MUPIROCIN ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MUPIROCIN (UNII: D0GX863OA5) (MUPIROCIN - UNII:D0GX863OA5)

Available from:

Advanced Rx Pharmacy of Tennessee, LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. 8.1 Pregnancy Risk Summary There are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [see CLINICAL PHARMACOLOGY (12.3)]. No developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 mg per kg per day or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). The estimated background risk of major birth defects and miscarriages for the indi

Product summary:

Each gram of mupirocin ointment contains 20 mg mupirocin in a water-miscible ointment base. Mupirocin Ointment USP, 2% is supplied as follows: 22-g tube NDC: 80425-0254-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MUPIROCIN- MUPIROCIN OINTMENT
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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MUPIROCIN 2% OINTMENT
1. INDICATIONS AND USAGE
Mupirocin Ointment USP, 2% is indicated for the topical treatment of
impetigo due to
susceptible isolates of Staphylococcus aureus (S. aureus) and
Streptococcus pyogenes
(S. pyogenes)
2. DOSAGE AND ADMINISTRATION
For Topical Use Only.
Apply a small amount of mupirocin ointment, with a cotton swab or
gauze pad, to the
affected area 3 times daily for up to 10 days.
Cover the treated area with gauze dressing if desired.
Re-evaluate patients not showing a clinical response within 3 to 5
days.
Mupirocin ointment is not for intranasal, ophthalmic, or other mucosal
use [see
WARNINGS AND PRECAUTIONS (5.2, 5.6)].
Do not apply mupirocin ointment concurrently with any other lotions,
creams, or
ointments [see CLINICAL PHARMACOLOGY (12.3)].
3. DOSAGE FORMS AND STRENGTHS
Each gram of mupirocin ointment contains 20 mg mupirocin in a
water-miscible ointment
base supplied in 15-gram, 22-gram and 30-gram tubes.
4. CONTRAINDICATIONS
Mupirocin ointment is contraindicated in patients with known
hypersensitivity to
mupirocin or any of the excipients of mupirocin ointment.
5. WARNINGS AND PRECAUTIONS
5.1 Severe Allergic Reactions
Systemic allergic reactions, including anaphylaxis, urticaria,
angioedema, and generalized
rash, have been reported in patients treated with formulations of
mupirocin, including
mupirocin ointment [see ADVERSE REACTIONS (6.2)].
5.2 Eye Irritation
Avoid contact with the eyes. In case of accidental contact, rinse well
with water.
5.3 Local Irritation
In the event of a sensitization or severe local irritation from
mupirocin ointment, usage
should be discontinued, and appropriate alternative therapy for the
infection instituted.
5.4 Clostridium difficile-Associated Diarrhea
Clostridium difficile-associated diarrhea (CDAD) has been reported
with use of nearly all
antibacterial agents and may range in severity from mild diarrhea to
fatal colitis.
Treatment with antibacterial agents alters th