Neomycin, polymyxin b, and hydrocortisone Otic

Name: Neomycin, polymyxin b, and hydrocortisone Otic

Before Using neomycin, polymyxin b, and hydrocortisone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For neomycin, polymyxin b, and hydrocortisone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to neomycin, polymyxin b, and hydrocortisone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of otic neomycin, polymyxin B, and hydrocortisone preparation in children with use in other age groups, this preparation is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of otic neomycin, polymyxin B, and hydrocortisone preparation in the elderly with use in other age groups, this preparation is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of neomycin, polymyxin b, and hydrocortisone. Make sure you tell your doctor if you have any other medical problems, especially:

  • Any other ear infection or condition (including punctured eardrum)—Use of neomycin, polymyxin B, and hydrocortisone otic preparations may make the condition worse

Contraindications

Hypersensitivity to neomycin, polymyxin B, hydrocortisone, or any component of the formulation; herpes simplex, vaccinia, and varicella infections (suspension only); cutaneous viral infection (herpes simplex virus, varicella zoster virus) of the external auditory canal (solution only)

Dosing Adult

Note: Duration of use should be limited to 10 days unless otherwise directed by the health care provider.

Otic infections: Otic: Instill 4 drops 3 to 4 times daily; otic suspension is the preferred otic preparation.

Dosing Pediatric

Note: Duration of use should be limited to 10 days unless otherwise directed by the health care provider.

Otic infections: Children ≥2 years and Adolescents: Otic: Instill 3 drops 3 to 4 times daily

Dosing Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Drug Interactions

There are no known significant interactions.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert, 2012).

• Neomycin sensitization: Neomycin may cause cutaneous sensitization. Symptoms of neomycin sensitization include itching, reddening, edema, and failure to heal. Discontinuation of product and avoidance of similar products should be considered.

• Ototoxicity: Neomycin may cause permanent sensorineural hearing loss due to cochlear damage. Risk of ototoxicity is increased in patients with extended use; limit therapy to 10 days. Do not use in any patient with a perforated tympanic membrane.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Special populations:

• Pediatric: Children may absorb proportionally larger amounts of corticosteroids after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Sulfites: Some formulations may contain sulfites, which may cause allergic-type reactions in susceptible individuals.

Other warnings/precautions:

• Appropriate use: For otic use only; do not use in the eyes. If infection is not improved after 1 week, preform cultures and susceptibility tests. Avoid contaminating the bottle tip with material from the ear, fingers, or other source.

Pregnancy Risk Factor C Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. See individual agents.

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