CLOTRIMAZOLE EXTRA STRENGTH EXTERNAL ANTIFUNGAL

1 Dosing Considerations Vaginal Candidiasis may be accompanied by irritation in the vaginal area. Therefore, concomitant local treatment with Clotrimazole vaginal creams, (or Clotrimazole external creams) applied to the irritated vaginal area and as far as the anal region twice a day is advisable.

Clotrimazole external creams (or Clotrimazole vaginal creams) applied on the glans penis may prevent re-infection by the partner. The cream should be inserted deep intravaginally by means of the applicator (See 7 WARNINGS AND PRECAUTIONS).

The plunger should then be depressed slowly. 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 Clotrimazole Vaginal 6 The recommended daily dose is ONE full applicator intravaginally for SIX consecutive days, preferably at bedtime.

Clotrimazole Vaginal 3 The recommended daily dose is ONE full applicator intravaginally for THREE consecutive days, preferably at bedtime. Clotrimazole External Cream, Clotrimazole External Antifungal Cream, Clotrimazole Extra Strength External Antifungal Cream 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 clotrimazole to be well tolerated after topical application. For Clotrimazole External Cream, Clotrimazole External Antifungal Cream, and Clotrimazole Extra Strength External Antifungal Cream: Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity Vascular disorder: syncope, hypotension Respiratory, thoracic and mediastinal disorders: dyspnea Skin and subcutaneous skin disorders: urticarial, blisters, discomfort/pain, edema, erythema, irritation, peeling/exfoliation, pruritis, rash, stinging/burning sensation.

For Clotrimazole Vaginal Cream 6 and Clotrimazole Vaginal 3 Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity Vascular disorder: syncope, hypotension Respiratory, thoracic and mediastinal disorders: dyspnea Reproductive system disorders and breast disorders: vaginal exfoliation vulvovaginal pruritus, vulvovaginal erythema, vulvovaginal burning sensation, blistering, vulvovaginal discomfort, vulvovaginal pain, vaginal hemorrhage, vaginal discharge.

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 Clotrimazole Vaginal 6 Clotrimazole Vaginal 3 Clotrimazole External Cream Clotrimazole External Antifungal Cream Clotrimazole Extra Strength External Antifungal Cream Page 9 of 43 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. 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. 9%) who received 2% 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. 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 Clotrimazole Vaginal 6 The recommended daily dose is ONE full applicator intravaginally for SIX consecutive days, preferably at bedtime.

Clotrimazole Vaginal 3 The recommended daily dose is ONE full applicator intravaginally for THREE consecutive days, preferably at bedtime. Clotrimazole External Cream, Clotrimazole External Antifungal Cream, Clotrimazole Extra Strength External Antifungal Cream 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, STRENGTH, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging Brand name Route of Administration Dosage Form/ Strength/Composition Non-medicinal Ingredients Clotrimazole Vaginal 6 Vaginal Vaginal cream / 1% / clotrimazole benzyl alcohol, cetyl esters wax, cetostearyl alcohol, 2-octyl dodecanol, sorbitan monostearate, polysorbate 60, water.

Clotrimazole vaginal 3 Vaginal Vaginal cream / 2% / clotrimazole benzyl alcohol, cetyl esters wax, cetostearyl alcohol, 2- octyl dodecanol, sorbitan monostearate, polysorbate 60, water. Clotrimazole Vaginal 6 Clotrimazole Vaginal 3 Clotrimazole External Cream Clotrimazole External Antifungal Cream Clotrimazole Extra Strength External Antifungal Cream Page 6 of 43 Clotrimazole External Cream, Clotrimazole External Antifungal Cream External cream / 1% / clotrimazole cream / 2 % / clotrimazole benzyl alcohol, cetyl esters wax, cetostearyl alcohol, 2-octyl dodecanol, sorbitan monostearate, polysorbate 60, water.

Clotrimazole Vaginal 6 is supplied in a 50 g tube of 1% vaginal cream in a carton containing 6 disposable plastic applicators and patient instructions. 50 g of Clotrimazole Vaginal Cream 1% is sufficient for 6 intravaginal applications with additional cream for extravaginal use if required.

Clotrimazole Vaginal 3 is supplied in a 25 g tube of 2% vaginal cream in a carton containing 3 disposable plastic applicators and patient instructions. 25 g of Clotrimazole Vaginal Cream 1% is sufficient for 3 intravaginal applications with additional cream for extravaginal use if required.

Clotrimazole External Cream is supplied in Clotrimazole-Fluconazole Combi-Pack, as a 15 g tube of 1% vaginal cream. Clotrimazole External Antifungal Cream is supplied in a 15 g tube of 1% vaginal cream in a carton and patient instructions.

Clotrimazole Extra Strength External Antifungal Cream is supplied in a 15 g tube of 2% vaginal cream in a carton and patient instructions. 7 WARNINGS AND PRECAUTIONS General Patients should seek medical advice if they have frequent vaginal infections or if their yeast infection returns in less than 2 months.

Treatment during the menstrual period should not be performed. The treatment should be finished before the onset of menstruation. Immune Patients should seek medical advice if they have underlying immunodeficiency disease (such as HIV-AIDS).

Ophthalmologic Clotrimazole vaginal cream and clotrimazole external creams are not for ophthalmic use. Clotrimazole Vaginal 6 Clotrimazole Vaginal 3 Clotrimazole External Cream Clotrimazole External Antifungal Cream Clotrimazole Extra Strength External Antifungal Cream Page 7 of 43 Renal Patients should seek medical advice if they suffer from diabetes mellitus.

Reproductive Health:

Female and Male Potential • 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. • Function While sexual relations may be had during treatment with clotrimazole topical preparations, most couples wait until treatment has finished as the partner could become infected.

Skin As with all topical agents, skin sensitization may result. Use of clotrimazole topical preparations should be discontinued should such reactions occur, and appropriate therapy instituted. 1 Pregnant Women There are limited amounts of data from the use of clotrimazole in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). Although intravaginal application of clotrimazole has shown negligible absorption from both normal and inflamed human vaginal mucosa, Clotrimazole Vaginal Cream should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.

The use of applicators may be undesirable in some pregnant patients. 2 Breast-feeding Available pharmacodynamics/toxicological studies in animals have shown excretion of clotrimazole/metabolites in milk. Breastfeeding should be discontinued during treatment with clotrimazole.

Clotrimazole Vaginal 6 Clotrimazole Vaginal 3 Clotrimazole External Cream Clotrimazole External Antifungal Cream Clotrimazole Extra Strength External Antifungal Cream Page 8 of 43

Clotrimazole is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any on-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, COMPOSITION AND PACKAGING.