Drugplain

Neomycin and Polymyxin B Sulfates 40 mg/mL

Neomycin and Polymyxin B Sulfates · SOLUTION · XGen Pharmaceuticals DJB, Inc.

3 Recalls on Record
Plain English

Neomycin and Polymyxin B Sulfates is a solution containing neomycin and polymyxin b sulfates at 40 mg/mL, taken irrigation. Manufactured by XGen Pharmaceuticals DJB, Inc..

Key Facts

Brand Name
Neomycin and Polymyxin B Sulfates
Generic Name
Neomycin and Polymyxin B Sulfates
NDC Code (Product)
39822-1220
Manufacturer
XGen Pharmaceuticals DJB, Inc.
Strength
40 mg/mL
Dosage Form
SOLUTION
Route
IRRIGATION
Marketing Status
Application #
ANDA065108
Marketing Start
01/31/2006

Recall History

3 Recalls on Record
Class III10/17/2019

Sandoz Inc

Labeling: Incorrect or missing package insert.

TerminatedVoluntary: Firm initiated
Class II10/13/2022

Akorn, Inc.

CGMP Deviations:

OngoingVoluntary: Firm initiated
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 Neomycin and Polymyxin B Sulfates used for?

Neomycin and Polymyxin B Sulfates contains Neomycin and Polymyxin B Sulfates. It is a solution taken irrigation. Consult your doctor for specific uses.

Is Neomycin and Polymyxin B Sulfates a controlled substance?

Neomycin and Polymyxin B Sulfates is not classified as a controlled substance by the DEA.

What is the generic name for Neomycin and Polymyxin B Sulfates?

The generic name for Neomycin and Polymyxin B Sulfates is Neomycin and Polymyxin B Sulfates. There are 8 other brand versions of Neomycin and Polymyxin B Sulfates.

What is the NDC code for Neomycin and Polymyxin B Sulfates 40 mg/mL?

The NDC (National Drug Code) for Neomycin and Polymyxin B Sulfates 40 mg/mL is 39822-1220, listed by XGen Pharmaceuticals DJB, Inc..

Product NDC

39822-1220

Package NDC

39822-1220-1

Other Neomycin and Polymyxin B Sulfates Dosages

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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