Mupirocin Ointment USP, 2%
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Mupirocin Ointment USP, 2% is available as follows: 22 g tube (NDC 45802- 112 -22) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *Bactroban Nasal® is a registered trademark of GlaxoSmithKline.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Mupirocin Ointment USP, 2% Rx Only NET WT 22 g Mupirocin Ointment USP, 2%; Chlorhexidine Gluconate 4% Chlorhexidine Gluconate 4%; Povidone-Iodine, USP 10% Povidone-Iodine, USP 10%; PS2 Aciurgy Pack Mupirocin 2% Chlorhexidine Gluconate 4% Povidone-Iodine, USP 10% NDC 69263-966-01 Oaklock LLC carton
- HOW SUPPLIED Mupirocin Ointment USP, 2% is available as follows: 22 g tube (NDC 45802- 112 -22) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *Bactroban Nasal® is a registered trademark of GlaxoSmithKline.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Mupirocin Ointment USP, 2% Rx Only NET WT 22 g Mupirocin Ointment USP, 2%
- Chlorhexidine Gluconate 4% Chlorhexidine Gluconate 4%
- Povidone-Iodine, USP 10% Povidone-Iodine, USP 10%
- PS2 Aciurgy Pack Mupirocin 2% Chlorhexidine Gluconate 4% Povidone-Iodine, USP 10% NDC 69263-966-01 Oaklock LLC carton
Overview
Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is ( E )-(2 S ,3 R ,4 R ,5 S )-5-[(2 S ,3 S ,4 S ,5 S )-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2 H -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C 26 H 44 O 9 and the molecular weight is 500.62. The chemical structure is: Image 1
Indications & Usage
Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes . Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healhcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery skin wound and general skin cleansing Uses First aid antiseptic to help prevent infection in minor cuts, scrapes and burns
Dosage & Administration
A small amount of Mupirocin Ointment USP, 2% should be applied to the affected area 3 times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated. Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 5 mL of product and a wet brush paying close attention to the nails, cuticles amd interdigital spaces a seprate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 mL of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleaning: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly Directions clean the affected area apply a small amount of this product on the area 1 to 3 times daily. may be covered with a sterile bandage if bandaged, let dry first
Warnings & Precautions
WARNINGS Avoid contact with the eyes. In case of accidental contact, rinse well with water. In the event of sensitization or severe local irritation from Mupirocin Ointment USP, 2%, usage should be discontinued. Clostridium difficile - associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including mupirocin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Warnings For external use only Alergy alert: This product may cause a severe allergic reaction. Symptoms may incloude wheezing/difficulty breathing shock facial swelling hives rash if an allergic reaction occurs, stop use and seek medical help right away Warnings For external use only. Do not use in the eyes longer than 1 week unless directed by a physician on individuals who are allergic or sensitive to iodine or apply over large areas of the body Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours in case of deep or puncture wounds, animal bites or serious burns Keep out of reach of children. If swallowed, get medical assistance or immediately contact a Poison Control Center.
Contraindications
This drug is contraindicated in patients with known hypersensitivity to any of the constituents of the product.
Adverse Reactions
The following local adverse reactions have been reported in connection with the use of mupirocin ointment USP, 2%: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of subjects. Systemic allergic reactions, including anaphylaxis, urticaria, angioedema and generalized rash have been reported in patients treated with mupirocin formulations.
Drug Interactions
- The effect of the concurrent application of Mupirocin Ointment USP, 2% and other drug products has not been studied.
Purpose
Purpose Antiseptic Purpose Antiseptic
Do Not Use
Do not use if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product in contact with meninges in the genital area as a preoperative skin preparation of the head or face Do not use in the eyes longer than 1 week unless directed by a physician on individuals who are allergic or sensitive to iodine or apply over large areas of the body
When Using
When using this product keep out of the eyes, ears and mouth. May cause serious and permenant eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated ear drums. if solution should contact these areas, rinse our promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done ecept when advised be a health care provider
Stop Use & Ask a Doctor
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours in case of deep or puncture wounds, animal bites or serious burns
Keep Out of Reach of Children
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children. If swallowed, get medical assistance or immediately contact a Poison Control Center.
Storage & Handling
Other information do not flush protect from freezing, avoid excessive heat
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