VELTIN- clindamycin phosphate and tretinoin gel

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Almirall, LLC

DCI (Dénomination commune internationale):

CLINDAMYCIN PHOSPHATE

Composition:

CLINDAMYCIN 10 mg in 1 g

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

VELTIN™ (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. VELTIN Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. Pregnancy Category C. There are no well-controlled studies in pregnant women treated with VELTIN Gel. VELTIN Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A limit teratology study performed in Sprague Dawley rats treated topically with VELTIN Gel or 0.025% tretinoin gel at a dose of 2 mL/kg during gestation days 6 to 15 did not result in teratogenic effects. Although no systemic levels of tretinoin were detected, craniofacial and heart abnormalities were described in drug-treated groups. These abnormalities are consistent with retinoid effects and occurred at 16 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison. For p

Descriptif du produit:

How Supplied VELTIN Gel is supplied as follows: Storage and Handling

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

VELTIN- CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL
ALMIRALL, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VELTIN™ GEL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VELTIN GEL.
VELTIN™ (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL 1.2%/0.025%
FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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•
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Observed local treatment-related adverse reactions (≥ 1%) in
clinical trials with VELTIN 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 ALMIRALL AT
1-866-665-2782 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 6/2019
VELTIN™ Gel is a lincosamide antibiotic and retinoid combination
product indicated for the topical
treatment of acne vulgaris in patients 12 years and older. (1)
Apply a pea-sized amount once daily in the evening lightly covering
the entire affected area. Avoid the
eyes, lips, and mucous membranes. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
Topical gel: clindamycin phosphate 1.2% and tretinoin 0.025% in
30-gram and 60-gram tubes. (3)
VELTIN Gel is contraindicated in patients with regional enteritis,
ulcerative colitis, or history of
antibiotic-associated colitis. (4)
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.
VELTIN Gel should be discontinued if significant diarrhea occurs.
(5.1)
Ultraviolet Light and Environmental Exposure: Avoid exposure to
sunlight, sunlamps, and weather
extremes. Wear sunscreen daily. (5.2)
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