Canesten is a broad-spectrum antifungal. It also exhibits activity against Trichomonas, Staphylococci, Streptococci and Bacteroides. It has no effect on Lactobacilli.
Pharmacology: Clotrimazole is an imidazole derivative with a broad-spectrum of antimycotic activity. It acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.
Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.
The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive.
Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.
Pharmacokinetics: Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3-10% of the dose) is absorbed. Due to the rapid hepatic metabolism of absorbed clotrimazole into pharmacologically inactive metabolites the resulting peak plasma concentrations of clotrimazole after vaginal application of a 0.5 g dose were <10 ng/mL, reflecting that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.
Treatment of candidal vaginitis.
The vaginal tablet 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.
Adults: 1 vag tab should be inserted at night. Using the applicator provided, the vaginal tablet should be inserted as high as possible into the vagina. This is best achieved when lying back with legs bent up. A 2nd treatment may be carried out if necessary.
Canesten vaginal tablets need moisture in the vagina in order to dissolve completely, otherwise undissolved pieces of the vaginal tablet might crumble out of the vagina. Pieces of undissolved vaginal tablet may be noticed by women who experience vaginal dryness. To help prevent this it is important that the vaginal tablet is inserted as high as possible into the vagina at bedtime.
Treatment during the menstrual period should not be performed due to the risk of the vaginal tablet being washed out by the menstrual flow. The treatment should be finished before the onset of menstruation.
Children: As the product is used with an applicator, paediatric usage is not recommended.
In the event of accidental oral ingestion, gastric lavage is rarely required and should be considered only if a life-threatening amount of clotrimazole has been ingested within the preceding hour or if clinical symptoms of overdose become apparent (eg, dizziness, nausea or vomiting).
Hypersensitivity to clotrimazole or any ingredient of Canesten.
Medical advice should be sought if this is the 1st time the patient has experienced symptoms of candidal vaginitis.
Before using Canesten vaginal tablets, medical advice must be sought if any of the following are applicable: >2 infections of candidal vaginitis in the last 6 months; previous history of sexually transmitted disease or exposure to partner with sexually transmitted disease; pregnancy or suspected pregnancy; patients <16 years or >60 years; known hypersensitivity to imidazoles or other vaginal antifungal products.
Canesten vaginal tablets should not be used if the patient has any of the following symptoms where upon medical advice should be sought: Irregular vaginal bleeding, abnormal vaginal bleeding or a blood-stained discharge, vulval or vaginal ulcers, blisters or sores, lower abdominal pain or dysuria, any adverse events eg, redness, irritation or swelling associated with the treatment, fever or chills, nausea or vomiting, diarrhoea, foul smelling vaginal discharge.
Patients should be advised to consult their physician if the symptoms have not been relieved within 1 week of using Canesten vaginal tablets. The vaginal tablets can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within 6 months, patients should be advised to consult their physician.
Seek medical advice in case of pregnancy or suspected pregnancy.
Rarely patients may experience local mild burning or irritation immediately after inserting the vaginal tablet. Very rarely the patient may find this intolerable and stop treatment.
Other Undesirable Effects: Body as a Whole: Allergic reaction (syncope, hypotension, dyspnea, gastrointestinal disorders), pain.
Skin and Appendages: Pruritis, rash.
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 5 days after using this product.
G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.