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Prega

Prega

pregabalin

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma
Concise Prescribing Info
Contents
Pregabalin
Indications/Uses
Neuropathic pain including diabetic peripheral neuropathy & post-herpetic neuralgia in adults. Adjunctive therapy of partial seizures w/ or w/o secondary generalisation in adults. Generalised anxiety disorder (GAD) in adults. Fibromyalgia management.
Dosage/Direction for Use
150-600 mg/day in 2-3 divided doses. Neuropathic pain Initially 150 mg/day, may increase to 300 mg/day after 3-7 days interval & if needed, to max dose of 600 mg/day after an additional 7-day interval. Epilepsy Initially 150 mg/day, may increase to 300 mg/day after 1 wk. Max dose of 600 mg/day may be achieved after an additional wk. GAD Initially 150 mg/day, may increase to 300 mg/day after 1 wk then 450 mg/day following an additional wk. Max dose of 600 mg/day may be achieved after an additional wk. Fibromyalgia Recommended dose: 300-450 mg/day. Initially 75 mg bd, may increase to 150 mg bd w/in 1 wk based on efficacy & tolerability. If benefit is insufficient w/ 300 mg/day, may further increase to 225 mg bd. Renal impairment CrCl ≥60 mL/min Initially 150 mg/day bd-tds. Max: 600 mg/day, ≥30-<60 mL/min Initially 75 mg/day bd-tds. Max: 300 mg/day, ≥15 to <30 mL/min Initially 25-50 mg/day once daily to bd. Max: 150 mg/day, <15 mL/min Initially 25 mg once daily. Max: 75 mg/day. Patient receiving haemodialysis In addition to daily dose, immediately give supplementary dose following every 4 hr haemodialysis treatment. Supplementary dose: 25 mg single dose. Max: 100 mg.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Immediately discontinue use if angioedema symptoms (eg, facial, perioral or upper airway swelling) occur. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption. May need to adjust hypoglycaemic medications in diabetic patients who gain wt on pregabalin treatment. Possible dizziness & somnolence which may increase occurrence of accidental injury in elderly; loss of consciousness, confusion & mental impairment. Possible transient visual blurring & other visual acuity changes; discontinuation may result in resolution or improvement of these visual symptoms. Possible w/drawal symptoms after discontinuation of short-term & long-term treatment. Carefully evaluate patients for history of drug abuse & observe for signs of misuse or abuse (eg, tolerance development, dose escalation, drug-seeking behaviour). Possible renal function improvement following discontinuation or dose reduction. Severe CHF patients. Discontinue use if myopathy is diagnosed/suspected or markedly elevated creatine kinase levels occur in the context of myopathy symptoms. Possible suicidal ideation & behaviour; monitor & consider appropriate treatment for signs of suicidal ideation & behaviours. Risk of CNS depression when concomitantly used w/ opioids; monitor for symptoms of resp depression & sedation; consider initiating pregabalin at low dose. May influence ability to drive or use machines. Higher risk of severe AR (eg, serious resp depression) in patients w/ renal impairment. Use effective contraception in women of child-bearing potential. Pregnancy. Not recommended to breast-feed during treatment. Not recommended in childn & adolescents. Elderly patients may require dose reduction due to decreased renal function.
Adverse Reactions
Dizziness, somnolence. Nasopharyngitis; increased appetite; euphoric mood, confusion, irritability, depression, disorientation, insomnia, decreased libido; ataxia, abnormal coordination, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoesthesia, sedation, balance disorder, lethargy; blurred vision, diplopia; vertigo; vomiting, constipation, flatulence, abdominal distension, dry mouth; muscle cramp, arthralgia, back & limb pain, cervical spasm; peripheral oedema, oedema, abnormal gait, fall, drunk & abnormal feeling, fatigue; increased wt.
Drug Interactions
May potentiate effects of ethanol & lorazepam. Additive in cognitive & gross motor function impairment caused by oxycodone. Possible resp failure, coma & death when concomitantly taken w/ other CNS depressants including patients who are substance abusers. May reduce lower GI tract function (eg, intestinal obstruction, paralytic ileus, constipation) when co-administered w/ medications that have potential to produce constipation (eg, opioid analgesics).
MIMS Class
Anticonvulsants
ATC Classification
N02BF02 - pregabalin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.
Presentation/Packing
Form
Prega cap 150 mg
Packing/Price
30's
Form
Prega cap 25 mg
Packing/Price
30's
Form
Prega cap 75 mg
Packing/Price
30's
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