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:

• Vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (vaginal candidiasis)

Contraindications

South African recommendations

• Hypersensitivity to clotrimazole or to any of the excipients
• Possibility of absorption of clotrimazole, when administered vaginally, cannot be excluded (10mg/g cre)

Recommendations in other jurisdictions

• Hypersensitivity to the active substance or to any of the excipients

Cautions

• Hypersensitivity to cetostearyl alcohol
• Known hypersensitivity to imidazoles or other vaginal antifungal products
• Pregnancy
• Breastfeeding
• Lower abdominal pain
• Foul smelling vaginal discharge
• Females <12 years
• More than two infections of candidal vaginitis in the last 6 months
• Previous history of sexually transmitted disease or exposure to partner with sexually transmitted disease
• Aged under 16 or over 60 years
• Abnormal vaginal bleeding or a blood-stained discharge
• Vulval or vaginal ulcers, blisters or sores
• Dysuria
• Any adverse effects such as redness, irritation or swelling associated with the treatment
• Fever or chills
• Nausea or vomiting
• Diarrhoea
• Concomitant use of latex products (condoms or diaphragms)

Forms avail. in SA and covered in this monograph: vaginal tab, 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

Vaginal discharge syndrome - Vaginal candidiasis
- Vulva red/scratched/inflamed and/or curd-like discharge

• Vaginal (tab): 500mg, insert as a single dose at night
  OR
• Vaginal (cre): Insert 1 applicator, 12hrly; Treatment duration: 7 days
  (STG, PHC 2020)

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If no response after 7 days, refer

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South African registered indications and dosages

Vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (vaginal candidiasis)

10mg/g

•  Vaginal (cre): Insert 1 filled applicator, 12-24hrly; Treatment duration: 6-7 days

20mg/g

• Vaginal (cre): Insert 1 filled applicator, dly before bed; Treatment duration: 3 days

OR

• Vaginal (cre): Insert 1 filled applicator, 12hrly; Treatment duration: 6-12 days

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10mg/g & 20mg/g: The treatment should be continued even if symptoms disappear

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Applicable to all cream strengths: Filled applicator (with 5g vaginal cream) should be inserted deeply into the vagina. This is best achieved when lying on the back with the legs pulled in a little towards the body. Use even during menstruation, although it is recommended that the treatment should not be carried out during menstruation but should be completed before menstruation begins

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- Candida vaginitis

500mg

• Vaginal (tab): 500mg, insert as a single dose at night; Repeat dose if needed

- Candida vulvitis or vulvo-vaginitis

10mg/g

• Vaginal (cre): Apply small quantity to affected area, 8-12hrly; Treatment duration: 7 days

20mg/g

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

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For the prevention of re-infection the partner should be treated locally with vaginal cream at the same time

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100mg

- First infections (candida vaginitis)

• Vaginal (tab): 200mg, insert dly at night; Treatment duration: 3 days

- Re-infections

• Vaginal (tab): 100mg, insert dly at night; Treatment duration: 6 days
  OR
• Vaginal (tab): 100mg, insert 12hrly; Treatment duration: 6-12 days

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Applicable to all vaginal tablets: Use even during menstruation, although it is recommended that the treatment should be timed so as to avoid the menstrual period and be finished before the onset of menstruation. Vaginal tablets are inserted as deeply as possible into the vagina. This is best achieved when lying down with the knees slightly bent. For prevention of re-infection, the partner should be treated locally with clotrimazole cream at the same time

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In individual cases where disintegration of the tablet does not occur, such as in dry vagina associated with menopause, it is recommended that clotrimazole vaginal cream be used

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Infections of the genital region (vaginitis) caused by candida

500mg/5g

• Vaginal (cre): Insert 1 filled applicator, as a single dose before bed

500mg vaginal tablet & 10mg/g vaginal cream (duo pack)

• Vaginal (tab): 500mg, insert as a single dose before bed

Candida infections of the labia and adjacent areas as well as candidal balanitis

500mg vaginal tablet & 10mg/g vaginal cream (duo pack)

• Vaginal (cre):  Apply small quantity to the affected area (from the external genital organs to the anus in woman; glans and prepuce in men), 8-12hrly; Treatment duration: 1-2 weeks

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For the formulations in the duo pack, it is recommended that treatment during the menstrual period should not be performed. The treatment should be completed before the onset of menstruation

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Indications and dosages registered in other jurisdictions

Candidal vaginitis

100mg/g

• Vaginal (cre): Insert 1 filled applicator, as a single dose before bed; Repeat dose if needed

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The contents of the filled applicator (5g) should be inserted as deeply as possible into the vagina, preferably at night

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100mg

• Vaginal (tab): 200mg, insert dly at night; Treatment duration: 3 days
  OR
• Vaginal (tab): 100mg, insert dly at night; Treatment duration: 6 days; A 2nd treatment may be carried out if required

500mg

• Vaginal (tab): 500mg, insert as a single dose at night; Repeat dose if needed

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The pessaries should be inserted into the vagina, as high as possible, using the applicator provided. This is best achieved when lying back with legs bent up

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

Paed. 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

Vulvovaginitis

• Vaginal (cre): Apply small quantity to affected area, dly at night; Treatment duration: 7-14 days
  (STG, Paed. 2017)

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Do not use applicator in girls who are not sexually active

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South African registered indications and dosages

Vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (vaginal candidiasis)

10mg/g, 20mg/g, 100mg/g, 100mg, 500mg, 500mg vaginal tablet & 10mg/g vaginal cream (duo pack)

Younger than 12 years

• Not recommended for use

12 years and older

• See adult dosage

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Indications and dosages registered in other jurisdictions

Candidal vaginitis

100mg/g, 100mg, 500mg

Younger than 16 years

• Not recommended for use

16 years and older

• See adult dosage

Pregnancy

• Safe
• There is 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 vaginal treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, but only under adequate supervision of dose. During pregnancy, the soft gel pessary should be inserted without using an applicator
• During pregnancy, the pessary should be inserted without using an applicator

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 on 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, reducing the effectiveness of such contraceptives. 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

• Possibly porphyrinogenic (PSP)

Drugs in Sport

• Permitted - No warnings

Gastrointestinal Disorders 

• Abdominal pain

Genitourinary Disorders

• Urinary frequency
• Genital peeling
• Genitourinary discomfort  
• Pelvic pain
• Vaginal haemorrhage

Skin and Subcutaneous Tissue Disorders

• Blisters
• Discomfort
• Oedema
• Erythema
• Exfoliation
• Pruritus
• Rash
• Stinging
• Burning
• Irritation
• Contact dermatitis

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Allergic reaction
  - Syncope
  - Hypotension  
  - Dyspnea
  - Urticaria

• Amphotericin and other polyene antibiotics
• Nystatin
• Tacrolimus  
• Sirolimus  
• Latex contraceptives

None routine

Unresolved symptoms and recurrent use

• Patients should be advised to consult their doctor if the symptoms have not been relieved within one week of using clotrimazole. Clotrimazole can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their doctor

Special precautions for use

• Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product
• Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected

Clotrimazole inhibits ergosterol synthesis, which leads to structural and functional impairment of the fungal cytoplasmic membrane.

Vaginal tablet 100mg

• Canesten  (Bayer) originator
• Glenmark Clotrimazole (Glenmark)

Vaginal tablet 500mg

• Canesten 1 Vaginal Tablet  (Bayer) originator
• Candizole Vaginal Tablet (Pharmacare)
• Glenmark Clotrimazole (Medivision)

Vaginal cream (per 5g) 500mg

• Canesten 1VC (Bayer) originator

Vaginal cream (per g) 10mg

• Adco-Normospor (Adcock)
• A-Por (Pharmacare)
• Canalba (Pharmacare)
• Canesten (Bayer) originator
• Candaspor (Be-Tabs)
• Canex V (Alliance)
• Closcript (Ranbaxy)
• Clotrimazole Biotech Vaginal (Biotech Laboratories)
• Clotrimazole Vaginal Cream Dis-Chem (Phyto OTC Health)
• Covospor (Adcock)
• Dynaspor (Thebe)
• Fungispore (Caps Pharmaceuticals)
• Gynezol (Gulf Drug)
• Gyno-Trimaze Vaginal (Pharmacare)
• Medaspor (Cipla Medpro)
• Micomisan (Adcock)
• Pinaspor V (Cipla Medpro)
• Xeraspor V (F.D.C. SA)

Vaginal cream (per g) 20mg

• Canesten 3VC (Bayer) originator

Vaginal cream (per 5g) 50mg 

• Candizole V (Pharmacare)

Vaginal tablet 500mg/ Topical cream (per 10g) 100mg

• Canesten DUOPAK (Bayer)

Also available in the following form: Topical cream.