Clindamycin Phosphate and Tretinoin
Generic: CLINDAMYCIN PHOSPHATE AND TRETINOIN
Basic Information
Manufacturer
Solaris Pharma Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
c3ad6c2d-d106-464d-8e27-67ae94793e88
Indications & Usage
1 INDICATIONS AND USAGE Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older.
Clindamycin phosphate and tretinoin gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years and older.
( 1 )
Clindamycin phosphate and tretinoin gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years and older.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS Observed local treatment-related adverse reactions (≥ 1%) in clinical studies with clindamycin phosphate and tretinoin gel were application site reactions, including dryness, irritation, exfoliation, erythema, pruritus, and dermatitis.
Sunburn was also reported.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solaris Pharma Corporation at 1-833-919-0527 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Adverse Reactions in Clinical Studies Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies 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 patients with acne vulgaris.
Patients were 12 years or older and were treated once daily in the evening for 12 weeks.
Adverse reactions that were reported in ≥1% of patients treated with clindamycin phosphate and tretinoin gel are presented in Table 1 .
Table 1: Treatment-Related Adverse Reactions Reported by ≥1% of Patients 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: Clindamycin Phosphate and Tretinoin Gel - Treated Patients with Local Skin Reactions 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.
Sunburn was also reported.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solaris Pharma Corporation at 1-833-919-0527 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Adverse Reactions in Clinical Studies Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies 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 patients with acne vulgaris.
Patients were 12 years or older and were treated once daily in the evening for 12 weeks.
Adverse reactions that were reported in ≥1% of patients treated with clindamycin phosphate and tretinoin gel are presented in Table 1 .
Table 1: Treatment-Related Adverse Reactions Reported by ≥1% of Patients 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: Clindamycin Phosphate and Tretinoin Gel - Treated Patients with Local Skin Reactions 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.