| Brief
Summary
Description:
Tycelex cream contains clotrimazole, a synthetic antifungal
agent.
Indications:
Tycelex cream is indicated for the topical treatment of the
following derma infections:
Tinea pedis, tinea cruris, and tinea corporis due to Trichophyton
Rubrum, Trichophyton Mentagrophytes, Epidermophyton Floccosum,
and Microsporum Canis; Candidiasis due to Candida Albicans,
and tinea versicolor due to Malassezia Furfur
Contraindication:
Tycelex cream is contraindicated in individuals sensitive
to any of its components.
Warnings:
Tycelex cream is not for ophthalmic use.
General Precautions:
If irritation or sensitivity develops with the use of Tycelex
cream, treatment should be discontinued and appropriate therapy
instituted.
Information for patients:
- Use the medication for the full treatment time even though
the symptoms may have improved. Notify the physician if
there is no improvement after four weeks of treatment.
- Inform the physician if the area of application shows
increased irritation (redness, itching, burning, swelling,
oozing) indicative of possible sensitization.
- Avoid the use of occlusive wrapping or dressings.
- Avoid sources of infection or re-infection.
Laboratory tests:
If there is a lack of response to Tycelex cream appropriate
microbiological test should be repeated to confirm the diagnosis
and rule out other pathogens before instituting another course
of antimycotic therapy.
Drug interactions:
Synergism or antagonism between clotrimazole and nystatin,
or amphotericin B, against strains of C. Albicans has not
been reported.
Pediatric use:
Safety and effectiveness in children have been established
for clotrimazole when used as indicated and in the recommended
dosage.
Adverse reactions:
The following adverse reactions have been reported in connection
with the use: erythema, stinging, blistering, peeling, edema,
pruritus, urticaria, burning and general irritation of the
skin.
Over dosage:
Acute over dosage with topical application of clotrimazole
is unlikely and would not be expected to lead to a life-threatening
situation.
Dosage and Administration:
Gently apply sufficient Tycelex Cream on to the affected and
surrounding skin areas twice a day, in the morning and evening.
Clinical improvement with relief of pruritus usually occurs
within the first week of treatment with Tycelex. If the patient
shows no clinical improvement after four weeks of treatment
with Tycelex, the diagnosis should be reviewed.
How Supplied:
Tycelex Cream 1% is supplied in 10 gm tube.
Store between:
2 to 30 C (36 to 86 F) |