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CANESTEN EXTRA STRENGTH EXTERNAL ANTIFUNGAL is a brand name for Clotrimazole, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CANESTEN® 6 DAY Internal Cream (clotrimazole) is indicated for the: • 6-day treatment of vaginal candidiasis. CANESTEN® 3 DAY Internal Cream (clotrimazole) is indicated for the: • 3-day treatment of vaginal candidiasis. CANESTEN® 1 DAY Internal Cream (clotrimazole) is indicated for the: • 1-day treatment of vaginal…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Vaginal Candidiasis may be accompanied by irritation in the vaginal area. Therefore, concomitant local treatment with CANESTEN® Vaginal Cream (or CANESTEN® External Cream) applied to the irritated vaginal area and as far as the anal region twice a day is advisable.
CANESTEN® External Cream (or CANESTEN® Vaginal Cream) applied on the penis glans may prevent re-infection by the partner. <CANESTEN®><clotrimazole> Page 6 of 63 • The cream, vaginal tablet or vaginal soft capsule should be inserted deep intravaginally by means of the applicator (See 7 WARNINGS AND PRECAUTIONS).
The plunger should then be depressed slowly. • CANESTEN® Vaginal Tablets and Vaginal Soft Capsules need moisture in the vagina to dissolve completely. Otherwise, undissolved pieces of the vaginal tablet or vaginal soft capsule might crumble out of the vagina.
To prevent this, it is important that the vaginal tablet and vaginal soft capsule are inserted deep into the vagina, preferably at bedtime. If the vaginal tablet or vaginal soft capsule does not dissolve completely within one night, the use of a vaginal cream should be considered.
• General hygienic measures such as twice daily tub baths and avoidance of tight underclothing are important in vaginal infections. 2 Recommended Dose and Dosage Adjustment • CANESTEN® 6 DAY Internal Cream The recommended daily dose is ONE full applicator intravaginally for SIX consecutive days, preferably at bedtime.
• CANESTEN® 3 DAY Internal Cream The recommended daily dose is ONE full applicator intravaginally for THREE consecutive days, preferably at bedtime. • CANESTEN® 1 DAY Internal Cream The recommended daily dose is ONE full applicator intravaginally (as a single dose therapy), preferably at bedtime.
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• CANESTEN® Combi 1 DAY Internal + External Creams The recommended dose is ONE full applicator intravaginally (as a single dose therapy) preferably at bedtime. The external cream should be spread onto the irritated area once or twice a day as needed, for up to seven consecutive days.
• CANESTEN® ComforTAB® 1 The recommended daily dose is ONE vaginal tablet intravaginally for ONE day, preferably at bedtime. [Sold as part of CANESTEN® Combi 1 DAY] • CANESTEN® Combi 1 DAY The recommended dose is ONE vaginal tablet intravaginally for ONE day, preferably at bedtime.
The cream should be spread onto the irritated area once or twice a day as needed, for up to seven consecutive days. • CANESTEN® Combi 1 DAY ComforTAB® + Extra Strength External Cream The recommended dose is ONE vaginal tablet intravaginally for ONE day, preferably at bedtime.
The cream should be spread onto the irritated area once or twice a day as needed, for up to seven consecutive days. • CANESTEN® SOFT CAPSULE 1 The recommended daily dose is ONE vaginal soft capsule intravaginally for ONE day, preferably at bedtime.
[Sold as part of CANESTEN® Combi 1 DAY Soft Capsule + Extra Strength External Cream] <CANESTEN®><clotrimazole> Page 7 of 63 • CANESTEN® Combi 1 DAY Soft Capsule + Extra Strength External Cream The recommended dose is ONE vaginal soft capsule intravaginally for ONE day, preferably at bedtime.
The cream should be spread onto the irritated area once or twice a day as needed, for up to seven consecutive days. • CANESTEN® ComforTAB® 3 The recommended daily dose is ONE vaginal tablet intravaginally for THREE consecutive days, preferably at bedtime.
[Sold as part of CANESTEN® Combi 3 DAY] • CANESTEN® Combi 3 DAY The recommended dose is ONE vaginal tablet intravaginally for THREE consecutive days, preferably at bedtime. The cream should be spread onto the irritated area once or twice a day as needed, for up to seven consecutive days.
• CANESTEN® Extra Strength External Antifungal Cream, CANESTEN® External Cream or CANESTEN® External Antifungal Cream Use only in conjunction with CANESTEN® Vaginal Tablets, Vaginal Soft Capsules, Creams (internal treatments) or CanesOral® capsule.
The cream should be spread onto the irritated area once or twice daily as needed, for up to seven consecutive days.
1 Adverse Reaction Overview Experimental, therapeutic, and large-scale clinical studies have shown CANESTEN® to be well tolerated after topical application. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Experimental, therapeutic, and large-scale clinical studies have shown CANESTEN® to be well tolerated after topical application. 5%) patients treated with the 1% vaginal cream experienced adverse reactions judged to be possibly drug related.
These were intercurrent cystitis and vaginal burning. Neither necessitated discontinuation of treatment. None were of serious consequence and no complications occurred. <CANESTEN®><clotrimazole> Page 12 of 63 The 100 mg vaginal tablets were also well tolerated.
Only a few cases consisting primarily of burning sensation and mild skin reactions were reported. 9%) in the 7 day group reported adverse reactions possibly related to treatment. These included: irritation, burning, cramping, itching, redness, abdominal bloating, bleeding and rash.
In an additional nine double-blind comparative studies, 5 out of 219 patients on the 7-day regimen with the 100 mg vaginal tablet experienced similar types of adverse reactions, none of which necessitated discontinuation of treatment.
8%) patients complained of possible drug- related side effects. Mild burning occurred in 4 patients while other reactions such as skin rash, lower abdominal cramps, slight urinary frequency and burning or irritation in the sexual partner occurred rarely.
In no case was it necessary to discontinue treatment. 9%) experienced an adverse reaction. 9%) who received 2% clotrimazole vaginal cream in clinical trials experienced an adverse reaction. 3%) experienced an adverse reaction. 3%) of patients in clinical trials involving 10% clotrimazole vaginal cream experienced an adverse reaction.
Most adverse reactions involved local itching and burning. Only rarely was it necessary to discontinue treatment.
). The plunger should then be depressed slowly. • CANESTEN® Vaginal Tablets and Vaginal Soft Capsules need moisture in the vagina to dissolve completely. Otherwise, undissolved pieces of the vaginal tablet or vaginal soft capsule might crumble out of the vagina.
To prevent this, it is important that the vaginal tablet and vaginal soft capsule are inserted deep into the vagina, preferably at bedtime. If the vaginal tablet or vaginal soft capsule does not dissolve completely within one night, the use of a vaginal cream should be considered.
• General hygienic measures such as twice daily tub baths and avoidance of tight underclothing are important in vaginal infections. 2 Recommended Dose and Dosage Adjustment • CANESTEN® 6 DAY Internal Cream The recommended daily dose is ONE full applicator intravaginally for SIX consecutive days, preferably at bedtime.
• CANESTEN® 3 DAY Internal Cream The recommended daily dose is ONE full applicator intravaginally for THREE consecutive days, preferably at bedtime. • CANESTEN® 1 DAY Internal Cream The recommended daily dose is ONE full applicator intravaginally (as a single dose therapy), preferably at bedtime.
• CANESTEN® Combi 1 DAY Internal + External Creams The recommended dose is ONE full applicator intravaginally (as a single dose therapy) preferably at bedtime. The external cream should be spread onto the irritated area once or twice a day as needed, for up to seven consecutive days.
• CANESTEN® ComforTAB® 1 The recommended daily dose is ONE vaginal tablet intravaginally for ONE day, preferably at bedtime. [Sold as part of CANESTEN® Combi 1 DAY] • CANESTEN® Combi 1 DAY The recommended dose is ONE vaginal tablet intravaginally for ONE day, preferably at bedtime.
The cream should be spread onto the irritated area once or twice a day as needed, for up to seven consecutive days. • CANESTEN® Combi 1 DAY ComforTAB® + Extra Strength External Cream The recommended dose is ONE vaginal tablet intravaginally for ONE day, preferably at bedtime.
The cream should be spread onto the irritated area once or twice a day as needed, for up to seven consecutive days. • CANESTEN® SOFT CAPSULE 1 The recommended daily dose is ONE vaginal soft capsule intravaginally for ONE day, preferably at bedtime.
[Sold as part of CANESTEN® Combi 1 DAY Soft Capsule + Extra Strength External Cream] <CANESTEN®><clotrimazole> Page 7 of 63 • CANESTEN® Combi 1 DAY Soft Capsule + Extra Strength External Cream The recommended dose is ONE vaginal soft capsule intravaginally for ONE day, preferably at bedtime.
The cream should be spread onto the irritated area once or twice a day as needed, for up to seven consecutive days. • CANESTEN® ComforTAB® 3 The recommended daily dose is ONE vaginal tablet intravaginally for THREE consecutive days, preferably at bedtime.
[Sold as part of CANESTEN® Combi 3 DAY] • CANESTEN® Combi 3 DAY The recommended dose is ONE vaginal tablet intravaginally for THREE consecutive days, preferably at bedtime. The cream should be spread onto the irritated area once or twice a day as needed, for up to seven consecutive days.
• CANESTEN® Extra Strength External Antifungal Cream, CANESTEN® External Cream or CANESTEN® External Antifungal Cream Use only in conjunction with CANESTEN® Vaginal Tablets, Vaginal Soft Capsules, Creams (internal treatments) or CanesOral® capsule.
The cream should be spread onto the irritated area once or twice daily as needed, for up to seven consecutive days. 5 OVERDOSAGE For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging Brand name Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients CANESTEN® 6 DAY Internal Cream vaginal vaginal cream / 1% / clotrimazole benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, water.
CANESTEN® 3 DAY Internal Cream vaginal vaginal cream / 2% / clotrimazole benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, water. CANESTEN® 1 DAY Internal Cream vaginal vaginal cream / 10 % / clotrimazole benzyl alcohol, cetostearyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, sorbitan monostearate, water.
CANESTEN® Combi 1 DAY Internal + External vaginal vaginal cream / 10% / clotrimazole benzyl alcohol, cetostearyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, sorbitan monostearate, water. <CANESTEN®><clotrimazole> Page 8 of 63 Brand name Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Creams external cream / 1 % / clotrimazole benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, water.
CANESTEN® Combi 1 DAY vaginal external vaginal tablet / 500 mg / clotrimazole cream / 1 % / clotrimazole calcium lactate, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, lactic acid, lactose, magnesium stearate, microcrystalline cellulose, maize starch.
benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, water. CANESTEN® Combi 1 DAY ComforTAB® + Extra Strength External Cream vaginal external vaginal tablet / 500 mg / clotrimazole cream / 2 % / clotrimazole calcium lactate, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, lactic acid, lactose, magnesium stearate, microcrystalline cellulose, maize starch.
benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, water. CANESTEN® Combi 1 DAY Soft Capsule + Extra Strength External Cream vaginal external vaginal capsule / 500 mg / clotrimazole cream / 2 % / clotrimazole gelatin, glycerol, lecithin, liquid paraffin, medium-chain triglycerides, quinoline yellow (E 104), sunset yellow (E 110) titanium dioxide, water, white soft […]
• CANESTEN® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.