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Logo DAKTARIN® oral gel

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

DAKTARIN® oral gel

COMPOSITION:
Miconazole 20 mg/g in a homogeneous starch base.
Ethyl alcohol content: 0,73% m/m.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2 Antimicrobial (Chemotherapeutic) agents. Fungicides.

PHARMACOLOGICAL ACTION:
Pharmacodynamics
Miconazole possesses in vitro antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis.

INDICATIONS:
DAKTARIN oral gel is indicated for the treatment of fungal infections of the mouth (e.g. thrush in babies and oral candidiasis in other age groups) and for fungal stomatitis occurring in association with dentures.

CONTRA-INDICATIONS:
DAKTARIN oral gel is contra-indicated in those patients who have shown hypersensitivity to miconazole or to any of its ingredients and patients with liver dysfunction.
Terfenadine, astemizole, mizolastine, cisapride, triazolam, oral midazolam, dofetilide, quinidine, pimozide, CYP3A4 metabolised HMG-CoA reductase inhibitors such as simvastatin and lovastatin, are contra-indicated with DAKTARIN oral gel. See “Drug interactions”.

WARNINGS:
Avoid contact with the eyes.
Particularly in infants and young children, caution is required, to ensure that the gel does not obstruct the throat. Hence, the gel should not be applied to the back of the throat and the full dose should be divided into smaller parts. Observe the patient for possible choking.

DOSAGE AND DIRECTIONS FOR USE:
DAKTARIN oral gel should be spread evenly over the affected areas of the oropharyngeal mucosa and tongue taking care to properly cover oral ulcerations and other lesions.
The application of DAKTARIN oral gel must be repeated two to three times daily depending upon the severity of the infection. Apply the gel regularly until all signs of the infection have disappeared. Continue using for another two days after the infection has cleared.
Application of the gel is preferably done after meals.
For best results in treatment of oral lesions, DAKTARIN oral gel must be kept in contact with the affected areas as long as possible. This can be achieved by retaining the gel in the mouth for the maximum time possible.
In fungal stomatitis, associated with dentures, apply the gel to the lesions in the evening and leave on overnight.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal discomfort such as nausea, vomiting and with long-term treatment, diarrhoea.
Allergic reactions have been reported less frequently.
Drug interaction
Avoid combination with other antifungal medicines, such as amphotericin B, as these agents in combination mutually reduce antifungal activity.
Miconazole can inhibit the metabolism of medicines metabolised by the cytochrome 3A and 2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including side effects. Examples are:
Drugs which should not be used during treatment with miconazole:
Terfenadine, astemizole, mizolastine, cisapride, triazolam, oral midazolam, dofetilide, quinidine, pimozide, CYP3A4 metabolised HMG-CoA reductase inhibitors such as simvastatin and lovastatin.
Drugs whose plasma levels, effects or side-effects should be monitored. Their dosage, if co-administered with miconazole, should be reduced if necessary.
Oral anti-coagulants,
HIV Protease inhibitors such as saquinavir,
Certain antineoplastic agents such as vinca alkaloids, busulfan and docetaxel,
CYP3A4 metabolised calcium channel blockers such as dihydropyridines and probably verapamil.
Certain immunosuppressive agents: cyclosporin, tacrolimus, sirolimus (= rapamycin).
Others: oral hypoglycaemics (CYP2C9), phenytoin (CYP2C9), carbamazepine, buspirone, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine, reboxetine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms
In general, miconazole is not highly toxic. In the event of accidental overdosage, vomiting and diarrhoea may occur.
Treatment
Treatment is symptomatic and supportive. A specific antidote is not available.

IDENTIFICATION:
White, homogeneous gel with orange flavour.

PRESENTATION:
DAKTARIN oral gel is supplied in tubes containing 30 g or 40 g.

STORAGE DIRECTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
L/20.2.2/183

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN –CILAG
Janssen Pharmaceutica (Pty) Ltd
(Reg. No. 1980/011122/07)
15th Road, Halfway House, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
13 June 1988
                Code No. 024139
                        2001H
                        Britepak

Updated on this site: December 2001
Current: May 2005
Source: Pharmaceutical Industry

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