Biconvex White-pale Yellow pessary with 1 Rounded end. One side has "BAYER" while the reverse has "MU".
Active Ingredient: CLOTRIMAZOLE 0.5 G.
ATC Code: G01A F02.
Pharmacology: Clotrimazole is an imidazole derivative with a broad spectrum antimycotic activity.
Mechanism of Action: Azoles (e.g. clotrimazole) are usually recommended for the local treatment of vulvovaginal candidiasis 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 cytoplasmic membrane.
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 g/ml substrate.
The mode of action of clotrimazole is primarily 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. In addition to its antimycotic action, clotrimazole also acts on gram-positive microorganisms (Streptococci/Staphylococci), and gram-negative microorganisms (Bacteroides/Gardnerella vaginalis). In vitro clotrimazole inhibits the multiplication of Corynebacteria and grampositive cocci - with the exception of Enterococci - in concentrations of 0.5-10 g/ml substrate and exerts a trichomonacidal action at 100 g/ml. 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%) is absorbed. Due to the rapid hepatic metabolization 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, suggesting that clotrimazole applied intravaginally is unlikely to lead to measurable systemic effects or side effects.
Infection of the genital region (vaginitis) caused by fungi (usually Candida) and super infections caused by clotrimazole-sensitive bacteria.
For treatment of vaginal infections: Single-dose treatment with Canesten GYN 1 Day Therapy: 1 vaginal tablet to be introduced in the evening or night.
Method of Administration: If product has been prescribed for the patient by a doctor, follow any instructions the doctor may have given.
If the patient purchased this product without a prescription, follow these directions closely: The applicator should be used to insert the vaginal tablet as deep as possible into the vagina, preferably before going to sleep.
Wash hands before removing the vaginal tablet and the applicator from the pack and again afterwards when the applicator had been used.
1. Remove the applicator from its packaging and pull out the plunger and red lock from the body.
2. Place the vaginal tablet into the open end of the body with the curved edge of the vaginal tablet facing down. Push the Plunger and Lock into the body until a click is felt.
3. Once the patient has felt the click, remove the Lock from the Plunger and then carefully insert the applicator into the vagina up to the patterned grip zone.
4. Hold the applicator body at the patterned grip zone and carefully push the plunger all the way until it stops to dispense the vaginal tablet. Insertion is best achieved when lying back with the legs slightly drawn up.
5. After use, disassemble all the components for cleaning and wash thoroughly in warm (not boiling) soapy water, rinse for 30 seconds and wipe the parts carefully. Store it in a clean and safe place.
For re-use, ensure the red lock is replaced on the plunger and repeat the process from Step 2.
After the final use, dispose of the applicator in a safe place, out of the reach of children.
The applicator cannot be flushed down the toilet.
Since the vaginal tablet need moisture in the vagina to dissolve completely, it may be helpful to wear a panty liner because it is quite common to notice a white chalky residue after using it. This does not mean that the treatment has not worked. However, if the patient notice pieces of undissolved vaginal tablet, speak to a doctor or a pharmacist, as the treatment may not have worked properly.
The symptoms of thrush should disappear within three days of treatment. If no improvement is seen after seven days or if symptoms return within 2 months the patient must tell a doctor.
A combination treatment is recommended (i.e vaginal cream and vaginal tablet) if the labia and adjacent areas are simultaneously infected.
The sexual partner should also undergo local treatment using an external cream if symptoms, e.g. pruritus, inflammation, etc. are present.
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 because the partner could become infected and the effectiveness and safety of latex products such as condoms and diaphragms may be reduced.
During pregnancy, the vaginal tablets should be used and inserted without using an applicator. Intended for use by adults and children 12 years of age and older.
No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal application of an overdose (application over a large area under conditions favorable to absorption) or inadvertent oral ingestion. There is no specific antidote.
If the patient forgets to use: When remembered, continue with the course of treatment. If the patient has forgotten for more than one day, the infection may not be fully treated, so if symptoms persist upon completion of this course, see a doctor.
Hypersensitivity to clotrimazole or to any other component of the product.
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.
Keep medicine out of the sight and reach of children. Avoid contact with eyes. Do not swallow.
Clotrimazole may reduce the effectiveness and safety of latex products such as condoms and diaphragms when applied on the genital area (women: intravaginally, labia and adjacent area of the vulva; men: prepuce and glans of the penis). The effect is temporary and occurs only during treatment.
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: While there is a limited amount of clinical data in pregnant women, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Clotrimazole can be used during pregnancy, but only under the direction of a Health Care Professional. During pregnancy, the treatment should be carried out with clotrimazole vaginal tablets, 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. The following adverse reactions have been identified during post-approval use of Clotrimazole. As these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.
Vascular disorder: syncope, hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnea.
Reproductive system and breast disorder disorders: vaginal exfoliation, vaginal discharge, vulvovaginal pruritus, vulvovaginal erythema, vulvovaginal discomfort, vulvovaginal burning sensation, vulvovaginal pain, vaginal haemorrhage.
Gastrointestinal disorders: abdominal pain, nausea.
Skin and Subcutaneous Tissue Disorders: rash, urticaria.
General disorders and administration site conditions: application site irritation, oedema, pain.
Concomitant treatment 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.
Incompatibilities: None known.
G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
Canesten VT1 vag tab 0.5 g
(w/ applicator) 1's
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