Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Pregabalin
GOLDPLUS UNIVERSAL PTE LTD
N02BF02
CAPSULE
Pregabalin 25 mg
ORAL
Prescription Only
Jubilant Generics Limited
ACTIVE
2023-05-30
LYRIJUB PREGABALIN CAPSULES 25 MG, 75 MG AND 150 MG NAME OF THE MEDICINAL PRODUCT Lyrijub Capsule 25 mg Lyrijub Capsule 75 mg Lyrijub Capsule 150 mg 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Pregabalin 25 mg hard capsules Each hard capsule contains 25 mg of pregabalin. Pregabalin 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin. Pregabalin 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin 2. PHARMACEUTICAL FORM Pregabalin 25 mg hard capsules: White to off-white colored cap and body, size ’4’ hard gelatin capsule printed in black ink with “25” on the cap and “608” on the body containing white to off-white powder. Pregabalin 75 mg hard capsules: Reddish brown colored cap and white to off-white colored body, size “4” hard gelatin capsule printed in black ink with “610” on the body containing white to off-white powder. Pregabalin 150 mg hard capsules: White to off white colored cap and body, size ‘2’ hard gelatin capsule printed in black ink with “612” on the body containing white to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neuropathic pain Pregabalin is indicated for the treatment of neuropathic pain, which includes diabetic peripheral neuropathy and post-herpetic neuralgia, in adults. Epilepsy Pregabalin is indicated as adjunctive therapy of partial seizures, with or without secondary generalisation, in adults. Generalised anxiety disorder Pregabalin is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. Fibromyalgia Pregabalin is indicated for the management of fibromyalgia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose range is 150 to 600 mg per day given in either two or three divided doses. Pregabalin may be taken with or without food. Neuropathic pain Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 Read the complete document