Cetraxal Plus

Cetraxal Plus

Manufacturer:

Laboratorios Salvat

Distributor:

Lee's Pharm
Concise Prescribing Info
Contents
Per mL Ciprofloxacin 3 mg, fluocinolone acetonide 0.25 mg
Indications/Uses
Acute otitis media in adults & childn ≥6 mth w/ tympanostomy tubes caused by ciprofloxacin-susceptible microorganisms.
Dosage/Direction for Use
Soln should be warmed before using by holding the bottle in the hand for several min. Adult, elderly, childn ≥6 mth Instill contents of 1 single-dose container into the affected ear canal every 12 hr for 7 days.
Contraindications
Hypersensitivity to ciprofloxacin, fluocinolone acetonide, or any member of the quinolone class of antimicrobial agents. Viral infections of the external ear canal, including varicella & herpes simplex infections & fungal otic infections.
Special Precautions
For auricular use only. Not for ophth use, inhalation or inj. Discontinue at the 1st appearance of skin rash or any other sign of hypersensitivity. May result in overgrowth of non-susceptible organisms, including bacterial strains, yeast & fungi. Corticosteroids may reduce resistance to, & aid in the establishment of bacterial, viral, or fungal infections; mask clinical signs of infection; or may suppress hypersensitivity reactions to substances in the product. Reports of visual disturbance. Pregnancy & lactation. Childn <6 mth.
Adverse Reactions
Ear pain, ear discomfort, ear pruritus; dysgeusia.
Drug Interactions
Not recommended to use other ear prep concomitantly. If >1 ear prep needs to be administered, it is advised to administer them apart.
ATC Classification
S02CA05 - fluocinolone acetonide and antiinfectives ; Belongs to the class of combinations of corticosteroids and antiinfectives used in the treatment of ear diseases.
Presentation/Packing
Form
Cetraxal Plus ear drops
Packing/Price
(single-dose) 0.25 mL x 15 × 1's
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