side Effects

ACEFLO Fluocinolone / Polymyxin B / Neomycin 250mcg / 10000IU / 3.5mg Otic Solution 5mL common side effects include: mild burning or stinging sensation in the ear after application. Some individuals may experience temporary hearing impairment, itching, or skin irritation around the application site. Rare but serious reactions include allergic responses with swelling or persistent discomfort.

Directions and Dosage

• Adults and adolescents (12+ years): 3-4 drops in affected ear(s) twice daily. Do not exceed 2 applications daily.
• Children (1-11 years): 2-3 drops in affected ear(s) twice daily. Maximum: 6 drops/day.
• Infants (under 1 year): Medical supervision required. Typically 1-2 drops twice daily based on weight.

Treatment duration should not exceed 10 days unless directed. Avoid use in ears with known tympanic membrane perforation.

Contraindications

Avoid if hypersensitive to any component, aminoglycosides, or corticosteroids. Not for use with perforated eardrum or viral ear infections (herpes simplex, varicella). Contraindicated in tubercular or fungal ear infections.

Use in Pregnancy and Lactation

Generally avoided due to potential fetal harm from neomycin absorption. Systemic corticosteroids may cause adverse developmental effects. Not recommended during breastfeeding due to risk of infant toxicity.

Special Precautions

• Discontinue if irritation, hypersensitivity, or superinfection occurs
• Prolonged use may increase risk of secondary infections
• Monitor for fungal or bacterial overgrowth with extended therapy

Is it safe to take it with other medications?

Concurrent use with other ototoxic drugs may increase adverse effects. Avoid combining with neuromuscular blocking agents due to polymyxin interactions. Always disclose current medications before treatment initiation.

How should I store it?

Store upright at 20°-25°C (68°-77°F). Protect from light and excessive heat. Keep container tightly closed. Discard 30 days after opening.

Used For

Ear infections

Age

From infants