"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 "...
Directions for Use
Patients should be advised that CETRAXAL (ciprofloxacin otic solution) is for otic use only. It is not for ophthalmic or inhalation use. It is not for injection.
CETRAXAL (ciprofloxacin otic solution) should be given 2 times each day (about 12 hours apart) in each infected ear.
CETRAXAL (ciprofloxacin otic solution) should be used for as long as it is prescribed, even if the symptoms improve. The patient should be advised to follow these directions while on CETRAXAL (ciprofloxacin otic solution) :
- Wash their hands before use.
- Warm the container in their hands for at least one minute prior to use to minimize dizziness that may result from the instillation of a cold solution into the ear canal. Twist off and discard top of container.
- Lie with the affected ear upward and then instill the contents of one container into the ear. Maintain this position for at least one minute to facilitate penetration of the drops into the ear.
- Repeat, if necessary, for the opposite ear.
- Discard used container.
- Store unused containers in pouch to protect from light.
Patients should be advised to immediately discontinue CETRAXAL (ciprofloxacin otic solution) at the first appearance of a skin rash or any other sign of hypersensitivity [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 5/26/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Cetraxal Information
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