CLINDAMYCIN PHOSPHATE 1.2% AND TRETINOIN 0.025%- clindamycin phosphate and tretinoin gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

clindamycin phosphate (UNII: EH6D7113I8) (clindamycin - UNII:3U02EL437C), tretinoin (UNII: 5688UTC01R) (tretinoin - UNII:5688UTC01R)

Available from:

Oceanside Pharmaceuticals

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel was tested for maternal and developmental toxicity in New Zealand White Rabbits with topical doses of 60, 180 and 600 mg/kg/day. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adve

Product summary:

Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is supplied as follows:         30 gram tube                      NDC 68682-300-30         60 gram tube                      NDC 68682-300-60 Storage and Handling

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE 1.2% AND TRETINOIN 0.025%- CLINDAMYCIN PHOSPHATE
AND
TRETINOIN GEL
OCEANSIDE PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLINDAMYCIN PHOSPHATE 1.2% AND
TRETINOIN 0.025% GEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CLINDAMYCIN
PHOSPHATE 1.2% AND TRETINOIN 0.025% GEL.
CLINDAMYCIN PHOSPHATE 1.2% AND TRETINOIN 0.025% GEL
FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is a lincosamide
antibiotic and retinoid combination product
indicated for the topical treatment of acne vulgaris in patients 12
years or older. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Topical gel: Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel in 30
and 60 gram tubes. (3)
CONTRAINDICATIONS
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is contraindicated
in patients with regional enteritis, ulcerative
colitis, or history of antibiotic-associated colitis. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Observed local adverse reactions in patients treated with Clindamycin
Phosphate 1.2% and Tretinoin 0.025% Gel were
skin erythema, scaling, itching, burning, and stinging. Other most
commonly reported adverse events (≥1% in patients
treated with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel) were
nasopharyngitis, pharyngolaryngeal pain, dry
skin, cough, and sinusitis. (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.
DRUG INTERACTIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
Apply a pea-sized amount to the entire face once daily at bedtime. Do
not apply to eyes, mouth, angles of the nose, or
mucous membranes. (2)
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Ge