Clotrimazole. Chemical name: 1-(o-chloro-α,α-diphenylbenzyl) imidazole. CAS number: 23593-75-1. Molecular
formula: C22H17ClN2. Molecular weight: 344.84. Vaginal creams.Canesten Clotrimazole Thrush 6 Day Cream.This product contains 10 mg/g (1%) of clotrimazole in a vanishing cream base. It also contains sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and purified water.Canesten Clotrimazole Thrush 3 Day Cream.This product contains 20 mg/g (2%) of clotrimazole in a vanishing cream base. It also contains sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and purified water.Canesten Clotrimazole Thrush 1 Day Cream.This product contains 100 mg/g (10%) of clotrimazole in a vanishing cream base. It also contains sorbitan monostearate, polysorbate 60, cetylpalmitate, cetostearyl alcohol, isopropyl myristate, benzyl alcohol and purified water.Vaginal tablets (compressed pessaries).Canesten Clotrimazole Thrush 6 Day Pessary.This product contains 100 mg of clotrimazole in each compressed pessary. It also contains lactose monohydrate, maize starch, magnesium stearate, silica-colloidal anhydrous, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose and cellulose-microcrystalline.Canesten Clotrimazole Thrush 1 Day Pessary.This product contains 500 mg of clotrimazole in one compressed pessary. It also contains lactose monohydrate, maize starch, magnesium stearate, silica-colloidal anhydrous, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose and cellulose-microcrystalline.Composite pack: '1 day' compressed pessary plus antifungal cream.Canesten Clotrimazole Thrush 1 Day Pessary + Cream.This composite pack includes:One Canesten compressed pessary containing 500 mg of clotrimazole. It also contains lactose monohydrate, maize starch, magnesium stearate, silica-colloidal anhydrous, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose and cellulose microcrystalline; One tube of Canesten antifungal cream containing 10 mg/g (1%) of clotrimazole in a vanishing cream base. It also contains sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and purified water. PharmacologyPharmacotherapeutic group (ATC code): G01A F02. 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.Pharmacodynamic properties.Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.Under appropriate test conditions, the minimum inhibitory concentration (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 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 Trichomonas vaginalis, gram-positive microorganisms (streptococci/staphylococci), and gram-negative microorganisms (bacteroides/Gardnerella vaginalis). In vitro clotrimazole inhibits the multiplication of corynebacteria and gram-positive cocci - with the exception of Enterococci - in concentrations of 0.5-10 microgram/mL substrate and exerts a trichomonacidal action at 100 microgram/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. Pharmacodynamic effects.A single course of intravaginal Canesten clotrimazole cream has produced mycological cure of vaginal candidiasis as follows:one 100 mg pessary daily for six days - 80%; two 100 mg pessary daily for three days - 75%; one 500 mg pessary - 84%; 5 g of 1% cream daily for six days - approx 75%. When a first course proved unsuccessful, a second course produced success in 8 of 12 women treated. Pharmacokinetic properties.Absorption and distribution.Studies using 14C-labelled clotrimazole have shown absorption of about 3% of the administered dose from normal or inflamed human vaginal mucosa (peak serum level of 0.03 microgram/mL) 24 hours after insertion of a 100 mg tablet.Studies in normal volunteers after vaginal insertion of one 500 mg pessary showed that plasma levels of clotrimazole up to 10 nanogram/mL were reached during the period of assay (up to 72 hours after insertion). Significant concentrations of clotrimazole were present in the vaginal secretion for up to 48 hours after insertion. Canesten clotrimazole cream containing 14C-labelled clotrimazole was administered intravaginally to five women (four without gynaecological disorder and one with Candida vaginitis). A maximum serum level of 0.01 microgram/mL was found between 10 and 30 hours after administration. Six hours after application of labeled topical Canesten clotrimazole cream the concentrations of clotrimazole ranged from 100 microgram/cm3 in the stratum corneum to 0.05-1.0 microgram/cm3 in the stratum reticulare and 0.1 microgram/cm3 in the subcutis. No measurable radioactivity was found in the serum within 48 hours after application of 0.8 g of the cream. Pharmacokinetic investigations after dermal application have shown that only a small amount of clotrimazole (< 2 % of the dose) is absorbed. The resulting peak plasma concentrations of the active ingredient are < 10 nanogram/mL (i.e. below the detection limit) and do not lead to measurable side effects. Metabolism and excretion.Studies of urinary excretion have shown that less than 0.5% of dermally applied Canesten clotrimazole cream appears in the urine over a five-day period of observation. Faecal excretion, the route by which most of the absorbed drug is likely to be eliminated, has not been studied in man.Preclinical safety data.Toxicological studies in rats, dogs and primates given clotrimazole cream or tablet intravaginally showed good vaginal tolerance, and skin applications of clotrimazole cream/lotion were well tolerated in rabbits. Although limited liver toxicity was observed in rats given clotrimazole orally for 18 months; overall, preclinical data reveal no special hazard for humans based on the totality of findings from single- and repeat-dose, genotoxicity, carcinogenicity and reproductive toxicity studies.IndicationsVaginal creams.Canesten clotrimazole vaginal creams are indicated for the topical treatment of vulvovaginal candidiasis.Vaginal tablets (compressed pessaries).Canesten clotrimazole vaginal pessaries are indicated for the topical treatment of vaginal candidiasis.Composite pack: '1 day' compressed pessary plus antifungal cream.Canesten clotrimazole composite pack is indicated for the treatment of candidal infections of the vagina and vulvovagina and sexual partner.ContraindicationsKnown hypersensitivity to clotrimazole, cetostearyl alcohol (only for products containing cetostearyl alcohol), and/or to any other excipients. PrecautionsIf evidence of local intolerance develops, consider withdrawal of the drug and institution of appropriate therapy. Carcinogenicity/mutagenicity.No carcinogenicity or mutagenicity has been observed in animal studies.Use in pregnancy.(Category A)In the first trimester of pregnancy, intravaginal Canesten products should be used only when the medical practitioner considers it essential for the welfare of the patient. Administration of Canesten clotrimazole vaginal pessaries to a small number of women in the 2nd and 3rd trimesters of pregnancy has produced no obvious untoward effect on the course of the pregnancy or on the foetus. This limited experience is insufficient to detect with reasonable certainty events occurring with an incidence of less than 3%. If treatment is carried out during pregnancy, Canesten clotrimazole vaginal pessaries are the preferable choice as they can be inserted without the use of an applicator. Sanitation of the birth canal should be ensured particularly during the last 4-6 weeks of pregnancy. Use in lactation.Although systemic absorption following topical or vaginal administration is low, caution should be exercised when clotrimazole is administered to nursing mothers as there is no information on whether or not clotrimazole is excreted in breast milk.Effects on ability to drive and use machines.No effects on ability to drive and use machines have been observed.Effects on laboratory tests.Not known.InteractionsConcomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506, an immunosuppressant) might lead to increased tacrolimus plasma levels. Patients should thus be thoroughly monitored for symptoms of tacrolimus overdosage, if necessary by determination of the respective plasma levels. Interactions with latex.Canesten clotrimazole vaginal creams and vaginal pessaries may reduce the effectiveness and safety of latex products, such as condoms and diaphragms. This effect is temporary and occurs only during treatment.Adverse EffectsThe listed adverse drug reactions are based on spontaneous reports, thus, an organisation according to CIOMS III categories of frequency is not possible. Immune system disorders.Allergic reaction (syncope, hypotension, dyspnoea, urticaria).Reproductive system and breast disorders.Genital peeling, pruritus, rash, oedema, discomfort, burning, irritation, pelvic pain.Gastrointestinal disorders.Abdominal pain.Canesten clotrimazole creams are generally well tolerated after local application. The following have been reported infrequently: erythema, stinging, blistering, peeling, oedema, pruritus, urticaria and general irritation. Eleven (1.6%) of 689 patients treated with Canesten clotrimazole vaginal pessaries complained of possibly drug-related effects. Mild burning occurred in four patients while other complaints such as skin rash and lower abdominal cramps were mentioned. Slight urinary frequency and burning or irritation in the sexual partner occurred rarely. In no case was it necessary to discontinue Canesten clotrimazole vaginal pessaries. Dosage and AdministrationNo dosage adjustment is necessary in patients with renal or hepatic impairment due to limited systemic absorption following
topical or vaginal application. Vaginal creams.Canesten Clotrimazole Thrush 6 Day Cream.Once daily, preferably at bedtime for six successive days, one applicator should be filled with cream (approximately 5 g) and inserted as deeply as possible into the vagina with the patient lying on her back with the legs slightly drawn up. The 35 g tube of cream for vaginal use provides for six such doses.Canesten Clotrimazole Thrush 3 Day Cream.Once daily, preferably at bedtime for three successive days, one applicator should be filled with cream (approximately 5 g) and inserted as deeply as possible into the vagina with the patient lying on her back with the legs slightly drawn up. The 20 g tube of cream for vaginal use provides for three such doses.Canesten Clotrimazole Thrush 1 Day Cream.The disposable applicator should be filled with the vaginal cream, ensuring the entire contents of the tube are used (approximately 5 g). The cream is then inserted as gently and deeply as possible into the vagina with the patient lying on her back with the legs slightly drawn up. The cream should be used preferably at bedtime as a single dose of treatment.Canesten clotrimazole vaginal creams may also be used in conjunction with Canesten clotrimazole vaginal pessaries in the management of Candida vulvovaginitis or infection of the peri-anal area while application of the cream to the glans penis of the partner may help prevent re-infection of the female. Vaginal tablets (compressed pessaries).Canesten Clotrimazole Thrush 6 Day Pessary, Canesten Clotrimazole Thrush 1 Day Pessary.A course of treatment normally consists of either a single 500 mg pessary (1 Day Pessary) or of six 100 mg pessaries (6 Day Pessary). The latter may be given either as two pessaries, inserted one after the other, daily for three days or as one pessary daily for six days. Clinical investigations have shown comparable efficacy from either dosage scheme. Where a first course proved unsuccessful, a second course produced success in 8 of 12 women treated.Canesten clotrimazole vaginal tablets (pessaries) should be inserted as deeply as possible into the vagina once daily, preferably at bedtime. This is best achieved using the plastic applicator provided and following the directions on the patient instruction sheet. In late pregnancy digital insertion is preferable to use instead of the applicator. The 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 pessaries as deeply as possible into the vagina preferably at bedtime. Should the vaginal tablet not dissolve completely within one night the use of a vaginal cream should be considered. It is suggested that treatment be timed so as to avoid the menstrual period and to be complete before the onset of menstruation. Composite pack: '1 day' compressed pessary plus antifungal cream.Canesten Clotrimazole Thrush 1 Day Pessary + Cream.The pessary should be inserted gently and as deeply as possible into the vagina, preferably at bedtime. This is best achieved using the plastic applicator provided and following the directions on the instruction leaflet. In late pregnancy digital insertion is preferable to use instead of the applicator. The 500 mg pessary provides therapy for three to four days as it creates high intravaginal concentrations of clotrimazole, however the symptoms may persist for these three to four days.The antifungal cream may be used in conjunction with the pessary in the management of candidal vulvovaginitis or infection of the peri-anal area while application of the cream to the glans penis of the partner may help prevent reinfection of the female. This should be applied thinly to the affected areas (external genital organs to the anus in the woman; glans and prepuce in men) 2 - 3 times daily and rubbed in. It is suggested that the treatment be timed so as to avoid the menstrual period and to be complete before the onset of menstruation. If the treatment does coincide with a menstrual period, use sanitary pads not tampons during therapy. A doctor should be consulted before use in the following instances: If it is the first occurrence of the problem; If there have been three or more thrush infections in the previous six months; If pregnant; If diabetic; If under 18 years of age or over the age of 60 years; If not better in four days. OverdosageThere have been no reports of overdosage with clotrimazole. In the event of overdosage, contact the Poisons Information Centre on 13 11 26 for advice. PresentationVaginal creams.Canesten Clotrimazole Thrush 6 Day Cream.Presented in a 35 g tube containing 10 mg clotrimazole per gram of cream (1%), and packed with six single-use disposable applicators and an instruction leaflet (Consumer Medicine Information).Canesten Clotrimazole Thrush 3 Day Cream.Presented in a 20 g tube containing 20 mg clotrimazole per gram of cream (2%), and packed with three single-use disposable applicators and an instruction leaflet (Consumer Medicine Information).Canesten Clotrimazole Thrush 1 Day Cream.Presented in a 5 g tube containing 100 mg clotrimazole per gram of cream (10%), and packed with one single-use disposable applicator and an instruction leaflet (Consumer Medicine Information).Vaginal tablets (compressed pessaries).Canesten Clotrimazole Thrush 6 Day Pessary.Presented in a blister pack of six compressed pessaries, and packed with a plastic applicator and an instruction leaflet (Consumer Medicine Information). Each pessary contains 100 mg clotrimazole.Canesten Clotrimazole Thrush 1 Day Pessary.Presented in a blister pack containing one compressed pessary, and packed with a plastic applicator and an instruction leaflet (Consumer Medicine Information). Each pessary contains 500 mg clotrimazole.Composite pack: '1 day' compressed pessary plus antifungal cream.Canesten Clotrimazole Thrush 1 Day Pessary + Cream.Presented in a carton that includes a blister pack of one Canesten compressed pessary containing 500 mg clotrimazole, and packed with a plastic applicator. Plus, it includes one 10 g tube of Canesten antifungal cream containing 10 mg clotrimazole per gram of cream (1%). An instruction leaflet (Consumer Medicine Information) is also included.StorageVaginal creams.Canesten Clotrimazole Thrush 6 Day Cream.Store below 25°C.Canesten Clotrimazole Thrush 3 Day Cream.Store below 25°C.Canesten Clotrimazole Thrush 1 Day Cream.Store below 25°C.Vaginal tablets (compressed pessaries).Canesten Clotrimazole Thrush 6 Day Pessary.Store below 30°C.Canesten Clotrimazole Thrush 1 Day Pessary.Store below 25°C.Composite pack: '1 day' compressed pessary plus antifungal cream.Canesten Clotrimazole Thrush 1 Day Pessary + Cream.Store below 25°C.Poison SchedulePharmacist Only Medicine. What happens after inserting a clotrimazole cream?Clotrimazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet).
How long does it take clotrimazole to absorb?Clotrimazole lozenge is absorbed by the body and begins to treat oral thrush within 30 to 60 minutes after taking your dose. Most people will begin to feel relief in about a week, but it takes 2 weeks to completely get rid of the fungus causing your infection.
Is clotrimazole cream supposed to come out?Cream, Tablet
The medicine will come out of your vagina, so wear a minipad or sanitary napkin to protect your clothing. Keep using this medicine for as long as your doctor tells you to. Continue to use it even if your menstrual period begins.
What comes out after using clotrimazole?It is normal for users to experience a discharge or chalky white residue from the vagina with the use of clotrimazole pessary. Hence, you are advised to wear pantyliner to avoid it staining your underwear.
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Can you pee after inserting clotrimazole cream
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