Pregabalin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Neuropathic pain Initial:150 mg/day, may increase up to 300 mg daily after a 3-7 days interval. Max: 600 mg/day after an additional 7 days interval. All doses to be given in 2-3 divided doses. Adjunct in partial seizures; Epilepsy Initial:150 mg/day, may increase up to 300 mg daily after 1 week. Max: 600 mg daily after an additional week. All doses to be given in 2 or 3 divided doses. Fibromyalgia Initial: 150 mg daily, may increase to 300 mg daily after 1 week. Max: 450 mg daily, if necessary. All doses to be given in 2 or 3 divided doses. Anxiety Initial: 150 mg daily, may increase in increments of 150 mg weekly. Max dose: 600 mg daily. All doses to be given in 2 or 3 divided doses.
Dosage Details
Oral
Adjunct in partial seizures, Epilepsy
Adult: Initially, 150 mg daily, may increase up to 300 mg daily after 1 week. Max: 600 mg daily after an additional week. All doses to be given in 2 or 3 divided doses. Adjust dose according to patient response and tolerability.

Oral
Fibromyalgia
Adult: Initially, 150 mg daily, may increase to 300 mg daily after 1 week. Max: 450 mg daily, if necessary. All doses to be given in 2 or 3 divided doses. Adjust dose according to patient response and tolerability.

Oral
Neuropathic pain
Adult: Initially, 150 mg daily, may increase up to 300 mg daily after a 3-7 day interval. Max: 600 mg daily after an additional 7 day interval. All doses to be given in 2 or 3 divided doses. Adjust dose according to patient response and tolerability.

Oral
Anxiety
Adult: Initially, 150 mg daily, may increase in increments of 150 mg weekly. Max dose: 600 mg daily. All doses to be given in 2 or 3 divided doses. Adjust dose according to patient response and tolerability.
Renal Impairment
Haemodialysis: Initially, 25mg daily. Max: 100 mg daily. Administered as a single supplementary dose.
CrCl Dosage
<15 Initially, 25 mg daily. Max: 75 mg daily. Administered as a single dose.
≥15-<30 Initially, 25-50 mg daily. Max: 150 mg daily. All doses given once daily or bid.
≥30-<60 Initially, 75 mg daily. Max: 300 mg daily. All doses given bid-tid.
 ≥60  Initially, 150 mg. Max: 600 mg. All doses given bid-tid.
Administration
May be taken with or without food.
Special Precautions
Patients with CV disease (including heart failure), history of angioedema episodes or substance abuse. Elderly. Renal impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity, peripheral oedema, dizziness, somnolence, visual disturbance, suicidal ideation, reduced platelet count, rhabdomyolysis, creatinine kinase elevations, weight gain, PR prolongation.
Blood and lymphatic system disorders: Neutropenia.
Cardiac disorders: Tachycardia, atrioventricular block first degree, sinus bradycardia, CHF.
Ear and labyrinth disorders: Vertigo, hyperacusis.
Eye disorders: Blurred vision, diplopia, peripheral vision loss, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, photopsia, dry eye, lacrimation increased, eye irritation.
Gastrointestinal disorders: Nausea, vomiting, constipation, diarrhoea, flatulence, abdominal distention, dry mouth, GERD, salivary hypersecretion, hypoaesthesia oral.
General disorders and administration site conditions: Oedema, abnormal gait, fatigue, pyrexia, thirst, chills, asthenia.
Hepatobiliary disorders: Elevated liver enzymes.
Metabolism and nutrition disorders: Appetite increased, anorexia, hypoglycaemia.
Musculoskeletal and connective tissue disorders: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm, joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness.
Nervous system disorders: Headache, ataxia, abnormal coordination, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy.
Psychiatric disorders: Euphoric mood, confusion, irritability, disorientation, insomnia, hallucination, panic attack, restlessness, agitation, aggression, mood swings, apathy.
Renal and urinary disorders: Urinary incontinence, dysuria.
Reproductive system and breast disorders: Erectile dysfunction, sexual dysfunction, delayed ejaculation, dysmenorrhoea, breast pain.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness.
Skin and subcutaneous tissue disorders: Rash papular, urticaria, hyperhidrosis, pruritus.
Vascular disorders: Hypotension, hypertension, flushing, peripheral coldness.
Potentially Fatal: Angioedema.
Patient Counseling Information
This drug may cause dizziness and somnolence, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor for signs of suicidal ideation and behaviour.
Overdosage
Symptoms: Somnolence, confusional state, agitation, restlessness, and seizures. Rarely, coma. Management: Symptomatic and supportive treatment. May be removed by haemodialysis. Consider administration of activated charcoal if ingestion is within 1 hour.
Drug Interactions
Additive CNS depressant effects with opiates (e.g. oxycodone) and benzodiazepines (e.g. lorazepam). May increase risk of angioedema with ACE inhibitors.
Food Interaction
May enhance CNS depressant effects of alcohol.
Action
Description: Pregabalin is an analog of the neurotransmitter GABA. It binds potently to the α2-δ 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.
Onset: Pain management: Noticeable effects on first 7 days of therapy.
Pharmacokinetics:
Absorption: Rapidly absorbed. Bioavailability: ≥90%. Time to peak plasma concentration: Within 1.5 hours.
Distribution: Volume of distribution: 0.5L/kg. Not bound to plasma protein.
Metabolism: Negligible metabolism.
Excretion: Mainly via urine (approx 98% as unchanged, minor metabolites). Half-life: Approx 6.3 hours.
Chemical Structure

Chemical Structure Image
Pregabalin

Source: National Center for Biotechnology Information. PubChem Database. Pregabalin, CID=5486971, https://pubchem.ncbi.nlm.nih.gov/compound/Pregabalin (accessed on Jan. 23, 2020)

Storage
Store between 15-30°C.
ATC Classification
N03AX16 - pregabalin ; Belongs to the class of other antiepileptics.
References
Anon. Pregabalin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/05/2019.

Anon. Pregabalin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/05/2019.

Buckingham R (ed). Pregabalin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/05/2019.

Joint Formulary Committee. Pregabalin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/05/2019.

Lyrica Capsule (Remedyrepack Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/05/2019.

Disclaimer: This information is independently developed by MIMS based on Pregabalin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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