CANESTEN Clotrimazole 500mg Vaginal Tablet 1's
RXDRUG-DR-XY32758
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Infections of the genital region (vaginitis) caused by fungi (usually Candida), and superinfections caused by clotrimazole-sensitive bacteria.
Dosage/Direction for Use
The vaginal tablet should be inserted as deeply as possible into the vagina in the evening before going to bed. Insertion is best achieved when lying back with the legs slightly drawn up.
Clotrimazole vaginal tablets need moisture in the vagina to dissolve completely, otherwise undissolved pieces of the vaginal tablet might crumble out of the vagina. To prevent this it is important to insert the medication as deeply as possible into the vagina at bedtime. Should the vaginal tablet not dissolve completely within one night, the use of a vaginal cream should be considered.
For treatment of vaginal infections: 6-day treatment with Clotrimazole (Canesten) 100 mg: 1 vaginal tablet to be introduced each evening on 6 successive days.
Single dose treatment with Clotrimazole (Canesten) 500 mg: 1 vaginal tablet to be introduced in the evening.
Generally: If symptoms persist, the patient should consult a doctor.
The treatment can be repeated if necessary, however, recurrent infections may indicate an underlying medical cause.
Patient should seek medical advice if symptoms return within 2 months.
If the labia and adjacent areas are simultaneously infected, local treatment with an external cream should also be given in addition to the intravaginal treatment (combination treatment).
Intended for use by adults and children 12 years of age and older.
Missed dose: No available information.
Clotrimazole vaginal tablets need moisture in the vagina to dissolve completely, otherwise undissolved pieces of the vaginal tablet might crumble out of the vagina. To prevent this it is important to insert the medication as deeply as possible into the vagina at bedtime. Should the vaginal tablet not dissolve completely within one night, the use of a vaginal cream should be considered.
For treatment of vaginal infections: 6-day treatment with Clotrimazole (Canesten) 100 mg: 1 vaginal tablet to be introduced each evening on 6 successive days.
Single dose treatment with Clotrimazole (Canesten) 500 mg: 1 vaginal tablet to be introduced in the evening.
Generally: If symptoms persist, the patient should consult a doctor.
The treatment can be repeated if necessary, however, recurrent infections may indicate an underlying medical cause.
Patient should seek medical advice if symptoms return within 2 months.
If the labia and adjacent areas are simultaneously infected, local treatment with an external cream should also be given in addition to the intravaginal treatment (combination treatment).
Intended for use by adults and children 12 years of age and older.
Missed dose: No available information.
Overdosage
Signs and Symptoms of Overdose: 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.
When the patient has taken more than the recommended dosage: There is no specific antidote.
When the patient has taken more than the recommended dosage: There is no specific antidote.
Contraindications
Hypersensitivity to the active substance or excipients (Calcium Lactate pentahydrate, Cellulose microcrystalline, Crospovidone, Hypromellose 15cP, Lactic Acid, Lactose monohydrate, Magnesium stearate, Maize starch, Silica colloidal anhydrous).
Special Precautions
If the patient has a fever (temperature of 38°C or above), lower abdominal pain, back pain, foul smelling vaginal discharge, nausea, vaginal haemorrhage, and/or associated shoulder pain the patient should consult a doctor.
Treatment during the menstrual period should not be performed. 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.
Avoidance of vaginal intercourse is recommended in case of vaginal infection and while using this product, the partner could become infected. The sexual partner should also undergo local treatment if symptoms, e.g. pruritus, inflammation, etc. are present.
When used in pregnancy, the vaginal tablets should be inserted without using an applicator.
Avoid contact with eyes. Do not swallow.
When to consult a doctor: If symptoms persist for more than 7 days, the patient may have a medical condition that requires treatment by a doctor.
Patient should seek medical advice if symptoms return within 2 months.
If the patient has a fever (temperature of 38°C or above), lower abdominal pain, back pain, foul smelling vaginal discharge, nausea, vaginal haemorrhage, and/or associated shoulder pain the patient should consult a doctor.
Treatment during the menstrual period should not be performed. 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.
Avoidance of vaginal intercourse is recommended in case of vaginal infection and while using this product, the partner could become infected. The sexual partner should also undergo local treatment if symptoms, e.g. pruritus, inflammation, etc. are present.
When used in pregnancy, the vaginal tablets should be inserted without using an applicator.
Avoid contact with eyes. Do not swallow.
When to consult a doctor: If symptoms persist for more than 7 days, the patient may have a medical condition that requires treatment by a doctor.
Patient should seek medical advice if symptoms return within 2 months.
If the patient has a fever (temperature of 38°C or above), lower abdominal pain, back pain, foul smelling vaginal discharge, nausea, vaginal haemorrhage, and/or associated shoulder pain the patient should consult a doctor.
Adverse Reactions
Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.
Vascular disorder: syncope, hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnea.
Reproductive system and breast disorders: vaginal exfoliation, vaginal discharge, vaginal haemorrhage, vulvovaginal discomfort, vulvovaginal erythema, vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal pain.
Gastrointestinal disorders: abdominal pain, nausea.
General disorders and administration site conditions: application site irritation, edema, pain.
Vascular disorder: syncope, hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnea.
Reproductive system and breast disorders: vaginal exfoliation, vaginal discharge, vaginal haemorrhage, vulvovaginal discomfort, vulvovaginal erythema, vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal pain.
Gastrointestinal disorders: abdominal pain, nausea.
General disorders and administration site conditions: application site irritation, edema, pain.
Drug Interactions
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 thoroughly monitored for symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.
Storage
Store at temperatures not exceeding 30°C.
Action
Vaginal tablet contains Clotrimazole which acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane.
MedsGo Class
Preparations for Vaginal Conditions
Features
Brand
Canesten
Full Details
Dosage Strength
500 mg
Drug Ingredients
- Clotrimazole
Drug Packaging
Vaginal Tablet 1's
Generic Name
Clotrimazole
Dosage Form
Vaginal Tablet
Registration Number
DR-XY47795
Drug Classification
Prescription Drug (RX)
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