Clotrimazole USP 1 %
In water miscible base q.s.
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)
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.
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.
Indicated for the treatment of:
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor
• Cutaneous Candidiasis
Except for possible hypersensitivity reactions, there are no
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.
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
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.
Storage Conditions, User Instructions and Pharmaceutical Precautions
Store below 25°C. Protect from