Philippines Product

Flusum Gel

Flusum Gel

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

Fluconazole gel (Flusum) is indicated in the treatment of dermatomycoses caused by dermatophytes, yeasts and molds: in particularly Tinea pedis, Tinea corporis, Ttinea cruris, Tinea versicolor and Candida infections.

 

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

You should consult your doctor if you experience any of the following:
“For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph

Please seek medical attention immediately at the first sign of any adverse drug reaction shall appear.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

  • Hypersensitivity to the components of the product or to other closely related substances from the chemical point of view.
  • Generally contraindicated in pregnancy and lactating mothers.
  • Should not be used for ophthalmic use.

Influence on velocity reactions while driving motor transport and operating other mechanisms:
It does not have an influence.

What to do if you accidentally take too much (overdose) of the medicine?

So far no cases of overdose have been reported.

Is it safe in pregnancy and breast-feeding?

Pregnancy:
Studies in animals have shown reproductive toxicity. There have been reports of multiple congenital abnormalities (including brachycephalia, ears dysplasia, giant anterior fontanelle, femoral bowing and radio-humeral synostosis) in infants whose mothers were treated for at least three or more months with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis. So use of Flusum is not advised during Pregnancy.

Lactation:
Fluconazole passes into breast milk to reach concentrations lower than those in plasma. Use of Flusum during lactation is not advised.

Fertility:
Fluconazole did not affect the fertility of male or female rats.

Storage Conditions:

Store at temperatures not exceeding 30°C.

Drug Description

Drug description
Composition:
Each gram of gel contains;
Fluconazole USP……… 5 mg (0.5% w/w)

Description:

Clear colourless to opaque smooth homogeneous gel with characteristics odour.

Indications and dosage.

Indications:
Fluconazole gel (Flusum) is indicated in the treatment of dermatomycoses caused by dermatophytes, yeasts and molds: in particularly Tinea pedis, Tinea corporis, Ttinea cruris, Tinea versicolor and Candida infections.

Dosage:
Fluconazole gel (Flusum) should be applied once in a day, using a gentle massage on the affected skin and the immediate surrounding area. In internal areas should be applied in small quantities and spread well to avoid phenomena of maceration.
The duration of treatment required for healing varies with etiological agent responsible for the infection. Treatment of 1-3 weeks is usually sufficient for healing in most patients. Particularly with resistant forms, the treatment period may be extended up to 6 weeks depending on the decision of the doctor.
Mode of administration: Topical.

Side effects and drug interactions.

Side effects:
You should consult your doctor if you experience any of the following:
“For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph

Please seek medical attention immediately at the first sign of any adverse drug reaction shall appear.

Drug interactions
In clinical trials conducted so far there were no interactions or incompatibility reported with other drugs. There have been no specific studies of drug interactions conducted related to fluconazole gel.

Warnings and precautions

    • Hypersensitivity to the components of the product or to other closely related substances from the chemical point of view.
    • Generally contraindicated in pregnancy and lactating mothers.
    • Should not be used for ophthalmic use.

Overdosage and Contraindications

Overdosage:
So far no cases of overdose have been reported.
 Contraindications
Hypersensitivity to the components of the product or to other closely related substances from the chemical point of view.
Generally contraindicated in pregnancy and lactating mothers.

Clinical pharmacology.

Pharmacodynamic properties

Antifungal for topical use. ATC Code: D01AC15

Fluconazole, antifungal belonging to a new class of triazole agents, which is a potent and specific inhibitor of fungal sterol synthesis. Administered orally or intravenously, proved active in several modes of fungal infections.
Its activity has been demonstrated to fungal infections, such as those of Candida spp., (Including systemic candidiasis in animals and immunocompromised), of Cryptococcus neoformans (including intracranial infections), of Microsporum spp. And of Tricophyton spp.

Fluconazole has also been shown to be active in animal models of endemic mycoses, including of Blastomyces dermatitidis and of Coccidioides immitis (including intracranial infections) and of Histoplasma capsulatum in normal and immunocompromised animals. Fluconazole used topically is a broad-spectrum antifungal agent.

It was effective against the microorganisms responsible for dermatomycoses, cutaneous candidiasis and versicolor pityriasis (i.e. Microsporum spp., Trichophyton spp., Epidermophyton spp., Candida spp. and Malassezia furfur or Pityrosporum orbiculata)

Its activities are performed against dermatophytes, yeasts and molds. Fluconazole is highly specific for fungal enzymes dependent on cytochrome P-450. It inhibits lanosterol C-14 demethylase enzyme that converts lanosterol in to the sterol present in the membrane of fungi i.e. the ergosterol.

Pharmacokinetic properties

A pharmacokinetic study conducted with the fluconazole gel, showed that plasma levels achieved by fluconazole are so low as to exclude a systemic effect of the drug. Moreover, the characteristics of a gel combined with the type of emulsion o/w allows excellent tolerability. There have been no pharmacokinetic studies conducted with the fluconazole gel in children, but studies in adults have shown that the drug has a very low absorption systemically. Fluconazole has also been widely studied systemically in pediatric patients and neonates and showed a good tolerability profile similar to that of the adult patient.

A study conducted to evaluate the dermal tolerance and phototoxicity of the drug showed that the fluconazole gel is well tolerated by human skin and is not phototoxic, so it is suitable for use as a topical antifungal.

Pharmaceutical characteristics:

Dosage forms and packaging available:
Lami tube X 30 g (Box of 1’s)

Conditions of supply:
By prescription.


CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780