Candigo

Vaginal cream: Each gram of cream contains: Clotrimazole BP 100 mg (10% w/w).
Vaginal suppository: Each vaginal suppository contains: Clotrimazole BP 100 mg or 500 mg.
Excipients/Inactive Ingredients. Vaginal cream: Tefose-63, Light liquid paraffin, cetostearyl alcohol, benzyl alcohol, butylated hydroxyl toluene, polysorbate-60, sodium phosphate monobasic dihydrate, purified water, Triethanolamine.
Excipients with known effect: Cetostearyl alcohol 35 mg in each gram of cream.
Benzyl alcohol 10 mg in each gram of cream.
Vaginal suppository: Hard Fat.

Pharmacotherapeutic group: Gynecological anti infectives and antiseptics, imidazole derivatives. ATC code: G01A F02.
Pharmacology: Pharmacodynamics: Azoles (e.g. clotrimazole) are usually recommended for the local treatment of vulvovaginal candidosis that is characterized by vulvovaginal symptoms such as itching, burning, discharge, redness, swelling and soreness.
Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane.
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 microgram/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 mg/ml, reflecting that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.

Clotrimazole (Candigo) cream or suppository is indicated for the treatment of candidal vaginitis.

Vaginal cream: Adults: The contents of the filled applicator (7 g) should be inserted as deeply as possible into the vagina, preferably at night. A second treatment may be carried out if necessary.
Children: Not for use in children under 16.
Route of administration: Vaginal.
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.
Vaginal suppository: The suppository should be inserted into the vagina, as high as possible. This is best achieved when lying back with legs bent up.
Adults: 100-mg: Two suppository should be inserted daily (preferably at night) for three consecutive days. Alternatively, one pessary may be inserted daily for six days, preferably at night. A second treatment may be carried out if necessary.
There is no separate dosage schedule for the elderly.
Clotrimazole (Candigo) suppositories need moisture in the vagina in order to dissolve completely; otherwise undissolved pieces of the suppository might crumble out of the vagina. Pieces of undissolved suppository may be noticed by women who experience vaginal dryness. To help prevent this it is important that the suppository is inserted as high as possible into the vagina at bedtime.
500-mg: One suppository should be inserted at night. A second treatment may be carried out if necessary.
There is no separate dosage schedule for the elderly.
Clotrimazole (Candigo) suppositories need moisture in the vagina in order to dissolve completely; otherwise undissolved pieces of the suppository might crumble out of the vagina. Pieces of undissolved suppository may be noticed by women who experience vaginal dryness. To help prevent this it is important that the suppository is inserted as high as possible into the vagina at bedtime.
Children: Not for use in children under 16.
Route of administration: Vaginal.
Remove the suppository from the strip and insert it deep into the vagina in lying position with the knees bent or in squatting position.
Do not cut the suppositories into parts as such change in storage conditions may cause misdistribution of the active substance.

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 favorable to absorption) or inadvertent oral ingestion. There is no specific antidote.
However, 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.

Vaginal cream: Hypersensitivity to clotrimazole or any other ingredient in this medicine.
Vaginal suppository: Hypersensitivity to the active substance or to any of the excipients listed in this medicine.

Effects on Ability to Drive and Use Machines: The medication has no or negligible influence on the ability to drive or use machinery.
Vaginal cream: 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.
Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Clotrimazole (Candigo) cream.
Clotrimazole (Candigo) cream 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). The product also contains benzyl alcohol which may cause allergic reactions and mild local irritation.
Vaginal suppository: Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.
Before using Clotrimazole (Candigo) Suppositories, medical advice must be sought if any of the following are applicable: More than two infections of candidal vaginitis in the last six 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 (Candigo) Suppositories 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.
Treatment during the menstrual period should not be performed due to the risk of the pessary 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.
When used in pregnancy, the pessary should be inserted without using an applicator (see Use in Pregnancy & Lactation).
Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Clotrimazole (Candigo) 500 mg Suppository. The Suppositories can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice.

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: There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects.
Clotrimazole may be used during lactation.

Frequency not known. As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.
Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.
Vascular disorder: syncope, hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnea. Gastrointestinal disorders: abdominal pain, nausea.
Skin and Subcutaneous Tissue Disorders: rash, urticaria, pruritus.
Reproductive system and breast disorders: vaginal exfoliation, vaginal discharge, vaginal hemorrhage, vulvovaginal discomfort, vulvovaginal erythema, vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal pain.
General disorders and administration site conditions: application site irritation, edema, pain.
Seek medical attention immediately at the first sign of any adverse drug reaction shall appear.

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 five days after using this product.
Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels and similarly with sirolimus. Patients should thus be closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

Vaginal cream: Store at temperatures not exceeding 30˚C. Protect from direct sunlight.
Vaginal suppository: Store at temperatures not exceeding 30°C, do not freeze.

Preparations for Vaginal Conditions

G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.

Rx