Balentin

Balentin

pregabalin

Manufacturer:

Millimed

Distributor:

Prosp Pharma

Marketer:

Prosp Pharma
Concise Prescribing Info
Contents
Pregabalin
Indications/Uses
Central & peripheral neuropathic pain including diabetic peripheral neuropathy & post herpetic neuralgia. Generalized anxiety disorder in adults. Management of fibromyalgia. Adjunctive therapy in epilepsy in adults w/ partial seizures w/ or w/o secondary generalization.
Dosage/Direction for Use
150-600 mg/day in 2 or 3 divided doses. Neuropathic pain Initially 150 mg/day, may be increased to 300 mg/day after an interval of 3-7 days. Max: 600 mg/day after an additional 7-day interval if needed. Epilepsy Initially 150 mg/day, may be increased to 300 mg/day after 1 wk. Max: 600 mg/day after an additional wk. Generalized anxiety disorder Initially 150 mg/day, may increase to 300 mg/day after wk 1. May further increase to 450 mg/day after an additional wk. Max: 600 mg/day after an additional wk. Fibromylagia 300-450 mg/day in 2 divided doses. Initially 75 mg bid, may be increased to 150 mg bid w/in 1 wk. May further increase to 225 mg bid. Max: 600 mg/day after an additional wk. Patients w/ renal impairment CrCl <15 Initially 25 mg/day single daily dose. Max: 75 mg/day single daily dose, CrCl ≥15 to <30  Initially 25-50 mg daily or bid. Max dose: 150 mg daily or bid, CrCl ≥30 to <60 Initially 75 mg/day bid or tid. Max: 300 mg/day bid or tid, CrCl ≥60 Initially 150 mg/day bid or tid. Max dose: 600 mg/day bid or tid. Hemodialysis Initially 25 mg as a single dose. Max dose: 100 mg as total daily dose.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue if hypersensitivity reactions occur. Monitor patient for notable changes in behavior that might indicate suicidal thoughts or depression. History of angioedema episodes. Concomitant use w/ other drugs that may cause angioedema eg, ACE inhibitors & thiazolidinediones (especially in patients w/ prior CVD). Discontinue treatment if angioedema, myopathy or elevated creatine kinase levels occurs. May cause wt gain. Patients w/ heart failure (NYHA Class III or IV). May decrease platelet count or prolong PR interval. Avoid abrupt w/drawal. History of substance abuse. Renal & hepatic impairment. May cause blood cells disorder. Should not operate vehicles or machinery. Pregnancy & lactation.
Adverse Reactions
Chest pain, edema, facial edema, HTN, hypotension, peripheral edema, prolonged PR interval on ECG; abnormal gait, abnormality in thinking, amnesia, anorgasmia, anxiety, ataxia, confusion, depersonalization, disorientation, attention disturbance, dizziness, drowsiness, equilibrium disturbance, euphoria, fatigue, feeling abnormal, headache, hypertonia, hypoesthesia, insomnia, intoxicated feeling, lethargy, memory impairment, myasthenia, nervousness, neuropathy, pain, paresthesia, sedation, speech disturbance, stupor, twitching (includes myokymia), vertigo; contact dermatitis, decubitus ulcer, ecchymoses, pruritus; decreased libido, fluid retention, hypoglycemia, wt gain; abdominal distension/pain, constipation, diarrhea, flatulence, gastroenteritis, increased appetite, nausea, viral gastroenteritis, vomiting, xerostomia; erectile dysfunction, impotence, urinary frequency/incontinence, UTI; thrombocytopenia; increased serum ALT/AST; arthralgia, back/neck pain, increased creatine phosphokinase, joint swelling, limb pain, leg cramps, muscle spasm, myalgia, tremor, weakness; blurred vision, conjunctivitis, decreased visual acuity/disturbance/field loss, diplopia, eye disease, nystagmus; otitis media, tinnitus; bronchitis, cough, dyspnea, flu-like symptoms, nasopharyngitis, pharyngolaryngeal pain, resp tract infection, sinusitis; accidental injury, fever.
Drug Interactions
Concomitant use w/ azelastine (nasal), bromperidol, orphenadrine, oxomemazine, paraldehyde, thalidomide. May increase the level/effects of alcohol (ethyl), azelastine (nasal), blonanserin, buprenorphine, CNS depressants, flunitrazepam, hydrocodone, methotrimeprazine, metyrosine, mirtazapine, opioid analgesics, orphenadrine, oxycodone, paraldehyde, piribedil; pramipexole, ropinirole, rotigotine, SSRIs, suvorexant, thalidomide, thiazolidinediones, zolpidem. Levels/effects may be increased by ACE inhibitors, brimonidine (topical), bromperidol, cannabis, chlormethiazole, chlorphenesin carbamate, dimethindene (topical), doxylamine, dronabinol, droperidol, hydroxyzine, kava kava, lofexidine, Mg sulfate, methotrimeprazine, minocycline, nabilone, oxomemazine, perampanel, rufinamide, Na oxybate, tapentadol, tetrahydrocannabinol, trimeprazine. Level/effect may be decreased by mefloquine, mianserin, orlistat.
MIMS Class
Anticonvulsants / Anxiolytics / Drugs for Neuropathic Pain
ATC Classification
N03AX16 - pregabalin ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Balentin 150 mg cap
Packing/Price
4 × 14's
Form
Balentin 75 mg cap
Packing/Price
4 × 14's
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