Drugs List

Therapeutic Indications

Uses

Fluconazole capsules and cream are indicated for the treatment of acute or recurrent candidal vaginitis, and candidal balanitis.

Clotrimazole cream is indicated may also be used to treat the penis of a sexual partner to prevent re-infection.

Contraindications

Galactosemia

Acute porphyria

Precautions and Warnings

Patients should seek medical advice before using fluconazole capsule with clotrimazole cream if:
Any illness or disease affecting the liver or kidneys or have had unexplained jaundice
First episode of candidal vaginitis/candidal balanitis
Any chronic illness or disease
Previous history of a sexually transmitted disease (patient or partner)
Aged under 16 years or over 60 years
More than two infections of thrush in the last six months

Women only
Pregnancy or suspected pregnancy - see Pregnancy section
Breastfeeding - see Lactation section
Abnormal or irregular vaginal bleeding or blood stained discharge
Vulval or vaginal ulcers, blisters or sores
Abdominal pain or burning sensation on passing water
Experiencing fever/chills or sickness or vomiting or diarrhoea

Men only
Sexual partner does not have thrush
Penile sores, ulcers or blisters
Abnormal penile discharge (leakage)
Pain on passing urine
Penis has started to smell

Latex contraceptives may be damaged by clotrimazole cream and consequently their efficacy may be reduced. Alternative precautions should therefore be adopted for at least 5 days after using the cream.

Patients should consult a doctor if the symptoms have not been relieved within one week of taking fluconazole capsule. If infection returns after 7 days another fluconazole capsule may be taken.

Women of child-bearing age should use adequate contraception.

The patient should not use this product again if anaphylaxis or rash develops.

Patients who are lactose intolerant or suffer from glucose-galactose malabsorption syndrome should use this product with caution due to the lactose content of fluconazole capsules.

Pregnancy and Lactation

Pregnancy

The manufacturer recommends that fluconazole should not be used in pregnancy. Women of child bearing potential should only use this product with adequate contraception. Clotrimazole cream can be used during pregnancy under medical supervision.

Systemic absorption of clotrimazole is minimal. There is considerable experience with this drug and there are no data to support embryotoxicity. Clotrimazole is the topical antimycotic of choice during pregnancy.

It is unknown if fluconazole crosses the placenta but it should be expected. Animal studies have shown teratogenic effects at very high doses. There have been reports of craniofacial, skeletal, and cardiac malformations in children. Malformations may also resemble those of Antley-Bixler syndrome. Although the data are very limited, the use of fluconazole appears to be teratogenic with continuous daily doses of 400mg/day or more. Briggs concluded that the published experience with the use of smaller doses (such as those prescribed for vaginal fungal infection) suggests that the risk for adverse outcomes is low, if it exists at all.

Schaefer concludes that fluconazole is the preferred and best documented 'conazole' for vaginal candidiasis where local treatment has failed. Treatment with fluconazole during pregnancy is not an indication for termination of pregnancy, however, a detail ultrasound examination should be carried out after first trimester use.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The manufacturer recommends not to use fluconazole during breastfeeding due to its presence in breast milk.

Schaefer states that clotrimazole is the local antimycotic of choice during breastfeeding. Extensive use shows that for practical purposes it is not absorbed by the infant and there is no toxic potential.

When systemic therapy is unavoidable, fluconazole may be used during breastfeeding. It should be taken, if possible, after the last breastfeed at night.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Syncope
Hypotension
Dyspnoea
Urticaria
Blisters (application site)
Skin pain
Skin discomfort
Oedema at application site
Skin irritation
Skin peeling
Skin exfoliation
Pruritus
Rash
Stinging
Local burning
Hepatotoxicity
Nausea
Abdominal pain
Diarrhoea
Flatulence
Headache
Seizures
Leukopenia
Neutropenia
Agranulocytosis
Thrombocytopenia
Alopecia
Anaphylaxis
Contact dermatitis
Dyspepsia
Toxic epidermal necrolysis
Stevens-Johnson syndrome

Presentation

Combination pack of 1 capsule containing fluconazole 150mg and cream containing clotrimazole 2% w/w

Drugs List

Therapeutic Indications

Uses

Fluconazole capsules and cream are indicated for the treatment of acute or recurrent candidal vaginitis, and candidal balanitis.

Clotrimazole cream is indicated may also be used to treat the penis of a sexual partner to prevent re-infection.

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Contraindications

Galactosemia

Acute porphyria

Precautions and Warnings

Patients should seek medical advice before using fluconazole capsule with clotrimazole cream if:
Any illness or disease affecting the liver or kidneys or have had unexplained jaundice
First episode of candidal vaginitis/candidal balanitis
Any chronic illness or disease
Previous history of a sexually transmitted disease (patient or partner)
Aged under 16 years or over 60 years
More than two infections of thrush in the last six months

Women only
Pregnancy or suspected pregnancy - see Pregnancy section
Breastfeeding - see Lactation section
Abnormal or irregular vaginal bleeding or blood stained discharge
Vulval or vaginal ulcers, blisters or sores
Abdominal pain or burning sensation on passing water
Experiencing fever/chills or sickness or vomiting or diarrhoea

Men only
Sexual partner does not have thrush
Penile sores, ulcers or blisters
Abnormal penile discharge (leakage)
Pain on passing urine
Penis has started to smell

Latex contraceptives may be damaged by clotrimazole cream and consequently their efficacy may be reduced. Alternative precautions should therefore be adopted for at least 5 days after using the cream.

Patients should consult a doctor if the symptoms have not been relieved within one week of taking fluconazole capsule. If infection returns after 7 days another fluconazole capsule may be taken.

Women of child-bearing age should use adequate contraception.

The patient should not use this product again if anaphylaxis or rash develops.

Patients who are lactose intolerant or suffer from glucose-galactose malabsorption syndrome should use this product with caution due to the lactose content of fluconazole capsules.

Pregnancy and Lactation

Pregnancy

The manufacturer recommends that fluconazole should not be used in pregnancy. Women of child bearing potential should only use this product with adequate contraception. Clotrimazole cream can be used during pregnancy under medical supervision.

Systemic absorption of clotrimazole is minimal. There is considerable experience with this drug and there are no data to support embryotoxicity. Clotrimazole is the topical antimycotic of choice during pregnancy.

It is unknown if fluconazole crosses the placenta but it should be expected. Animal studies have shown teratogenic effects at very high doses. There have been reports of craniofacial, skeletal, and cardiac malformations in children. Malformations may also resemble those of Antley-Bixler syndrome. Although the data are very limited, the use of fluconazole appears to be teratogenic with continuous daily doses of 400mg/day or more. Briggs concluded that the published experience with the use of smaller doses (such as those prescribed for vaginal fungal infection) suggests that the risk for adverse outcomes is low, if it exists at all.

Schaefer concludes that fluconazole is the preferred and best documented 'conazole' for vaginal candidiasis where local treatment has failed. Treatment with fluconazole during pregnancy is not an indication for termination of pregnancy, however, a detail ultrasound examination should be carried out after first trimester use.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The manufacturer recommends not to use fluconazole during breastfeeding due to its presence in breast milk.

Schaefer states that clotrimazole is the local antimycotic of choice during breastfeeding. Extensive use shows that for practical purposes it is not absorbed by the infant and there is no toxic potential.

When systemic therapy is unavoidable, fluconazole may be used during breastfeeding. It should be taken, if possible, after the last breastfeed at night.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

None known.

Counselling

Patients should be advised to consult their physician if symptoms have not resolved within 7 days of starting treatment.

Latex contraceptives may be damaged by clotrimazole cream and consequently their efficacy may be reduced. Patients should be advised to adopt alternative precautions for at least 5 days after using the cream.

Advise women of child-bearing age that they should use adequate contraception during treatment.

Side Effects

Allergic reaction
Syncope
Hypotension
Dyspnoea
Urticaria
Blisters (application site)
Skin pain
Skin discomfort
Oedema at application site
Skin irritation
Skin peeling
Skin exfoliation
Pruritus
Rash
Stinging
Local burning
Hepatotoxicity
Nausea
Abdominal pain
Diarrhoea
Flatulence
Headache
Seizures
Leukopenia
Neutropenia
Agranulocytosis
Thrombocytopenia
Alopecia
Anaphylaxis
Contact dermatitis
Dyspepsia
Toxic epidermal necrolysis
Stevens-Johnson syndrome

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Capsule
No special requirements

Cream
Store below 25 degrees C

Reference Sources

British National Formulary, 60th Edition (2010) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Canesten Oral Capsule. Bayer plc. Revised October 2009.

Summary of Product Characteristics: Canesten Thrush Cream. Bayer plc. Revised July 2010.