Candigo 10%

Candigo 10%

clotrimazole

Manufacturer:

Kusum

Distributor:

JDS
Full Prescribing Info
Contents
Clotrimazole.
Description
Each gram of cream contains Clotrimazole BP 100 mg (10% w/w).
Excipients/Inactive Ingredients: Tefose-63, Light liquid paraffin, cetostearyl alcohol, benzyl alcohol, butylated hydroxyl toluene, polysorbate-60, sodium phosphate monobasic dehydrate, purified water, triethanolamine.
Action
Pharmacotherapeutic Group: Antifungal. ATC code: G01AF02.
Pharmacology: Pharmacodynamics: 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.
Mechanism of Action: Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.
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 500mg dose were less than 10 ng/ml, reflecting that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.
Indications/Uses
Candigo is indicated for the treatment of candidal vaginitis.
Dosage/Direction for Use
RECOMMENDED DOSE: Adults: The contents of the filled applicator (5g) 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.
Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected.
Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.
Children: Not for use in children under 16.
MODE OF ADMINISTRATION: The cream should be administered intravaginally using the applicator supplied.
1. Pull out plunger A until it stops.
Place cream into the applicator.
2. 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.)
3. Push plunger A until it stops, thereby depositing the cream into the vagina. Remove the applicator.
4. After use, remove plunger A completely by pulling it out of the applicator B.
Then wash it in warm (not boiling) soapy water, rinse and dry carefully.
Overdosage
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 (e.g. dizziness, nausea or vomiting). It should be carried out only if the airway can be protected adequately.
Contraindications
Hypersensitivity to clotrimazole or any other ingredient in this medicine.
Hypersensitivity to cetostearyl alcohol.
Special Precautions
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 Clotrimazole Cream, 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 clotrimazole cream. 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).
Use In Pregnancy & Lactation
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.
Adverse Reactions
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.
Gastrointestinal disorders: abdominal pain.
Adverse Drug Reaction: Inform doctors about unexpected reactions after using drugs.
Drug Interactions
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.
Storage
Store below 30°C.
Shelf Life: 2 years.
MIMS Class
Preparations for Vaginal Conditions
ATC Classification
G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
Presentation/Packing
Vag cream (w/ applicator) 100 mg/g (white, smooth, viscous uniform) x 7 g x 1's.
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