Revision Year: 2016 Publisher: RIEMSER Pharma GmbH, An der Wiek 7, 17493 Greifswald – Insel Riems, Germany, phone: +49 30 338427-0, fax: +49 3 83 51 308, e-mail: info@RIEMSER.com
TERIZIDON is indicated for adults within the scope of an anti-tuberculosis combination therapy for the treatment of tuberculosis, caused by Mycobacterium tuberculosis (see sections 4.4 and 5.1).
TERIZIDON may only then be used if insufficient combination partners are available due to verified resistances or incompatibilities.
The official guidelines for appropriate use of antibacterial substances must be observed.
750-1000 mg terizidone per day are generally administered to adults in 3 or 4 single doses, meaning 3 or 4 TERIZIDON capsules, hard. The maximum daily dose is 1000 mg terizidone.
There are no recommendations for the application of terizidone for patients with renal insufficiency. Because terizidone is a Prodrug of the active substance cycloserine, the recommendations for cycloserine can be used as a basis:
Patients with a creatinine clearance of 30 ml/min should be given 250 mg terizidone (equals 1 TERIZIDON capsule, hard) daily or intermittently 500 mg terizidone (equals 2 TERIZIDON capsules, hard) 3 days per week, for example Monday, Wednesday and Friday.
Please observe that terizidone can be dialyzed (peritoneal and haemodialysis). Terizidone should therefore be administered to dialysis patients immediately after dialysis. For dialysis patients who have a continuous form of dialysis, please observe the guidelines in section 4.4.
TERIZIDON is contraindicated with serum creatinine over 2 mg/dl due to severe renal insufficiency (see section 4.3).
The capsules, hard have to be administered equally over the course of the day unchewed with sufficient fluids (one capsule, hard every 6 or 8 hours) during mealtimes. In order to avoid compatibility disorders, the dose can be gradually increased to the optimum quantity.
The duration of the application of terizidone in a combination therapy with other antimycobacterial substances is dependent on the clinical progression, in particular on the time point of conversion and the severity of the illness, as well as the therapy regimen applied based on the resistance test. The duration of therapy generally totals 18 – 24 months after conversion has taken place.
As a result of overdose, the side effects listed in section 4.8 may worsen. The central nervous system is particularly affected. Headaches, dizziness, confusion, drowsiness, excitability, paraesthesia, dysarthria, psychoses, paresis, tremor, cramps and comas may occur.
On overdose, measures for the prevention of reabsorption and for the acceleration of elimination are required. Terizidone and cycloserine are haemodialyzable and peritoneal dialyzable.
3 years.
Do not store above 30°C.
Capsules, hard in PVC/aluminium blister packs.
Original package containing 50 capsules, hard.
Package for hospital use containing 1050 capsules, hard.
No special requirements.
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