Moxifloxacin Hydrochloride (Page 3 of 17)

4 CONTRAINDICATIONS

Moxifloxacin Hydrochloride is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions ( 5.8)] .

5 WARNINGS AND PRECAUTIONS

5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects

Fluoroquinolones, including Moxifloxacin Hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting Moxifloxacin Hydrochloride. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions ( 5.2, 5.3, 5.4)].

Discontinue Moxifloxacin Hydrochloride immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including Moxifloxacin Hydrochloride, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

5.2 Tendinitis and Tendon Rupture

Fluoroquinolones, including Moxifloxacin Hydrochloride, have been associated with an increased risk of tendinitis and tendon rupture in all ages [see Warnings and Precautions ( 5.1) and Adverse Reactions ( 6.2)] . This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur within hours or days of starting moxifloxacin or as long as several months after completion of therapy. Tendinitis and tendon rupture can occur bilaterally.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue Moxifloxacin Hydrochloride immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug. Avoid fluoroquinolones, including Moxifloxacin Hydrochloride, in patients who have a history of tendon disorders or who have experienced tendinitis or tendon rupture [see Adverse Reactions ( 6.2)].

5.3 Peripheral Neuropathy

Fluoroquinolones, including Moxifloxacin Hydrochloride, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones including Moxifloxacin Hydrochloride. Symptoms may occur soon after initiation of Moxifloxacin Hydrochloride and may be irreversible in some patients [see Warnings and Precautions ( 5.1) and Adverse Reactions ( 6.1, 6.2)] .

Discontinue Moxifloxacin Hydrochloride immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation . Avoid fluoroquinolones, including Moxifloxacin Hydrochloride, in patients who have previously experienced peripheral neuropathy

5.4 Central Nervous System Effects

Psychiatric Adverse Reactions

Fluoroquinolones, including Moxifloxacin Hydrochloride, have been associated with an increased risk of hallucinations, or paranoia; depression or suicidal thoughts or acts; anxiety, agitation, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment. These adverse reactions may occur following the first dose. If these reactions occur in patients receiving Moxifloxacin Hydrochloride, discontinue Moxifloxacin Hydrochloride immediately and institute appropriate measures [see Adverse Reactions ( 6.1, 6.2)].

Central Nervous System Adverse Reactions

Fluoroquinolones, including Moxifloxacin Hydrochloridehave been associated with an increased risk of seizures (convulsions), increased intracranial pressure (including pseudotumor cerebri), dizziness, and tremors. As with all fluoroquinolones, use Moxifloxacin Hydrochloride with caution in patients with known or suspected CNS disorders (for example, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold. These adverse reactions may occur following the first dose. If these reactions occur in patients receiving Moxifloxacin Hydrochloride, discontinue Moxifloxacin Hydrochloride immediately and institute appropriate measures [see Drug Interactions ( 7.4) Adverse Reactions ( 6.1, 6.2), and Patient Counseling Information ( 17)] .

5.5 Exacerbation of Myasthenia Gravis

Fluoroquinolones, including Moxifloxacin Hydrochloride, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Avoid Moxifloxacin Hydrochloride in patients with known history of myasthenia gravis .

5.6 QT Prolongation

Moxifloxacin Hydrochloride has been shown to prolong the QT interval of the electrocardiogram in some patients. Following oral dosing with 400 mg of Moxifloxacin Hydrochloride the mean (± SD) change in QTc from the pre-dose value at the time of maximum drug concentration was 6 msec (± 26) (n = 787). Following a course of daily intravenous dosing (400 mg; 1 hour infusion each day) the mean change in QTc from the Day 1 pre-dose value was 10 msec (±22) on Day 1 (n=667) and 7 msec (± 24) on Day 3 (n = 667). Moxifloxacin Hydrochloride has been shown to prolong the QT interval of the electrocardiogram in some patients. Following oral dosing with 400 mg of Moxifloxacin Hydrochloride the mean (± SD) change in QTc from the pre-dose value at the time of maximum drug concentration was 6 msec (± 26) (n = 787). Following a course of daily intravenous dosing (400 mg; 1 hour infusion each day) the mean change in QTc from the Day 1 pre-dose value was 10 msec (±22) on Day 1 (n=667) and 7 msec (± 24) on Day 3 (n = 667).

Avoid Moxifloxacin Hydrochloride in patients with the following risk factors due to the lack of clinical experience with the drug in these patient populations:Avoid Moxifloxacin Hydrochloride in patients with the following risk factors due to the lack of clinical experience with the drug in these patient populations:

  • Known prolongation of the QT interval
  • Ventricular arrhythmias including torsade de pointes because QT prolongation may lead to an increased risk for these conditions
  • Ongoing proarrhythmic conditions, such as clinically significant bradycardia and acute myocardial ischemia,
  • Uncorrected hypokalemia or hypomagnesemia
  • Class IA (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic agents
  • Other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants

Elderly patients using intravenous Moxifloxacin Hydrochloride may be more susceptible to drug-associated QT prolongation [see Use In Specific Populations ( 8.5)].

In patients with mild, moderate, or severe liver cirrhosis, metabolic disturbances associated with hepatic insufficiency may lead to QT prolongation. Monitor ECG in patients with liver cirrhosis treated with Moxifloxacin Hydrochloride In patients with mild, moderate, or severe liver cirrhosis, metabolic disturbances associated with hepatic insufficiency may lead to QT prolongation. Monitor ECG in patients with liver cirrhosis treated with Moxifloxacin Hydrochloride [see Clinical Pharmacology ( 12.3)].

The magnitude of QT prolongation may increase with increasing concentrations of the drug or increasing rates of infusion of the intravenous formulation. Therefore the recommended dose or infusion rate should not be exceeded.The magnitude of QT prolongation may increase with increasing concentrations of the drug or increasing rates of infusion of the intravenous formulation. Therefore the recommended dose or infusion rate should not be exceeded.

In premarketing clinical trials, the rate of cardiovascular adverse reactions was similar in 798 Moxifloxacin Hydrochloride and 702 comparator treated patients who received concomitant therapy with drugs known to prolong the QTc interval. No excess in cardiovascular morbidity or mortality attributable to QTc prolongation occurred with Moxifloxacin Hydrochloride treatment in over 15,500 patients in controlled clinical studies, including 759 patients who were hypokalemic at the start of treatment, and there was no increase in mortality in over 18,000 Moxifloxacin Hydrochloride tablet treated patients in a postmarketing observational study in which ECGs were not performed. In premarketing clinical trials, the rate of cardiovascular adverse reactions was similar in 798 Moxifloxacin Hydrochloride and 702 comparator treated patients who received concomitant therapy with drugs known to prolong the QTc interval. No excess in cardiovascular morbidity or mortality attributable to QTc prolongation occurred with Moxifloxacin Hydrochloride treatment in over 15,500 patients in controlled clinical studies, including 759 patients who were hypokalemic at the start of treatment, and there was no increase in mortality in over 18,000 Moxifloxacin Hydrochloride tablet treated patients in a postmarketing observational study in which ECGs were not performed.

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