Zylin 75

Pregabalin

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

150-600 mg daily in 2 or 3 divided doses. 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. GAD Initially 150 mg daily. May be increased to 300 mg daily after 1 wk & may further increase to 450 mg daily following an additional wk. Max: 600 mg daily after an additional wk. Fibromyalgia Usual dose: 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 further increase to 225 mg bid (450 mg daily). Max: 600 mg daily after an additional wk. Epilepsy Initially 150 mg daily. May be increased to 300 mg daily after 1 wk. Max: 600 mg daily after an 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 in 2 or 3 divided doses. Max: 300 mg daily, ≥15 to <30 mL/min Initially 25-50 mg daily in single or 2 divided doses. Max: 150 mg daily, <15 mL/min Initially 25 mg daily in single dose. Max: 75 mg daily. Patients receiving hemodialysis Initially 25 mg daily. Max: 100 mg daily. Administer single supplementary dose following every 4-hr hemodialysis.

May be taken with or without food.

Hypersensitivity.

Discontinue treatment if symptoms of hypersensitivity reactions including skin redness, blisters, hives, rash, dyspnea & wheezing; angioedema develop; marked elevations of creatine kinase occur, or if myopathy is suspected or diagnosed. Discontinue treatment or coadministered CNS depressants in serious, life-threatening, or fatal resp depression w/ or w/o coadministration of CNS depressants (eg, opioids) or in patients w/ underlying resp impairment. W/draw gradually by tapering dose over at least 1 wk when discontinuing therapy. Syncope, impaired psychomotor, ataxia. NYHA class III & IV CHF. Increased risk of peripheral edema. PR interval prolongation; wt gain; thrombocytopenia; angioedema, including life-threatening cases. Reduced visual acuity, visual field changes & blurred vision. Suicidal ideation & behavior, worsening of depression & unusual changes in mood or behavior. W/drawal seizure & insomnia, nausea, headache, anxiety, hyperhidrosis & diarrhea may be precipitated by abrupt discontinuation. Avoid concomitant use of ≥3 CNS active agents in any combination; opioids. Concomitant use w/ thiazolidinediones; medications associated w/ angioedema eg, ACE inhibitors. Renal impairment (CrCl <60 mL/min). Effective contraception must be used in women of childbearing potential. Pregnancy. Not recommended in lactation. Significant dizziness & somnolence or sedation including lethargy, sluggishness & hypersomnia in patients <4 yr. Ped patients <12 yr. Not recommended in childn. Elderly >65 yr. Avoid use in older adults w/ history of falls or fractures.

Peripheral edema; increased appetite, wt gain; constipation, nausea, xerostomia; asthenia, ataxia, dizziness, headache, incoordination, somnolence, tremor; diplopia; disturbance in thinking, euphoria; nasopharyngitis; fatigue.

Avoid concomitant use w/ nasal azelastine, bromperidol, orphenadrine, oxomemazine, paraldehyde, thalidomide. Increased levels/effects of ethyl alcohol, nasal azelastine, blonanserin, buprenorphine, CNS depressants, flunitrazepam, hydrocodone, methotrimeprazine, metyrosine, mirtazapine, opioid analgesics, orphenadrine, oxycodone, paraldehyde, piribedil, pramipexole, ropinirole, rotigotine, SSRIs, suvorexant, thalidomide, thiazolidinediones, zolpidem. Increased levels/effects w/ alizapride, ACE inhibitors, topical brimonidine, bromopride, bromperidol, cannabidiol, cannabis, chlormethiazole, chlorphenesin, carbamate, topical dimethindene, doxylamine, dronabinol, droperidol, hydroxyzine, kava kava, lofexidine, Mg sulfate, methotrimeprazine, minocycline, nabilone, oxomemazine, perampanel, rufinamide, Na oxybate, tapentadol, tetrahydrocannabinol, tetrahydrocannabinol & cannabidiol, trimeprazine. Decreased levels/effects w/ mefloquine, mianserin, orlistat.

Anxiolytics / Drugs for Neuropathic Pain / Anticonvulsants

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

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