Clotrimazole (Canesten®)

Section 1.1

Midwives may independently prescribe, order and administer this drug.

Anti-fungal agent which binds to phospholipids in the cell membrane altering cell wall permeability.

Indications and Clinical Use:

For the treatment of susceptible fungal infections; vaginal and nipple Candidiasis.

Contraindications:

Hypersensitivity to Clotrimazole or any component of the formulation

Warnings and Precautions:

Avoid contact with eyes when using topical formulation.
Any excess cream or ointment should be removed from the nipples before nursing.

Pregnancy:

Compatible

Lactation:

Category L1 – Compatible

Clotrimazole has poor oral bioavailability and is unlikely to adversely affect the breastfed newborns, including topical application to the nipples.

Adverse Reactions:

Vulvar/vaginal burning, itching, soreness and edema.

Dosage and Administration:

Intravaginal or topical.

  • Canesten® 1% vaginal cream: 1 full applicator intravaginally for 6 consecutive days, at bedtime.
  • Canesten® 100 mg vaginal inserts: 1 insert intravaginally for 6 consecutive days at bedtime.
  • Canesten® 2% vaginal cream: 1 full applicator intravaginally for 3 consecutive days at bedtime.
  • Canesten® combi-pak 3-day therapy: 1 insert intravaginally for 3 consecutive days at bedtime. The cream should be spread onto the irritated area once or twice a day as needed, for up to 7 consecutive days.
  • Canesten® combi-pak 1-day therapy: 1 insert intravaginally for 1 day, at bedtime. The cream should be spread onto the irritated area once or twice a day as needed, for up to 7 consecutive days.
  • Canesten® Topical Cream or Solution: Thinly apply and massage sufficient solution or cream into the affected area and surrounding skin areas twice daily, in the morning and evening. To be successful, the cream or solution should be applied regularly and in sufficient quantities. Continue treatment for 2 weeks.

The blue section of the CPS contains Information for the Patient for Canesten® Vaginal and Canesten® Topical.

Duration of Action:

Time to peak, serum: Vaginal cream: ~24 hours