INN monograph
Clotrimazole / Tannic acid / Choline salicylate / Cetrimide
Azole Antifungal [EPC] · POM
Verified · Updated 01 Aug 2026 · Source: FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Local active-ingredient clinical extract; Professional class pharmacology (Antifungal)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- [From component Clotrimazole / Beclomethasone Dipropionate] Use on rosacea acne, peri-oral dermatitis, scabies, leg ulcers, tuberculous, untreated viral, bacterial or fungal infections, reaction to smallpox vaccination, first three months of pregnancy, continous prophylactic use.
Precautions
- [From component Clotrimazole / Beclomethasone Dipropionate] Limit use in children or on face to maximum of 5 days.
- It should be withdrawn gradually following prolonged therapy.
- Unless fully unavoidable, potent corticosteroids should not be used on the face as they may precipitate a rosacea-like disorder and aggravate any pre-existing rosacea, avoid use in an occluded area, near the eye, use in the presence of skin infections without concomitant use of anti-microbial, children under 1yr, on weeping foci.
Point of care
Dosing
Adult
Directions • Wash the affected area and dry thoroughly. ● Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor. ● Supervise children in the use of this product. ● For athlete’s foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily. ● For athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. ● If conditions persists longer, consult a doctor. ● This product is not effective on the scalp or nails.
Paediatric
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Renal
Fluconazole dose-adjust in CKD; amphotericin nephrotoxicity high-alert.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Monitor LFTs for courses >14 days or higher-risk patients.
Safety
Drug interactions
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Clotrimazole / Beclomethasone Dipropionate.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- [From component Clotrimazole / Beclomethasone Dipropionate] Local irritation e.g burning sensation and itching, erythema rare, dryness of the skin, aggravation of concurrent untreated infections, thinning of the skin (this may be reversible), loss of skin elasticity, folliculitis, change in skin pigmentation, telangiectasia, purpura and steroid acne, increased growth of hair, severe pituitary-adrenal axis suppression and hypercotism, cushoid state, growth retardation, benign intra-cranial hypertension.
Use
Indications
- Uses Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
- Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.
- Clinical selection for Clotrimazole / Tannic acid / Choline salicylate / Cetrimide should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Azole Antifungal [EPC].
- Confirm site-specific dose, duration and monitoring before prescribing.
Pharmacology
Mode of action
Azoles inhibit fungal CYP51 (lanosterol 14α-demethylase), depleting ergosterol and disrupting membrane integrity.
Full mechanism text
Azoles inhibit fungal CYP51 (lanosterol 14α-demethylase), depleting ergosterol and disrupting membrane integrity. Terbinafine inhibits squalene epoxidase. Polyenes bind ergosterol creating membrane pores. Echinocandins inhibit β-glucan synthase (cell wall).
ADME
Pharmacokinetics & PD
| Onset | Days for clinical response (varies) |
|---|---|
| Duration | Days–weeks per indication |
| Route | ORAL / TOPICAL / IV |
| Metabolism | with major interactions. Topicals: minimal systemic |
Full PK/PD text
Fluconazole: excellent bioavailability, renal excretion, CSF penetration. Itraconazole/voriconazole: complex absorption and CYP metabolism with major interactions. Topicals: minimal systemic absorption when intact skin.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| Orush | Cipla Ltd. | Standard Commercial Pack | — |
Special populations
Pregnancy & lactation
Pregnancy
[From component Clotrimazole / Beclomethasone Dipropionate] [From component Beclomethasone Dipropionate /Clioquinol] 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate and well‑controlled studies with QVAR REDIHALER or beclomethasone dipropionate in pregnant women. There are clinical considerations with the use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women [see Clinical Considerations] . Also, no published studies, including studies of large birth registries, have to date related the use of ICS to any increases in congenital malformations or other adverse perinatal outcomes. Thus, available human data do not establish the presence or absence of drug‑associated risk to the fetus. In animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 0.75 times the maximum recommended human daily inhalation dose (MRHDID) in adults (0.64 mg/day) [see Data] . In rats exposed to beclomethasone dipropionate by inhalation, dose‑related gross injury to the fetal adrenal glands was observed at doses greater than 180 times the MRHDID, but there was no evidence of external or skeletal malformations or embryolethality at inhalation doses of up to 440 times the MRHDID. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the US general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2‑4% and 15‑20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk The risk of complications to the mother and developing fetus from inadequate control of asthma must be balanced against the risks from exposure to beclomethasone dipropionate. In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age for the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted to maintain optimal control. Labor or Delivery There are no specific human data regarding any adverse effects of inhaled beclomethasone dipropionate on labor and delivery. Data Animal Data In an embryofetal development study in pregnant rats, beclomethasone dipropionate administration during organogenesis from gestation days 6 to 15 at inhaled doses 180 times the MRHDID in adults and higher (on a mg/m 2 basis at maternal doses of 11.5 and 28.3 mg/kg/day) produced dose‑dependent gross injury (characterized by red foci) of the adrenal glands in fetuses. There were no findings in the adrenal glands of rat fetuses at an inhaled dose that was 40 times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of 2.4 mg/kg/day). There was no evidence of external or skeletal malformations or embryolethality in rat at inhaled doses up to 440 times the MRHDID (on a mg/m 2 basis at maternal doses up to 28.3 mg/kg/day). In an embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 18 at subcutaneous doses equal to and greater than 0.75 times the MRHDID in adults (on a mg/m 2 basis at maternal doses of 0.1 mg/kg/day and higher) produced adverse developmental effects (increased incidence of cleft palate). A no-effect dose in mice was not identified. In a second embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 13 at subcutaneous doses equal to and greater than 2.3 times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of 0.3 mg/kg/day) produced embryolethal effects (increased fetal resorptions) and decreased pup survival. In an embryofetal development study in pregnant rabbits, beclomethasone dipropionate administration during organogenesis from gestation days 7 to 16 at subcutaneous doses equal to and greater than 0.75 times the MRHDID in adults (on a mg/m 2 b
Lactation
[From component Clotrimazole / Beclomethasone Dipropionate] [From component Beclomethasone Dipropionate /Clioquinol] 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate and well‑controlled studies with QVAR REDIHALER or beclomethasone dipropionate in pregnant women. There are clinical considerations with the use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women [see Clinical Considerations] . Also, no published studies, including studies of large birth registries, have to date related the use of ICS to any increases in congenital malformations or other adverse perinatal outcomes. Thus, available human data do not establish the presence or absence of drug‑associated risk to the fetus. In animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 0.75 times the maximum recommended human daily inhalation dose (MRHDID) in adults (0.64 mg/day) [see Data] . In rats exposed to beclomethasone dipropionate by inhalation, dose‑related gross injury to the fetal adrenal glands was observed at doses greater than 180 times the MRHDID, but there was no evidence of external or skeletal malformations or embryolethality at inhalation doses of up to 440 times the MRHDID. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the US general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2‑4% and 15‑20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk The risk of complications to the mother and developing fetus from inadequate control of asthma must be balanced against the risks from exposure to beclomethasone dipropionate. In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age for the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted to maintain optimal control. Labor or Delivery There are no specific human data regarding any adverse effects of inhaled beclomethasone dipropionate on labor and delivery. Data Animal Data In an embryofetal development study in pregnant rats, beclomethasone dipropionate administration during organogenesis from gestation days 6 to 15 at inhaled doses 180 times the MRHDID in adults and higher (on a mg/m 2 basis at maternal doses of 11.5 and 28.3 mg/kg/day) produced dose‑dependent gross injury (characterized by red foci) of the adrenal glands in fetuses. There were no findings in the adrenal glands of rat fetuses at an inhaled dose that was 40 times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of 2.4 mg/kg/day). There was no evidence of external or skeletal malformations or embryolethality in rat at inhaled doses up to 440 times the MRHDID (on a mg/m 2 basis at maternal doses up to 28.3 mg/kg/day). In an embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 18 at subcutaneous doses equal to and greater than 0.75 times the MRHDID in adults (on a mg/m 2 basis at maternal doses of 0.1 mg/kg/day and higher) produced adverse developmental effects (increased incidence of cleft palate). A no-effect dose in mice was not identified. In a second embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 13 at subcutaneous doses equal to and greater than 2.3 times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of 0.3 mg/kg/day) produced embryolethal effects (increased fetal resorptions) and decreased pup survival. In an embryofetal development study in pregnant rabbits, beclomethasone dipropionate administration during organogenesis from gestation days 7 to 16 at subcutaneous doses equal to and greater than 0.75 times the MRHDID in adults (on a mg/m 2 b
Diet
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Sources & disclaimer
Source: FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Local active-ingredient clinical extract; Professional class pharmacology (Antifungal)
Last reviewed: 01 Aug 2026
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.