Pregabalin Sandoz

Pregabalin Sandoz

pregabalin

Manufacturer:

Sandoz

Distributor:

Zuellig
Concise Prescribing Info
Contents
Pregabalin
Indications/Uses
Treatment of peripheral & central neuropathic pain in adults. Adjunctive therapy in adults w/ partial seizures w/ or w/o secondary generalisation. Generalised anxiety disorder (GAD) in adults.
Dosage/Direction for Use
150-600 mg/day given in either 2 or 3 divided doses. Neuropathic pain Initially 150 mg/day given in 2 or 3 divided doses, may be increased to 300 mg/day after an interval of 3-7 days, & if needed, to a max dose of 600 mg/day after an additional 7-day interval. Epilepsy Initially 150 mg/day given in 2 or 3 divided doses, may be increased to 300 mg/day after 1 wk. Max: 600 mg/day may be achieved after an additional wk. GAD Initially 150 mg/day, may be increased to 300 mg/day after 1 wk. Following an additional wk, dose may be increased to 450 mg/day. Max: 600 mg/day may be achieved after an additional wk. Renal impairment, CrCl ≥60 mL/min Initially 150 mg/day in 2 or 3 divided doses. Max: 600 mg/day, CrCl ≥30 to <60 mL/min Initially 75 mg/day in 2 or 3 divided doses. Max: 300 mg/day, CrCl ≥15 to <30 mL/min Initially 25-50 mg/day once daily or in 2 divided doses. Max: 150 mg/day, CrCl <15 mL/min Initially 25 mg/day once daily. Max: 75 mg/day. Supplementary dose following haemodialysis Initially 25 mg as a single dose. Max: 100 mg/day. Hepatic impairment No dose adjustment. Elderly >65 yr May require dose reduction.
Administration
May be taken with or without food.
Special Precautions
Diabetic patients. Hypersensitivity reactions. Reports of loss of consciousness, confusion & mental impairment; blurred vision; withdrawal symptoms; CHF mostly seen in elderly CV compromised patients for a neuropathic indication; suicidal ideation & behaviour; reduced lower GI tract function when co-administered w/ medications that have potential to produce constipation. Insufficient data for withdrawal of concomitant antiepileptic medicinal products. Increased incidence of CNS adverse events especially somnolence in the treatment of central neuropathic pain due to spinal cord injury. Cases of renal failure; misuse, abuse & dependence; encephalopathy. Minor or moderate influence on the ability to drive & use machines. Women of childbearing potential must use effective contraception. Pregnancy & lactation. Childn <12 yr & adolescents 12-17 yr. Elderly.
Adverse Reactions
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; vertigo; vomiting, nausea, diarrhoea, dry mouth, constipation, flatulence, abdominal distension; muscle cramp, arthralgia, back pain, pain in limb, cervical spasm; erectile dysfunction; oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue; wt increased.
Drug Interactions
May potentiate the effects of ethanol & lorazepam. Reports of resp failure & coma w/ other CNS depressants. Additive effect in the impairment of cognitive & gross motor function caused by oxycodone.
ATC Classification
N03AX16 - pregabalin ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Pregabalin Sandoz cap 150 mg
Packing/Price
56's
Form
Pregabalin Sandoz cap 25 mg
Packing/Price
56's
Form
Pregabalin Sandoz cap 75 mg
Packing/Price
56's
Form
Pregabalin Sandoz cap 300 mg
Packing/Price
56's
Form
Pregabalin Sandoz cap 50 mg
Packing/Price
56's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in