| a) Generic Name |
Levofloxacin INN
|
| b) Trade/Brand Name |
To be submitted at the time of inclusion.
|
| a) Presentation |
Film Coated Tablet.
Each tablet contains Levofloxacin INN 250 mg.
|
| b) Indications |
Levofloxacin is a synthetic broad spectrum antibacterial agent for oral administration.
Levofloxacin is indicated for the treatment of infections caused by susceptible microorganisms in the conditions listed below in adults (18 years or more than 18 years of age):
i) Acute bacterial sinusitis.
ii) Acute bacterial exacerbation of chronic bronchitis.
iii) Mild to moderate community acquired pneumonia.
|
| c) Dosage & administration |
i) Acute bacterial sinusitis: 250 – 500 mg once daily for 10 – 14 days.
ii) Acute bacterial exacerbation of chronic bronchitis:
250 – 500 mg once daily for 7 – 10 days.
iii) Mild to moderate community acquired pneumonia:
250 – 500 mg once daily for 7 days.
iv) Complicated UTI : 250 mg daily for 7 – 10 days.
Levofloxacin should be given at least 4 hours before or 8 hours after taking antacids (containing magnesium or aluminium, or both), iron preparations, multivitamins with zinc, etc.
No dosage adjustment is required in patients with impaired renal function, & with mild to moderate hepatic insufficiency.
Levofloxacin may be given without regard to food.
|
| d) Contraindications
|
Known hypersensitivity to Levofloxacin. Hydrochloride or any excipient of the medication, paediatric patients and adolescents less than 18 years of age, severe hepatic insufficiency, etc.
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| e) Side Effects |
Abdominal pain, anorexia, anxiety, constipation, dry mouth, Dizziness, rash, vaginitis etc.
|
| f) Precautions and
Warnings
|
The safety & effectiveness of Levofloxacin in paediatric patients & adolescents (less than 18 years of age), pregnant women, nursing mothers have not been established.
Dehydration, renal insufficiency, patients on concomitant treatment with glyburide, glibenclamide or insulin.
|
| g)Drug Interactions |
Antacids, analgesics, Fe preparation Warfarin.
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| h)Paediatric Use |
The safety & effectiveness of Levofloxacin have not been established in paediatric patients & adolescents less than 18 years of age.
|
| i)Use in Pregnancy |
There are no adequate and well-controlled studies in pregnant women. So, Levofloxacin should only be given during pregnancy if the potential benefit justifies the potential risk to the foetus.
|
| j)Use in Lactation |
Levofloxacin is excreted in the breast milk of rats, but not known whether it is excreted in human milk. So, a decision should be made whether to discontinue nursing or to give Levofloxacin, taking into account the importance of the drug to the mother.
|
| k) Over dosage |
In the event of acute overdosage, the stomach should be emptied & ECG monitoring is recommended due to the possible prolongation of the QT interval. The patient should be carefully observed and given supportive treatment. Adequate hydration must be maintained. It is not known whether Levofloxacin is dialyzable.
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| l) Package Quantity |
To be submitted at the time of inclusion.
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