Pactib 320 mg (Gemifloxacin Mesylate)

Adult dose

<For domestic use> Usually, adults are given 320 mg of gemifloxacin per dose orally, with or without food. 1. Acute exacerbation of chronic respiratory disease (chronic bronchitis): Administer 320 mg once daily for 5 days. 2. Community-acquired pneumonia: Administer 320 mg once daily for 7 days; in severe pneumonia, treatment may be continued for up to 14 days depending on symptoms. 3. Sinusitis: Administer 320 mg once daily for 5 to 7 days. 4. Otitis media (excluding preoperative use for chronic cholesteatomatous otitis media and chronic otitis media with bony extension): Administer 320 mg once daily for 7 days. 5. Patients with renal impairment 1) No dosage adjustment is required for patients with mild or moderate renal impairment (creatinine clearance ≥ 40 mL/min). 2) Reduce the dose to 160 mg once daily for patients with severe renal impairment (creatinine clearance < 40 mL/min), patients receiving hemodialysis, and patients receiving peritoneal dialysis. 6. Elderly patients and patients with hepatic impairment: No dosage adjustment is required. <For export> For all indications, administer 1 tablet (320 mg) once daily orally, with or without food. 1. Acute exacerbation of chronic respiratory disease (chronic bronchitis): Administer 320 mg once daily for 5 days. 2. Community-acquired pneumonia: Administer 320 mg once daily for 7 days; in severe pneumonia, treatment may be continued for up to 14 days depending on symptoms. 3. Sinusitis: Administer 320 mg once daily for 5 to 7 days. 4. Otitis media (excluding preoperative use for chronic cholesteatomatous otitis media and chronic otitis media with bony extension): Administer 320 mg once daily for 7 days. 5. Uncomplicated urinary tract infection: Administer 320 mg once daily for 3 days. 6. Complicated urinary tract infection, acute pyelonephritis: Administer 320 mg once daily for 10 days. 7. Patients with renal impairment 1) No dosage adjustment is required for patients with mild or moderate renal impairment (creatinine clearance ≥ 40 mL/min). 2) Reduce the dose to 160 mg once daily for patients with severe renal impairment (creatinine clearance < 40 mL/min), patients receiving hemodialysis, and patients receiving peritoneal dialysis. 8. Elderly patients and patients with hepatic impairment: No dosage adjustment is required.

This medication can cause serious tendon problems such as tendonitis or tendon rupture, so it should be discontinued immediately if such symptoms occur. Caution is necessary as it may affect peripheral neuropathy or the central nervous system, leading to symptoms such as neuralgia, confusion, and seizures. Patients with myasthenia gravis may experience worsening symptoms when taking this medication, and it is advisable to avoid its use. This medication is used to treat specific bacterial infections, but should only be employed when no other treatment options are available. Elderly patients, patients with impaired renal function, and those taking corticosteroids are at increased risk of tendon rupture and should be careful. Pregnant or breastfeeding women, and growing children or adolescents should not take this medication. If sudden allergic reactions such as skin rashes, hives, or breathing difficulties occur during treatment, consult medical personnel immediately. It is advisable to consume sufficient fluids while taking this medication and to avoid strong sunlight or UV exposure. When taking this medication with others, absorption may be reduced, so antacids or iron supplements should not be taken within 3 hours before or after this medication. Diabetic patients taking blood sugar control medication should closely monitor blood sugar changes, and report any hypoglycemic symptoms to healthcare providers immediately. During treatment with this medication, if central nervous system symptoms such as vision disturbances, severe headaches, dizziness, or seizures occur, avoid driving or operating machinery and consult a doctor immediately. In the event of overdose, vomiting should be induced or the drug removed through gastric lavage, and the patient's condition should be closely monitored for appropriate treatment.

• Tendinitis
• tendon rupture
• peripheral neuropathy
• central nervous system effects
• exacerbation of myasthenia gravis
• anaphylactic shock
• anaphylactic reactions
• tremors
• anxiety
• photophobia

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

White or nearly white oval film-coated tablet

Package unit

5 tablets (5 tablets/PTP packaging x 1), 30 tablets (5 tablets/PTP packaging x 6)