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 following adverse reaction is described in more detail in the Warnings and Precautions section of the label: • Colitis [ see Warnings and Precautions ( 5.1 ) ].
• The most common local adverse reactions (≥5%) are erythema, peeling, dryness, and burning.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical trials, 397 subjects used clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% once daily for 11 weeks for the treatment of moderate to moderately severe facial acne vulgaris.
All subjects were graded for facial local skin reactions (erythema, peeling, burning, and dryness) on the following scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe.
The percentage of subjects that had symptoms present before treatment (at baseline) and during treatment is presented in Table
Local Skin Reactions With Use Of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% Combined Results From Five Trials (n=397) % of Subjects Using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% with Symptom Present Before Treatment (Baseline) During Treatment Symptom Mild Moderate Severe Mild Moderate Severe Erythema 28% 3% 0 26% 5% 0 Peeling 6% <1% 0 17% 2% 0 Burning 3% <1% 0 5% <1% 0 Dryness 6% <1% 0 15% 1% 0 (Percentages derived by number of subjects receiving clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% with symptom score/number of enrolled subjects receiving clindamycin phosphate and benzoyl peroxide gel, 1.2%/5%).
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of clindamycin phosphate and benzoyl peroxide gel, 1.2%/5%.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5 WARNINGS AND PRECAUTIONS • Colitis: Clindamycin can cause severe colitis, which may result in death.
Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin.
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% should be discontinued if significant diarrhea occurs.
( 5.1 ) • Ultraviolet light and environmental exposure (including use of tanning beds or sun lamps): Minimize sun exposure following drug application.
( 5.2 ) 5.1 Colitis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin.
Like all medications, Clindamycin Phosphate And Benzoyl Peroxide 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: