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Pharmacologic Category
Antibiotic, Topical; Antibiotic/Corticosteroid, Topical; Corticosteroid, Topical
Dosing: Adult
Dermatoses, corticosteroid responsive: Apply to affected area 2 to 3 times daily.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Pediatric
Ophthalmic or otic infection/inflammation: Children ≥8 years and Adolescents: Topical: Refer to adult dosing.
Dosing: Renal Impairment: Pediatric
There are no dosage adjustments provided in manufacturer’s labeling. Dosage adjustment unlikely due to low systemic absorption.
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in manufacturer’s labeling. Dosage adjustment unlikely due to low systemic absorption.
Use: Labeled Indications
Note: Not approved in the United States.
Dermatoses: Topical management of secondarily infected allergic or inflammatory dermatoses responsive to corticosteroid therapy.
Administration: Topical
For topical use only. Occlusive dressing may be used for refractory lesions or deep-seated dermatoses.
Administration: Pediatric
For topical use only. The same bottle should not be used to treat otic and ophthalmic infections, nor should it be used by more than one person.
Ophthalmic use: Contact lenses should not be worn during therapy with ophthalmic solution. Apply solution by tilting head back and instilling in conjunctival sac and close eye(s). Do not touch dropper to eye or any other surface.
Otic use: Carefully clear the ear canal of cerumen and debris. Patient should lie down with affected ear upward and medication instilled. Patients should remain in the position for several minutes to allow penetration of solution. Alternatively, the manufacturer suggests that a cotton wick may be placed in the canal then saturated with solution every 4 hours; cotton wick should be replaced every 24 hours.
Storage/Stability
Store at 15°C to 30°C (59°F to 86°F).
Contraindications
Hypersensitivity to betamethasone, gentamicin, or any component of the formulation; viral diseases including chickenpox, herpes simplex, and vaccinia; tuberculosis of the skin; ophthalmic administration.
Warnings/Precautions
Concerns related to adverse effects:
• Adrenal suppression: 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.
• Contact dermatitis: Allergic contact dermatitis can occur and is usually diagnosed by failure to heal rather than clinical exacerbation; discontinue use if irritation occurs and treat appropriately.
• Hypersensitivity: Discontinue use for signs/symptoms of hypersensitivity (eg, irritation).
• Infection: Prolonged use may result in secondary bacterial or fungal superinfection due to immunosuppression. Lack of prompt clinical response may indicate resistance to therapy and warrant discontinuation of therapy and further evaluation.
• Ocular effects: Topical corticosteroids, including betamethasone, may increase the risk of posterior subcapsular cataracts and glaucoma. Monitor for ocular symptoms. Avoid contact with eyes.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome (rare), hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, application to large surface areas, or prolonged use.
Other warnings/precautions:
• Appropriate use: For topical use only. Avoid use around eyes.
Pregnancy Considerations
Refer to individual agents.
Breast-Feeding Considerations
It is not known if betamethasone/gentamicin is excreted in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
See individual agents.
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Betamethasone (Ophthalmic). Risk C: Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider therapy modification
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Risk C: Monitor therapy
Monitoring Parameters
HPA axis suppression and adrenal insufficiency, especially in children; ocular symptoms.
Product Availability
Not available in the US
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Diprogen: Betamethasone 0.05% and gentamicin 0.1% ([DSC])
Valisone-G: Betamethasone 0.1% and gentamicin 0.1% (30 g)
Ointment, External:
Diprogen: Betamethasone 0.05% and gentamicin 0.1% ([DSC])
Solution, Combination:
Generic: Betamethasone 0.1% and gentamicin 0.3% ([DSC])
Anatomic Therapeutic Chemical (ATC) Classification
- D06AX07
- D07CC01
Generic Available (US)
Yes
Mechanism of Action
Refer to individual agents.
Pharmacodynamics/Kinetics
Refer to individual agents.
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
No significant effects or complications reported
Effects on Bleeding
No information available to require special precautions
Related Information
Index Terms
Betamethasone Valerate and Gentamicin Sulfate; Gentamicin and Betamethasone; Gentamicin Sulfate and Betamethasone Valerate
References
Valisone-G (betamethasone/gentamicin) [product monograph]. Laval, Quebec, Canada; August 2018.
Last Updated 12/16/19
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