Duopharma Manufacturing (Bangi)


Duopharma Marketing
Full Prescribing Info
Each film coated tablets contains 400 mg Moxifloxacin.
Pharmacology: Pharmacodynamics: Moxifloxacin is a DNA gyrase inhibitor and also inhibits topoisomerase IV. DNA gyrase (topoisomerase II) is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination and transposition; inhibition is bactericidal.
Pharmacokinetics: Moxifloxacin is well-absorbed with a bioavailability of 90%. Its absorption is not affected by high-fat meal or yogurt. The volume of distribution is approximately 1.7-2.7 L/kg with tissue concentration often exceeding plasma concentrations in respiratory tissues, alveolar macrophages, abdominal tissues/ fluids, uterine tissue (endometrium, myometrium), and sinus tissues. Moxifloxacin is approximately 30-50% bound to proteins. 52% of the dose is hepatically metabolised via glucuronide and sulfate conjugation. The half-life elimination of a single oral dose is 12-16 hours. Moxifloxacin is excreted via urine (as unchanged druged and glucuronide conjugates) and feces (as unchanged drug and sulfate conjugates).
Moxifloxacin tablets are indicated for treatment of adults (≥18 years of age) with the following bacterial infections caused by susceptible strains: Acute bacterial sinusitis.
Acute exacerbations of chronic bronchitis.
Community acquired pneumonia.
Mild to moderately severe inflammatory pelvic diseases (i.e. infections of the upper female genital tract, including salpingitis and endometritis) without an associated tubo-ovarian or pelvic abscess. Moxifloxacin is not recommended for monotherapy of mild to moderately severe inflammatory pelvic diseases. Preferably, they should be administered in combination with another suited antibiotic (eg: cephalosporin), due to the increasing resistance of Neisseria gonorrhoeae to moxifloxacin; that is, unless moxifloxacin-resistant Neisseria gonorrhoeae can be ruled out.
Complicated skin and skin structure infections.
Complicated intraabdominal infections including polymicrobial such as abscesses.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Dosage/Direction for Use
Dose: Adult: One 400 mg film-coated tablet once daily.
Pediatrics: The efficacy of Moxifloxacin in children and adolescents has not been established. No recommendation on posology can be made. The safety of Moxifloxacin in children below the age of 6 years has not been established.
Renal impairment: No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis.
Hepatic impairment: No dosage adjustment is required in patients with impaired liver function.
Other special populations: No adjustment of dosage is required in the elderly and in patients with low bodyweight.
Duration: The duration of treatment should be determined by the severity of the indication or clinical response. Moxifloxacin tablets should be used for the following treatment durations: Acute exacerbation of chronic bronchitis: 5 days.
Community acquired pneumonia: 10 days.
Acute bacterial sinusitis: 7 days.
Mild to moderate pelvic inflammatory disease: 14 days.
Complicated skin and skin structure infections total treatment duration for sequential therapy (intravenous followed by oral therapy): 7-21 days.
Complicated intraabdominal infections total treatment duration for sequential therapy (intravenous followed by oral therapy): 5-14 days.
The recommended dose and duration of therapy for the indication being treated should not be exceeded.
Route of Administration: For oral administration only. The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Only limited data on overdose are available. No specific countermeasures after accidental overdose are recommended. In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Concomitant administration of charcoal with a dose of 400 mg oral moxifloxacin will reduce systemic availability of the drug by more than 80%. The use of charcoal early during absorption may be useful to prevent excessive increase in the systemic exposure to moxifloxacin in cases of oral overdose.
Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.
Pregnancy and lactation.
Patients below 18 years of age.
Patients with a history of tendon disease/ disorder related to quinolone treatment.
Changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation. For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with: Congenital or documented acquired QT prolongation,
Electrolyte disturbances, particularly in uncorrected hypokalaemia,
Clinically relevant bradycardia,
Clinically relevant heart failure with reduced left-ventricular ejection fraction,
Previous history of symptomatic arrhythmias.
Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval.
Due to limited data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminase increase > 5fold ULN.
Special Precautions
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. 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. 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 (including 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 cases of clinical manifestations of severe hypersensitivity reactions, moxifloxacin should be discontinued and suitable treatment (eg: 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.
Peripheral neuropathy: Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving quinolones including moxifloxacin. 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 in order to prevent the development of an irreversible condition.
Psychiatric reactions: 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-injurious behaviour 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 diarrhoea including colitis: Antibiotic-associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficle-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis. Therefore, it is important to consider this diagnosis in patients who develop serious diarrhoea 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 diarrhoea.
Patients with myasthenia gravis: Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
Exacerbation of myasthenia gravis: Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in person with myasthenia gravis. Post marketing serious adverse events, including deaths and requirement for ventilator support have been associated with fluoroquinolones use in persons with myasthenia gravis. Avoid fluoroquinolones in patients with known history of myasthenia gravis.
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 (eg: 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.
Vision disorders: If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Dysglycemia: As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with moxifloxacin. In moxifloxacin-treated patients, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g. sulfonylurea) or with insulin. In diabetic patients, careful monitoring of blood glucose is recommended.
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 deficiency: Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic 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 (e.g. associated with a tubo-ovarian or pelvic abscess), for whom an intravenous treatment is considered necessary, treatment with moxifloxacin 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 (e.g. 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.
Interference with biological tests: Moxifloxacin therapy may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth causing false negative results in samples taken from patients currently receiving moxifloxacin.
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.
Effects on Ability to Drive or Use Machines: Fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions and vision disorders.
Use In Pregnancy & Lactation
Use in Pregnancy: The safe use of moxifloxacin in human pregnancy has not been established. Reversible joint injuries are described in children receiving some quinolones, however this effect has not been reported as occurring on exposed foetuses. The potential risk for humans is unknown. Consequently, use of moxifloxacin during pregnancy is contraindicated.
Use in Lactation: There is no data available in lactating or nursing women. Therefore, the use of moxifloxacin in nursing mothers is contraindicated.
Adverse Reactions
Adverse reactions are listed as follows: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: common, uncommon, rare, very rare. (See table.)

Click on icon to see table/diagram/image

There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: hypernatraemia, hypercalcaemia, haemolytic anaemia, rhabdomyolysis, photosensitivity reactions.
Exacerbation of Myasthenia Gravis: Post Marketing Experience.
Drug Interactions
For the following substances absence of a clinically relevant interaction with moxifloxacin was proven: atenolol, ranitidine, calcium supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid. No dose adjustment is necessary for those drugs.
An additive effect on QT interval prolongation of moxifloxacin and other medicinal products that may prolong the QTc interval cannot be excluded. This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes. Therefore, co-administration of moxifloxacin with any of the following medicinal products is contraindicated: anti-arrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide); anti-arrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide); antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride); tricyclic antidepressive agents; certain antimicrobial agents (saquinavir, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine); certain antihistaminics (terfenadine, astemizole, mizolastine); others (cisapride, vincamine IV, bepridil, diphemanil).
Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels (e.g. loop and thiazide-type diuretics, laxatives and enemas [high doses], corticosteroids, amphotericin B) or medication that is associated with clinically significant bradycardia.
Concomitant ingestion of moxifloxacin together with antacids, minerals and multivitamins may result in impaired absorption of moxifloxacin after oral administration due to formation of chelate complexes with multi-valent cations contained in these preparations. This may lead to plasma concentrations considerably lower than desired. Hence, antacids, anti-retroviral drugs (eg: didanosine) and other preparations containing magnesium or aluminum, sucralfate and agents containing iron or zinc should be administered at least 4 hours before or 2 hours after ingestion of an oral moxifloxacin dose.
Changes in INR (International normalized ratio): Cases of increased anticoagulant activity have been reported in patients receiving anticoagulants concurrently with antibiotics, including moxifloxacin. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Under these circumstances, it is difficult to evaluate whether the infection or the treatment caused the INR disorder. A precautionary measure would be to more frequently monitor the INR. If necessary, the oral anticoagulant dose should be adjusted as appropriate.
Concomitant administration of charcoal with an oral dose of 400 mg moxifloxacin led 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).
Moxifloxacin has no clinically relevant interaction with food including dairy products.
Store in a dry place below 30°C. Store in original package to protect from moisture.
MIMS Class
ATC Classification
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
FC tab 400 mg (dull red, 17 mm oblong shaped, plain on both sides) x 1 x 5's.
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