Clindamycin Phosphate and Benzoyl Peroxide
Generic: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Basic Information
Manufacturer
Oceanside Pharmaceuticals
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
1d53ec2b-d33d-4245-99f1-e41b30303660
Indications & Usage
1 INDICATIONS AND USAGE Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Clindamycin Phosphate and Benzoyl Peroxide Gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
( 1 )
Clindamycin Phosphate and Benzoyl Peroxide Gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
( 1 )
Adverse Reactions
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 adverse reactions are: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 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 clinical trials of a drug cannot be directly compared to rates observed in clinical trials of another drug and may not reflect the rates observed in clinical practice.
These adverse reactions occurred in less than 0.5% of subjects treated with clindamycin phosphate and benzoyl peroxide gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).
During the clinical trial, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging.
Most local skin reactions either were the same as baseline or increased and peaked around Week 4 and were near or improved from baseline levels by Week 12.
The percentage of subjects that had symptoms present before treatment (at baseline), during treatment, and the percent with symptoms present at Week 12 are shown in Table 1.
Table 1: Percent of Subjects with Local Skin Reactions.
Results from the Phase 3 Trial (N = 243) Before Treatment (Baseline) During Treatment End of Treatment (Week 12) Mild Mod.
* Severe Mild Mod.
* Severe Mild Mod.
* Severe Erythema 20 6 0 28 5 <1 15 2 0 Scaling 10 1 0 19 3 0 10 <1 0 Itching 14 3 <1 15 3 0 7 2 0 Burning 5 <1 <1 7 1 <1 3 <1 0 Stinging 5 <1 0 7 0 <1 3 0 <1 *Mod.
= Moderate 6.2 Postmarketing Experience Because postmarketing adverse 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.
Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin phosphate/benzoyl peroxide.
The most common adverse reactions are: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 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 clinical trials of a drug cannot be directly compared to rates observed in clinical trials of another drug and may not reflect the rates observed in clinical practice.
These adverse reactions occurred in less than 0.5% of subjects treated with clindamycin phosphate and benzoyl peroxide gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).
During the clinical trial, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging.
Most local skin reactions either were the same as baseline or increased and peaked around Week 4 and were near or improved from baseline levels by Week 12.
The percentage of subjects that had symptoms present before treatment (at baseline), during treatment, and the percent with symptoms present at Week 12 are shown in Table 1.
Table 1: Percent of Subjects with Local Skin Reactions.
Results from the Phase 3 Trial (N = 243) Before Treatment (Baseline) During Treatment End of Treatment (Week 12) Mild Mod.
* Severe Mild Mod.
* Severe Mild Mod.
* Severe Erythema 20 6 0 28 5 <1 15 2 0 Scaling 10 1 0 19 3 0 10 <1 0 Itching 14 3 <1 15 3 0 7 2 0 Burning 5 <1 <1 7 1 <1 3 <1 0 Stinging 5 <1 0 7 0 <1 3 0 <1 *Mod.
= Moderate 6.2 Postmarketing Experience Because postmarketing adverse 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.
Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin phosphate/benzoyl peroxide.