CLINDAMYCIN PHOSPHATE AND TRETINOIN gel

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C), TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Disponible desde:

Actavis Pharma, Inc.

Designación común internacional (DCI):

CLINDAMYCIN PHOSPHATE

Composición:

CLINDAMYCIN 12 mg in 1 g

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin phosphate and tretinoin 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 and tretinoin gel. Clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clindamycin phosphate and tretinoin 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 and tretinoin 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-adverse-effect level (NOAEL) for maternal and developmental toxicity following dermal administration of clindamycin phosphate and tretinoin gel for two weeks prior to artificial insemination and continuing until gestation day 18, inclusive. For purposes of comparisons of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of clindamycin phosphate and tretinoin gel applied daily to a 60 kg person. Clindamycin Teratology (Segment II) studies using clindamycin were performed orally in rats (up to 600 mg/kg/day) and mice (up to 100 mg/kg/day) (583 and 49 times amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) or with subcutaneous doses of clindamycin up to 180 mg/kg/day (175 and 88 times the amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) revealed no evidence of teratogenicity. Tretinoin In oral Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (~ 78 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison). With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty cases of temporally associated congenital malformations have been reported during two decades of clinical use of another formulation of topical tretinoin. Although no definite pattern of teratogenicity and no causal association have been established from these cases, 5 of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known. Dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 40 times the recommended human clinical dose based on a body surface area comparison. Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 78 times the recommended clinical dose based on a body surface area comparison. It is not known whether clindamycin is excreted in human milk following use of clindamycin phosphate and tretinoin gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. It is not known whether tretinoin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when clindamycin phosphate and tretinoin gel is administered to a nursing woman. Safety and effectiveness of clindamycin phosphate and tretinoin gel in pediatric patients under the age of 12 have not been established. Clinical trials of clindamycin phosphate and tretinoin gel included patients 12 to 17 years of age. [See Clinical Studies (14)] Clinical studies of clindamycin phosphate and tretinoin gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Resumen del producto:

Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is supplied as follows: 30 gram tube NDC 0472-1790-30 60 gram tube NDC 0472-1790-60 Storage and Handling Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from light. Protect from freezing. Keep away from heat. Keep tube tightly closed. Keep out of the reach of children.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CLINDAMYCIN PHOSPHATE AND TRETINOIN- CLINDAMYCIN PHOSPHATE AND
TRETINOIN GEL
ACTAVIS PHARMA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLINDAMYCIN PHOSPHATE
AND TRETINOIN GEL 1.2% / 0.025% SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL 1.2% / 0.025%.
CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL 1.2% / 0.025%, FOR TOPICAL USE
ONLY
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Clindamycin phosphate and tretinoin gel 1.2% / 0.025% 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
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 and tretinoin gel is not for oral, ophthalmic,
or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Topical gel: Clindamycin phosphate, USP 1.2% and tretinoin, USP 0.025%
gel in 30 and 60 gram tubes. (3)
CONTRAINDICATIONS
Clindamycin phosphate and tretinoin gel is contraindicated in patients
with regional enteritis, ulcerative
colitis, or history of antibiotic–associated colitis. (4)
WARNINGS AND PRECAUTIONS
Colitis: Clindamycin can cause severe colitis, which may result in
death. Diarrhea, bloody diarrhea, and
colitis (including pseudomembranous colitis) have been reported with
the use of clindamycin.
Clindamycin phosphate and tretinoin gel should be discontinued if
significant diarrhea occurs. (5.1)
Ultraviolet Light and Environmental Exposures: Avoid exposure to
sunlight and sunlamps. Wear
sunscreen daily. (5.2)
ADVERSE REACTIONS
Observed local adverse reactions in patients treated with clindamycin
phosphate and tretinoin gel were
skin erythema, scaling, itching, burning, and stinging. Other most
commonly reported adverse events (≥
1% in patients treated with clindamycin phosphate and tretinoin gel)
were nasopharyngitis,
ph