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Hypersensitivity reactions: Hypersensitivity reactions including rash and pruritus may occur. Cases of anaphylaxis have also been reported. Serious reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) may occur. Discontinue use if symptoms of fever, erythema, blistering, itching, ocular congestion, or stomatitis occur.
CNS depression: May cause CNS depression, which may impair physical or mental abilities. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Special population: Use with caution in patients with hepatic impairment. May worsen hepatic function.
Use in the Elderly: Use with caution in elderly patients. Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy.
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