Clotrimazole

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• All dermatomycoses due to dermatophytes (e.g. Trichophyton species)
• All dermatomycoses due to yeasts (e.g. Candida species)
• Dermatomycoses due to moulds and other fungi
• Skin diseases with secondary infection by these fungi

Contraindications

South African recommendations

• Hypersensitivity to clotrimazole or to any of the excipients

Recommendations in other jurisdictions

• Hypersensitivity to the active substance or to any of the excipients
• Do not use the cream to treat nail or scalp infections

Caution

• Hypersensitivity to cetostearyl alcohol
• Breastfeeding

Forms avail. in SA and covered in this monograph: cre

Dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions 

Infections caused by: Most fungi (including dermatophytes, yeasts, dimorphic fungi)

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guidelines indications and dosages

Candidiasis of the skin

• Topical (cre):1%: Apply to affected area(s), 8hrly; Treatment duration: 14 days
  (STG, PHC 2020)

Ringworm - tinea corporis

• Topical (cre):1%: Apply to affected area(s), 8hrly; Treatment duration: Until at least 2 weeks after lesions have cleared
  (STG, PHC 2020)

Athlete's foot - tinea pedis

• Topical (cre):1%: Apply to affected area(s), 12hrly; Treatment duration: 4 weeks
  (STG, PHC 2020)

Fungal infections
- Yeast and dermatophytes (fungal infection of the skin)

• Topical (cre):1%: Apply to affected area(s), 8hrly; Treatment duration: Until at least 2 weeks after lesions have cleared
  (STG, Adult 2019)

Treatment of >1 STI syndrome (Additional agents required)
- Male urethritis syndrome + Balanitis/ balanoposthitis

• Topical (cre): Apply to affected area(s), 12hrly; Treatment duration: 7 days 
  (STG, PHC 2020)

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South African registered indications and dosages

Dermatomycoses due to moulds and other fungi
Skin diseases with secondary infection by these fungi

• Topical (cre): Apply small quantity to affected area(s), 8-12hrly

All dermatomycoses due to dermatophytes (e.g. Trichophyton species)
All dermatomycoses due to yeasts (e.g. Candida species)

• Topical (cre): Apply small quantity to affected area(s), 8-12hrly; Treatment duration: 3-4 weeks

- Candida vulvitis (vulval thrush)
- Candida balanitis (thrush of the glans penis)

• Topical (cre): Apply small quantity to affected area(s), 8-12hrly; Treatment duration: 1-2 weeks

- Erythrasma

• Topical (cre): Apply small quantity to affected area(s), 8-12hrly; Treatment duration: 2-4 weeks

- Pityriasis (tinea) versicolor

• Topical (cre): Apply small quantity to affected area(s), 8-12hrly; Treatment duration: 1-3 weeks

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The dermatomycoses mentioned above include amongst others:
- Mycoses of the skin and skin folds, (e.g. fungal infections of the groin, perineum, axillae, Dhobies’ or jock itch and barber’s itch)
- Ringworm
- Interdigital mycoses, e.g. athlete's foot
- Paronychias (associated with nail mycoses, (fungal infections of the tissues adjacent to the nail of a finger or toe)

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Successful treatment demands that clotrimazole cream is applied correctly (apply thin layer and rub in, with a small amount of cream being sufficient for an area about the size of the palm) and over a sufficiently long period of time. Treatment of fungal infection should continue for approximately 2 weeks after disappearance of all symptoms despite a rapid, subjective improvement, in order to prevent relapse

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Athlete's foot requires careful drying of feet, especially between toes

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Indications and dosages registered in other jurisdictions 

All dermatomycoses due to moulds and other fungi (e.g. Trichophyton species)
All dermatomycoses due to yeasts (Candida species)
Skin diseases showing secondary infection with these fungi
Candidal diaper rash, vulvitis and balanitis

• Topical (cre): Apply small quantity to affected area(s), 8-12hrly; Dermatophyte infections: Treatment duration: ≥1 month; Candidal infections: Treatment duration: ≥2 weeks

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The cream should be applied thinly and rubbed in gently. A strip of cream (½cm long) is enough to treat an area of about the size of the hand

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If the feet are infected they should be washed and dried, especially between the toes, before applying the cream

Paed. forms avail. in SA and covered in this monograph: cre

Paed. dosages below include:

• South African Standard Treatment Guideline indications and dosages

Infections caused by: Most fungi (including dermatophytes, yeasts, and dimorphic fungi)

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guideline indications and dosages

Candidiasis

• Topical (cre): Apply small quantity to affected area(s), 8hrly; Treatment duration: 14 days
  (STG, Paed. 2023)

Nappy rash
- If rash involves the flexures and candida is suspected

• Topical (cre): Apply to affected area, beneath zinc and castor oil ointment after each nappy change until symptoms are resolved
  (STG, PHC 2020)

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South African registered indications and dosages

No information available

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No specific recommendations for children are provided

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Indications and dosages registered in other jurisdictions 

All dermatomycoses due to moulds and other fungi (e.g. Trichophyton species)
All dermatomycoses due to yeasts (Candida species)
Skin diseases showing secondary infection with these fungi
Candidal nappy rash, vulvitis and balanitis

• See adult dosage

Pregnancy

• Safe
• There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses. At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, with adequate supervision of dose by a healthcare professional

Breastfeeding

• Caution
• Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration. A risk to the suckling child cannot be excluded.  A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

• No human studies of the effects of clotrimazole on fertility have been performed, however, animal studies have not demonstrated any effects of the drug on fertility
• Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Blisters
• Skin discomfort/pain
• Oedema
• Erythema
• Irritation
• Peeling/exfoliation
• Pruritus
• Rash
• Stinging/burning

Immune, Blood and Lymphatic System Disorders

• Allergic reactions
  - Syncope
  - Hypotension
  - Dyspnoea
  - Urticaria

• Latex contraceptives

None routine

Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity. It inhibits biosynthesis of the sterol ergostol, an important component of fungal cell membranes. Its action leads to increased membrane permeability and disruption of enzyme systems bound to the membrane. 

Spectrum of activity: Most fungi (including dermatophytes, yeasts, dimorphic fungi)

Cream (per g) 10mg

• Adco-Normospor (Adcock)
• A-Por (Pharmacare)
• Canalba (Pharmacare)
• Candaspor (Be-Tabs)
• Candizole (Pharmacare)
• Canesten (Bayer) originator
• Canex (Alliance)
• Clomaderm (Gulf Drug)
• Closcript (Ranbaxy)
• Clotrimazole Topical Biotech (Biotech)
• Dynaspor (Thebe)
• Fungispore (Caps Pharma)
• Innospore (Imovata)
• Medaspor topical (Cipla Medpro)
• Micomisan (Adcock)
• Trimaze (Pharmacare)
• Xeraspor T (F.D.C. SA)

Also available in the following forms: Vaginal cream and vaginal tablet.