Consumer medicine information

1. Why am I using VORICONAZOLE INTERPHARMA?

VORICONAZOLE INTERPHARMA contains the active ingredient voriconazole. VORICONAZOLE INTERPHARMA is used to treat fungal and yeast infections.
For more information, see Section 1. Why am I using VORICONAZOLE INTERPHARMA? in the full CMI.

2. What should I know before I use VORICONAZOLE INTERPHARMA?

Do not use if you have ever had an allergic reaction to voriconazole, any similar medicines, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant, or are breastfeeding. VORICONAZOLE INTERPHARMA should NOT be used during pregnancy or breastfeeding, unless indicated by your doctor. Effective contraception should be used in women of childbearing potential.
For more information, see Section 2. What should I know before I use VORICONAZOLE INTERPHARMA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with VORICONAZOLE INTERPHARMA 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 VORICONAZOLE INTERPHARMA?

• Your doctor will prescribe the amount required of VORICONAZOLE INTERPHARMA based on your weight. The dose will be based on the form being prescribed.

• More instructions can be found in Section 4. How do I use VORICONAZOLE INTERPHARMA? in the full CMI.

5. What should I know while using VORICONAZOLE INTERPHARMA?

6. Are there any side effects?

Common side effects may be pain at injection site, headache, nausea or rash. More serious side effects maybe sudden skin symptoms or changes, allergic reaction, changes to urine colour or seizures.
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.

Notes

Distributed by InterPharma Pty Ltd

1 Name of Medicine

Voriconazole.

2 Qualitative and Quantitative Composition

Each vial contains 200 mg voriconazole as the active ingredient, as a lyophilised powder.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White to off-white sterile lyophilised powder.

4 Clinical Particulars

4.9 Overdose

Clinical data on overdose with this agent is scant.
In clinical trials there were three cases of accidental overdose. All occurred in paediatric patients, who received up to 5 times the recommended intravenous dose of voriconazole. A single adverse event of photophobia of 10 minutes duration was reported.
There is no known antidote to voriconazole. It is recommended that treatment of overdose is symptomatic and supportive.
Monitor potassium, full blood count and liver function following an overdose.
Consider administration of activated charcoal in the event of a potentially toxic ingestion. Activated charcoal is most effective when administered within one hour of ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected.
Voriconazole is haemodialysed with a clearance of 121 mL/min. The intravenous vehicle, hydroxypropylbetadex, is haemodialysed with a clearance of 37.5 ± 24 mL/min. In an overdose, haemodialysis may assist in the removal of voriconazole and hydroxypropylbetadex from the body.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Voriconazole showed no mutagenic potential in gene-mutation assays in bacterial (Salmonella typhimurium) and mammalian (Chinese hamster ovary) cells. While in vitro exposure of human lymphocytes to voriconazole produced equivocal effects on chromosomes, in vivo treatment of male and female mice at doses up to and including the maximum tolerated dose produced no evidence of chromosome damage as determined by the micronucleus assay.
Carcinogenicity. Carcinogenic potential was studied in mice and rats at oral doses of up to 100 mg/kg/day and 50 mg/kg/day for 24 months, respectively. Hepatocellular adenoma appeared in male and female mice at 100 mg/kg/day and in female rats at 50 mg/kg/day. There was also an increased incidence of hepatocellular carcinoma in mice at 100 mg/kg/day. Although mean plasma drug concentrations indicated there is no safety margin in humans in terms of exposure, adenoma and carcinoma (as well as non-neoplastic changes) are known to occur in rodents after chronic administration of compounds that are hepatic enzyme inducers.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Voriconazole, a broad-spectrum triazole antifungal agent, is a white to off-white powder. Its aqueous solubility is very low, at 0.7 mg/mL at 25°C. The log P n-octanol/water is 1.72. It has pKa values of 12.71 and 2.27.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSVORICO.gif Chemical name: (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl) butan-2-ol.
Molecular formula: C₁₆H₁₄F₃N₅O.
Molecular weight: 349.3.
CAS number. 137234-62-9.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/VORINTST.gif