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Betamethasone and clotrimazole: Drug information

Betamethasone and clotrimazole: Drug information
(For additional information see "Betamethasone and clotrimazole: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Lotrisone [DSC]
Brand Names: Canada
  • Lotriderm;
  • TARO-Clotri/Betameth Dipro
Pharmacologic Category
  • Antifungal Agent, Topical;
  • Corticosteroid, Topical
Dosing: Adult
Tinea corporis, tinea cruris

Tinea corporis, tinea cruris: Topical:

Cream: Massage into affected area twice daily, morning and evening for 1 week; re-evaluate after 1 week if no clinical improvement; maximum dose: 45 g cream per week; maximum duration: 2 weeks.

Lotion: Massage into affected area twice daily, morning and evening; re-evaluate after 1 week if no clinical improvement; maximum dose: 45 mL lotion per week; maximum duration: 2 weeks.

Tinea pedis

Tinea pedis: Topical:

Cream: Massage into affected area twice daily, morning and evening for 2 weeks; re-evaluate after 2 weeks if no clinical improvement; maximum dose: 45 g cream per week; maximum duration: 4 weeks.

Lotion: Massage into affected area twice daily, morning and evening; re-evaluate after 2 weeks if no clinical improvement; maximum dose: 45 mL lotion per week; maximum duration: 4 weeks.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney 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

Adolescents ≥17 years: Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.

1% to 10%:

Dermatologic: Xeroderma (2%)

Central nervous system: Localized burning (2%), paresthesia (2%)

<1%, postmarketing, and/or case reports: Cushing's syndrome (HPA axis suppression; children), dermal ulcer (rare), edema, growth suppression (children), pseudotumor cerebri (children), secondary infection, skin atrophy (children), skin rash, stinging of the skin

Contraindications

Cream: There are no contraindications listed in the manufacturer's labeling

Lotion: Hypersensitivity to betamethasone, clotrimazole, other corticosteroids or imidazoles, or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Cream: Hypersensitivity to betamethasone, clotrimazole, other corticosteroids or imidazoles, or any component of the formulation; untreated bacterial and tubercular skin infections; viral diseases (eg, herpes simplex, chicken pox, vaccinia)

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.

• 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 2002).

• Ocular effects: Topical corticosteroids, including betamethasone, may increase the risk of posterior subcapsular cataracts and glaucoma. Monitor for ocular changes. Avoid contact with eyes.

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

Disease-related concerns:

• Diaper dermatitis: Do not use for diaper dermatitis in any age group; adverse reactions associated with corticosteroids have occurred.

Special populations:

• Older adult: Use topical corticosteroids with caution in the elderly; skin atrophy and, rarely, skin ulcerations have been reported.

• Pediatric: Skin atrophy, including striae, has been reported with topical corticosteroid use in pediatric patients. 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 syndrome have been reported in pediatric patients receiving topical corticosteroids. Prolonged use may affect growth velocity and delay weight gain; growth should be routinely monitored in pediatric patients.

Other warnings/precautions:

• Appropriate use: For topical use only; do not use intravaginally. Avoid contact with eyes or mouth. Do not use occlusive dressings; discontinue use if irritation occurs.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Lotrisone: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (15 g [DSC], 45 g [DSC]) [contains benzyl alcohol]

Generic: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (15 g, 45 g)

Lotion, External:

Generic: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (30 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Clotrimazole-Betamethasone External)

1-0.05% (per gram): $1.35 - $2.58

Lotion (Clotrimazole-Betamethasone External)

1-0.05% (per mL): $4.95 - $5.59

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Cream, External:

Lotriderm: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (15 g, 50 g) [contains benzyl alcohol, cetyl alcohol, propylene glycol]

Generic: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (15 g, 50 g)

Administration: Adult

For topical use only; not for oral, ophthalmic, or intravaginal use. Do not cover with occlusive dressings. Shake lotion well prior to use.

Administration: Pediatric

Topical: For topical use only; not for oral, ophthalmic, or intravaginal use. Do not cover with occlusive dressings. Shake lotion well prior to use.

Use: Labeled Indications

Fungal infections: Topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, T. mentagrophytes, and Epidermophyton floccosum in patients ≥17 years

Limitations of use: Efficacy in the treatment of zoophilic dermatophytes (eg, Microsporum canis) has not been established.

Medication Safety Issues
Sound-alike/look-alike issues:

Clotrimazole may be confused with co-trimoxazole

Lotrisone may be confused with Lotrimin

Pediatric patients: High-risk medication:

KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

Metabolism/Transport Effects

None known.

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

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

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Risk X: Avoid combination

Sirolimus (Conventional): Clotrimazole (Topical) may increase the serum concentration of Sirolimus (Conventional). Risk C: Monitor therapy

Tacrolimus (Systemic): Clotrimazole (Topical) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Pregnancy Considerations

Use of this combination product in large amounts and use over prolonged periods of time should be avoided during pregnancy. Also see individual monographs for additional information.

Breastfeeding Considerations

Corticosteroids are excreted in breast milk; it is not known if systemic absorption following topical administration results in detectable quantities in human milk. It is not known if clotrimazole is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. To decrease potential exposure to the breastfeeding infant, the use of this combination product in large amounts and use over prolonged periods of time should be avoided; in addition, avoid application to the nipple and surrounding area.

Also see individual monographs for additional information.

Monitoring Parameters

Growth (children and adolescents); signs/symptoms of HPA axis suppression/adrenal insufficiency; signs of skin infection; ocular changes

Mechanism of Action

Betamethasone: A corticosteroid which controls the rate of protein synthesis; depresses the migration of polymorphonuclear leukocytes, fibroblasts; reverses capillary permeability and lysosomal stabilization at the cellular level to prevent or control inflammation.

Clotrimazole: An antifungal agent that binds to phospholipids in the fungal cell membrane altering cell wall permeability resulting in loss of essential intracellular elements.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

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

  • (AE) United Arab Emirates: Lotriderm | Opizole B;
  • (AR) Argentina: Cortispec | Lotricomb | Micosep b | Micosep b nf;
  • (BD) Bangladesh: Bantovet cl | Bet cl | Betameson cl | Betavate | Betnovate CL | Betson CL | Clozosone | Fungin-b | Oni | Stebet cl | Topibet cl;
  • (BE) Belgium: Lotriderm;
  • (CL) Chile: B-laboterol | Cestop b | Clotrimazol + betametasona | Clotrimin-b | Creminem b | Dermicin b | Donomix | Esancort plus | Locrim | Lotriderm | Novadrel | Novarnela;
  • (CN) China: Clotrasone | Clotrimazole and betamethasone dipropionate;
  • (CO) Colombia: Frotagen | Lotriderm;
  • (DE) Germany: Clotrasone | Flotiran | Lotricomb | Lotriderm;
  • (DO) Dominican Republic: Beta 2 | Danixa | Lotriderm | Lotrisone | Novarnela;
  • (EC) Ecuador: Clotrimazol + betametasona | Lotriderm | Novarnela;
  • (EG) Egypt: Beta micoter | Betapronate plus | Clotrisone | Lotriderm;
  • (ES) Spain: Beta micoter | Clotrasone;
  • (GB) United Kingdom: Lotriderm;
  • (HK) Hong Kong: Bacda B | Betamazole | Derzid-c;
  • (ID) Indonesia: Heltiskin | Lotriderm;
  • (IE) Ireland: Lotriderm;
  • (IL) Israel: Clotrisone;
  • (IN) India: Canstat b | Clotrin-b | Kansel-b | Lotriderm | Mycoban-b | Propyzole | Statum-b;
  • (KE) Kenya: Benasten b | Clotrine b | Clozole b | Dazole b | Lotriderm | Medizole b;
  • (KW) Kuwait: Lotriderm | Opizole b;
  • (LB) Lebanon: Beta micoter | Lotriderm | Opizole b;
  • (LU) Luxembourg: Lotriderm;
  • (LV) Latvia: Lotriderm;
  • (MX) Mexico: Clotibet | Lotriderm;
  • (MY) Malaysia: Bencovee | Betamethasone Clo | Creobic double action | Diproderma c | Triderm-c;
  • (NZ) New Zealand: Lotricomb;
  • (OM) Oman: Opizole B;
  • (PE) Peru: Fungolisin | Novadrel;
  • (PH) Philippines: Clotrasone;
  • (PK) Pakistan: Clomafin b | Clomet | Dermosporin b | Dimed z | Diprocort c | Lotricort | Lotriderm | Spectrazole | Timasone;
  • (PL) Poland: Lotriderm;
  • (PR) Puerto Rico: Clotrimazole / betameth | Clotrimazole and Betamethasone | Clotrimazole and betamethasone dipropionate | Clotrimazole and Betamethazone Dipropionate | Clotrimazole/betamethasone dipropionate | Lotrisone;
  • (PT) Portugal: Beta micoter | Flotiran;
  • (PY) Paraguay: Clotrimazol betametasona mintlab | Crinexol | Lotricomb;
  • (QA) Qatar: Lotriderm | Opizole-B;
  • (RO) Romania: Clo ekarzin;
  • (RU) Russian Federation: Lotriderm;
  • (SA) Saudi Arabia: Lotriderm;
  • (SG) Singapore: Clotrasone;
  • (SI) Slovenia: Lotriderm;
  • (SK) Slovakia: Lotriderm;
  • (TH) Thailand: Bacda B | Canasole | Canasone | Canazol-be | Candex Plus | Canescin-b | Chingazone | Clomaderm-b | Closone | Clotrasone | Clotri B | Clotribet | Clotribet-d | Clotrin-b | Cobacta | Derzid-c | Dibeclot | Dibeclot Be | Doderm | Fango-b | Feminex Bet | Fungiderm-b | Gynesten-b | Hofra B | Mycobet | Mycosone-b | Mycozole B | Myda-b | Myrazole-b | Pinda-b | Rakoma | Sema X | Tanocs B F | Twina | Zema b;
  • (TW) Taiwan: B.z. | Betaclosone | Betamazole | Clobe | Clodai | Clofusone | Closone | Clotrasone | Clotrisone | Forever | Fulian | Ninerlnin | Prurinon | Safelon | Shukang | Suhao | Utrasone | Vigordonor | Yuhealfu;
  • (UA) Ukraine: Lotriderm;
  • (UY) Uruguay: Lotricomb;
  • (VE) Venezuela, Bolivarian Republic of: Lotricomb | Lotrisone;
  • (ZA) South Africa: Lotriderm;
  • (ZM) Zambia: Dazole b
  1. Clotrimazole and Betamethasone lotion [prescribing information]. Melville, NY: Fougera Pharmaceuticals Inc; December 2015.
  2. Goedert JJ, Vitale F, Lauria C, et al, “Risk Factors for Classical Kaposi's Sarcoma,” J Natl Cancer Inst, 2002, 94(22):1712-8. [PubMed 12441327]
  3. Lotrisone cream (clotrimazole and betamethasone) [prescribing information]. Whitehouse Station, NJ: Merck & Co Inc; June 2019.
  4. Lotriderm (clotrimazole and betamethasone) [product monograph]. Kirkland, Quebec, Canada: Organon Canada Inc; April 2021.
  5. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
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