ARTG Entry
GABALEP
ARTG entry for GABALEP (gabapentin), ARTG 284400 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: gabapentin
- Therapeutic area: Neurology
What it is
GABALEP is available as 600 mg and 800 mg film coated tablets containing gabapentin. GABALEP tablets are unscored and cannot be used for initiation of treatment, dose titration or to achieve lower daily dose regimens, and can only be used in stabilised patients.
Approved indications
— Treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults who have not achieved adequate control with standard antiepileptic drugs. — Treatment of neuropathic pain.
Dosing overview
Alternative brands of gabapentin must be used for initiation of treatment and dose titration.
Key safety warnings
GABALEP is a potential drug of abuse and dependence, and poses risks of abuse and dependence which can lead to overdose and death especially when used concomitantly with opioids and other CNS depressants. Patients' risk of abuse or dependence should be assessed before prescribing and the patient should be monitored regularly during treatment, particularly amongst patients with current or past abuse or dependence of opioids and/or benzodiazepines.
Regulatory history
GABALEP gabapentin 800 mg film coated tablets (ARTG 284397) and GABALEP gabapentin 600 mg film coated tablets (ARTG 284400) were first listed on the ARTG on 5 December 2017.