FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
The potential exists for cross sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
With nonsteroidal anti-inflammatory drugs, the potential exists for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding tendency of ocular tissues in conjunction with ocular surgery.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
PROFENAL Ophthalmic Solution is indicated for inhibition of intraoperative miosis.
History
There is currently no drug history available for this drug.
Other Information
PROFENAL® (suprofen) 1% ophthalmic solution is a topical nonsteroidal anti-inflammatory product for ophthalmic use. Suprofen chemically is α -methyl-4-(2-thienylcarbonyl)benzeneacetic acid, with an empirical formula of C14H12O3S, and a molecular weight of 260.3. The chemical structure of suprofen is:
PROFENAL Sterile Ophthalmic Solution contains suprofen 1.0% (10 mg/mL), thimerosal 0.005% (0.05 mg/mL), caffeine 2% (20 mg/mL), edetate disodium, dibasic sodium phosphate, monobasic sodium phosphate, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH to 7.4) and purified water.
DM-00
Sources
Profenal Manufacturers
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Alcon Laboratories, Inc.
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