Samjin

[Natrapharm]

Regulatory Class: Rx

C: Pregabalin

I: Adjunctive therapy in adult w/ partial seizures w/ or w/o secondary generalization. Generalized anxiety disorder (GAD) in adult.

D: Epilepsy Adult 150 mg/day in 2 or 3 divided doses. May be increased to 300 mg/day after an interval of 3-7 days. Max: 600 mg/day after an additional 7-day interval. GAD Adult 150-600 mg/day in 2 or 3 divided doses. Initially 150 mg/day, may be increased to 450 mg/day. Max: 600 mg/day after an additional 7 days. Renal impairment CrCl ≥60 mL/min Starting dose: 150 mg/day bid or tid, max: 600 mg/day bid or tid, ≥30 to <60 mL/min Starting dose: 75 mg/day bid or tid, max: 300 mg/day bid or tid, ≥15 to <30 mL/min Starting dose: 25-50 mg/day once daily or bid, max: 150 mg/day once daily or bid. CrCl <15 mL/min Starting dose: 25 mg once daily, max: 75 mg once daily. Supplementary dose following haemodialysis 25 mg as a single dose. Max: 100 mg as a single dose.

A: 

CI: Hypersensitivity.

SP: Hypersensitivity including angioedema. Increased risk if suicidal thoughts or behavior, worsening of depression &/or unusual changes in mood/behavior. Increased occurrence of accidental injury (fall) in elderly. Loss of vision, visual blurring or other changes of visual acuity; visual improvement upon discontinuation. Renal failure; CHF; diabetic patients. May have minor or moderate influence on the ability to drive or use of machinery. Not to be used during pregnancy. Not recommended during lactation. Adolescents 12-17 yr & childn <12 yr. Elderly >65 yr.

AR: Dizziness, somnolence. Increased appetite & wt; euphoric mood, confusion, irritability, decreased libido, disorientation, insomnia; ataxia, abnormal coordination, tremor, dysarthria, memory impairment, disturbance in attention, paraesthesia, sedation, balance disorder, lethargy, amnesia; blurred vision, dysgraphia; vertigo; vomiting, dry mouth, constipation, flatulence, abdominal distension; erectile dysfunction; abnormal gait, feeling drunk, fatigue, edema, peripheral edema.

INT: May potentiate the effects of ethanol & lorazepam. May cause resp failure & coma w/ other CNS depressant. Additive in the impairment of cognitive & gross motor function w/ oxycodone.

P/P: Cap 75 mg x 30's. 150 mg x 30's

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