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APO-MOXIFLOXACIN HYDROCHLORIDE is a brand name for Moxifloxacin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS ..................................................................................................... 5 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions Fluoroquinolones, including APO-MOXIFLOXACIN HYDROCHLORIDE (moxifloxacin hydrochloride), have been associated with disabling and potentially persistent adverse reactions which to date include, but are not limited to: tendonitis, tendon rupture, peripheral neuropathy and neuropsychiatric effects.
Moxifloxacin hydrochloride has been shown to prolong the QT interval of the electrocardiogram in some patients (see WARNINGS AND PRECAUTIONS: Cardiovascular: QT Interval Prolongation). Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving fluoroquinolone therapy, including moxifloxacin hydrochloride (see WARNINGS AND PRECAUTIONS: Hypersensitivity).
Fluoroquinolones, including APO-MOXIFLOXACIN HYDROCHLORIDE, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see WARNINGS AND PRECAUTIONS: Musculoskeletal).
Fluoroquinolones, including APO-MOXIFLOXACIN HYDROCHLORIDE, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid moxifloxacin hydrochloride in patients with a known history of myasthenia gravis (see WARNINGS AND PRECAUTIONS: Musculoskeletal).
Seizures and toxic psychoses may occur with fluoroquinolone therapy. Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychoses have been reported in patients receiving fluoroquinolones, including moxifloxacin hydrochloride.
APO-MOXIFLOXACIN HYDROCHLORIDE should be used with caution in patients with known or suspected CNS disorders which may predispose to seizures or lower the seizure threshold (see WARNINGS AND PRECAUTIONS: Central Nervous System Effects).
Cases of fulminant hepatitis potentially leading to liver failure (including fatal case) have been reported with moxifloxacin hydrochloride (see WARNINGS AND PRECAUTIONS: Hepatic/Biliary). Carcinogenesis and Mutagenesis From the results of animal studies, there is no evidence to suggest that moxifloxacin hydrochloride is carcinogenic or mutagenic (see TOXICOLOGY).
Cardiovascular QT Interval Prolongation Moxifloxacin hydrochloride has been shown to prolong the QT interval of the electrocardiogram in some patients. , amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with the drug in these patient populations and the potential r isk.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Moxifloxacin in Canada.
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Sotalol, a Class III antiarrhythmic, has been shown to increase the QTc interval when combined with high doses of intravenous moxifloxacin hydrochloride in dogs (see DETAILED PHARMACOLOGY). APO-MOXIFLOXACIN HYDROCHLORIDE, Moxifloxacin Tablets Page 7 of 71 Pharmacokinetic studies between moxifloxacin hydrochloride and other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics and tricyclic antidepressants have not been performed.
An additive effect of moxifloxacin hydrochloride and these drugs cannot be excluded, therefore APO-MOXIFLOXACIN HYDROCHLORIDE should be used with caution when given concurrently with these drugs. The effect of moxifloxacin hydrochloride on patients with congenital prolongation of the QT interval has not been studied, but it is expected that these individuals may be more susceptible to drug-induced QT prolongation.
Moxifloxacin hydrochloride should be used with caution in patients with ongoing proarrhythmic conditions such as clinically significant bradycardia, acute myocardial ischemia, clinically relevant heart failure with reduced left-ventricular ejection fraction or previous history of symptomatic arrhythmias.
QT prolongation may lead to an increased risk for ventricular arrhythmias including Torsades de Pointes. It has been observed with drugs that prolong the QT interval (including moxifloxacin) that females may be at greater risk compared to males for developing Torsades de Pointes because women tend to have a longer baseline QT interval compared to men.
Elderl y patients may also be more susceptible to drug-associated effects on the QT interval. In 787 patients with paired valid ECGs in Phase III clinical trials, the mean±SD prolongation of the QTc interval after oral dosing with moxifloxacin hydrochloride tablets 400 mg was 6±26 msec.
In patients with paired valid ECGs in Phase III clinical trials, the mean±SD prolongation of the QTc interval within 0-4 hours after a one hour infusion of intravenous moxifloxacin hydrochloride 400 mg was 9±24 msec (Day 1; n=176) and 3±29 msec (Day 3; n=290) (see ACTION AND CLINICAL PHARMACOLOGY, DETAILED PHARMACOLOGY).
No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin hydrochloride treatment in clinical trials involving over 4000 patients. However, certain predisposing conditions may increase the risk for ventricular arrhythmias.
If signs of cardiac arrhythmia occur during treatment with APO-MOXIFLOXACIN HYDROCHLORIDE, treatment should be stopped and an ECG should be performed. APO-MOXIFLOXACIN HYDROCHLORIDE should be used with caution in patients with liver cirrhosis as pre-existing QT prolongation in these patients cannot be excluded.
, amiodarone, sotalol) antiarrhythmic agents that APO-MOXIFLOXACIN HYDROCHLORIDE may add to the QTc prolonging effects […]