Is Mupirocid Ointment 2% For Human Or Animal Use

What is Mupirocin Cream and how is information technology used?

Mupirocin Cream is a prescription medicine used to treat the symptoms of Impetigo, Secondary Skin Infection and Emptying of MRSA Colonization. Mupirocin Cream may be used lone or with other medications.

Mupirocin Cream belongs to a class of drugs called Antibacterials, Topical.

It is not known if Mupirocin Foam is prophylactic and effective in children younger than 2 years of historic period.

What are the possible side effects of Mupirocin Cream?

Mupirocin Foam may cause serious side effects including:

• hives,
• problem breathing,
• wheezing,
• swelling of your face, lips, mouth, or tongue,
• dizziness,
• fast heartbeat,
• pounding in your chest,
• rash over your whole trunk,
• eye irritation,
• irritation in the area the medication was applied, and
• diarrhea (Clostridium difficile)

Go medical aid right away, if you take any of the symptoms listed to a higher place.

The most mutual side effects of Mupirocin Foam include:

• headache,
• rash,
• nausea,
• abdominal pain,
• burning at the application site,
• severe bacterial pare infection (cellulitis),
• peel inflammation,
• dizziness,
• itching,
• secondary wound infection, and
• mouth sores

Tell the medico if you lot have whatsoever side effect that bothers you or that does not go away.

These are not all the possible side effects of Mupirocin Cream. For more information, ask your doctor or pharmacist.

Telephone call your physician for medical communication about side effects. Y'all may report side effects to FDA at 1-800-FDA-1088.

Description

Mupirocin cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (αDue east,iiS,iiiR,4R,5S)-5-[(twoSouthward,iiiS,4S,5Due south)-2,3-epoxy-five- hydroxy-4-methylhexyl]tetrahydro-3,four-dihydroxy-β-methyl-2H-pyran-two-crotonic acid, ester with 9- hydroxynonanoic acid, calcium salt (ii:ane), dihydrate.

The molecular formula of mupirocin calcium USP is (C₂₆H₄₃O₉)₂ Ca•2H_twoO, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium USP is:

Mupirocin cream USP is a white cream that contains two.xv% west/w mupirocin calcium USP (equivalent to 2% mupirocin free acid) in an oil- and water-based emulsion. The inactive ingredients are benzyl alcohol, glycerol monostearate, mineral oil, phenoxyethanol, polyoxyl xx cetostearyl ether, purified water and xanthan gum.

INDICATIONS

Mupirocin cream is indicated for the handling of secondarily infected traumatic skin lesions (up to x cm in length or 100 cm² in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).

DOSAGE AND Assistants

• For Topical Use Only.
• Apply a small-scale amount of mupirocin foam, with a cotton swab or gauze pad, to the affected expanse three times daily for 10 days.
• Comprehend the treated area with gauze dressing if desired.
• Re-evaluate patients not showing a clinical response within iii to 5 days.
• Mupirocin cream is not for intranasal, ophthalmic, or other mucosal use [see WARNINGS AND PRECAUTIONS].
• Practice not apply mupirocin foam concurrently with whatsoever other lotions, creams or ointments [run into CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

Mupirocin cream USP is a white cream that contains 2.15% w/w mupirocin calcium USP (equivalent to two% mupirocin free acrid) in an oil- and water-based emulsion supplied in fifteen-gram and 30-gram tubes.

Stronge And Treatment

Mupirocin foam USP, 2% is supplied in 15-gram and xxx-gram tubes.

Mupirocin cream USP is a white cream that contains two.fifteen% w/west mupirocin calcium USP (equivalent to 2% mupirocin gratuitous acrid) in an oil- and h2o-based emulsion.

NDC 69150-225-01 xv-gram tube (one tube per carton)
NDC 69150-225-03 30-gram tube (1 tube per carton)

Shop at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do non freeze.

Manufactured by: Biomes Pharmaceuticals LLC.,Lansing, MI 48906. Revised: Mar 2016

SLIDESHOW

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Side Effects & Drug Interactions

SIDE EFFECTS

The post-obit adverse reactions are discussed in more particular in other sections of the labeling:

• Severe Allergic Reactions [run into WARNINGS AND PRECAUTIONS]
• Eye Irritation [see WARNINGS AND PRECAUTIONS]
• Local Irritation [see WARNINGS AND PRECAUTIONS]
• Clostridium difficile-Associated Diarrhea [run across WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted nether widely varying conditions, agin reaction rates observed in the clinical trials of a drug cannot be straight compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 2 randomized, double-blind, double-dummy trials, 339 subjects were treated with topical mupirocin foam plus oral placebo. Adverse reactions occurred in 28 (8.3%) subjects. The following adverse reactions were reported by at least 1% of subjects in connection with the utilize of mupirocin cream in clinical trials: headache (one.vii%), rash (1.ane%), and nausea (1.1%).

Other agin reactions which occurred in less than 1% of subjects were: abdominal pain, burning at awarding site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis.

In a supportive trial in the treatment of secondarily infected eczema, 82 subjects were treated with mupirocin foam. The incidence of agin reactions was equally follows: nausea (four.9%), headache and called-for at application site (3.half dozen% each), pruritus (2.4%), and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry pare, and rash.

Postmarketing Feel

In add-on to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of mupirocin cream. Considering they are reported voluntarily from a population of unknown size, estimates of frequency cannot be fabricated. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to mupirocin cream.

Allowed System Disorders

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [encounter WARNINGS AND PRECAUTIONS].

DRUG INTERACTIONS

No Data Provided

WARNINGS

Included every bit function of the "PRECAUTIONS" Section

PRECAUTIONS

Click hither to enter Warnings and Precautions

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 cream [see Adverse REACTIONS].

Eye Irritation

Avoid contact with the eyes. In instance of accidental contact, rinse well with h2o.

Local Irritation

In the event of a sensitization or severe local irritation from mupirocin foam, usage should be discontinued, and appropriate alternative therapy for the infection instituted.

Clostridium Difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with utilize of almost all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Handling 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. Hypertoxinproducing strains of C. difficile cause increased morbidity and mortality, as these infections tin be refractory to antimicrobial therapy and may crave 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 2 months later on the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may demand to be discontinued. Appropriate fluid and electrolyte direction, poly peptide supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted equally clinically indicated.

Potential For Microbial Overgrowth

Equally with other antibacterial products, prolonged utilise of mupirocin cream may consequence in overgrowth of nonsusceptible microorganisms, including fungi [run into DOSAGE AND ADMINISTRATION].

Risk Associated With Mucosal Utilize

Mupirocin cream is non formulated for use on mucosal surfaces. A separate formulation, †Bactroban (mupirocin calcium) nasal ointment, is available for intranasal utilize.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).

Propose the patient to administer mupirocin cream equally follows:

• Utilize mupirocin foam only as directed by the healthcare provider. It is for external utilise just. Avoid contact of mupirocin cream with the eyes. If mupirocin cream gets in the eyes, rinse thoroughly with water.
• Exercise not use mupirocin cream in the nose.
• Launder your easily before and after applying mupirocin cream.
• Apply a gauze pad or cotton wool swab to use a small corporeality of mupirocin cream to the afflicted expanse.
• The treated area may be covered by gauze dressing if desired.
• Written report to the healthcare provider whatever signs of local adverse reactions. Mupirocin foam should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs. Report to the healthcare provider or go to the nearest emergency room if severe allergic reactions, such equally swelling of the lips, face, or tongue, or wheezing occur [see WARNINGS AND PRECAUTIONS].
• If no improvement is seen in three to 5 days, contact the healthcare provider.

Nonclinical Toxicology

Click here to enter Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to evaluate carcinogenic potential of mupirocin calcium take not been conducted.

Results of the post-obit studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not betoken a potential for genotoxicity: rat primary hepatocyte unscheduled Dna synthesis, sediment assay for Dna strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation analysis, metaphase assay of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.

Reproduction studies were performed with mupirocin administered subcutaneously to male and female person rats at doses upwards to 100 mg per kg per day which is 14 times the human topical dose (approximately 60 mg mupirocin per twenty-four hour period) based on body surface expanse. Neither testify of impaired fertility nor dumb reproductive operation attributable to mupirocin was observed.

Utilize In Specific Populations

Pregnancy

Pregnancy Category B

There are no adequate and well-controlled studies of mupirocin foam (contains equivalent of 2% mupirocin free acrid) in meaning women. Because animal reproduction studies are not always predictive of man response, this drug should be used during pregnancy only if clearly needed.

Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per twenty-four hour period in both species. This dose is 22 and 43 times, respectively, the human being topical dose (approximately threescore mg mupirocin per day) based on body area. There was no evidence of fetal harm due to mupirocin.

Nursing Mothers

It is non known whether this drug is excreted in homo milk. Because many drugs are excreted in homo milk, circumspection should exist exercised when mupirocin cream is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of mupirocin cream have been established in the historic period-groups iii months to 16 years. Use of mupirocin cream in these age-groups is supported by show from acceptable and well-controlled trials of mupirocin cream in adults with additional data from 93 pediatric subjects studied every bit office of the pivotal trials in adults [see Clinical Studies].

Geriatric Use

In 2 acceptable and well-controlled trials, thirty subjects older than 65 years were treated with mupirocin cream. No overall departure in the efficacy or safety of mupirocin foam was observed in this patient population when compared with that observed in younger patients.

Overdosage & Contraindications

OVERDOSE

No Information Provided

CONTRAINDICATIONS

Mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or whatever of the excipients of mupirocin foam.

CLINICAL PHARMACOLOGY

Click here to enter Clinical Pharmacology

Mechanism Of Action

Mupirocin is an RNA synthetase inhibitor antibacterial [see Microbiology].

Pharmacokinetics

Assimilation

Systemic assimilation of mupirocin through intact human being skin is minimal. The systemic assimilation of mupirocin was studied post-obit application of mupirocin cream three times daily for 5 days to various skin lesions greater than 10 cm in length or 100 cm² in area in 16 adults (aged 29 to 60 years) and x children (anile 3 to 12 years). Some systemic absorption was observed as evidenced by the detection of the metabolite, monic acid, in urine. Data from this trial indicated more frequent occurrence of percutaneous absorption in children (90% of subjects) compared with adults (44% of subjects); yet, the observed urinary concentrations in children (0.07 to 1.3 mcg per mL [1 pediatric subject area had no detectable level]) are inside the observed range (0.08 to 10.03 mcg per mL [ix adults had no detectable level]) in the adult population. In full general, the degree of percutaneous assimilation post-obit multiple dosing appears to be minimal in adults and children.

The effect of the concurrent awarding of mupirocin cream with other topical products has not been studied [see DOSAGE AND Assistants].

Emptying

In a trial conducted in 7 healthy adult male subjects, the elimination half-life afterwards intravenous administration of mupirocin was 20 to forty minutes for mupirocin and 30 to 80 minutes for monic acid.

Metabolism:

Following intravenous or oral administration, mupirocin is rapidly metabolized. The main metabolite, monic acid, demonstrates no antibacterial activity.

Excretion:

Monic acid is predominantly eliminated by renal excretion.

Special Populations

Renal Harm

The pharmacokinetics of mupirocin have not been studied in individuals with renal insufficiency.

Microbiology

Mupirocin is an RNA synthetase inhibitor antibacterial produced by fermentation using the organism Pseudomonas fluorescens.

Mechanism Of Action

Mupirocin inhibits bacterial protein synthesis by reversibly and specifically bounden to bacterial isoleucyltransfer RNA (tRNA) synthetase.

Mupirocin is bactericidal at concentrations achieved by topical administration. Mupirocin is highly protein bound (greater than 97%) and the result of wound secretions on the minimum inhibitory concentrations (MICs) of mupirocin has not been determined.

Mechanism Of Resistance

When mupirocin resistance occurs, it results from the product of a modified isoleucyl-tRNA synthetase, or the conquering of, past genetic transfer, a plasmid mediating a new isoleucyl-tRNA synthetase. Loftier-level plasmid-mediated resistance (MIC ≥512 mcg/mL) has been reported in increasing numbers of isolates of Southward. aureus and with higher frequency in coagulase-negative staphylococci. Mupirocin resistance occurs with greater frequency in methicillin-resistant than methicillin-susceptible staphylococci.

Cross Resistance

Due to its mode of activity, mupirocin does non demonstrate cross resistance with other classes of antimicrobial agents.

Antimicrobial Activity

Mupirocin has been shown to be active against susceptible isolates of S. aureus and S. pyogenes, both in vitro and in clinical trials [see INDICATIONS AND USAGE]. The following in vitro data are available, only their clinical significance is unknown. Mupirocin is active against about isolates of Staphylococcus epidermidis.

Susceptibility Testing

Loftier-level mupirocin resistance (≥512 mcg/mL) may be determined using standard deejay diffusion or broth microdilution tests.^1,2 Because of the occurrence of mupirocin resistance in methicillin-resistant South. aureus (MRSA), it is appropriate to test MRSA populations for mupirocin susceptibility prior to the use of mupirocin using a standardized method.^3,4,5

Clinical Studies

The efficacy of topical mupirocin foam for the treatment of secondarily infected traumatic skin lesions (due east.thousand., lacerations, sutured wounds, and abrasions not more 10 cm in length or 100 cm² in total expanse) was compared with that of oral cephalexin in ii randomized, double-blind, double-dummy clinical trials. Clinical efficacy rates at follow-up in the per-protocol populations (adults and pediatric subjects included) were 96.1% for mupirocin cream (n = 231) and 93.1% for oral cephalexin (n = 219). Pathogen eradication rates at follow-up in the per-protocol populations were 100% for both mupirocin cream and oral cephalexin.

Pediatrics

In that location were 93 pediatric subjects anile 2 weeks to 16 years enrolled per protocol in the secondarily infected skin lesion trials, although just iii were younger than 2 years of age in the population treated with mupirocin foam. Subjects were randomized to either 10 days of topical mupirocin cream 3 times daily or x days of oral cephalexin (250 mg four times daily for subjects greater than twoscore kg or 25 mg per kg per day oral suspension in iv divided doses for subjects less than or equal to 40 kg). Clinical efficacy at follow-up (vii to 12 days post-therapy) in the per-protocol populations was 97.7% (43 of 44) for mupirocin cream and 93.9% (46 of 49) for cephalexin.

REFERENCES

one. Clinical and Laboratory Standards Constitute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement. CLSI document M100-S25. Clinical and Laboratory Standards Constitute, 950 West Valley Rd., Suite 2500, Wayne, PA 19087, U.s., 2015.

2. Patel J, Gorwitz RJ, et al. Mupirocin Resistance. Clinical Infectious Diseases. 2009; 49(6): 935-41.

iii. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition. CLSI document M07- A10. Clinical and Laboratory Standards Establish, 950 Westward Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

4. Clinical and Laboratory Standards Institute (CLSI). Functioning Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Canonical Standard – 12th Edition. CLSI certificate M02-A12. Clinical and Laboratory Standards Found, 950 Westward Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

5. Finlay JE, Miller LA, Poupard JA. Interpretive criteria for testing susceptibility of staphylococci to mupirocin. Antimicrob Agents Chemother 1997;41(5):1137-1139.

PATIENT INFORMATION

Mupirocin
(mue-PIR-oh-sin)
Foam, USP

What is mupirocin foam?

Mupirocin cream is a prescription medicine used on the skin (topical use) to care for certain skin infections caused by bacteria called Staphylococcus aureus and Streptococcus pyogenes. It is not known if mupirocin foam is safe and effective in children nether iii months of age.

Who should not use mupirocin foam?

Do not use mupirocin foam if:

• you are allergic to mupirocin or any of the ingredients in mupirocin cream. Come across the end of this Patient Data leaflet for a consummate list of the ingredients in mupirocin foam.

What should I tell my healthcare provider before using mupirocin cream?

Before using mupirocin cream, tell your healthcare provider well-nigh all of your medical conditions including if you:

• are pregnant or plan to become pregnant. Information technology is non known if mupirocin cream volition damage your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if mupirocin cream passes into your breast milk. You and your healthcare provider should decide if you lot tin apply mupirocin foam while breastfeeding.

Tell your healthcare provider nearly all of the medicines you take, including prescription and overthe- counter medicines, vitamins, and herbal supplements. Do not mix mupirocin cream with other lotions, creams, or ointments.

How should I use mupirocin cream?

• Mupirocin foam is for utilize on the peel (topical).Exercise non get mupirocin cream in your optics, nose, mouth, or vagina (mucosal surfaces).
• Use mupirocin cream exactly equally your healthcare provider tells you lot to use it.
• Apply a minor amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area iii times each day. Apply mupirocin cream for ten days.
• It is important that you take the total course of mupirocin cream. Do not end early because your symptoms may disappear before the infection is fully cleared.
• Launder your hands earlier and after applying mupirocin cream.
• After applying mupirocin foam, you lot may cover the treated surface area with a clean gauze pad, unless your healthcare provider has told you to go out information technology uncovered.
• Talk to your healthcare provider if your pare does non better later on 3 to 5 days of treatment with mupirocin foam.

What are the possible side effects of mupirocin cream?

Mupirocin cream may cause serious side effects, including:

• astringent allergic reactions.finish using mupirocin cream and call your healthcare provider or go to the nearest emergency room right away if you lot take any of the following signs or symptoms of a severe allergic reaction:
  • hives
  • problem breathing or wheezing
  • swelling of your confront, lips, mouth, or natural language
  • dizziness, fast heartbeat, or pounding in your chest
  • a rash over your whole body
• heart irritation.Do non get mupirocin cream in your eyes. If mupirocin cream gets in your optics, rinse your eyes well with water.
• irritation in the surface area mupirocin foam is used.A rash may occur after using mupirocin cream and can be severe. Stop using mupirocin cream and call your healthcare provider if y'all develop an irritation, severe itching, or a rash while using mupirocin cream.
• a type of diarrhea called clostridium difficile-associated diarrhea (CDAD). CDAD may happen in people who apply or have used medicine to treat bacterial infections. The severity of CDAD tin can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Call your healthcare provider or go to the nearest emergency room correct away if you have diarrhea while using or after you stop using mupirocin cream.

The most common side effects of mupirocin cream include:

• headache
• rash
• nausea

These are not all the possible side furnishings of mupirocin cream. Telephone call your doctor for medical advice nearly side effects. You may report side effects to FDA at i-800-FDA-1088.

How should I shop mupirocin cream?

• Store at 20° to 25°C (68° to 77°F).
• Do not freeze mupirocin cream.
• Go on mupirocin foam and all medicines out of the reach of children.

General information about the safety and effective use of mupirocin cream

Medicines are sometimes prescribed for purposes other than those listed in a Patient Data leaflet. Do not employ mupirocin cream for a status for which it was not prescribed. Do non give mupirocin cream to other people, even if they accept the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information virtually mupirocin cream that is written for health professionals.

What are the ingredients in mupirocin cream?

Agile Ingredient: mupirocin calcium USP

Inactive Ingredients: benzyl booze, glycerol monostearate, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water and xanthan mucilage.

From

Report Issues to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or phone call 1-800-FDA-1088.

Source: https://www.rxlist.com/mupirocin-cream-drug.htm

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