Mupirocin
Generic Name: mupirocin
Brand Names:
Mupirocin
11 DESCRIPTION Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin, USP. The chemical name is (E)- (2S,3R,4R,5S) -5-[ (2S,3S,4S,5S) -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, USP is C 26 H 44 O 9 , and the molecular weight is 500.6. The structural formula of mupirocin, USP is: Figure 1.
Overview
11 DESCRIPTION Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin, USP. The chemical name is (E)- (2S,3R,4R,5S) -5-[ (2S,3S,4S,5S) -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, USP is C 26 H 44 O 9 , and the molecular weight is 500.6. The structural formula of mupirocin, USP is: Figure 1.
Uses
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) . Mupirocin ointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. ( 1 )
Dosage
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 ) ]. • For Topical Use Only. ( 2 ) • 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.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Severe Allergic Reactions [ see Warnings and Precautions ( 5.1 ) ] • Eye Irritation [ see Warnings and Precautions ( 5.2 ) ] • Local Irritation [ see Warnings and Precautions ( 5.3 ) ] • Clostridium difficile-Associated Diarrhea [ see Warnings and Precautions ( 5.4 ) ] • The most frequent adverse reactions (at least 1%) were burning, stinging or pain, and itching. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
5 WARNINGS AND PRECAUTIONS • Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of mupirocin, including Mupirocin ointment. ( 5.1 ) • Eye Irritation: Avoid contact with eyes. ( 5.2 ) • Local Irritation: Discontinue in the event of sensitization or severe local irritation. ( 5.3 ) • Clostridium difficile -Associated Diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. ( 5.4 ) • Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. ( 5.5 ) • Risk Associated with Mucosal Use: Mupirocin ointment is not formulated for use on mucosal surfaces. 4 CONTRAINDICATIONS Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. • Known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. ( 4 )
Pregnancy
8.1 Pregnancy 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) ].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin, USP in a water-miscible ointment base. Mupirocin Ointment USP, 2% is supplied as follows: NDC 21922-073-04 (15-gram tube) NDC 21922-073-25 (22-gram tube) NDC 21922-073-05 (30-gram tube) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Mupirocin used for?▼
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) . Mupirocin ointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. ( 1 )
What are the side effects of Mupirocin?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Severe Allergic Reactions [ see Warnings and Precautions ( 5.1 ) ] • Eye Irritation [ see Warnings and Precautions ( 5.2 ) ] • Local Irritation [ see Warnings and Precautions ( 5.3 ) ] • Clostridium difficile-Associated Diarrhea [ see Warnings and Precautions ( 5.4 ) ] • The most frequent adverse reactions (at least 1%) were burning, stinging or pain, and itching. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Mupirocin during pregnancy?▼
8.1 Pregnancy 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) ].
What are the important warnings for Mupirocin?▼
5 WARNINGS AND PRECAUTIONS • Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of mupirocin, including Mupirocin ointment. ( 5.1 ) • Eye Irritation: Avoid contact with eyes. ( 5.2 ) • Local Irritation: Discontinue in the event of sensitization or severe local irritation. ( 5.3 ) • Clostridium difficile -Associated Diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. ( 5.4 ) • Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. ( 5.5 ) • Risk Associated with Mucosal Use: Mupirocin ointment is not formulated for use on mucosal surfaces. 4 CONTRAINDICATIONS Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. • Known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.