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Betamethasone and gentamicin (United States: Not available): Pediatric drug information

Betamethasone and gentamicin (United States: Not available): Pediatric drug information
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Brand Names: Canada
  • Valisone-G
Therapeutic Category
  • Antibiotic/Corticosteroid, Ophthalmic;
  • Antibiotic/Corticosteroid, Otic
Dosing: Pediatric
Dermatosis, corticosteroid responsive, infected

Dermatosis, corticosteroid responsive, infected: Children and Adolescents: Topical: Apply to affected area 2 to 3 times daily.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Adult

(For additional information see "Betamethasone and gentamicin (United States: Not available): Drug information")

Dermatosis, corticosteroid responsive

Dermatosis, corticosteroid responsive: Apply to affected area 2 to 3 times daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

See individual agents.

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.

Warnings: Additional Pediatric Considerations

The extent of percutaneous absorption is dependent on several factors, including epidermal integrity (intact versus abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Infants and small children may be more susceptible to hypothalamic-pituitary-adrenal (HPA) axis suppression, intracranial hypertension, Cushing syndrome, or other systemic toxicities due to larger skin surface area to body mass ratio.

Product Availability

Not available in the US

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Valisone-G: Betamethasone 0.1% and gentamicin 0.1% (30 g) [contains cetostearyl alcohol, chlorocresol (chloro-m-cresol)]

Ointment, External:

Valisone-G: Betamethasone 0.1% and gentamicin 0.1% (15 g, 30 g)

Administration: Pediatric

Topical: For topical use only. Avoid application in or around eyes. Occlusive dressing may be used for refractory lesions or deep-seated dermatoses.

Administration: Adult

Topical: For topical use only. Occlusive dressing may be used for refractory lesions or deep-seated dermatoses.

Storage/Stability

Store at 15°C to 30°C (59°F to 86°F).

Use

Note: Not approved in the United States.

Canadian labeling: Topical management of secondarily infected allergic or inflammatory dermatoses responsive to corticosteroid therapy (indicated in pediatric patients [age not specified] and adults).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

CYP3A4 Inhibitors (Strong): May increase serum concentration of Betamethasone (Ophthalmic). Risk C: Monitor

Nirmatrelvir and Ritonavir: May increase serum concentration of Corticosteroids (Ophthalmic). Risk C: Monitor

Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May increase adverse/toxic effects of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor

Pregnancy Considerations

Refer to individual agents.

Monitoring Parameters

Growth; assess hypothalamic-pituitary-adrenal (HPA) axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test); ocular symptoms/visual disturbances. Monitor for skin irritation, sensitization, or superinfection.

Mechanism of Action

Refer to individual agents.

Pharmacokinetics (Adult Data Unless Noted)

Refer to individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Diprogenta;
  • (AR) Argentina: Bacticort | Dexalergin nf | Diprogenta | Quiacort g | Sirotamicin bg;
  • (AT) Austria: Diprogenta;
  • (AU) Australia: Celestone vg;
  • (BG) Bulgaria: Betaderm | Betazongent | Diprogenta;
  • (BR) Brazil: Betogenta | Dibederm | Diprogenta | Dipropionato Betametasona+Sulfato Gentamicina | Dipropionato de betametasona + sulfato de gen | Dipropionato de betametasona + sulfato de gentamicina | Dipropionato de Betametasona+Sulfato de Gent. | Diprozil | Duotrat | Trok g;
  • (CH) Switzerland: Diprogenta;
  • (CL) Chile: Diprospan G | Labosona G | Mixgen;
  • (CO) Colombia: Besogen | Diprogenta | Trok g;
  • (CZ) Czech Republic: Belogent;
  • (DE) Germany: Diprogenta | Sulmycin mit celestan-v;
  • (DO) Dominican Republic: Beta biotic | Diprogenta | Gentacort;
  • (EC) Ecuador: Diprogenta | Mixgen;
  • (EE) Estonia: Diprogenta;
  • (EG) Egypt: Genmycin plus | Gentacure | Gentazone;
  • (ES) Spain: Celestoderm gentamicina | Diprogenta | Mibetin;
  • (ET) Ethiopia: B Mycin;
  • (FI) Finland: Celestoderm garamycin;
  • (GR) Greece: Celestoderm v with garamycin | Propiogenta;
  • (HK) Hong Kong: B+G | Beprogent | Beta-genta | Betacorten G | Betagent | Dermal G | Diprogenta | Progensone | Skinfect B;
  • (HR) Croatia: Belogent | Diprogenta;
  • (HU) Hungary: Bedicortal;
  • (ID) Indonesia: Benoson g | Betasin | Biocort | Celestoderm v with garamycin | Derticort | Digenta | Diprogenta | Diprosta | Mastroson | Salgen Plus | Skilone | Skinal | Sonigen | Zensoderm;
  • (IL) Israel: Betacorten G | Diprogenta;
  • (IN) India: Betaderm-g | Betagel-g | Cortiderm-g | Dipgenta | Diprovate g | Exevate-g | Gentalene | Gentopic | Lupiderm-g | Mediderm | Propygenta | Sternon-g | Ultravate-g;
  • (IQ) Iraq: Betnosam g;
  • (IT) Italy: Brexagenbeta | Dermabiolene | Egerian | Fidagenbeta | Gentalyn beta | Gentam/betam Alm | Gentamicina e betametasone hexal | Gentamicina e betametasone pensa | Gentamicina e betametasone ratiopharm italia | Gentamicina/betametasone mylan generics | Kamelyn | Sterozinil | Tevabeta;
  • (JP) Japan: Betnoval g glaxosmithkline | Betnoval g sato | Cordel g | Dermosol g | Dexan | Dexan vg | Rinderon vg;
  • (KE) Kenya: Diprogenta;
  • (KR) Korea, Republic of: Acylo | Amol g a | Antasone | Aricort s | Asem-g | Ballenat | Baroma-g | Bedesta-g | Bencort | Bergen-g | Berocort-g | Beta | Betaderm-g | Betagen | Betagen-g | Betason-g | Better m | Betterderm g | Bistone-G | Br betacin | Broderm | Cabaclean | Caraben | Caravan | Cecolon-g | Cecoron G | Cecrason | Celasone | Celastone | Celecort | Celederm g | Celeron g | Celestone g | Celetone | Cellason | Celogen | Celton | Cerestin | Cestin | Ceston g | Cetasone | Chmaron-g | Clean g | Cleastone g | Clin-G | Clobegen-a | Combiderm G | Danagenta | Danason | Demacot-s | Derma g | Dermabetacin | Dermace g | Dermagood | Dermastop | Dermo beta | Dermonia | Diprogenta | Elskin | G ston | Genjistone | Genmason-g | Gentaderm | Gentrisone-g | Genzistone | I gee | Lavenderm | Lestone | Methagen | Modaderm-s | Myderm-g | Nivera | Novason | Perican-g | Restone | Saecrason | Saerogenta | Selecsking | Selston | Sensta-g | Sepiderm-gn | Seron | Setajina | Silcron g | Silcron-s | Silkron g | Stason-g | Sterocin g | Sterocin-g | Tragel g | Trifulg | Trigenta-g | Vameson-G | Verosin-g;
  • (KW) Kuwait: Diprogenta;
  • (LB) Lebanon: Diprogenta;
  • (LV) Latvia: Bedicort g | Betacorten G | Celestoderm v gara | Diprogenta;
  • (MX) Mexico: Diprosone g | Garamicina v | Valgeben;
  • (MY) Malaysia: Antasone | B Mycin | Beprogent | Betamethasone G | Betnesone g | Celestoderm v with garamycin | Dermal G | Diprogenta | Gentasone;
  • (NG) Nigeria: Becloderm g;
  • (NO) Norway: Diprogenta;
  • (PE) Peru: Diprogenta;
  • (PH) Philippines: Bactrigen | Diprogenta;
  • (PK) Pakistan: Austagent | Bactroid g | Beprogent | Bepronate | Betacline g | Betagenic | Betagent | Betamycin | Betasol g | Bg cure | Cutibet g | Digent | Digrit | Dipgen | Diprogenta | Effigenta | Encore G | Eponix G | Genivate | Genticyn b | Glovat g | Mysoderm | Proderm g | Provate-g | Vimrazin;
  • (PL) Poland: Bedicort g | Belogent | Diprogenta | Gebetil;
  • (PT) Portugal: Dibetop g | Diprogenta | Epione;
  • (PY) Paraguay: Crinex gen | Diprogenta | Gental beta;
  • (RO) Romania: Belogent | Diprogenta;
  • (RU) Russian Federation: Akriderm genta | Belogent | Betaderm | Celederm with gentamicin | Celestoderm v with garamycin | Diprogent;
  • (SA) Saudi Arabia: Celestoderm v gara | Diprogenta;
  • (SE) Sweden: Celeston valerat med gentamycin;
  • (SG) Singapore: Antasone | B Mycin | B-Tasone-G | Beprogent | Celestoderm v with garamycin | Diprogenta;
  • (SI) Slovenia: Belogent | Diprogenta | Kuterid G;
  • (SK) Slovakia: Belogent;
  • (SR) Suriname: Dipgen;
  • (TH) Thailand: Beprogenta | Betaderm-g | Betagen | Betagram | Betrocot | Diprogenta | Genta-betasone | Skinfect B;
  • (TR) Turkey: Belogent;
  • (TW) Taiwan: Anta | B Gencin | Bencogen | Bencort | Betaderm | Betagen | Betason-G | Biderlon | Dermaca | Diproderm | Diprogenta | Futusoa | Genderon | Gentacon | Gentaderm | Gentason | Gentasone | Gentesone | Menlin | Metagin | Sinbeta derm | Soft;
  • (UA) Ukraine: Belogent | Betason plus | Betazone plus | Celederm | Celektoderm vg with gentamicine | Celestoderm v with garamycin | Diprogent | Kuterid G;
  • (UG) Uganda: Dipgen;
  • (UY) Uruguay: Diprogenta | Mixgen;
  • (VE) Venezuela, Bolivarian Republic of: Beproderm | Betaderm con gentamicina | Betadex g | Betagemer | Celestoderm con gentalyn | Diprogenta;
  • (ZA) South Africa: Diprogenta;
  • (ZM) Zambia: Beprogent
  1. Valisone-G (betamethasone/gentamicin) [product monograph]. Laval, Quebec, Canada; August 2018.
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