Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
itraconazole, Quantity: 50 mg
Mayne Pharma International Pty Ltd
Itraconazole
Capsule
Excipient Ingredients: silicon dioxide; magnesium stearate; sodium starch glycollate type A; hypromellose phthalate; Gelatin; brilliant blue FCF; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
28, 60, 15
(S4) Prescription Only Medicine
Superficial mycoses: LOZANOC is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and Pityriasis versicolor. Systemic mycoses: Lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. Consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see PHARMACOLOGY).
Visual Identification: light blue opaque capsule with i-50 printed in black on the cap; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-04-16
LOZANOC ® 50MG CAPSULES 1 LOZANOC ® 50MG CAPSULES _itraconazole _ CONSUMER MEDICINE INFORMATION WARNING: LOZANOC HAS A HIGHER ABSORPTION THAN OTHER ITRACONAZOLE CAPSULES. ONE CAPSULE OF LOZANOC 50 MG IS THERAPEUTICALLY EQUIVALENT TO ONE 100 MG CAPSULE OF CONVENTIONAL ITRACONAZOLE CAPSULES. LOZANOC 50MG CAPSULES AND CONVENTIONAL ITRACONAZOLE 100MG CAPSULES ARE NOT INTERCHANGEABLE. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LOZANOC Capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking LOZANOC Capsules against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING LOZANOC CAPSULES, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT LOZANOC ® CAPSULES ARE USED FOR LOZANOC Capsules are 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. LOZANOC works by killing or stopping the growth of the fungus that causes the infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE LOZANOC ® CAPSULES _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE LOZANOC CAPSULES IF: • you have an allergy to LOZANOC Capsules or any of the ingredients (see Product Description at the end of this Leaflet). • you have a condition called heart failure (also called congestive heart failure or CHF), LOZANOC could make it worse. • you are pregnant or may become pregnant. If there is a chance yo read_full_document
v 4.0 1 AUSTRALIAN PRODUCT INFORMATION LOZANOC (ITRACONAZOLE) CAPSULES 1. NAME OF THE 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 4.1. THERAPEUTIC INDICATIONS Superficial mycoses LOZANOC is indicated – if external treatment is not effective or not appropriate – for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, onychomycosis) and pityriasis versicolor. Systemic mycoses LOZANOC is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. WARNING: LOZANOC HAS A HIGHER BIOAVAILABILITY THAN OTHER ITRACONAZOLE CAPSULES. ONE CAPSULE OF LOZANOC 50 MG IS THERAPEUTICALLY EQUIVALENT TO ONE 100 MG CAPSULE OF CONVENTIONAL ITRACONAZOLE CAPSULES. THE RECOMMENDED DOSE FOR LOZANOC IS THEREFORE HALF THE RECOMMENDED DOSE FOR CONVENTIONAL ITRACONAZOLE CAPSULES. LOZANOC 50 MG CAPSULES AND CONVENTIONAL ITRACONAZOLE 100 MG CAPSULES ARE NOT INTERCHANGEABLE. v 4.0 2 Consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see _section 5.1 _ _Pharmacodynamic Properties_ ). 4.2. DOSE AND METHOD OF ADMINISTRATION LOZANOC is for oral administration and can be taken with or without food. One capsule of LOZANOC 50 mg is therapeutically equivalent to one 100 mg capsule of conventional itraconazole capsules. The recommended dose for LOZANOC is therefore half the recommended dose fo read_full_document