Moflox Film Coated Tablets
Usage and indications:
Moflox are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin.
Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed:
- Acute bacterial sinusitis (adequately diagnosed).
- Acute exacerbations of chronic bronchitis (adequately diagnosed).
- Community acquired pneumonia, except severe cases.
- Mild to moderate pelvic inflammatory disease (infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.
Moflox is not recommended for use in mono-therapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded.
Moflox may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications:
- Community-acquired pneumonia.
- Complicated skin and skin structure infections.
Moflox should not be used to initiate therapy for any type of skin and skin structure infection or in severe community-acquired pneumonia.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Dosage and administration:
Adults: one 400mg film-coated tablet once daily.
Renal/hepatic impairment: no adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis (haemodialysis and continuous ambulatory peritoneal dialysis).
There is insufficient data in patients with impaired liver function.
Other special populations: no adjustment of dosage is required in the elderly and in patients with low bodyweight.
Children and adolescents: moxifloxacin is contraindicated in children and adolescents < 18 years. Efficacy and safety of moxifloxacin in children and adolescents have not been established.
Infections and Infestations:
Common: super infections due to resistant bacteria or fungi e.g. oral and vaginal candidiasis.
Blood and Lymphatic System Disorders:
Uncommon: anemia, leucopenia(s), Neutropenia, thrombocytopenia, thrombocythemia, Blood eosinophilia, prothrombin time prolonged / INR increased.
Very rare: prothrombin level increased / INR decreased, agranulocytosis.
Immune System Disorders:
Uncommon: allergic reaction.
Rare: anaphylaxis incl. very rarely life-threatening shock, allergic oedema / angiooedema (incl. laryngeal oedema, potentially life-threatening).
Metabolism and Nutrition Disorders:
Rare: hyperglycemia, hyperuricemia.
Uncommon: anxiety reactions, psychomotor hyperactivity / agitation.
Rare: emotional lability, depression (in very rare cases potentially culminating in self-endangering behavior, such as suicidal ideations/ thoughts, or suicide attempts), hallucination.
Very rare: depersonalization, psychotic reactions (potentially culminating in self-endangering behavior, such as suicidal ideations/ thoughts, or suicide attempts).
Nervous System Disorders:
Common: headache, dizziness
Uncommon: par- and dysaesthesia, taste disorders (incl. ageusia in very rare cases), confusion and disorientation, sleep disorders (predominantly insomnia), tremor, vertigo, somnolence.
Rare: hypoaesthesia, smell disorders (including anosmia), abnormal dreams, disturbed coordination (incl. gait disturbances, esp. due to dizziness or vertigo), seizures incl. grand mal convulsions, disturbed attention, speech disorders, amnesia.
Very rare: hyperaesthesia.
Uncommon: visual disturbances incl. diplopic and blurred vision (especially in the course of CNS reactions).
Very rare: transient loss of vision (especially in the course of CNS reactions).
Ear and Labyrinth Disorders:
Rare: tinnitus, hearing impairment incl. deafness (usually reversible).
Common: QT prolongation in patients with hypokalaemia.
Uncommon: QT prolongation, palpitations, tachycardia, atrial fibrillation, angina pectoris.
Rare: ventricular tachyarrhythmias, syncope (i.e., acute and short lasting loss of consciousness).
Very rare: unspecified arrhythmias, torsade de pointes, cardiac arrest
Rare: hypertension, Hypotension.
Respiratory, Thoracic and Mediastinal Disorders:
Uncommon: dyspnea (including asthmatic conditions).
Common: nausea, vomiting, gastrointestinal and abdominal pains, diarrhea.
Uncommon: anorexia, constipation, dyspepsia, flatulence, gastritis, increased amylase.
Rare: dysphagia, stomatitis, antibiotic associated colitis (incl. pseudo membranous colitis, in very rare cases associated with life-threatening complications).
Common: increase in transaminases
Uncommon: hepatic impairment (incl. LDH increase), increased bilirubin, increased gamma-glutamyl-transferase, Increase in blood alkaline phosphatase.
Rare: jaundice, hepatitis (predominantly cholestatic).
Very rare: fulminant hepatitis potentially leading to life-threatening liver failure (incl. fatal cases).
Skin and Subcutaneous Tissue Disorders:
Uncommon: pruritus, rash, urticaria, dry skin.
Very rare: bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).
Musculoskeletal, Connective Tissue and Bone Disorders:
Uncommon: arthralgia, myalgia.
Rare: tendonitis, muscle cramp, muscle twitching, muscle weakness.
Very rare: tendon rupture arthritis, muscle rigidity, exacerbation of symptoms of myasthenia gravis.
Renal and Urinary Disorders:
Rare: renal impairment (including increase in BUN and creatinine), renal failure.
General Disorders and Administration Site Conditions:
Uncommon: feeling unwell (predominantly asthenia or fatigue), painful conditions (including pain in back, chest, pelvic and extremities), Sweating.
Warnings and precautions:
Exacerbation of myasthenia gravis:
- Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Post-marketing serious adverse events, including deaths and requirement for ventilator support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid fluoroquinolones in patients with known history of myasthenia gravis.
Quinolones should not generally be used in patients aged less than 18 years, pregnant women, or breast-feeding mothers unless the benefits outweigh the risks. The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section.
Prolongation of QTc interval and potentially QTc-prolongation-related clinical conditions
- Moxifloxacin 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 moxifloxacin was 6 msec ± 26 msec, 1.4% compared to baseline. As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging medications. Elderly patients may also be more susceptible to drug-associated effects on the QT interval.
- Medication that can reduce potassium levels should be used with caution in patients receiving moxifloxacin.
- Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions (especially women and elderly patients), 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 not be exceeded.
- If signs of cardiac arrhythmia occur during treatment with moxifloxacin, treatment should be stopped and an ECG should be performed.
Hypersensitivity / allergic reactions
- Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin 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 (treatment for shock) initiated.
Severe liver disorders
- Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin. Patients should be advised to contact their doctor prior to continuing 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 dysfunction occur.
Serious bullous skin reactions
- Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Patients predisposed to seizures
- Quinolones are known to trigger seizures. Use should be with caution in patients with CNS disorders or in the presence of other risk factors which may predispose to seizures or lower the seizure threshold. In case of seizures, treatment with moxifloxacin should be discontinued and appropriate measures instituted.
- Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving quinolones. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop.
- Psychiatric reactions may occur even after the first administration of quinolones, including moxifloxacin. In very rare cases depression or psychotic reactions have progressed to suicidal thoughts and self-endangering behavior such as suicide attempts. In the event that the patient develops these reactions, moxifloxacin should be discontinued and appropriate measures instituted. Caution is recommended if moxifloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.
Antibiotic-associated diarrhea including colitis
- Antibiotic-associated diarrhea (AAD) and antibiotic-associated colitis (AAC), including pseudo membranous colitis and Clostridium difficile-associated diarrhea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhea to fatal colitis. Therefore it is important to consider this diagnosis in patients who develop serious diarrhea during or after the use of moxifloxacin. If AAD or AAC is suspected or confirmed, ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic measures should be initiated immediately. Furthermore, appropriate infection control measures should be undertaken to reduce the risk of transmission. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhea.
Tendon inflammation, tendon rupture
- Tendon inflammation and rupture (especially Achilles tendon), sometimes bilateral, may occur with quinolone therapy including moxifloxacin, even within 48 hours of starting treatment and have been reported up to several months after discontinuation of therapy. The risk of tendinitis and tendon rupture is increased in elderly patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue treatment with moxifloxacin, rest the affected limb(s) and consult their doctor immediately in order to initiate appropriate treatment (immobilization) for the affected tendon.
Patients with renal impairment
- Elderly patients with renal disorders should use moxifloxacin 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.
Prevention of photosensitivity reactions
- Quinolones have been shown to cause photosensitivity reactions in patients. However, studies have shown that moxifloxacin 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 glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to hemolytic reactions when treated with quinolones. Therefore, moxifloxacin should be used with caution in these patients.
Patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Patients with pelvic inflammatory disease
- For patients with complicated pelvic inflammatory disease (associated with a tubo-ovarian or pelvic abscess), for whom an intravenous treatment is considered necessary, treatment with Moflox is not recommended.
- Pelvic inflammatory disease may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae. Therefore in such cases empirical moxifloxacin should be co-administered with another appropriate antibiotic (a cephalosporin) unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
Patients with special cSSSi
- Clinical efficacy of intravenous moxifloxacin in the treatment of severe burn infections, fasciitis and diabetic foot infections with osteomyelitis has not been established.
Interference with biological tests
- Moxifloxacin therapy may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth causing false negative results.
Patients with MRSA infections
- Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be started.
- Due to adverse effects on the cartilage in juvenile animals the use of moxifloxacin in children and adolescents <18 years is contraindicated.
Pack: carton box containing (AL-PVC) strip of 5 tablets.