Maxlox™

[Moxifloxacin]

Maxlox

Active Ingredients

Maxlox™ [Moxifloxacin BP] is available for oral administration as: Maxlox™ 400mg Tablets. Each film coated tablet contains: 400mg Moxifloxacin BP as hydrochloride.

Description / Properties

Maxlox™ is bactericidal against a range of Gram-positive and Gram-negative organisms. Such activity arises through the inhibition of DNA gyrase (topoisomerase II) and topoisomerase IV, which bacteria require for DNA replication, transcription, repair, and recombination. Maxlox™ contains the C8-methoxy moiety that augments its antibacterial activity and reduces the possibility of Gram-positive mutations. Because the 8-fluroquinolones use a different mechanism of action than do the aminoglycosides, beta-lactams, macrolides, or tetracyclines, there has been no cross resistance between the quinolones and these antimicrobial agents.

Indications

Maxlox™ tablets are indicated for the treatment of following bacterial infections:

  • Acute bacterial sinusitis
  • Acute bacterial exacerbation of chronic bronchitis
  • Community acquired pneumonia
  • Un-complicated skin infections and skin structure infections
  • Complicated skin infections and skin structure infections

    Drug Interactions

    Maxlox™ should be taken at least 4 hours before or 8 hours after antacids containing magnesium, calcium or aluminium, as well as sucralfate, metal cations such as iron and multivitamin preparations with zinc or didanosine. Medication that can reduce potassium levels should be used with caution in patients receiving Maxlox™. Concomitant administration of charcoal with an oral dose of 400mg Maxlox™ leads to a pronounced prevention of drug absorption and a reduced systemic availability of the drug by more than 80%. Therefore, the concomitant use of these two drugs is not recommended (except for overdose cases). The prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if a quinolone is administered concomitantly with warfarin or its derivatives. Concomitant administration of NSAIDs with Quinolones may increase the risk of CNS stimulation and convulsion.

    Side Effects

    Common: Headache, dizziness, abdominal pain, vomiting, QT prolongation in patients with hypokalaemia, increase in transaminases, superinfection due to resistant bacteria.

    Uncommon: Anorexia, constipation, dyspepsia, flatulence, gastritis, increase amylase, QT prolongation, palpitations, tachycardia, artrial fibrillation, angina pectoris, dyspnea, hepatic impairment, increased bilirubin, increase gamma glutarryl transferase, increase in blood alkaline phosphatase, pruritis rash, urticaria, dry skin, arthralgia, myalgia, dehydration, visual disturbances, anxiety reactions, psychomotor hyperactivity, taste disorder, paresthesia/dysesthesia, confusion, disorientation, hyperlipidemia, allergic reaction, Anemia, leucopenia, neutropenia, thrombocytopenia.

    Rare: Dysphagia, pseudomembranous colitis, ventricular tachyarrhythmia, syncope, hypertension, hypotension, vasodilatation, tinnitus, hypoesthesia, smell disorder, abnormal dreams, disturbed coordination, seizures, disturbed attention, speech disorders, amnesia, anaphylaxis, allergic edema/angioedema, hyperglycaemia, hyperuricemia, emotional liability, depression, hallucination, prolonged prothrombin time.

    Warning and Precautions

    Hypersensitivity and allergic reactions have been reported for flouroquinolones including Maxlox™ after first administration. Anaphylactic reactions can progress to a life-threatening shock, even after the first administration. In these cases moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.

    Maxlox™ has been shown to prolong the QTc interval on the electrocardiogram in some patients. In the analysis of ECGs obtained in the clinical trial program, QTc prolongation with Maxlox™ was 6 msec +_ 26 msec, 1.4% compared to baseline. Medication that can reduce potassium levels should be used with caution in patients receiving Maxlox™.

    Maxlox™ should be used with caution in patients with ongoing proarrhythmic conditions, such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl. torsade de pointes) and cardiac arrest. The magnitude of QT prolongation may increase with increasing concentrations of the drug. Therefore, the recommended dose should no be exceeded.

    The benefit of Maxlox™ treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions. If signs of cardiac arrhythmia occur during treatment with Maxlox™, treatment should be stopped and an ECG should be performed.

    Cases of fulminant hapatitis potentially leading to life-threatening liver failure have been reported with Maxlox™. Patients should be advised to contact their doctor prior to continuning treatment if signs and symptoms of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy. Liver function tests/investigations should be performed in cases where indications of liver dysfuction occur.

    Quinolones are known to trigger seizures. Use should be with caution in patients with CNS disorders which may predispose to seizures or lower the seizure threshold. Antibiotic associated colitis (incl. pseudomembranous colitis) has been reported in association with the use of broad spectrum antibiotics including Maxlox™; therefore it is important to consider this diagnosis in patients who develop serious diahorrea during or after the use of Maxlox™. In this situation adequate therepeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in this situation.

    Tendon inflammation and rupture may occur with quinolone therapy including Maxlox™, particularly in elderly patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue treatment with Maxlox™ and rest the affected limb(s).

    Elderly patients with renal disorders should use Maxlox™ with caution if they are unable to maintain adequate fluid intake, because dehydration may increase the risk of renal failure. If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.

    Quinolones have been shown to cause photosensitivity reactions in patients. However, studies have shown that Maxlox™ has a lower risk to induce photosensitivity. Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight during treatment with moxifloxacin.

    Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones. Therefore, Maxlox™ should be used with caution in these patients.

    Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

    Effects on ability to drive and use machines: No studies on the effects of Maxlox™ on the ability to drive and use machines have been performed. However, fluroquinolones including Maxlox™ may result in an impairment of the patient’s ability to drive or operate machinery due to CNS reactions (e.g. dizziness). Patients should be advised to see how they react to Maxlox™ before driving or operating machinery.

    Dosage

    One 400 mg film-coated tablet once daily.

    Presentations Available

    Maxlox™ 400mg tablets are available in Alu-Alu blister pack of 5 tablets.

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