CLINDAMYCIN PHOSPHATE aerosol, foam

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)

Disponible depuis:

Padagis Israel Pharmaceuticals Ltd

DCI (Dénomination commune internationale):

CLINDAMYCIN PHOSPHATE

Composition:

CLINDAMYCIN 10 mg in 1 g

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Clindamycin phosphate foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older. Clindamycin phosphate foam is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis). Risk Summary There are no available data on clindamycin phosphate foam use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with clindamycin phosphate foam. No evidence of fetal harm or malformations was observed in pregnant rats and mice administered daily subcutaneous or oral doses of clindamycin salts during organogenesis at doses that produced exposures up to 84 and 42 times, respectively, the maximum recommended human dose (MRHD) of clindamycin phosphate foam based on body surface area (BSA) comparisons and assuming 100% absorption [see Data] . In the U.S. general population, the estimat

Descriptif du produit:

Clindamycin Phosphate Foam, 1% contains 10 mg of clindamycin as clindamycin phosphate, USP per gram. The white to off-white thermolabile foam is available as follows: Store at 20º to 25°C (68º to 77°F) [See USP Controlled Room Temperature]. Flammable. Avoid fire, flame or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperature above 120°F (49°C). Keep out of reach of children.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE AEROSOL, FOAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLINDAMYCIN
PHOSPHATE FOAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CLINDAMYCIN
PHOSPHATE FOAM.
CLINDAMYCIN PHOSPHATE FOAM, 1%
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1970
INDICATIONS AND USAGE
Clindamycin phosphate foam is a lincosamide product indicated for acne
vulgaris in patients 12 years and
older. (1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Foam containing 1% clindamycin as clindamycin phosphate. (3)
CONTRAINDICATIONS
Clindamycin phosphate foam is contraindicated in individuals with a
history of regional enteritis or
ulcerative colitis, or a history of antibiotic-associated colitis,
(including pseudomembranous colitis). (4)
WARNINGS AND PRECAUTIONS
•
ADVERSE REACTIONS
The most common adverse reactions (>1%) are headache and application
site reactions including
burning, pruritus, and dryness. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PADAGIS AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Colitis
5.2 Irritation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
For topical use only; not for oral, ophthalmic, or intravaginal use.
(2)
Apply clindamycin phosphate foam once daily to affected areas. (2)
Flammable; avoid fire, flame and/or smoking during and immediately
following application. (2)
_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 foam shou