candicure

candicure

Candicure
Composition:
Each 1 gm contains:
Isoconazole nitrate 10 mg
Contains also inactive material: purified water, white petrolatum,
stearyl alcohol, propylene glycol, polysorbate 60, cetyl alcohol, and
benzoic acid.
Properties
Isoconazole nitrate is an imidazole derivative with antifungal activity.
It is active against a wide spectrum of pathogenic fungi including
Candida spp., dermatophytes, yeast & yeast like microorganisms as
floccosum, Trichophyton mentagrophytes,
Epidermophyton
Trichophyton rubrum, Malassezia furfur, pityriasis versicolor and
molds. In addition, It is active on the Office Erythrasma.
Pharmacokinetics:
Absorption: Isoconazole cream penetrates rapidly through skin. The
active principle reaches the maximum rate in all cutaneous layers
within one hour and maintained for at least 7 hrs. (In corneal layer
approx. 3500gg/ml 7mmol,'1, epidermis sustainable to approx.
20pg/ml i- 40gmol/l, dermis approx. 3pg/ml 6gmol/l). All the active
principle exceed several times the minimal inhibitory concentration &
fungi
the most important
microbicidal concentration for
(dermatophytes, moulds & yeast) in corneal layer, epidermis &
reached all areas in dermis.
Distribution: the systemic concentration through the percutaneous
absorption was minimal. Even after the removal of the corneal layer,
the part of the used dose that reached the general circulation within 4
hrs from exposure was less than 1%.
Metabolismi Isoconazole doesnt undefg6 metabolic inactivation in
the skin. The absorbed quantitiy through percutaneous route is very
minimal to study the pharmacokinetic performance of isoconazole
nitrate in human.
Indication and usage
Candicure cream is indicated for topical treatment of fungal infection of
the skin including in the area of external genitals, the hands, the
interdigital spaces of the feet, and in the inguinal and genital regions,
e.g.:
• Tinea pedis (Athlete's foot)
• Tinea manum
• Tinea cruris
• Tinea corporis
• Tinea (pityriasis) versicolor.
• Erythrasma
Dosage & administration
Tinea pedis, tinea corporis, or tinea cruris: CANDICURE Cream
should be applied twice daily to affected and surrounding skin.
ltwtopical treatmentshould be-applied over a period of 2 - 4 weeks
while tinea pedis should be treated for 1 month to reduce the
possibility of recurrence.
It is recommended to insert gauze bandage soaked with
Candicure cream in the interdigital spaces.
To avoid recurrence, treatment should still be continued
for at least 2 weeks after clinical recovery.
If a patient shows no clinical improvement after the
treatment period, the diagnosis should be
reviewed.
Contraindication
CANDICURE Cream is contraindicated in
shown
have
individuals who
hypersensitivity to isoconazole or any
of its exciepients.
Topical Cream
Isoconazole nitrate 1%
Side effects:
In few cases, local reactions including burning, blistering or itching
may occur following the application of isoconazole. Also, allergic
cutaneous reactions are possible.
Pregnancy & lactations:
There are, however, no adequate and well-controlled studies in
pregnant women and there is no data about risks on fetus. Also, it is
unlikely that effective doses of isoconazole pass into breast milk. so;
this drug should be used during first trimester of pregnancy or for
nursing woman only if clearly needed.
Overdose toxicity:
The results of acute toxicity studies not provide any evidence of over
toxicity due to single topical application on body surface even in
conditions that promot resorption, but the accidental ingestion of
Isoconazole provoke the risks of acute toxicity.
Drug interactions:
No interaction is known.
Preclinical data:
The results of toxicity studies after repeated administration did not
indicate the existence of health risks when the drug is used as
prescribed.
Studies in vitro and in vivo conducted in order to identify gene
mutations and chromosomal did not indicate the existence of a
mutagenic potential of isoconazole.
No studies of tumorigenicity in vivo has been made.
In the current state of knowledge, or the results of mutagenicity
studies and studies of toxicity after repeated administration, nor the
chemical structure of isoconazole nor its mechanism of action does
not allow finding a tumorigenic potential of the drug.
Studies of reproductive toxicity have not shown any negative effect
on the isoconazole different reproductive stages
In particular, they found no evidence of teratogenic potential.
According to the results of studies of local tolerance to the skin and
mucous membranes, there is no reason to fear that the drug does
extensive local irritative effects in therapeutic conditions. The results
obtained in the model of the rabbit eye show a likelihood of
conjunctivitis if the drug is accidentally come into contact with the
eye.
Warnings & precautions
- If Candicure cream is used on face, avoid contact with eyes.
- To avoid re-infection, personal linen (gloves, towels & underwear-
preferably of cotton) should be changed daily & boiled.
- During the treatment with Candicure cream the hygienic
measures should be monitored regularly to get successful
recovery.
- In case of Tinea pedis (Athlete'sfoot), the interdigital spaces
should be dried carefully after washing foot & the socks should be
changed daily.
Package & storage:
- Carton box containing 30 gm laminated plastic (LDPE ethylene
acrylic copolymerX Aluminum ethylene vinyl alcohol copolymer
LLDPE) tube with cap & shoulder consists of PP, HDPE & titanium
dioxide) & insert leaflet.
- Store at temperature not exceeding 30 0 C
- Keep all medicines away from children.
Manufactured by: Al Esraa pharmaceutical optima