Consumer medicine information

1. WHY AM I USING MOXIMED?

MOXIMED tablets contain the active ingredient, moxifloxacin, which is an antibiotic belonging to a group of medicines called quinolones. MOXIMED tablets are used in adults for the treatment of infections of the lungs, airways and sinuses. These antibiotics work by killing the bacteria that are causing your infection.
For more information, see Section 1. Why am I using MOXIMED? in the full CMI.

2. WHAT SHOULD I KNOW BEFORE I USE MOXIMED?

Do not use if you have ever had an allergic reaction to moxifloxacin 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 use MOXIMED? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with MOXIMED 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 MOXIMED?

• The usual adult dose is one 400 mg tablet once daily for 5 to 10 days.

• MOXIMED should be taken at least 2 hours before or 4 hours after any multivitamins, antacids, sucralfate, didanosine or medicines containing iron, zinc, magnesium, calcium or aluminium.

5. WHAT SHOULD I KNOW WHILE USING MOXIMED?

6. Are there any side effects?

Common side effects: thrush in the mouth or in the vagina. Serious side effects: allergic reactions such as skin rashes, watery or bloody diarrhea, Pain, swelling or rupture of a tendon, fits visual disturbances. Yellowing of the skin and in the whites of your eyes, also called jaundice, Skin reaction or blistering and/or peeling of the skin and/or mucosal reactions.
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

Serious disabling and potentially irreversible adverse reactions. Fluoroquinolones, including moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without preexisting risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system (see Section 4.4, Seizures, Peripheral neuropathy), musculoskeletal system (see Section 4.4, Tendonitis and tendon rupture) and psychiatric effects (see Section 4.4, Psychiatric reactions).

1 Name of Medicine

Moxifloxacin hydrochloride monohydrate.

2 Qualitative and Quantitative Composition

Each tablet contains 436.34 mg moxifloxacin hydrochloride (as monohydrate), equivalent to 400 mg moxifloxacin.

3 Pharmaceutical Form

Pink coloured, capsule shaped, biconvex, bevelled edge, film-coated tablet marked with 'MF' on one side and plain on other side.
Excipient with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

4 Clinical Particulars

4.9 Overdose

Only limited data on overdose are available. Single oral doses of up to 2.8 g and multiple doses of 600 mg over 10 days were administered to healthy subjects without any significant undesirable effects. In the event of overdosage it is recommended that appropriate supportive care should be instituted as dictated by the patient's clinical status. The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase in systemic moxifloxacin exposure. Due to the potential for moxifloxacin to cause QT prolongation, patients should be carefully monitored following an overdose.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Moxifloxacin was not mutagenic in 4 of 5 strains in the Salmonella reversion assay, however, as with other quinolones, a positive response was observed in strain TA 102. This may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay and gave an equivocal result in the V79/HGPRT mammalian cell gene mutation assay. Moxifloxacin was clastogenic in the v79 chromosome aberration assay in vitro but inactive in vivo in dominant lethal and micronucleus tests in mice. Moxifloxacin was inactive in an assay for unscheduled DNA synthesis in vitro.
Carcinogenicity. Conventional long-term carcinogenicity studies in rodents have not been carried out. Moxifloxacin at an oral dose of 459 mg/kg/day, was inactive in a limited 38 week tumour-initiation-promotion bioassay in rats. This dose resulted in a systemic drug exposure that was 1.9 times (males) and 0.3 (females), compared with the clinical exposure at the maximum recommended clinical exposure (AUC).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

The drug substance is moxifloxacin hydrochloride monohydrate, namely 1-Cyclopropyl-7[(1S, 6S)-2,8-diazabicyclo[4.3.0] non-8-yl]-6-fluoro-8-methoxy-4-oxo-quinoline-3-carboxylic acid hydrochloride monohydrate or 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridine-6-yl]-4-oxo-3-quinoline carboxylic acid hydrochloride monohydrate. It is a light yellow or yellow-coloured powder or crystals. The substance shows a 250°C - 255°C melting point. It is sparingly soluble in water and methanol, slightly soluble in ethanol (96 percent) and practically insoluble in acetone. It has the following chemical structure:
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMOXHYM.gif Chemical formula: C₂₁H₂₇ClFN₃O₅.
Molecular weight: 455.91 g/mol.
CAS number. 192927-63-2.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine - Schedule 4.

Summary Table of Changes

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