ALTABAX- retapamulin ointment

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

RETAPAMULIN (UNII: 4MG6O8991R) (RETAPAMULIN - UNII:4MG6O8991R)

Beszerezhető a:

Almirall, LLC

INN (nemzetközi neve):

RETAPAMULIN

Összetétel:

RETAPAMULIN 10 mg

Az alkalmazás módja:

TOPICAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

ALTABAX® is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies (14)] . Safety in patients younger than 9 months has not been established. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ALTABAX and other antibacterial drugs, ALTABAX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. None. Risk Summary There are no available data on ALTABAX use in pregnant women to inform any drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. Retapamulin is negligibly absorbed systemically following topical administration and maternal use is not expected to result in fetal exp

Termék összefoglaló:

ALTABAX is supplied in 15-gram and 30-gram tubes. NDC 16110-518-15 (15-gram tube) NDC 16110-518-30 (30-gram tube) Store at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F).

Engedélyezési státusz:

New Drug Application

Termékjellemzők

ALTABAX- RETAPAMULIN OINTMENT
ALMIRALL, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALTABAX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALTABAX.
ALTABAX (RETAPAMULIN OINTMENT), FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
ALTABAX, a pleuromutilin antibacterial, is indicated for the topical
treatment of impetigo due to
_Staphylococcus aureus_ (methicillin-susceptible isolates only) or
_Streptococcus pyogenes_ in patients aged
9 months or older. (1) Safety in patients younger than 9 months has
not been established.
DOSAGE AND ADMINISTRATION
Apply a thin layer of ALTABAX to the affected area (up to 100 cm in
total area in adults or 2% total
body surface area in pediatric patients aged 9 months or older) twice
daily for 5 days. (2)
The treated area may be covered with a sterile bandage or gauze
dressing if desired. (2)
DOSAGE FORMS AND STRENGTHS
10 mg retapamulin per 1g of ointment (1%) in 15- and 30-gram tubes (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Discontinue in the event of sensitization or severe local irritation.
(5.1)
Not intended for ingestion. Not for intraoral, intranasal, ophthalmic,
or intravaginal use. (5.2)
ADVERSE REACTIONS
The most common drug-related adverse reaction was application site
irritation (less than or equal to 2% of
subjects). (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.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2023
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 Local Irritation
5.2 Not for Systemic or Mucosal Use
5.3 Potential for Microbial Overgrowth
6 ADVERSE REACTIONS
2
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric