Lirystad 75

Rx

Indications:

• The treatment of peripheral and central neuropathic pain in adults.
• Adjunctive therapy in adults with partial seizures with or without secondary generalisation.
• Generalised anxiety disorder (GAD) in adults.

Dosage:

The dose range is 150 to 600 mg daily given in either two or three divided doses.

• Neuropathic pain: Start with 150 mg daily given as two or three divided doses, the dose may be increased to 300 mg daily after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg daily after an additional 7-day interval.
• Epilepsy: Start with 150 mg daily given as two or three divided doses, the dose may be increased to 300 mg daily after 1 week. The maximum dose of 600 mg daily may be achieved after an additional week.
• Generalised anxiety disorder: 150 to 600 mg daily given as two or three divided doses. The need for treatment should be reassessed regularly. Start with 150 mg daily, the dose may be increased to 300 mg daily after 1 week. Following an additional week the dose may be increased to 450 mg daily. The maximum dose of 600 mg daily may be achieved after an additional week.

Renal impairment

• CLcr ≥ 60 ml/min: Start with 150 mg daily, maximum of 600 mg daily, twice or three times daily.
• CLcr = 30 – 60 ml/ min: Start with 75 mg daily, maximum of 300 mg daily twice or three times daily.
• CLcr = 15 – 30 ml/ min: Start with 25 – 50 mg daily, maximum of 150 mg daily, once or twice daily.
• CLcr < 15 ml/ min: Start with 25 mg daily, maximum of 75 mg daily, once daily.
• Supplementary dosage following haemodialysis: Start with 25 mg, maximum of 100 mg, as a single dose.

Elderly (over 65 years of age): Require dose reduction.

Usage:

Lirystad 75 is orally administered with or without food.

Hypersensitivity to the active substance or to any of the excipients.

Very common: Dizziness, somnolence, headache.

Common: Nasopharyngitis; appetite increased; euphoric mood, confusion, irritability, disorientation, insomnia, libido decreased; ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy; vision blurred, diplopia; vertigo; vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth; muscle cramp, arthralgia, back pain, pain in limb, cervical spasm; erectile dysfunction; oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue; weight increased.

It is not recommended for children and adolescent under 17 years old.

Caution should be given when use Lirystad 75 in:

• Diabetic patients (may need to adjust hypoglycaemic medicinal products).
• Elderly cardiovascular compromised patients.
• Patients with a history of substance abuse and the patient should be monitored for symptoms of pregabalin misuse, abuse or dependence (development of tolerance, dose escalation, drug-seeking behaviour have been reported).

Moreover, the following should be taken into account:

• Dizziness, somnolence, loss of consciousness, confusion and mental impairment, which could increase the occurrence of accidental injury (fall) in the elderly population. There have also been post-marketing reports of loss of consciousness, confusion and mental impairment.
• Loss of vision, visual blurring or other changes of visual acuity, discontinuation of pregabalin may result in resolution or improvement of these symptoms.
• Renal failure has been reported and in some cases discontinuation of pregabalin did show reversibility of this adverse reaction.
• It is recommended that discontinuation of pregabalin should be done gradually over a minimum of 1 week. Before treatment with pregabalin, the patient should be informed about withdrawal symptoms if abrupt discontinuation occurs, these are including insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence.
• Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use or shortly after discontinuing pregabalin.
• Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
• Reduced lower gastrointestinal tract function (e.g. intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
• Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy.

Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take Lirystad 75.

Lirystad 75 should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus). A decision must be made whether to discontinue breast-feeding or to discontinue Lirystad 75 therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Lirystad 75 may cause dizziness and somnolence and therefore may influence the ability to drive or use machines. Patients are advised not to drive, operate complex machine or engage in other potentially hazardous activities.