Pregabalin Actavis

Pregabalin

Treatment of peripheral & central neuropathic pain in adults. Adjunctive therapy in adults w/ partial seizures w/ or w/o secondary generalisation. Treatment of generalised anxiety disorder in adults. Management of fibromyalgia.

Dose range: 150-600 mg daily, given in either 2 or 3 divided doses. Neuropathic pain Initially 150 mg daily in 2 or 3 divided doses, may be increased to 300 mg daily after an interval of 3-7 days, & if needed, to a max dose 600 mg daily after an additional 7-day interval. Epilepsy Initially 150 mg daily in 2 or 3 divided doses, may be increased to 300 mg daily after 1 wk based on patient response & tolerability. May be increased to max 600 mg daily after an additional wk. Generalised anxiety disorder Initially 150 mg daily in 2 or 3 divided doses, may be increased to 300 mg daily after 1 wk based on patient response & tolerability. May be further increased to 450 mg daily following an additional wk, then to max 600 mg daily after an additional wk. Fibromyalgia Recommended dose: 300-450 mg daily. Initially 75 mg bd, may be increased to 150 mg bd w/in 1 wk based on efficacy & tolerability. May be further increased to 225 mg bd.

May be taken with or without food.

Hypersensitivity.

Some diabetic patients who gain wt on pregabalin treatment may need to adjust hypoglycaemic medicinal products. Associated w/ dizziness & somnolence. Reports of hypersensitivity reactions, including cases of angioedema; loss of consciousness, confusion, & mental impairment; visual adverse reactions including loss of vision, visual blurring or other changes of visual acuity; renal failure; CHF mostly seen in elderly CV compromised patients during pregabalin treatment for a neuropathic indication; severe resp depression; suicidal ideation & behaviour; reduced lower GIT function (eg, intestinal obstruction, paralytic ileus, constipation) when co-administered w/ medications that have the potential to produce constipation eg, opioid analgesics; cases of misuse, abuse & dependence; encephalopathy mostly in patients w/ underlying conditions that may precipitate encephalopathy. Insufficient data for the w/drawal of concomitant anti-epileptic medicinal products, once seizure control w/ pregabalin in the add-on situation has been reached. Risk of w/drawal symptoms. Gradually discontinue treatment over a min of 1 wk. Convulsions, including status epilepticus & grand mal convulsions, may occur during pregabalin use or shortly after discontinuing. Increased incidence of adverse reactions in the treatment of central neuropathic pain due to spinal cord injury. Monitor patients for signs of suicidal ideation & behaviours. Monitor patients for symptoms of pregabalin misuse, abuse or dependence. Risk of CNS depression w/ concomitant opioids. Minor or moderate influence on the ability to drive & use machines. Patients w/ renal impairment. Effective contraception must be used in women of childbearing potential. Should not be used during pregnancy unless clearly necessary. Discontinue breast-feeding while on treatment or discontinue pregabalin therapy during breast-feeding. Safety & efficacy in childn <12 yr & in adolescents 12-17 yr have not been established. Elderly.

Dizziness, somnolence, headache. Nasopharyngitis; increased appetite; euphoric mood, confusion, irritability, disorientation, insomnia, decreased libido; ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoesthesia, sedation, balance disorder, lethargy; blurred vision, diplopia; vertigo; vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth; muscle cramp, arthralgia, back pain, pain in limb, cervical spasm; erectile dysfunction; peripheral oedema, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue; increased wt.

Potentiated effects of ethanol & lorazepam. Reports of resp failure, coma & death w/ opioids &/or other CNS depressants. Additive effect in the impairment of cognitive & gross motor function caused by oxycodone.

Anticonvulsants / Anxiolytics

N02BF02 - pregabalin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.

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