Pigus

Pigus

pregabalin

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Pregabalin
Indications/Uses
Peripheral & central neuropathic pain in adults which includes diabetic peripheral neuropathy & post herpetic neuralgia. Adjunctive therapy in adults w/ partial seizures w/ or w/o secondary generalisation. Generalised anxiety disorder (GAD) in adults. Management of fibromyalgia.
Dosage/Direction for Use
Adult 150-600 mg/day given in 2 or 3 divided doses. Neuropathic pain Initially 150 mg/day given as 2 or 3 divided doses. May be increased to 300 mg/day after an interval of 3-7 days based on individual patient response & tolerability. Max dose: 600 mg/day after an additional 7-day interval, if needed. Epilepsy Initially 150 mg/day given as 2 or 3 divided doses. May be increased to 300 mg/day after a wk based on individual patient response & tolerability. Max dose: 600 mg/day may be achieved after an additional wk. GAD 150-600 mg/day given as 2 or 3 divided doses. Initially 150 mg/day. May be increased to 300 mg/day after 1 wk based on individual patient response & tolerability. Following an additional wk, dose may be increased to 450 mg/day. Max dose: 600 mg/day may be achieved after an additional wk. Management of fibromyalgia 300-450 mg daily. Initially 150 mg daily (75 mg bid). May be increased to 300 mg daily (150 mg bid) w/in 1 wk based on efficacy & tolerability. Max dose: 450 mg daily (225 mg bid). Renal impairment CrCl ≥60 mL/min Initially 150 mg/day. Max: 600 mg/day Dose regimen: Bid or tid; CrCl ≥30 to <60 mL/min Initially 75 mg/day. Max: 300 mg/day. Dose regimen: Bid or tid; CrCl ≥15 to <30 mL/min Initially 25-50 mg/day. Max: 150 mg/day. Dose regimen: Once daily or bid; CrCl <15 mL/min Initially 25 mg/day. Max: 75 mg/day. Dose regimen: Once daily. Supplementary dosage following haemodialysis Initially 25 mg/day. Max: 100 mg/day. Dose regimen: Single dose.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue use if angioedema symptoms eg, facial, perioral, or upper airway swelling occur. Diabetics. Dizziness, somnolence, loss of consciousness, confusion & mental impairment, & w/drawal symptoms may occur. Vision-related effects. Renal failure. W/drawal of concomitant antiepileptic drugs. Concomitant use w/ anti-spasticity agents in treatment of central neuropathic pain due to spinal cord injury. Monitor patients for signs of suicidal ideation & behaviours. Reduced lower GI tract function. History of substance abuse. Encephalopathy. CHF may occur in CV compromised elderly. May have minor or moderate influence on the ability to drive & use machines. Effective contraception must be used in women of childbearing potential. Pregnancy & lactation. Childn <12 yr & adolescents 12-17 yr. Elderly >65 yr.
Adverse Reactions
Dizziness, somnolence, headache. Nasopharyngitis; increased appetite; euphoric mood, confusion, irritability, decreased libido, disorientation, insomnia; ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy; blurred vision, diplopia; vertigo; vomiting, nausea, dry mouth, constipation, diarrhea, flatulence, abdominal distension; muscle cramp, arthralgia, back pain, pain in limb, cervical spasm; erectile dysfunction; gait abnormal, fall, feeling drunk, fatigue, peripheral oedema, feeling abnormal, oedema; increased wt.
Drug Interactions
May potentiate effects of ethanol & lorazepam. Resp failure & coma may occur w/ other CNS depressants. Additive in the impairment of cognitive & gross motor function caused by oxycodone.
MIMS Class
Anticonvulsants / Anxiolytics / Drugs for Neuropathic Pain
ATC Classification
N03AX16 - pregabalin ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Pigus hard cap 75 mg
Packing/Price
8 × 7's
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