Gracevit Special Precautions

Careful Administration (Gracevit Tab 50 should be administered with caution in the following patients): Patients with renal impairment [Persistent increased serum sitafloxacin concentration has been reported in patients with renal impairment (See Pharmacology: Pharmacokinetics under Actions)].
Patients with convulsive diseases such as epilepsy or with a history of convulsive diseases [Convulsion in association with the use of the other quinolones has been reported].
Patients with myasthenia gravis [Exacerbation of myasthenia gravis in associated with the use of the other quinolones has been reported].
Patients complicated with aortic aneurysm or aortic dissection, or patients who have a previous history, positive family history, or risk factors (Marfan syndrome/Loeys-Dietz syndrome) of aortic aneurysm or aortic dissection [The increased risk of aortic aneurysm and dissection after intake of fluoroquinolones have been reported in overseas epidemiologic studies (see Important Precautions as follows and Clinically significant adverse reactions under Adverse Reactions)].
Important Precautions: Aortic aneurysm or aortic dissection may occur; therefore, patients should be carefully observed and instructed to seek medical attention immediately if they experience symptoms, e.g., in case of pain in the abdomen, chest, or back. Imaging assessment should be considered if necessary for patients complicated with aortic aneurysm or aortic dissection, or patients who have a previous history, positive family history, or risk factors of aortic aneurysm or aortic dissection (see Careful Administration as previously mentioned and Clinically significant adverse reactions under Adverse Reactions).
Precautions concerning use: Precaution regarding dispensing: When Gracevit Tab 50 is dispensed, patients should be instructed to remove each tablet from the PTP blister package before taking the drug. (It has been reported that accidental ingestion of the blister package can lead to esophageal mucosal injury and subsequent perforation caused by the pointed corner of the package, resulting in serious complications such as mediastinitis.)
Effects on Ability to Drive and Use Machines: Some undesirable effects (e.g. dizziness or vertigo), which may affect the ability to drive or operate machinery, have been reported uncommonly (less than 1.0%).
Sitafloxacin may have some influence on the ability to drive and use machine.
Use in the Elderly: Elderly patients [It has been reported that tendon disorders are more likely to occur since elderly patients generally have reduced physiological function, Gracevit Tab 50 should be used with caution while closely observation of the patient's condition (see Pharmacology: Pharmacokinetics under Actions)].