Moxiflox GPO

Moxiflox GPO Special Precautions





Full Prescribing Info
Special Precautions
Warnings: Moxifloxacin is contraindicated in patients with a history of hypersensitivity to the drug or to other quinolones.
The use of moxifloxacin in pregnancy and lactating women is not recommended.
Discontinue therapy of any fluoroquinolone antibiotics at the first signs or symptoms of rash, pain, myalgia, or tenodynia.
Moxifloxacin may be harmful to the liver and kidney.
Moxifloxacin should not be used or, if necessary, be used with caution in patients with known or suspected CNS disorders that predisposed to seizure and related to the administered dose.
Moxifloxacin may cause QT prolongation, use with caution in patients with the causative risks of QT prolongation e.g., elderly, cardiovascular disease especially arrhythmia, hypertension, hypokalemia etc.
Avoid concomitant use with the drugs known to cause QT prolongation e.g., antiarrhythmic drugs class IA (e.g., quinidine, procainamide), class III (e.g., amiodarone), cisapride, erythromycin, antipsychotic drugs, tricyclic antidepressants etc.
Moxifloxacin may cause phototoxic reactions or severe hypersensitivity such as Toxic Epidermal Necrolysis, Stevens-Johnson syndrome, Erythema Multiforme.
Moxifloxacin may alter blood glucose. Use with caution in patients with diabetes mellitus.
Concomitant use with warfarin may result in increased warfarin effect.
Fluoroquinolones, including moxifloxacin, are associated with an increased risk of tendonitis and tendon rupture in all ages. This risk is further increased in older patients usually older than 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants.
Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid moxifloxacin in patients with known history of myasthenia gravis.
Cardiac toxicity: Moxifloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients. Avoid in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with these drugs in these patients populations. Use with caution in patients with ongoing proarrhythmic conditions, such as significant bradycardia or acute myocardial ischemia.
Convulsion: Increased intracranial pressure, convulsion, and toxic psychosis have occurred. CNS stimulation may also occur, which may lead to tremor, restlessness, lightheadedness, confusion, dizziness, depression, hallucinations, and rarely, suicidal thoughts. Use with caution in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or other factors that predispose to seizures or lower the seizure threshold, or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction). If these reactions occur, stop the drug, and institute appropriate measures.
Peripheral neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in dysesthesias, hypesthesias, paresthesias, and weakness have been reported in patients receiving quinolones.
Clostridium difficile-associated diarrhea (CDAD): This has been reported with nearly all antibacterial agents, including fluoroquinolones, and may range from mild diarrhea to fatal colitis. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.
Blood glucose abnormalities: As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs, initiate appropriate therapy immediately.
Hypersensitivity reactions: Serious and occasionally fatal reactions have occurred in patients receiving quinolone therapy, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. If an allergic reaction occurs, discontinue the drug.
Superinfection: Use of antibiotics (especially prolonged or repeated therapy) may result in bacterial or fungal overgrowth of nonsusceptible organisms. Such overgrowth may lead to a secondary infection. Take appropriate measures if superinfection occurs.
Renal function impairment: The pharmacokinetic parameters of moxifloxacin are not significantly altered by mild, moderate, or severe renal impairment. No dosage adjustment is necessary in patients with renal impairment.
Hepatic function impairment: Moxifloxacin should be used with caution in mild, moderate, or severe hepatic insufficiency (Child-Pugh class A, B, or C) because the metabolic disturbances associated with hepatic insufficiency may lead to QT prolongation.
Use in Children: Safety and efficacy of moxifloxacin in children younger than 18 years of age have not been established. Moxifloxacin caused arthropathy and osteochondrosis in immature animals. Administration of moxifloxacin caused lameness in immature dogs due to permanent cartilage lesions.
Use in Elderly: Elderly patients may be more susceptible to drug-associated effects of QT interval and 7 tendon disorders. Use with caution, especially in those on corticosteroids.
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