flusum Tablets
flusum Tablets

Mayanmar Product

Flusum Tablets

Flusum Gel

Flusum Gel

Why you have been prescribed this medicine?

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

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
In clinical trials conducted prior to marketing mild skin irritation were seen rarely. The use of topical products, especially if prolonged, may give rise to phenomena of sensitization and produce side effects. In this case you must stop treatment and establish an appropriate therapy.
Adverse Drug reaction:
"Inform doctors about unexpected reactions after using drugs".

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?

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.

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

Overdosage:
So far no cases of overdose have been reported.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store below 30°C.

Drug Description

Composition:
Each gram of gel contains:
Fluconazole USP ...... 0.5 % w/w
Additional ingredients:
Carbomer 940, Propylene glycol, Benzyl alcohol, Polysorbate 80, 2- Octyldodecanol, Fragrance delite & Sodium hydroxide

Indications and dosage.

Indications:
Flusum gel (fluconazole) is indicated for the treatment of dermatomycoses caused by dermatophytes, yeasts and molds: in particularly Tinea pedis, tinea corporis, tinea cruris, tinea versicolor and infections of Candida.
Dosage & Administration:
Flusum gel (fluconazole) 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.

Side effects and drug interactions.

Side effects:
In clinical trials conducted prior to marketing mild skin irritation were seen rarely. The use of topical products, especially if prolonged, may give rise to phenomena of sensitization and produce side effects. In this case you must stop treatment and establish an appropriate therapy.
Adverse Drug reaction:
"Inform doctors about unexpected reactions after using drugs".

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

Precautions for use:
Should not be used for ophthalmic use.

Overdosage and Contraindications

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.
Overdosage:
So far no cases of overdose have been reported.

Clinical pharmacology.

Pharmaceutical Form:
Topical gel
Pharmacotherapeutic group:
Antifungal agent
Pharmacological properties
Pharmacodynamics
Therapeutic category: Antifungal for topical use
ATC Code: D01AC
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.
Pharmacokinetics A pharmacokinetic study conducted with the Flusum 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 Flusum 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 Flusum Gel is well tolerated by human skin and is not phototoxic, so it is suitable for use as a topical antifungal.

Storage conditions:
Store below 30°C.
Shelf-life:
2 years
Conditions of supply:
This drug is administered according to doctor's prescription only.
Packing:
Flusum gel 0.5% w/w is packed in a 30 g aluminium barrier laminated lamitubes fitted with white screw cap and one such tube is packed in a carton along with pack insert
Name and address of manufacturer:
Kusum Healthcare Pvt. Ltd.
SP 289(A), RIICO Indl. Area,
Chopanki, Bhiwadi (Rajasthan), India
MM Reg. No.: 1812AA 7073

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575