ALTABAX- retapamulin ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp.

INN (International Name):

RETAPAMULIN

Composition:

RETAPAMULIN 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] . To reduce the development of drug-resistant bacteria and maintain the effectiveness of ALTABAX and other antibacterial drugs, ALTABAX should None. 8.1 Pregnancy Pregnancy Category B . Effects on embryo-fetal development were assessed in pregnant rats given 50, 150, or 450 mg/kg/day by oral gavage on days 6 to 17 postcoitus. Maternal toxicity (decreased body weight gain and food consumption) and developmental toxicity (decreased fetal body weight and delayed skeletal ossification) were evident at doses ≥150 mg/kg/day. There were no treatment-related malformations observed in fetal rats. Retapamulin was given as a continuous intravenous infusion to pre

Product summary:

ALTABAX is supplied in 10 gram tubes. NDC 21695-644-10 (10 gram tube) Store at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

ALTABAX- RETAPAMULIN OINTMENT
REBEL DISTRIBUTORS CORP.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
ALTABAX is indicated for use in adults and pediatric patients aged 9
months and older for the topical
treatment of impetigo (up to 100 cm 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)]_.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ALTABAX and
other antibacterial drugs, ALTABAX should
2 DOSAGE AND ADMINISTRATION
A thin layer of ALTABAX should be applied 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. The
treated area may be covered with a sterile bandage or gauze dressing
if desired _[see Patient Counseling_
_Information (17)]_.
3 DOSAGE FORMS AND STRENGTHS
10 mg retapamulin/1g of ointment in 5, 10, 15, and 30 gram tubes
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Local Irritation
In the event of sensitization or severe local irritation from ALTABAX,
usage should be discontinued,
the ointment wiped off, and appropriate alternative therapy for the
infection instituted _[see Patient_
_Counseling Information (17)]_.
5.2 Not for Systemic or Mucosal Use
ALTABAX is not intended for ingestion or for oral, intranasal,
ophthalmic, or intravaginal use.
ALTABAX has not been evaluated for use on mucosal surfaces _[see
Patient Counseling Information_
_(17)]_.
5.3 Potential for Microbial Overgrowth
The use of antibiotics may promote the selection of nonsusceptible
organisms. Should superinfection
occur during therapy, appropriate measures should be taken.
Prescribing ALTABAX in the absence of a proven or strongly suspected
bacterial infection is unlikely
to provide benefit to the patient and increases the risk of the
development of drug-resistant bacteria.
6 ADVERSE REACTI