CLINDAMYCIN PHOSPHATE aerosol, foam

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Bryant Ranch Prepack

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Clindamycin Phosphate Foam, 1% is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older. Clindamycin Phosphate Foam, 1% is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis). Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women treated with clindamycin phosphate foam, 1%. Clindamycin Phosphate Foam, 1% should be used during pregnancy only if the potential benefit clearly outweighs the potential risk to the fetus. Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin phosphate, clindamycin hydrochloride and clindamycin palmitate hydrochloride. These studies revealed no evidence of fetal harm. The highest dose used in the rat and mouse teratogenicity studies was equivalent to a clindamycin phosphate dose of 432 mg/kg. For a rat, this dose is 84 fold higher,

Produkt oversigt:

16.1 How Supplied Clindamycin Phosphate Foam, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is white to off-white in color and thermolabile. It is available in the following sizes: 16.2 Storage and Handling Store at 20-25°C (68-77°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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE AEROSOL, FOAM
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLINDAMYCIN PHOSPHATE
FOAM, 1% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CLINDAMYCIN
PHOSPHATE FOAM, 1%.
CLINDAMYCIN PHOSPHATE FOAM, 1%
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1970
INDICATIONS AND USAGE
Clindamycin Phosphate Foam, 1% is a lincosamide product indicated for
acne vulgaris in patients 12 years
and older. ( 1)
DOSAGE AND ADMINISTRATION
For topical use only; not for oral, ophthalmic, or intravaginal use. (
2)
Apply Clindamycin Phosphate Foam, 1% once daily to affected areas. (
2)
Flammable; avoid fire, flame and/or smoking during and immediately
following application. ( 2)
DOSAGE FORMS AND STRENGTHS
Foam containing 1% clindamycin as clindamycin phosphate. ( 3)
CONTRAINDICATIONS
Clindamycin Phosphate Foam, 1% 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
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, 1% should be discontinued if significant
diarrhea occurs. ( 5.1)
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 PERRIGO 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: 2/2022
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 Exp