Lyrica^®

Abbreviated Prescribing Information¹

Composition: Pregabalin 50 mg, 75 mg and 150 mg in hard capsule. Dosage and indications: The dose range is 150–600 mg/day given in either 2 or 3 divided doses. Pregabalin may be taken with or without food. Neuropathic pain: Pregabalin treatment can be started at a dose of 150 mg/day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg/day after an interval of 3–7 days, and if needed, to a maximum dose of 600 mg/day after an additional 7-day interval. Epilepsy: Pregabalin treatment can be started with a dose of 150 mg/day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg/day after 1 week. The maximum dosage of 600 mg/day may be achieved after an additional week. Generalised anxiety disorder: The dose range is 150–600 mg/day given as 2 or 3 divided doses. The need for treatment should be reassessed regularly. Pregabalin treatment can be started with a dose of 150 mg/day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg/day after 1 week. Following an additional week, the dosage may be increased to 450 mg/day. The maximum dosage of 600 mg/day may be achieved after an additional week. Fibromyalgia: The recommended dose of pregabalin is 300–450 mg/day. Dosing should begin at 75 mg 2 times a day (150 mg/day) and may be increased to 150 mg 2 times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg 2 times a day (450 mg/day). The dose may be increased to a maximum dosage of 600 mg/day after an additional week if needed. Because Lyrica^® is eliminated primarily by renal excretion, the dose should be adjusted for patients with reduced renal function (creatinine clearance <60 mL/min). Discontinuation of pregabalin: In accordance with current clinical practice, if pregabalin has to be discontinued, it is recommended that this should be done gradually over a minimum of 1 week independent of the indication. Special precautions: Exercise caution when prescribing pregabalin to patients who have had a previous episode of angioedema and discontinue immediately if the symptoms are life-threatening with respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in patients with hypersensitivity reactions (skin redness, blisters, hives, rash, dyspnea and wheezing). Withdraw pregabalin gradually to minimise the potential of increased seizure frequency in patients with seizure disorders. Monitor patients treated with any AED including pregabalin, for any indication of the emergence or worsening of depression, suicidal thoughts or behaviour, and/or any unusual changes in mood or behaviour. Pregabalin may cause peripheral oedema. Exercise caution when using in congestive heart failure patients with NYHA Class III or IV cardiac status. Pregabalin may cause dizziness, somnolence and weight gain. Inform patients of the withdrawal symptoms following abrupt or rapid discontinuation of short- and long-term treatment with pregabalin. Inform patients to notify their physician if changes in vision occur. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness particularly if these symptoms are accompanied by malaise or fever. Pregabalin treatment was associated with creatinine kinase elevations, a decrease in platelet count and PR interval prolongation. There is evidence from case reports, human studies and animal studies associating pregabalin with serious, life-threatening or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe pregabalin with another CNS depressant, particularly an opioid, or to prescribe pregabalin to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating pregabalin at a low dose. The management of respiratory depression may include close observation, supportive measures and reduction or withdrawal of CNS depressants (including pregabalin). There is more limited evidence from case reports, animal studies and human studies associating pregabalin with serious respiratory depression, without co-administered CNS depressants or without underlying respiratory impairment. Caution should be exercised in patients with a history of substance abuse. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose–galactose malabsorption should not take this medicine. Pregabalin may cause major birth defects in unborn children during the first trimester and contraception should be recommended for women of childbearing potential. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Undesirable effects: The very common (≥1/10) adverse reactions reported were dizziness and somnolence. Other common (≥1/100, <1/10) side effects reported were nasopharyngitis, increased appetite, confusion, disorientation, irritability, depression, euphoric mood, decreased libido, insomnia, ataxia, abnormal coordination, balance disorder, amnesia, disturbance inattention, memory impairment, tremor, dysarthria, paresthesia, hypoesthesia, sedation, lethargy, blurred vision, diplopia, vertigo, vomiting, abdominal distension, constipation, dry mouth, flatulence, muscle cramp, arthralgia, back pain, pain in limb, cervical spasm, peripheral oedema, oedema, abnormal gait, fall, feeling drunk, feeling abnormal, fatigue, increased weight. Presentation: 50 mg (56’s), 75 mg (56’s) and 150 mg (56’s).

API-LYRICA-0325

Reference: 1. Malaysia Lyrica^® Prescribing Information, Dated 13 March 2025.