Polymyxin B 500000 [iU]/1
Polymyxin B sulfate · INJECTION, POWDER, FOR SOLUTION · Hikma Pharmaceuticals USA Inc.
Polymyxin B is a injection, powder, for solution containing polymyxin b sulfate at 500000 [iU]/1, taken intramuscular. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Polymyxin B
- Generic Name
- Polymyxin B sulfate
- NDC Code (Product)
0143-9941- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 500000 [iU]/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, OPHTHALMIC
- Marketing Status
- Application #
- ANDA060716
- Marketing Start
- 06/01/1998
Recall History
AuroMedics Pharma LLC
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Sandoz Inc
Labeling: Incorrect or missing package insert.
Preferred Pharmaceuticals, Inc
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Faria Limited LLC dba Sheffield Pharmaceuticals
Failed Stability Specifications: Unable to meet shelf life expiry.
Akorn, Inc.
CGMP Deviations:
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.
Dosage & Administration
DOSAGE AND ADMINISTRATION Therapy with this product should be limited to 10 consecutive days. The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. For adults, four drops of the solution should be instilled into the affected ear 3 or 4 times daily. For infants and children, three drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the solution. This wick should be kept moist by adding further solution every 4 hours. The wick should be replaced at least once every 24 hours.
Warnings
WARNINGS Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk of ototoxicity is greater with prolonged use; therefore, duration of therapy should be limited to 10 consecutive days (see PRECAUTIONS - General ). Patients being treated with eardrops containing neomycin should be under close clinical observation. Due to its acidity, which may cause burning and stinging, neomycin and polymyxin B sulfates and hydrocortisone otic solution should not be used in any patients with a perforated tympanic membrane. Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known. Discontinue this product promptly if sensitization or irritation occurs. When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances, including neomycin. The manifestation of sensitization to neomycin is usuall…
Contraindications
CONTRAINDICATIONS This product is contraindicated in those individuals who have shown hypersensitivity to any of its components. This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (for example, herpes simplex virus or varicella zoster virus).
Adverse Reactions
ADVERSE REACTIONS Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS ). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general population. 2 In another study, the incidence was found to be approximately 1%. 3 Skin hyperpigmentation has been reported with polymyxin B containing products. The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Stinging and burning have been reported when this product has gained access to the middle ear. To report SUSPECTED…
Frequently Asked Questions
What is Polymyxin B used for?
Polymyxin B contains Polymyxin B sulfate. It is a injection, powder, for solution taken intramuscular. Consult your doctor for specific uses.
Is Polymyxin B a controlled substance?
Polymyxin B is not classified as a controlled substance by the DEA.
What is the generic name for Polymyxin B?
The generic name for Polymyxin B is Polymyxin B sulfate. There are 10 other brand versions of Polymyxin B sulfate.
What is the NDC code for Polymyxin B 500000 [iU]/1?
The NDC (National Drug Code) for Polymyxin B 500000 [iU]/1 is 0143-9941, listed by Hikma Pharmaceuticals USA Inc..
Other Polymyxin B Dosages
Other Polymyxin Brands
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- Polymyxin B Sulfate and Trimethoprim10000 [USP'U]/mL68071-1651
- Walgreens Kids Multi-Antibiotic with Pain Relief Cream3.5 mg/g0363-2122
- polymyxin b sulfate and trimethoprim sulfate10000 [iU]/mL70518-4381
- sunmark triple antibiotic plus pain relief500 [iU]/g49348-600
- Polymyxin B Sulfate and Trimethoprim10000 [USP'U]/mL61314-628
- Walgreens Multi-Antibiotic with Pain Relief Cream3.5 mg/g0363-2123
- Polymyxin B Sulfate and Trimethoprim10000 [USP'U]/mL70518-1735
- POLYMYXIN B500000 [USP'U]/172266-249
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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