Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions are application site reactions (2%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sebela Pharmaceuticals Inc.
at 1-888-271-4621 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In two randomized, vehicle-controlled trials, 1143 subjects were treated with NAFTIN ® Gel versus 571 subjects treated with the vehicle.
The trial subjects were 12 to 92 years old, were primarily male (76%), and were 59% Caucasian, 38% Black or African American, and 23% Hispanic or Latino.
Subjects received doses once daily, topically, for 2 weeks to cover the affected skin areas plus a ½-inch margin of surrounding healthy skin.
The most common adverse reactions were application site reactions which occurred at the rate of 2% in NAFTIN Gel arm versus 1% in vehicle arm.
Most adverse reactions were mild in severity.
In an open-label pediatric pharmacokinetics and safety trial 22 pediatric subjects 12-17 years of age with interdigital tinea pedis received NAFTIN ® Gel.
5 WARNINGS AND PRECAUTIONS If redness or irritation develops with the use of NAFTIN ® Gel treatment should be discontinued.
( 5.1 ) 5.1 Local Adverse Reactions If irritation or sensitivity develops with the use of NAFTIN ® Gel, treatment should be discontinued.
Like all medications, Naftin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: