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Pregabalin and Nortriptyline Tablets is indicated for indicated for the treatment of peripheral and central neuropathic pain in adults.
Pregabalin and Nortriptyline Tablets is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
The dose range is 150 to 600 mg per day of pregabalin given in either two or three divided doses.
Treatment can be started at a dose of 150 mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose 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 mg per day after an additional 7-day interval.
For Generalised Anxiety Disorder the need for treatment should be reassessed regularly.
As pregabalin clearance is directly proportional to creatinine clearance dose reduction in patients with compromised renal function must be individualised according to creatinine clearance.
Elderly patients may require a dose reduction of pregabalin due to a decreased renal function.
Dizziness, somnolence, headache, 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, Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth.
In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medicinal products.
Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur.
Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population.
After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients. The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence. The patient should be informed about this at the start of the treatment.
Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use or shortly after discontinuing pregabalin.
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased. This may be attributed to an additive effect due to concomitant medicinal products (e.g. anti-spasticity medicinal products) needed for this condition. This should be considered when prescribing pregabalin in this condition.
There have been reports of congestive heart failure in some patients receiving pregabalin. These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication. Pregabalin should be used with caution in these patients. Discontinuation of pregabalin may resolve the reaction.
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications.
Cases of misuse, abuse and dependence have been reported. Caution should be exercised in 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).
Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy.
Patients with cardiovascular disease should be given nortriptyline only under close supervision because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction time. Myocardial infarction, arrhythmia and strokes have occurred. Great care is necessary if nortriptyline is administered to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop.
Store below 30°C and protect from light and moisture.
Keep the medicine out of reach of children.
Alu-PVC blister pack.
Prenor is available in an Alu-PVC blister of 10 tablets. Such 03 blisters in a unit carton with package insert.
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