Consumer medicine information

1. Why am I taking LOZANOC?

LOZANOC contains the active ingredient itraconazole. LOZANOC is used to treat certain fungal infections which include the following: persistent infections of the nails, skin, hands, feet or groin; persistent candida (yeast) infections of the vagina; eye infections which have not responded to other treatment or which may be affecting vision; candida (yeast) infections of the mouth or throat in patients with lower resistance to disease; generalised infections. For more information, see Section 1. Why am I taking LOZANOC? in the full CMI.

2. What should I know before I take LOZANOC?

Do not take if you have ever had an allergic reaction to LOZANOC 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. For more information, see Section 2. What should I know before I take LOZANOC? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with LOZANOC 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 take LOZANOC?

Only take as many LOZANOC capsules as you have been prescribed and ask your doctor or pharmacist if you are not sure. More instructions can be found in Section 4. How do I take LOZANOC? in the full CMI.

5. What should I know while taking LOZANOC?

6. Are there any side effects?

Common side effects include: stomach upset/pain/discomfort, nausea, vomiting, diarrhoea, constipation, unpleasant taste in mouth, shortness of breath, headache, dizziness, fever, change in menstrual pattern, hair loss/thinning, erectile dysfunction, muscle weakness/pain, painful joints, tremors, confusion, cough, chills, high or low blood pressure. Serious side effects include: tingling/numbness/weakness in hands/feet, swelling of hands/ankles/feet/legs/abdomen, shortness of breath, weight gain, tiredness/fatigue/beginning to wake up at night, oversensitivity to sunlight, blurry/double vision, ringing in ears, loss of ability to control bladder/urinating more, loss of appetite, nausea, vomiting, dark urine, pale stools, yellowing of skin/eyes, sudden signs of allergy (rash/itching/hives on skin, swelling of the face/lips/tongue/other parts of the body, shortness of breath/trouble breathing), severe skin disorder (widespread skin rashes/peeling and blisters in mouth/eyes/genitals), any hearing loss symptoms. 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.

Boxed Warnings

Warning. Do not substitute Lozanoc with other brands of itraconazole, as they are not interchangeable.
Lozanoc has a higher bioavailability than other itraconazole capsules and requires a different dose. For dosing information, see Section 4.2 Dose and Method of Administration.

1 Name of Medicine

Itraconazole.

2 Qualitative and Quantitative Composition

The active ingredient in Lozanoc is itraconazole. Lozanoc is available as capsules containing 50 mg of suprabioavailable itraconazole.
Itraconazole is a synthetic triazole antifungal agent.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Lozanoc are powder-filled capsules consisting of a blend of itraconazole spray-dried powder and excipients, encapsulated into hard gelatin capsules.
The capsules are light blue with i-50 printed in black on the cap.

4 Clinical Particulars

4.9 Overdose

In the event of overdosage, patients should be treated symptomatically with supportive measures. No specific antidote is available and itraconazole is not removed by dialysis. Itraconazole cannot be removed by haemodialysis. Activated charcoal may be given if considered appropriate. For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Itraconazole produced no mutagenic effects when assayed in appropriate bacterial nonmammalian and mammalian test systems.
Carcinogenicity. Itraconazole showed no evidence of carcinogenicity potential in mice treated orally for 23 months at dosage levels of up to 80 mg/kg/day. Male rats treated with 25 mg/kg/day had a slightly increased incidence of soft tissue sarcoma. These sarcomas may have been a consequence of hypercholesterolaemia, which is a response of rats, but not dogs or humans to chronic itraconazole administration.
Female rats treated with 50 mg/kg/day had an increased incidence of squamous cell carcinoma of the lung (2/50) as compared to the untreated group. Although the occurrence of squamous cell carcinoma in the lung is extremely uncommon in untreated rats, the increase in this study was not statistically significant.
Toxicology. In three toxicology studies using rats, itraconazole induced bone defects at dosage levels as low as 20 mg/kg/day. The induced defects included reduced bone plate activity, thinning of the zona compacta of the large bones and increased bone fragility. At a dosage level of 80 mg/kg/day over one year or 160 mg/kg/day for six months, itraconazole induced small tooth pulp with hypocellular appearance in some rats.
Increased relative adrenal weights and swollen adrenals (reversible) were seen in rats and dogs where plasma levels were comparable to those of human therapeutic doses. Adrenocortical function was not affected in studies in humans after the recommended daily doses; with higher doses (600 mg/day for 3 months), adrenal cortex response to ACTH stimulation was reduced in 1 of 8 patients but returned to normal when the dosage was reduced.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Itraconazole has three chiral centres and is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs). The chemical structure of itraconazole is shown below:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSITRACO.gif Molecular formula: C₃₅H₃₈CI₂N₈O₄.
(±)-cis-4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2- (1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]- 1-piperazinyl]phenyl]-2,4-dihydro-2- (1-methylpropyl)-3H-1,2,4-triazol-3-one.
CAS number. CAS No. 84625-61-6.
It is a white to slightly yellowish powder, with a pKa of 3.7. It is highly hydrophobic and lipophilic with a log partition coefficient of 5.66 in the n-octanol/aqueous buffer solution of pH = 8.1. Itraconazole is insoluble in water at pH 1-12, very slightly soluble in alcohol and freely soluble in dichloromethane.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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