Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
itraconazole, Quantity: 100 mg
Arrotex Pharmaceuticals Pty Ltd
Itraconazole
Capsule
Excipient Ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
28 capsules, 15 capsules, 60 capsules, 6 capsules, 4 capsules
(S4) Prescription Only Medicine
APO-ITRACONAZOLE indicated for use in adults for the treatment of: ? Superficial dermatomycoses not responding to topical treatment. ? Fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. ? Pityriasis versicolor not responding to any other treatment. ? Vulvovaginal candidiasis not responding to topical treatment. ? Oral candidiasis in immunocompromised patients. ? Onychomycosis caused by dermatophytes. ? Systemic mycoses: - Systemic aspergillosis, histoplasmosis, sporotrichosis. - Treatment and maintenance therapy in AIDS patients with disseminated or chronic pulmonary histoplasmosis infection. - Treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. - Treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.
Visual Identification: Size 0el hard gelatin white opaque capsules filled with off-white to cream colored pellets and imprinting with ITR on cap and 100 on body; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-08-09
APO-ITRACONAZOLE 1 APO-ITRACONAZOLE _Itraconazole _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about itraconazole. 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 using itraconazole against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR Itraconazole is used to treat certain fungal infections, such as: • infections of the nails, skin, hands, feet or groin • persistent candida (yeast) vaginal infections • 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 a weakened immune system • generalised infections Itraconazole 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 itraconazole for another reason. This medicine is not addictive. This medicine is only available with a doctor’s prescription._ _ Itraconazole is not recommended for use in children and in the elderly. BEFORE YOU USE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ITRACONAZOLE IF YOU HAVE AN ALLERGY TO: • itraconazole • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE ITRACONAZOLE IF YOU ARE ALSO TAKING ANY OF THE FOLLOWING MEDICINES: • terfenadine, astemizole or mizolastine, used for allergies • Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION APO-ITRACONAZOLE (ITRACONAZOLE) CAPSULES 1 NAME OF THE MEDICINE Itraconazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION APO-Itraconazole capsules contain itraconazole 100 mg. EXCIPIENTS WITH KNOWN EFFECT Sucrose, gelatin. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM APO-Itraconazole is available as white opaque capsules printed with ITR on the cap and 100 on the body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS APO-Itraconazole is indicated for use in adults for the treatment of: • Superficial dermatomycoses not responding to topical treatment. • Fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. • Pityriasis versicolor not responding to any other treatment. • Vulvovaginal candidiasis not responding to topical treatment. • Oral candidiasis in immunocompromised patients. • Onychomycosis caused by dermatophytes. • Systemic mycoses, only in the following fungal infections: - Systemic aspergillosis, histoplasmosis, lymphocutaneous/cutaneous sporotrichosis. - Treatment and maintenance therapy in AIDS patients with disseminated or chronic pulmonary histoplasmosis infection. - Treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. - Treatment of non-invasive candidiasis in non-neutropenic patients when first- line systemic antifungal therapy is inappropriate or has proven ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity. 2 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Itraconazole capsules are intended for oral administration. DOSAGE It is essential that APO-Itraconazole capsules are taken immediately after a meal for maximal absorption. The capsules must be swallowed whole. Treatment schedules are as follows: _SUPERFICIAL DERMATOMYCOSES: _ • Tinea corporis, tinea cruris: 1 capsule ( Read the complete document