5.3 Peripheral Neuropathy
Fluoroquinolones, including CIPRO, 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 CIPRO. Symptoms may occur soon after initiation of CIPRO and
may be irreversible in some patients [see Warnings and Precautions (5.1) and Adverse Reactions (6.1
,
6.2)].
Discontinue CIPRO immediately if the patient experiences symptoms of peripheral neuropathy including
pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light
touch, pain, temperature, position sense and vibratory sensation, and/or motor strength in order to
minimize the development of an irreversible condition. Avoid fluoroquinolones, including CIPRO, in
patients who have previously experienced peripheral neuropathy [see Adverse Reactions (6.1, 6.2
)].
5.4 Central Nervous System Effects
Fluoroquinolones, including CIPRO, have been associated with an increased risk of central nervous
system (CNS) effects, including. convulsions, increased intracranial pressure (including pseudotumor
cerebri), and toxic psychosis CIPRO may also cause central nervous system (CNS) events including:
nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors,
hallucinations, depression, and psychotic reactions have progressed to suicidal ideations/thoughts and
self-injurious behavior such as attempted or completed suicide. These reactions may occur following the
first dose. Advise patients receiving CIPRO to inform their healthcare provider immediately if these
reactions occur, discontinue the drug, and institute appropriate care. CIPRO, like other fluoroquinolones,
is known to trigger seizures or lower the seizure threshold. As with all fluoroquinolones, use CIPRO with
caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to
seizures or lower the seizure threshold (for example, severe cerebral arteriosclerosis, previous history of
convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk
factors that may predispose to seizures or lower the seizure threshold (for example, certain drug therapy,
renal dysfunction). Use CIPRO when the benefits of treatment exceed the risks, since these patients are
endangered because of possible undesirable CNS side effects. Cases of status epilepticus have been
reported. If seizures occur, discontinue CIPRO [see Adverse Reactions (6.1) and Drug Interactions (7
)].
5.5 Exacerbation of Myasthenia Gravis
Fluoroquinolones, including CIPRO, 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 CIPRO in patients with known history of myasthenia gravis [see Adverse
Reactions (6.2
)].
5.6 Other Serious and Sometimes Fatal Adverse Reactions
Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to
uncertain etiology, have been reported in patients receiving therapy with quinolones, including CIPRO.
These events may be severe and generally occur following the administration of multiple doses. Clinical
manifestations may include one or more of the following:
Reference ID: 3963446
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