Neurontin^®

Abbreviated Prescribing Information¹

Formulation/presentation: Neurontin^® (Gabapentin) capsule is available in 100 mg × 50’s and 300 mg × 100’s. The tablet is available in 600 mg × 100’s. Indications: Adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children >3 yrs. It is also indicated for the treatment of neuropathic pain inclusive of diabetic neuropathy, post-herpetic neuralgia and trigeminal neuralgia in adults ≥18 yrs. Dosage: The recommended dose for Epilepsy: Adults and children >12 yrs: Initially 300 mg tds on day 1 or by titrating dose as: 300 mg once daily on day 1, 300 mg bd on day 2 and 300 mg tds on day 3. Thereafter, dose can be increased in three equally divided doses up to 3600 mg daily. Children: 3–12 yrs: Initially 10–15 mg/kg/day in equally divided doses; 3–5 yrs: 40 mg/kg/day in equally divided doses; ≥5 yrs: Initially 25–35 mg/kg/day in equally divided doses. Neuropathic pain adult: 900 mg/day in three equally divided doses. Max: 3600 mg/day. Contraindications: Hypersensitive to gabapentin or the product’s components. Special precautions: Elderly, renal impairment, hemodialysis. Abrupt withdrawal may precipitate status epilepticus. Dizziness and somnolence. Confusion, loss of consciousness and mental impairment. Concomitant use with opioids and other central nervous system (CNS) depressants may cause CNS depression and respiratory depression. Drug rash with eosinophilia and systemic symptoms (DRESS). Abuse and dependence. Pregnancy and lactation. Adverse events: Body as a whole (abdominal pain, back pain, fatigue, fever, headache, viral infection, asthenia, malaise, facial edema); skin and appendages (acne, abrasion, pruritus, rash); digestive system (constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, mouth or dry throat, nausea and/or vomiting, flatulence, anorexia, gingivitis, dysphagia); metabolic and nutritional (peripheral edema, weight increase); musculoskeletal system (myalgia, arthralgia, fracture); nervous system (amnesia, ataxia, confusion, abnormal coordination, depression, dizziness, dysarthria, emotional lability, insomnia, nervousness, nystagmus, somnolence, abnormal thinking, tremor, twitching, vertigo, hyperkinesia, abnormal reflexes, paresthesia, anxiety, hostility); respiratory system (pharyngitis, rhinitis, pneumonia, coughing); cardiovascular system (hypertension, vasodilation); urogenital system (urinary tract infection, impotence); hematologic and lymphatic system (leukopenia, decreased WBC, purpura); special senses (amblyopia, diplopia, abnormal vision). Anaphylaxis.

API-NEURONTIN-0125

Reference: 1. Malaysia Neurontin^® Prescribing Information dated 7 January 2025.