CLOTREX OTIC SOLUTION 20ML

CLOTREX OTIC SOLUTION 20ML
Clotrex belongs to the Antifungal class of medicines. Antifungals are a group of drugs that treat fungal infections of the skin and body, including athlete’s foot, fungal nail infections, ringworm, and vaginal candidiasis. These medicines limit the growth of a wide range of fungi by damaging the fungal cell membrane.
1. Name of the medicinal product
Canesten Solution
2. Qualitative and quantitative composition
Clotrimazole 1.0% w/v.
For excipients, see 6.1.
3. Pharmaceutical form
A clear solution.
4. Clinical particulars
4.1 Therapeutic indications
Canesten Solution should be used to treat all fungal skin infections due to dermatophytes, yeasts, moulds and other fungi.
It is particularly suitable for use on hairy skin and in fungal infections of the outer ear (otitis externa) and middle ear (otomycoses).
4.2 Posology and method of administration
Canesten Solution should be thinly and evenly applied to the affected area 2 or 3 times a day and gently rubbed in. A few drops are enough to treat an area of about the size of the hand. To prevent relapse, treatment should be continued for at least two weeks after the disappearance of all signs of infection.
There is no separate dosage schedule for the elderly or the young.
4.3 Contraindications
Hypersensitivity to clotrimazole or macrogol 400.
4.4 Special warnings and precautions for use
None known.
4.5 Interaction with other medicinal products and other forms of interaction
There have been reports of a heat reaction when Canesten Solution is used concomitantly with Sofradex drops in the ear.
4.6 Fertility, pregnancy and lactation
 
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:
There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted.
Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.
Lactation:
Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration (see section 5.3). A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
4.7 Effects on ability to drive and use machines
Clotrimazole has no or negligible influence on the ability to drive or use machines.
4.8 Undesirable effects
As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.
Immune system disorders: allergic reaction (syncope, hypotension, dyspnea, urticaria)
Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, erythema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Clotrex 0.2 g/20ml Otic drops
Clotrex 0.2 g/20ml Otic drops
Clotrex Otic Solution 20ml: View Usage, Side Effects, Price and Substitutes | Buy online in Qatar
 
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CLOTREX SOLUTION 20ML
antifungal solution