Consumer medicine information

1. Why am I using Fluconazole-WGR?

Fluconazole-WGR contains the active ingredient fluconazole. Fluconazole-WGR capsules are used to treat certain fungal and yeast infections.
For more information, see Section 1. Why am I using Fluconazole-WGR? in the full CMI.

2. What should I know before I use Fluconazole-WGR?

Do not start treatment if you are allergic to any medicine containing fluconazole, any of the ingredients listed at the end of this CMI, or any other similar medicines such as miconazole, ketoconazole or clotrimazole. Tell your doctor if you have had any allergic reactions to any antifungal or any food, preservatives or dyes or any other medicines, if you are pregnant, plan to become pregnant or are breastfeeding. You must not be given Fluconazole-WGR if you are taking certain medicines.
For more information, see Section 2. What should I know before I use Fluconazole-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Fluconazole-WGR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Fluconazole-WGR?

Fluconazole-WGR is available as capsules which are swallowed whole with water. Your doctor will decide how much Fluconazole-WGR will be given to you each day and for how long. It will depend on your condition and other factors.
More instructions can be found in Section 4. How do I use Fluconazole-WGR? in the full CMI.

5. What should I know while using Fluconazole-WGR?

6. Are there any side effects?

Fluconazole-WGR is generally well tolerated. Side effects may include nausea, vomiting, abdominal pain, diarrhoea, headache, skin rash or redness and easy bruising of the skin, seizures, signs of frequent or worrying infections such as fever, severe chills, sore throat, or mouth ulcers, or change in liver function.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Fluconazole.

2 Qualitative and Quantitative Composition

Fluconazole is a member of the bis-triazole class of antifungal agents.
Fluconazole is a white crystalline powder, slightly soluble in water, freely soluble in methanol.
Fluconazole-WGR (fluconazole) capsules contain 50, 100 and 200 mg of the active ingredient, fluconazole.
Excipient with known effect. Contains sugars (as lactose). For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Fluconazole-WGR is available as:
Blue/ white hard gelatin, self locked capsules of size '4' imprinted with 'RANBAXY' in black edible ink on both cap and body containing white to off white powder, containing 50 mg of fluconazole.
Blue/ white hard gelatin, self locked capsules of size '2' imprinted with 'RANBAXY' in black edible ink on both cap and body containing white to off white powder, containing 100 mg of fluconazole.
Purple/ white hard gelatin, self locked capsules of size '0' imprinted with 'RANBAXY' in black edible ink on both cap and body containing white to off white powder, containing 200 mg of fluconazole.

4 Clinical Particulars

4.9 Overdose

There have been reports of overdosage with fluconazole, and in one case, a 42-year old patient infected with human immunodeficiency virus developed hallucinations and exhibited paranoid behaviour after reportedly ingesting 8,200 mg of fluconazole. The patient was admitted to hospital, and his condition resolved within 48 hours.
In the event of overdosage, symptomatic treatment (with supportive measures if necessary) should be undertaken.
Signs and symptoms are likely to be an extension of those under Section 4.8 Adverse Effects (Undesirable Effects).
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
Fluconazole is largely excreted in the urine; forced volume diuresis would probably increase the elimination rate. A three-hour haemodialysis session decreases plasma levels by approximately 50%.
In mice and rats receiving very high doses of fluconazole, clinical effects, in both species, included decreased motility and respiration, ptosis, lacrimation, salivation, urinary incontinence, loss of righting reflex and cyanosis; death was sometimes preceded by clonic convulsions.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Fluconazole, with or without metabolic activation, was negative in tests for mutagenicity in 4 strains of Salmonella typhimurium and in the mouse lymphoma system. Cytogenetic studies in vivo and in vitro showed no evidence of chromosomal mutations.
Carcinogenicity. Fluconazole showed no evidence of carcinogenic potential in mice and rats treated orally for 24 months at doses of 2.5, 5 or 10 mg/kg/day (approximately 2-7 x recommended human dose). Male rats treated with 5 and 10 mg/kg/day had an increased incidence of hepatocellular adenomas.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFLUCON.gif It is chemically designated as 2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)-2-propanol.
Its molecular formula is C₁₃H₁₂F₂N₆O and molecular weight is 306.3.
CAS number. CAS number: 86386-73-4.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

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