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Candid cream

Composition
Clotrimazole USP          1 % w/w
In water miscible base    q.s.

Therapeutic Class

T0130


Description
A printed carton with an insert and a printed aluminium collapsible tube containing a white semi-solid cream.


Actions and Mode or Mechanism of Action
Clotrimazole has broad spectrum fungicidal activity against Dermatophytes (Trichophyton, Epidermophyton and Microsporum spp.), Candida and Aspergillus spp., Malassezia furfur and other fungi. It also inhibits some strains of Gram-positive and Gram-negative bacteria.


Pharmacology (Summary of Pharmacodynamics and Pharmacokinetics)
Pharmacodynamics

Clotrimazole is an imidazole antifungal agent and is effective against a wide variety of fungi including Epidermophyton, Microsporum and Trichophyton spp., Coccidioides immitis, Histoplasma capsulatum, Aspergillus and Candida spp. Other fungi responding to Clotrimazole include Cryptococcus neoformans, Malassezia furfur (Pityrosporum orbiculare), Paracoccidioides brasilliensis, Sporothrix schenckii, Pseudallescheria, Medurella and Phialophora spp. Clotrimazole also has antibacterial action and some strains of Staphylococcus aureus and Streptococcus pyogenes have been reported to be sensitive. Clotrimazole is believed to exert its activity on the cell membrane of the fungus. It appears that the drug inhibits protein synthesis and so influences the utilisation and the incorporation of the acylated amino acids essential for fungi.


Pharmacokinetics
Clotrimazole appears to be well absorbed in humans following oral administration and is eliminated mainly as inactive metabolites. Following topical and vaginal administration, however, Clotrimazole appears to be minimally absorbed. Six hours after the application of radioactive Clotrimazole 1 % cream and 1 % solution onto intact and acutely inflamed skin, the concentration of Clotrimazole varied from 100 mcg / cm3 in the stratum corneum to 0.5 to 1 mcg / cm' in the stratum reticulare, and 0.1 mcg / cm3 in the subcutis. No measurable amount of radioactivity (≤0.001 mcg/ml) was found in the serum within 48 hours after application under occlusive dressing of 0.5 ml of the solution or 0.8 g of the cream. Only 0.5% or less of the applied radioactivity was excreted in the urine.


Indications
Indicated for the treatment of:
Tinea Corporis
Tinea Cruris
Tinea Pedis
Tinea Versicolor
Cutaneous Candidiasis


Contraindications
Except for possible hypersensitivity reactions, there are no contraindications.


Side Effects /Adverse Reactions
The local tolerance of CANDID Cream is excellent and no systemic effects are seen with topical use. Rarely patients may experience local irritation. This generally disappears on continuing the therapy.


Drug Interactions

None reported.
 

Precautions /Warnings
For irritation or sensitivity caused with the use of Clotrimazole; treatment should be discontinued and appropriate therapy instituted.
The patient should be advised to use the medication for the full treatment time even though the symptoms may have improved. This medicine should be used in the first trimester of pregnancy after consideration of the benefit/risk relation and by physician's decision. It is not known whether Clotrimazole is excreted in human being's milk. As many drugs are excreted in human being's milk, caution should be exercised with Clotrimazole used by nursing mothers.


Pregnancy and Lactation
This medicine should be used in the first trimester of pregnancy after consideration of the benefit / risk relation and by physician's decision. It is not known whether Clotrimazole is excreted in human being's milk. As many drugs are excreted in human being's milk, caution should be exercised with Clotrimazole used by nursing mothers.


Recommended Dosage, Dosage Schedule and Route of Administration
The affected area should be washed and thoroughly dried. CANDID Cream is evenly rubbed into the affected area 2-3 times daily. Treatment should continue for 2-4 weeks after the disappearance of all signs of infection to ensure mycological cure and prevent relapse.


Symptoms and Treatment for Overdosage and Antidote (s)
Acute overdose with topical application of Clotrimazole is unlikely and it is not expected to represent a life-threatening situation.


Packing /Pack Sizes

Tube of 20 g & 60 g.


Shelf Life

4 years


Storage Conditions, User Instructions and Pharmaceutical Precautions

Store below 25C. Protect from light.

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