Pregaben CR 82.5

Anxiety, Fibromyalgia, Post herpetic Neuralgia, Partial seizures, Pain from diabetic neuropathy, Neuropathic pain associated with spinal cord injury

May be taken with or without food.

Oral Neuropathic pain, Postherpetic Neuralgia Adult: Initially, 150 mg/day, may increase to 300 mg/day after 3-7 days. Max: 600 mg/day after a 7-day interval. All doses to be given in 2 or 3 divided doses. Diabetic Peripheral Neuropathic Pain Initial: 50 mg PO q8hr Maintenance: May increase to 100 mg PO q8hr within 1 week, as needed; not to exceed 300 mg/day Adjunct in partial seizures Adult: Initially, 150 mg/day, may increase to 300 mg/day after a wk. Max: 600 mg/day. All doses to be given in 2 or 3 divided doses. Fibromyalgia Adult: Initially, 150 mg/day, may increase to 300 mg/day after a wk. Max: 450 mg/day, if needed. All doses to be given in 2 or 3 divided doses.

Safety and efficacy not established

Renal impairment: Haemodialysis: 25-100 mg immediately after each 4-hr haemodialysis session. CrCl (ml/min) Dosage Recommendation 30 to <60 75 mg/day. Max: 300 mg/day. All doses to be given in 2 or 3 divided doses. 15 to <30 Initially, 25-50 mg/day. Max: 150 mg/day. All doses to be given as a single dose or in 2 divided doses. <15 Initially, 25 mg/day. Max: 75 mg/day. All doses to be given as a single dose.

Hypersensitivity. Pregnancy, lactation. Driving or working with machines, or do other dangerous activities.

Pregabalin is an analog of the neurotransmitter GABA. It binds potently to the alpha2-delta subunit resulting in modulation of Ca channels and reduction in the release of several neurotransmitters, including glutamate, norepinephrine, serotonin, dopamine, calcitonin gene-related peptide and substance P.

Abrupt or rapid discontinuation of Pregabalin may produce some symptoms including insomnia, nausea, headache and diarrhoea. So Pregabalin should be tapered gradually over a minimum of 1 week rather than discontinued abruptly. Pregabalin treatment may associate with creatine kinase elevations. It should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur. Discontinue treatment if patients develop severe angioedema. Regular vision check is recommended. May decrease platelet count and prolong PR interval. Patient w/ history of angioedema episodes, severe CV disease, renal impairment. Pregnancy and lactation. Patient Counselling May impair ability to drive, operate machinery or engage in hazardous activities. Monitoring Parameters Monitor visual disturbances. Closely observe for clinical worsening, suicidality and unusual changes in behaviour. Suicidal thoughts or behaviors Antiepileptic drugs increase risk of suicidal thoughts or behavior in patients taking these drugs for any indication; monitor for emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior Inform patients, their caregivers, and families of the increase the risk of suicidal thoughts and behavior; advise to be alert for the emergence or worsening of signs and symptoms Angioedema Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported during initial and chronic treatment, including reports of life-threatening angioedema with respiratory compromise requiring emergency intervention If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, discontinue therapy and institute appropriate therapy immediately Coadministration of ACE inhibitors or mTOR (mammalian target of rapamycin) inhibitors (eg, temsirolimus, sirolimus, everolimus), or previous history of angioedema may increase risk Lactation: Unknown if excreted in milk; not recommended

>10% Dizziness (8-45%),Somnolence (4-36%),Peripheral edema (16%),Ataxia (1-20%),Fatigue (5-11%),Xerostomia (1-15%),Weight gain (16%),Tremor (11%),Blurred vision (1-12%),Diplopia (12%) 1-10% Asthenia (5%),Edema (8%),Facial edema (<3%),Hypotension (2%),Neuropathy (2-9%),Pain (5%),Disorientation (<2%),Constipation (5%),Weight gain (4%),Accidental injury (4%),Abnormal thinking (2%),Confusion (<7%),Amnesia (<6%),Vertigo (1-4%),Hypoesthesia (2-3%),Euphoria (2%),Decreased libido (>1%),Incoordination (2%),Vomiting (1-3%),Balance disorder (2-9%),Myoclonus (4%),Nasopharyngitis pain (1-3%),Flu-like syndrome (1-2%) <1% Addiction,Anemia,Diarrhea,Gynecomastia and breast enlargement,Epididymitis,Esophagitis,Dysmenorrhea,Dystonia,Heart failure,Hirsutism,Uveitis <0.1% Neutropenia, first degree heart block, hypotension, hypertension, pancreatitis, dysphagia, oliguria, rhabdomyolysis, suicidal thoughts or behavior

May potentiate the effects of lorazepam. Additive CNS depressant effects w/ opiates and benzodiazepines. May increase risk of angioedema w/ ACE inhibitors. May increase risk of wt gain and peripheral oedema w/ thiazolidinediones.