Each gram of cream contains: Clotrimazole BP 100 mg (10% w/w).
Excipients/Inactive Ingredients: Tefose, light liquid paraffin, cetostearyl alcohol, benzyl alcohol, butylated hydroxyl toluene, polysorbate, sodium phosphate monobasic dihydrate, triethanolamine and purified water.
Pharmacotherapeutic group: Anti-infectives and antiseptics, excl. combinations with corticosteroids. Imidazole derivatives. ATC code: G01AF02.
Pharmacology: Pharmacodynamics: Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.
Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062-8.0 μg/ml substrate. 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 500 mg dose were less than 10 ng/ml, reflecting that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.
Candigo is indicated for the treatment of candidal vaginitis.
Dosage: Adults: The contents of the filled applicator (5 g) should be inserted as deeply as possible into the vagina, preferably at night. A second treatment may be carried out if necessary.
Generally: Treatment during the menstrual period should not be performed due to the risk of the cream being washed out by the menstrual flow. The treatment should be finished before the onset of menstruation.
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.
Children: Not for use in children under 16.
Method of Administration: The cream should be administered intravaginally using the applicator supplied.
Unless directed otherwise, the cream should be inserted as high as possible into the vagina, preferably before going to sleep at night for convenient and comfortable treatment. Wash hands before and after use.
1. Open the tube with the help of back side of the cap. Screw the applicator to the nozzle of the tube. By pressing the tube the applicator is filled with cream.
2. Unscrew and insert applicator containing the cream carefully as deeply as is comfortable into the vagina. (This is best done with the patient lying on her back with the knees bent up.) Push plunger until it stops, thereby depositing the cream into the vagina.
3. Remove the applicator. Discard the tube and applicator after use.
No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.
In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.
Hypersensitivity to clotrimazole or any other ingredient in this medicine.
Legal Category P Only.
Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.
Before using Candigo, medical advice must be sought if any of the following are applicable: More than two infections of candidal vaginitis in the last 6 months; Previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease; Pregnancy or suspected pregnancy; Aged under 16 or over 60 years; Known hypersensitivity to imidazoles or other vaginal antifungal products.
Clotrimazole Cream should not be used if the patient has any of the following symptoms whereupon 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 such as 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 one week of using Candigo. It 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 physician.
This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Effects on Ability to Drive and Use Machines: The medication has no or negligible influence on the ability to drive or use machinery.
Fertility: No human studies of the effects of clotrimazole on fertility have been performed; however, animal studies have not demonstrated any effects of the drug on fertility.
Pregnancy: There are 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 the supervision of a physician or midwife.
During pregnancy the treatment should be carried out with clotrimazole pessary, since these can be inserted without using an applicator.
Lactation: 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 breast-feeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Immune system disorders:
Allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus).
Reproductive system and breast disorders:
Genital peeling, pruritus, rash, oedema, discomfort, burning, irritation, pelvic pain.
Inform doctors about unexpected reactions after using drugs.
Clotrimazole Cream may cause damage to latex contraceptives. Consequently patient should be advised to use alternative precautions for at least five days after using this product.
Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels. Patients should thus be closely monitored for signs and symptoms of tacrolimus overdosage, if necessary by determination of the respective plasma levels.
Store below 30°C.
Shelf Life: 24 months.
G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
Vag cream (w/ applicator) 100 mg/g (white, smooth, viscous uniform) x 7 g x 1's.