Neurica

Pregabalin

Central & peripheral neuropathic pain in adults including diabetic peripheral neuropathy & post-herpetic neuralgia. Generalized anxiety disorder (GAD) in adults. Adjunctive therapy in adults w/ partial seizures w/ or w/o secondary generalization. Management of fibromyalgia.

Neuropathic pain Initially 150 mg daily. May be increased to 300 mg daily after 3-7 days interval. Max: 600 mg daily after additional 7-day interval. Epilepsy Initially 150 mg daily. May be increased to 300 mg daily after 1 wk. Max: 600 mg daily after additional wk. GAD Dose range: 150-600 mg daily in 2 or 3 divided doses. Initially 150 mg daily. May be increased to 300 mg daily after 1 wk, then further increased to 450 mg daily following additional wk. Max: 600 mg daily after additional wk. Fibromyalgia Dose range: 300-450 mg daily in 2 divided doses. Initially 75 mg bid (150 mg daily). May be increased to 150 mg bid (300 mg daily) w/in 1 wk. May be further increased to 225 mg bid (450 mg daily) in patients who do not experience sufficient benefit w/ 300 mg daily. Max: 600 mg daily after additional wk. Renal impairment CrCl ≥60 mL/min Initially 150 mg daily in 2 or 3 divided doses. Max: 600 mg daily, ≥30 to <60 mL/min Initially 75 mg daily in 2 or 3 divided doses. Max: 300 mg daily, ≥15 to <30 mL/min Initially 25-50 mg once daily or in 2 divided doses. Max: 150 mg daily, <15 mL/min Initially 25 mg once daily. Max: 75 mg daily. Supplementary dose following hemodialysis Initially 25 mg as single additional dose. Max: 100 mg. Give immediately following every 4-hr hemodialysis treatment.

May be taken with or without food.

Hypersensitivity.

Discontinue treatment immediately in patients w/ symptoms of angioedema including swelling of face, mouth (eg, tongue, lips, gums) & neck (eg, throat, larynx); hypersensitivity reactions (ie, skin redness, blisters, hives, rash, dyspnea, wheezing); if myopathy is diagnosed or suspected or if elevated creatine kinase, creatine phosphokinase conc occur. May cause hematologic disorder; dizziness & somnolence at higher doses; wt gain & peripheral edema in concomitant use w/ thiazolidinediones. Increased risk of angioedema in patients receiving ACE inhibitors; suicidal behavior or ideation especially in patients w/ epilepsy. Serious, life threatening, or fatal resp depression in combination w/ opiate analgesics, other CNS depressants (eg, benzodiazepine) or underlying resp impairment. Increased seizure frequency & physical dependence or w/drawal symptoms (eg, insomnia, nausea, headache, anxiety, hyperhidrosis, diarrhea) in abrupt or rapid treatment discontinuance. Possible carcinogenicity (eg, hemangiosarcoma). Thrombocytopenia w/ platelet count <150,000/mm³ & 20% below baseline value; severe thrombocytopenia w/ platelet count <20,000/mm³. PR interval prolongation. Patients w/ previous episode of angioedema; NYHA class III or IV heart failure. Closely monitor patients for emergence or worsening of suicidal thoughts or behavior, or depression; resp depression & sedation. Manage resp depression through supportive measures, reduction or w/drawal of treatment. Consider ophthalmologic assessment if visual disturbance persists. Carefully evaluate patients for history of drug abuse & observe for signs of misuse or abuse (eg, development of tolerance, dose escalation, drug-seeking behavior). Not to be taken in patients w/ lactose intolerance. May impair ability to drive or use machines. Liver or kidney disease. Patients undergoing hemodialysis. May cause teratogenesis. Not to be used during pregnancy. Not recommended during lactation. Not recommended in childn. Ped patient (<12 yr) & adolescent (12-17 yr).

Peripheral edema; wt gain; xerostomia; dizziness, drowsiness, fatigue, headache; blurred vision, visual field loss. Chest pain, edema, facial edema, HTN, hypotension; contact dermatitis, ecchymoses, pressure ulcer; decreased libido, fluid retention, hypoglycemia; abdominal distension & pain, constipation, diarrhea, flatulence, gastroenteritis, increased appetite, nausea, sialorrhea, viral gastroenteritis, vomiting; erectile dysfunction, impotence, urinary frequency & incontinence, UTI; thrombocytopenia (including severe thrombocytopenia); increased serum ALT & AST; hypersensitivity reaction; infection, viral infection; abnormal gait, thinking abnormality, amnesia, anorgasmia, ataxia, balance & memory impairment, confusion, depersonalization, disorientation, attention & speech disturbance, euphoria, feeling abnormal & intoxicated, hypertonia, hypoesthesia, insomnia, lethargy, myasthenia, nervousness, neuropathy, pain, paresthesia, sedated state, stupor, twitching (including myokymia), vertigo; arthralgia, asthenia, increased creatine phosphokinase in blood specimen, joint swelling, lower limb cramp, muscle spasm, tremor; conjunctivitis, decreased visual acuity, diplopia, eye disease, nystagmus disorder, visual disturbance; otitis media, tinnitus; bronchitis, dyspnea, flu-like symptoms, nasopharyngitis, pharyngolaryngeal pain, pneumonia, resp tract infection, sinusitis; accidental injury, fever. SJS, TEN, DRESS.

Reduced lower GIT function (eg, intestinal obstruction, paralytic ileus, constipation) w/ drugs causing constipation eg, opiate analgesics. Potential risk of developing angioedema w/ ACE inhibitors. May increase risk of wt gain & peripheral edema possibly exacerbating or causing heart failure w/ thiazolidinediones. Additive CNS & resp depressant effects w/ CNS depressants including opiates & benzodiazepines. Decreased systemic exposure w/ erythromycin. Additive effects on cognitive & gross motor functioning w/ alcohol, lorazepam & oxycodone.

Anticonvulsants / Anxiolytics / Drugs for Neuropathic Pain

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

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