Clindamycin Phosphate and Tretinion

CLINDAMYCIN PHOSPHATE AND TRETINION- clindamycin phosphate and tretinoin gel
Prasco Laboratories

1 INDICATIONS AND USAGE

Clindamycin Phosphate and Tretinoin Gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years and older.

2 DOSAGE AND ADMINISTRATION

Clindamycin Phosphate and Tretinoin Gel should be applied once daily in the evening, gently rubbing the medication to lightly cover the entire affected area. Approximately a pea-sized amount will be needed for each application. Avoid the eyes, lips, and mucous membranes.

Clindamycin Phosphate and Tretinoin Gel is not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Clindamycin Phosphate and Tretinoin Gel, containing clindamycin phosphate 1.2% and tretinoin 0.025%, is a yellow, opaque topical gel. Each gram of Clindamycin Phosphate and Tretinoin Gel contains, as dispensed, 10 mg (1%) clindamycin as clindamycin phosphate, and 0.25 mg (0.025%) tretinoin solubilized in an aqueous-based gel.

4 CONTRAINDICATIONS

Clindamycin Phosphate and Tretinoin Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis.

5 WARNINGS AND PRECAUTIONS

5.1 Colitis

Systemic absorption of clindamycin has been demonstrated following topical use. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. If significant diarrhea occurs, Clindamycin Phosphate and Tretinoin Gel should be discontinued.

Severe colitis has occurred following oral or parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.

Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

5.2 Ultraviolet Light and Environmental Exposure

Exposure to sunlight, including sunlamps, should be avoided during the use of Clindamycin Phosphate and Tretinoin Gel. Patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Daily use of sunscreen products and protective apparel (e.g., a hat) are recommended. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with Clindamycin Phosphate and Tretinoin Gel.

6 ADVERSE REACTIONS

6.1 Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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 clinical practice.

The safety data reflect exposure to Clindamycin Phosphate and Tretinoin Gel in 1,104 subjects with acne vulgaris. Subjects were 12 years and older and were treated once daily in the evening for 12 weeks. Adverse reactions that were reported in ≥1% of subjects treated with Clindamycin Phosphate and Tretinoin Gel are presented in Table 1.

Table 1. Treatment-Related Adverse Reactions Reported by ≥1% of Subjects

Clindamycin Phosphate and Tretinoin Gel

N = 1,104

n (%)

Clindamycin Gel

N = 1,091

n (%)

Tretinoin Gel

N = 1,084

n (%)

Vehicle Gel

N = 552

n (%)
Patients with at least one adverse reaction 140 (13) 38 (3) 141 (13) 17 (3)
Application site dryness 64 (6) 12 (1) 62 (6) 3 (1)
Application site irritation 50 (5) 4 (<1) 57 (5) 5 (<1)
Application site exfoliation 50 (5) 2 (<1) 56 (5) 2 (<1)
Application site erythema 40 (4) 6 (1) 39 (4) 3 (1)
Application site pruritus 26 (2) 7 (1) 23 (2) 6 (1)
Sunburn 11 (1) 6 (1) 7 (1) 3 (1)
Application site dermatitis 6 (1) 0 (0) 8 (1) 1 (<1)

Local skin reactions actively assessed at baseline and end of treatment with a score >0 are presented in Table 2.

Table 2. Local Skin Reactions in Subjects Treated With Clindamycin Phosphate and Tretinoin Gel

Clindamycin Phosphate

and Tretinoin Gel


Vehicle Gel
Local Reaction

Baseline

N=476

(%)

End of Treatment

N= 409

(%)

Baseline

N=219

(%)

End of Treatment

N=209

(%)

Erythema 24% 21% 31% 35%
Scaling 8% 19% 14% 12%
Dryness 11% 22% 18% 13%
Burning 8% 13% 8% 4%
Itching 17% 15% 22% 14%

During the 12 weeks of treatment, each local skin reaction peaked at Week 2 and gradually reduced thereafter.

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