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Pregabalin oral


Oral formulations containing pregabalin.

Drugs List

  • ALZAIN 100mg capsules
  • ALZAIN 150mg capsules
  • ALZAIN 200mg capsules
  • ALZAIN 225mg capsules
  • ALZAIN 25mg capsules
  • ALZAIN 300mg capsules
  • ALZAIN 50mg capsules
  • ALZAIN 75mg capsules
  • AXALID 100mg capsules
  • AXALID 150mg capsules
  • AXALID 200mg capsules
  • AXALID 225mg capsules
  • AXALID 25mg capsules
  • AXALID 300mg capsules
  • AXALID 50mg capsules
  • AXALID 75mg capsules
  • LYRICA 100mg capsules
  • LYRICA 150mg capsules
  • LYRICA 200mg capsules
  • LYRICA 20mg/ml oral solution
  • LYRICA 225mg capsules
  • LYRICA 25mg capsules
  • LYRICA 300mg capsules
  • LYRICA 50mg capsules
  • LYRICA 75mg capsules
  • pregabalin 100mg capsules
  • pregabalin 100mg tablets
  • pregabalin 150mg capsules
  • pregabalin 150mg tablets
  • pregabalin 200mg capsules
  • pregabalin 200mg tablets
  • pregabalin 20mg/ml oral solution sugar-free
  • pregabalin 225mg capsules
  • pregabalin 225mg tablets
  • pregabalin 25mg capsules
  • pregabalin 25mg tablets
  • pregabalin 300mg capsules
  • pregabalin 300mg tablets
  • pregabalin 50mg capsules
  • pregabalin 50mg tablets
  • pregabalin 75mg capsules
  • pregabalin 75mg tablets
  • Therapeutic Indications


    Epilepsy-partial seizures (adjunctive treatment)
    Neuropathic pain
    Treatment of generalised anxiety disorder (GAD)



    Dose ranges from 150mg to 600mg a day, given in 2 to 3 divided doses.

    Neuropathic Pain
    Initial dose: 150mg a day, given in 2 to 3 divided doses.
    Dose may be increased to 300mg a day after 3 to 7 days, based on individual response. Maximum daily dose of 600mg after an additional 7 day interval.

    Initial dose: 150mg a day, given in 2 to 3 divided doses.
    Dose may be increased to 300mg a day after 7 days, based on individual response. Maximum daily dose of 600mg after an additional 7 day interval.

    Generalised Anxiety Disorder (GAD)
    Initial dose: 150mg a day, given in 2 to 3 divided doses.
    Dose may be increased to 300mg a day after 7 days, based on individual response. After another 7 days dose may be increased further to 450mg a day. Maximum daily dose of 600mg after an additional 7 day interval.

    Patients with Renal Impairment

    Dosage reduction in patients with renal impairment should be individualised according to creatinine clearance:

    Creatinine clearance equal to or greater than 60ml/minute
    Starting dose 150mg a day, maximum daily dose 600mg.
    The daily dose may be administered twice or three times daily.

    Creatinine clearance 30 to 59ml/minute
    Starting dose 75mg a day, maximum daily dose 300mg.
    The daily dose may be administered twice or three times daily.

    Creatinine clearance 15 to 29ml/minute
    Starting dose 25mg to 50 mg a day, maximum daily dose 150mg.
    The daily dose may be administered once or twice daily.

    Creatinine clearance less than 15ml/minute
    Starting dose 25mg per day, maximum daily dose 75mg.
    The daily dose may be administered once daily.

    Supplementary dosage following every 4 hour haemodialysis session of 25mg to 100mg pregabalin administered as a single additional dose.


    Children under 18 years

    Precautions and Warnings

    Females of childbearing potential
    Suicidal ideation
    Cardiac disorder in the elderly
    Diabetes mellitus
    Glucose-galactose malabsorption syndrome
    History of drug misuse
    Lactose intolerance
    Neurological disorder
    Paralytic ileus
    Renal impairment - creatinine clearance below 60ml/minute
    Respiratory impairment

    Consider antidiabetic drug dosage in diabetic patients who gain weight
    Reduce dose in patients with creatinine clearance below 60ml/min
    Advise ability to drive/operate machinery may be affected by side effects
    Folic acid 5mg daily required pre-conception to end of 1st trimester
    Oral liquid contains hydroxybenzoate: caution in hypersensitivity
    Some formulations contain lactose
    Monitor for constipation; give laxatives as required
    Monitor for depressive disorders/suicidal ideation-consider discontinuation
    Monitor for signs of tolerance and dependence
    Potential for drug abuse
    Refer women considering pregnancy for specialist advice and monitoring
    Advise patient of potential side effects and risks associated with therapy
    Consider discontinuing if visual function deteriorates unexpectedly
    May cause convulsions
    May cause dependence
    Patient should be made aware of possible adverse effects on mood/behaviour
    Potential for withdrawal symptoms
    To discontinue, reduce dose gradually over at least 1-2 weeks
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if angioedema occurs
    Discontinue if renal failure develops
    Reduce dose in elderly
    Advise patient not to take St John's wort concurrently
    Advise that effects are potentiated by CNS depressants (including alcohol)
    Female: Ensure adequate contraception during treatment
    Advise patient of increased risk of falls
    Advise patient/carers to report signs of suicide ideation or behaviour

    Antiepileptic treatment is associated with a small increased risk of suicidal thoughts and behaviour; available data suggest that the increased risk applies to all antiepileptics and is seen as early as 1 week after staring treatment. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for pregabalin.

    The available evidence does not define whether the risk of suicidal thoughts and behaviour differs between antiepileptics. Patients should not stop or switch treatment on the basis of this information and without speaking to a healthcare professional.

    There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin. These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication. Pregabalin should be used with caution in these patients, and discontinuation may resolve the reaction.

    There are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics. When pregabalin and opioids are used in combination, measures to prevent constipation may be considered (especially in female patients and elderly).

    Visual disturbances may occur with pregabalin, which should resolve or improve upon discontinuation. These may include: visual blurring, visual acuity reduction, visual field changes, fundoscopic changes or loss of vision.

    Discontinuation of concurrent antiepileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, is not recommended due to insufficient data. There is no experience of monotherapy with pregabalin.

    Concerning discontinuation of short or long term treatment, there is no data on the incidence and severity of withdrawal symptoms in relation to duration of use or dosage of pregabalin.

    The incidence of general adverse effects, central nervous system adverse reactions and especially somnolence, may be increased in patients with spinal cord injury being treated for central neuropathic pain. This may be attributed to an additive effect due to concomitant medicinal products needed for this condition. This should be considered when prescribing pregabalin in this condition.

    Severe respiratory depression has been reported with the use of pregabalin. Dose adjustment may be necessary in patients at higher risk of developing severe respiratory depression including patients with respiratory impairment, respiratory disorder, neurological disorder, renal impairment, elderly patients and concomitant use with CNS depressants.

    Pregnancy and Lactation


    Use pregabalin with caution during pregnancy.

    The manufacturer does not recommend using pregabalin during pregnancy. Pregabalin should only be used if the benefit to the mother clearly outweighs the potential risk to the foetus. There is no adequate data on the use of pregabalin in human pregnancy. It is not known whether it crosses the placenta, but the low molecular weight, minimal metabolism, lack of protein binding and moderately long elimination half life are consistent with embryo/foetal transfer (Briggs 2015). Some studies have shown a higher risk for major congenital malformations in the first trimester among the paediatric population compared to the unexposed population.

    Animal studies have shown some reproductive toxicity, mainly skeletal abnormalities and neural tube defects. Reproduction studies in rats found developmental toxicity (growth retardation, behavioural defects, death) at doses from 10 times the human exposure at the maximum recommended dose, and pregabalin was found to be carcinogenic in mice.

    Schaefer (2015) concludes that there is insufficient experience to allow for an accurate risk assessment. Exposure does not require termination, but a detailed ultrasound diagnosis should be conducted in the second trimester as an additional preventative measure. Briggs agrees that since the available data suggest a potential for toxicity, the best course is to avoid use until more experience is available.

    However, adjusting or stopping any anti-epileptic medication during pregnancy should not be done without specialist advice, and the relative benefits and risks should be discussed carefully first. The risk of inadequate seizure control may be more detrimental to the foetus than the use of antiepileptic drugs. Pregnancy in epileptic women is associated with a higher risk of congenital abnormalities, which are mainly associated with the use of anti-epileptic drugs rather than the disease itself. This risk is increased when multiple drugs are used. Routine monitoring of antiepileptic drugs is not recommended, but may be useful in cases where seizures have increased or are likely to, in order to plan the extent of dose adjustment needed. The Clinical Knowledge Summaries recommend that folic acid 5 mg daily should be prescribed to all women with epilepsy who are taking antiepileptic drugs, prior to conception and continued until the 12th week of pregnancy.


    Use pregabalin with caution during breastfeeding.

    The manufacturers suggest that pregabalin can be used in breastfeeding if the benefit to the mother or infant is deemed acceptable versus the lack of data. Pregabalin is excreted into human milk but the effects of exposure on the nursing infant are unknown. LactMed also says that very limited data indicate that amounts of pregabalin in breast milk are low. If pregabalin is required by the mother of an older infant, it is not a reason to discontinue breastfeeding, but until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. Though Briggs (2015) concludes that it should not be used during breastfeeding as it has been found to be carcinogenic in long-term studies in mice, which, coupled with the lack of excretion data and potential for serious toxicity.


    Advise patients not to use products containing St John's Wort with pregabalin.

    Patients should be advised to consult their physician if they are planning a pregnancy, and consider taking folic acid 5mg daily before conception.

    Patients and caregivers should be aware of the need to monitor for the emergence of suicidal thoughts and behaviour, and the need to seek medical advice immediately if they present.

    Pregabalin may cause dizziness and somnolence and therefore may influence the ability to drive or operate machinery. Patients should be advised to refrain from hazardous activities until their susceptibility is known.

    Advise patients that withdrawal symptoms such as insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, sweating and dizziness have been reported after discontinuation of pregabalin treatment.

    Side Effects

    Alanine aminotransferase increased
    Allergic reaction
    Aspartate aminotransferase increased
    Attention disturbances
    Blood dyscrasias
    Blood glucose disturbances
    Blurred vision
    Breast changes
    Burning sensation
    Cervical muscle spasm
    Changes in blood chemistry
    Changes in libido
    Chest tightness
    Cognitive impairment
    Congestive cardiac failure
    Creatine phosphokinase increased
    Disturbances of appetite
    Dream abnormalities
    Eye disorder
    First degree AV block
    Gait abnormality
    Gastroesophageal reflux
    Gastrointestinal disorder
    Hot flushes
    Hypersensitivity reactions
    Impaired co-ordination
    Impaired memory
    Impairment of mental skills
    Influenza-like syndrome
    Joint swelling
    Loss of consciousness (transient)
    Menstrual disturbances
    Mood changes
    Muscle cramps
    Muscle disorders
    Nasal congestion
    Nasal dryness
    Prolongation of QT interval
    Psychomotor hyperactivity
    Renal failure
    Sexual dysfunction
    Speech disturbances
    Stevens-Johnson syndrome
    Suicidal tendencies
    Throat tightness
    Urinary abnormalities
    Visual disturbances
    Weight changes


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last full review date: January 2017

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Axalid capsules. Kent Pharmaceuticals Limited. Revised October 2016.
    Summary of Product Characteristics: Lyrica capsules. Pfizer Ltd. Revised November 2022.
    Summary of Product Characteristics: Lyrica oral solution. Pfizer Ltd. Revised March 2021.
    Summary of Product Characteristics: Pregabalin capsules. Consilient Health Limited. Revised December 2014.
    Summary of Product Characteristics: Pregabalin tablets. Neuraxpharm Arzneimittel GmbH. Revised January 2019.

    Clinical Knowledge Summaries - Epilepsy
    Available at:
    Last accessed: 20 January 2017

    MHRA Drug Safety Update April 2019
    Available at:
    Last accessed: 03 May 2019

    MHRA Drug Safety Update Vol 2, Issue 1, August 2008
    Antiepileptics: risk of suicidal thoughts and behaviour
    Available at:
    Last accessed: 20 January 2017

    NICE clinical guideline - The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
    Available at:
    Last accessed: 20 January 2017

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Pregabalin Last revised: 11 October 2016
    Last accessed: 20 January 2017

    NICE Evidence Services Available at: Last accessed: 23 January 2020

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