"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
DOSAGE AND ADMINISTRATION
The contents of one single use container (deliverable volume: 0.25 mL) should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.
Wash hands before use. The solution should be warmed, by holding the container in the hands for at least 1 minute, to minimize the dizziness that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the solution should be instilled. This position should be maintained for at least 1 minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.
Dosage Forms And Strengths
CETRAXAL is a sterile, preservative-free, otic solution of ciprofloxacin hydrochloride quivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single use container.
Storage And Handling
CETRAXAL (ciprofloxacin otic solution) is a clear, colorless, sterile, preservative-free solution. CETRAXAL (ciprofloxacin otic solution) is supplied as a 0.2% otic solution in a low-density polyethylene (LDPE) single use container. Each single use container delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin; 14 single use containers are packaged in a foil overwrap pouch in a carton (NDC 66992-450-14).
Store at 15°C to 25°C (59°F to 77°F). Discard used containers. Store unused containers in pouch to protect from light.
CETRAXAL (ciprofloxacin otic solution) is: Distributed by: WraSer Pharmaceuticals, Ridgeland, MS 39157. Manufactured by: The Ritedose Corporation, Columbia, SC 29203 USA.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/26/2009
Additional Cetraxal Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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