Revision Year: 2018
Erelan 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin (see sections 4.4, 4.8 and 5.1).
Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed:
Moxifloxacin may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications:
Moxifloxacin should not be used to initiate therapy for any type of skin and skin structure infection or in severe community-acquired pneumonia.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The recommended dose is one 400 mg film-coated tablet once daily.
No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details). There is insufficient data in patients with impaired liver function (see section 4.3).
No adjustment of dosage is required in the elderly and in patients with low bodyweight.
Moxifloxacin is contraindicated in children and adolescents (<18 years). Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).
The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Moxifloxacin should be used for the following treatment durations:
Moxifloxacin has been studied in clinical trials for up to 14 days treatment.
In clinical studies with sequential therapy most patients switched from intravenous to oral therapy within 4 days (community-acquired pneumonia) or 6 days (complicated skin and skin structure infections). The recommended total duration of intravenous and oral treatment is 7-14 days for community-acquired pneumonia and 7-21 days for complicated skin and skin structure infections. The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
No specific countermeasures after accidental overdose are recommended. In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Concomitant administration of charcoal with a dose of 400mg oral moxifloxacin will reduce systemic availability of the drug by more than 80%. The use of charcoal early during absorption may be useful to prevent excessive increase in the systemic exposure to moxifloxacin in cases of oral overdose.
24 months.
This medicinal product does not require any special storage conditions.
Tablets are packed in Al/Al blisters.
Pack sizes of 5, 7, 10, 50, 70, 80 and 100 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
