Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
clindamycin phosphate (UNII: EH6D7113I8) (clindamycin - UNII:3U02EL437C), tretinoin (UNII: 5688UTC01R) (tretinoin - UNII:5688UTC01R)
Oceanside Pharmaceuticals
TOPICAL
PRESCRIPTION DRUG
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
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
New Drug Application Authorized Generic
CLINDAMYCIN PHOSPHATE 1.2% AND TRETINOIN 0.025%- CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL OCEANSIDE PHARMACEUTICALS ---------- 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 Soma hati kamili