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Pregabalin Uses, Dosage, Side Effects & Warnings | DrugsAtlas

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Therapeutic Class

Anticonvulsant / Neuropathic Pain Agent

Subclass

Alpha-2-delta Calcium Channel Ligand

Speciality

Neurology

Schedule (India)

Schedule H

Routes

Oral

Formulations

Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 300 mg
Oral solution: 20 mg/mL (limited availability)
Sustained-release tablets: 75 mg, 150 mg (limited availability)

Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Peripheral Neuropathic Pain (Diabetic Peripheral Neuropathy, Post herpetic Neuralgia)

Parameter	Dose
Starting dose	75 mg orally twice daily (OR 50 mg three times daily)
Titration	Increase to 150 mg twice daily after 3–7 days based on response and tolerability; further increase to 300 mg twice daily after 2–4 weeks if needed
Usual maintenance dose	150–300 mg/day in 2–3 divided doses
Maximum dose	600 mg/day (rarely required; increased sedation and fall risk at higher doses)

Clinical Notes:

In frail or elderly patients, start at 25–50 mg once or twice daily
Therapeutic effect may take 1–2 weeks to manifest
Pain relief usually optimal at 150–300 mg/day; doses above this rarely add benefit
Divide doses evenly (morning and evening) to maintain steady plasma levels

2. Adjunctive Therapy in Focal (Partial) Seizures with or without Secondary Generalization

Parameter	Dose
Starting dose	75 mg orally twice daily (150 mg/day)
Titration	Increase to 150 mg twice daily after 1 week; further increase to 200–300 mg twice daily based on response
Usual maintenance dose	300–600 mg/day in 2–3 divided doses
Maximum dose	600 mg/day

Clinical Notes:

Not first-line monotherapy for epilepsy
Use as adjunct when first-line anticonvulsants (levetiracetam, carbamazepine, valproate) are inadequate
Benefit in refractory focal epilepsy
Do not discontinue abruptly — taper over minimum 1 week

Secondary Indications – Adults (Off-label)

Indication	Dose	Duration	Supervision	Evidence Basis
Fibromyalgia (OFF-LABEL)	Starting: 75 mg twice daily; Titration: increase to 150–225 mg twice daily over 2–4 weeks; Maintenance: 300–450 mg/day; Maximum: 450 mg/day	Long-term as needed	Rheumatology/Pain Medicine specialist recommended	Multiple RCTs (Crofford et al.); used in Indian pain clinics
Generalised Anxiety Disorder (GAD) (OFF-LABEL)	Starting: 75 mg twice daily; Titration: increase to 150–300 mg/day over 1–2 weeks; Maximum: 600 mg/day	Short to medium term (≤12 weeks recommended); reassess need	Specialist only (Psychiatrist)	Meta-analyses; Indian psychiatric practice consensus; not first-line
Central Neuropathic Pain (Spinal Cord Injury, Post-stroke) (OFF-LABEL)	Starting: 75 mg twice daily; Titration: as per peripheral neuropathic pain; Maintenance: 150–600 mg/day	Long-term	Specialist only (Neurologist/Pain specialist)	RCTs in spinal cord injury; Indian rehabilitation centre protocols
Restless Legs Syndrome (OFF-LABEL)	Starting: 75 mg once daily at bedtime; Titration: increase to 150–300 mg at bedtime; Maximum: 300 mg/day	Long-term as needed	Specialist only	International RCTs; limited Indian data

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

⚠️ Not routinely approved for paediatric use in India. Use only under specialist paediatric neurology supervision.

Primary Indications

Not applicable — no approved paediatric indications in India.

Secondary Indications – Paediatrics (Off-label)

Indication	Age	Dose	Duration	Supervision	Evidence Basis
Adjunctive Therapy in Focal Seizures (OFF-LABEL)	≥12 years	Starting: 2.5 mg/kg/day in 2–3 divided doses; Titration: increase every 7 days based on response; Maintenance: 5–10 mg/kg/day; Maximum: 600 mg/day or 10 mg/kg/day (whichever is lower)	Long-term as needed	Specialist only (Paediatric Neurologist)	Limited paediatric RCTs; extrapolated from adult data

Safety Monitoring:

CNS effects (sedation, dizziness, ataxia)
Behavioural changes, mood disturbance
Suicidal ideation (particularly in first few weeks)
Weight gain
Vision changes

Age Restriction:

Not recommended below 12 years of age except under exceptional circumstances with paediatric neurology supervision
Use in neuropathic pain or anxiety in children is NOT SUPPORTED by Indian guidelines

Renal Adjustments

⚠️ Pregabalin is renally excreted (>90% unchanged). Dose adjustment is mandatory in renal impairment.

Creatinine Clearance (CrCl)	Starting Dose	Maximum Daily Dose	Dosing Frequency
≥60 mL/min	75 mg twice daily	600 mg/day	2–3 divided doses
30–59 mL/min	25–50 mg twice daily	300 mg/day	2–3 divided doses
15–29 mL/min	25–50 mg once daily	150 mg/day	1–2 divided doses
<15 mL/min	25 mg once daily	75 mg/day	Once daily
Haemodialysis	25 mg once daily (base dose)	75 mg/day (base)	Once daily + supplemental dose

Haemodialysis Supplementation:

Pregabalin is effectively removed by haemodialysis
Give supplemental dose of 25–75 mg immediately after each 4-hour dialysis session
Supplement based on base daily dose (approximately 50% of daily dose post-dialysis)

Hepatic adjustment

Contraindications

Known hypersensitivity to pregabalin or any excipients
History of angioedema to pregabalin or gabapentin
Lactose intolerance (some capsule formulations contain lactose — use oral solution if essential)

Cautions

Elderly patients (increased risk of sedation, dizziness, falls, cognitive impairment)
History of substance use disorder or drug dependence (potential for misuse and dependence)
Congestive heart failure (NYHA Class III–IV) — risk of peripheral oedema and weight gain; may exacerbate symptoms
Renal impairment (mandatory dose reduction)
Concurrent use of CNS depressants (opioids, benzodiazepines, alcohol) — additive sedation
History of depression or suicidal ideation
Patients requiring driving or operating heavy machinery
Diabetic patients (weight gain may worsen glycaemic control)
Avoid abrupt discontinuation — taper over minimum 1 week to prevent withdrawal symptoms

Pregnancy

Parameter	Information
Overall Safety	Limited human data; animal studies show teratogenic effects; avoid unless clearly necessary
Risk	Possible increased risk of major birth defects (based on registry data); neonatal withdrawal possible
Preferred Alternatives	Gabapentin (more human pregnancy data available); for epilepsy — lamotrigine or levetiracetam preferred
When Use May Be Justified	Only when no safer alternative and benefit clearly outweighs risk; requires joint neurology/obstetric decision
Monitoring	Fetal anomaly scan; fetal growth monitoring; neonatal observation for withdrawal if used near term

Lactation

Parameter	Information
Compatibility	Generally compatible at standard doses; appears in breast milk in low concentrations
Expected Drug Level in Milk	Low (milk:plasma ratio approximately 0.5–0.8)
Risk to Infant	Sedation, poor feeding, irritability possible but rare at therapeutic maternal doses
Preferred Alternatives	Gabapentin may be preferred (more breastfeeding safety data available)
Infant Monitoring	Sedation, feeding difficulties, weight gain, developmental milestones
Precautions	Avoid high doses; avoid concurrent CNS depressants during breastfeeding

Elderly

Parameter	Recommendation
Starting dose	25–50 mg once or twice daily
Titration	Increase slowly every 7–10 days (slower than general adults)
Maximum recommended	300 mg/day (lower than general adult maximum due to increased CNS sensitivity)
Increased Risks	Sedation, dizziness, falls, fractures, cognitive impairment, confusion
Additional Precautions	Assess renal function before dosing (age-related decline in CrCl); monitor gait and balance; counsel on fall prevention

Major drug interactions

Interacting Drug	Mechanism	Effect	Management
Opioids (morphine, tramadol, fentanyl, oxycodone)	Additive CNS depression	Profound sedation, respiratory depression, increased overdose risk, death	Avoid combination if possible; if essential, reduce doses of both drugs and monitor closely
Benzodiazepines (diazepam, clonazepam, lorazepam)	Additive CNS depression	Enhanced sedation, respiratory depression	Unidentified
Alcohol	Additive CNS depression	Severe sedation, psychomotor impairment	Avoid concurrent use; patient counselling mandatory
Thiazolidinediones (pioglitazone, rosiglitazone)	Both cause fluid retention	Increased peripheral oedema, weight gain; potential worsening of heart failure	Avoid combination in patients with heart failure; monitor for oedema

Moderate drug interactions

Interacting Drug	Effect	Management
Other anticonvulsants (phenytoin, carbamazepine, valproate)	Additive CNS effects; no significant pharmacokinetic interaction	Monitor for increased sedation; no dose adjustment usually required
Antihypertensives	Additive dizziness, hypotension	Monitor blood pressure; counsel on postural changes
Diuretics (loop, thiazide)	Additive dizziness; potential fluid/electrolyte imbalance	Monitor particularly in elderly
ACE inhibitors	Rare reports of increased angioedema risk	Monitor for facial/airway swelling; discontinue if angioedema occurs
Antidiabetic agents (insulin, sulfonylureas)	Weight gain from pregabalin may worsen glycaemic control	Monitor blood glucose; adjust antidiabetic doses as needed
First-generation antihistamines (chlorpheniramine, diphenhydramine)	Additive sedation	Use with caution; consider non-sedating alternatives

Common Adverse effects

Dizziness (most common; dose-related)
Somnolence, sedation
Peripheral oedema
Weight gain
Dry mouth
Blurred vision
Fatigue, asthenia
Ataxia, incoordination
Headache
Constipation
Euphoria (may contribute to misuse potential)
Difficulty with concentration and attention

Serious Adverse effects

Adverse Effect	Clinical Action
Angioedema (face, tongue, larynx)	Discontinue immediately; emergency management if airway compromise; do not rechallenge
Suicidal ideation and behaviour	Close monitoring especially in first few weeks; psychiatric evaluation; consider discontinuation
Severe hypersensitivity reactions (anaphylaxis, skin reactions)	Discontinue permanently; supportive care
Rhabdomyolysis (rare; usually with concurrent statin or after excessive physical exertion)	Discontinue; check CK levels; supportive care
Respiratory depression (particularly with opioids)	Reduce doses; supportive care; may require reversal agents
Heart failure exacerbation (in predisposed patients)	Discontinue; manage heart failure
Withdrawal syndrome (on abrupt cessation: insomnia, nausea, headache, diarrhoea, anxiety, sweating, rarely seizures)	Taper gradually over minimum 1 week; reinstitute and taper if severe withdrawal

Monitoring requirements

Timing	Parameters
Baseline	Renal function (serum creatinine, eGFR/CrCl), psychiatric history (depression, suicidal ideation, substance use), weight, cardiac status (if CHF history)
After initiation / dose change (1–4 weeks)	Sedation level, dizziness, coordination/gait, suicidal ideation (especially first 2–4 weeks), efficacy assessment
Long-term (every 3–6 months)	Weight, peripheral oedema, signs of misuse or dependence, renal function (in elderly/CKD patients), mood and behaviour, glycaemic control (in diabetics)
On discontinuation	Taper over minimum 1 week; monitor for withdrawal symptoms

Brands in India

Lyrica™ (Pfizer) — 25 mg, 50 mg, 75 mg, 150 mg, 300 mg
Pregabid™ (Torrent) — 75 mg, 150 mg
Nervijen-P™ (Jenburkt) — 75 mg, 150 mg
Maxgalin™ (Sun Pharma) — 50 mg, 75 mg, 150 mg, 300 mg
Pregeb™ (Glenmark) — 75 mg, 150 mg
Pregalin™ (Alkem) — 75 mg, 150 mg
Pregastar™ (Lupin) — 75 mg, 150 mg

Fixed-Dose Combinations (FDCs):

Pregabalin + Methylcobalamin (e.g., Pregabid-M, Nervijen-P Plus) — commonly used for diabetic neuropathy
Pregabalin + Nortriptyline (e.g., Pregalin-NT) — for neuropathic pain with depression component
Note: FDCs should be used with caution; assess need for each component individually

Price range (INR)

Formulation	Price Range	Notes
25 mg capsule	₹3–₹8 per capsule	—
50 mg capsule	₹4–₹10 per capsule	—
75 mg capsule	₹6–₹15 per capsule	Most commonly prescribed strength
150 mg capsule	₹10–₹25 per capsule	—
300 mg capsule	₹18–₹40 per capsule	—
Oral solution (20 mg/mL)	₹70–₹120 per 100 mL	Limited availability

Regulatory: Not listed under NLEM 2022; not under NPPA price control; prices vary significantly by brand

Clinical pearls

Start low in special populations — Begin at 25–50 mg/day in elderly, renal impairment, or frail patients; rapid titration increases adverse effects without improving efficacy
Therapeutic plateau at moderate doses — Most patients achieve optimal pain relief at 150–300 mg/day; doses above 300 mg rarely add benefit but significantly increase sedation, dizziness, and fall risk
Never stop abruptly — Taper over minimum 1 week to avoid withdrawal symptoms (insomnia, nausea, anxiety, and rarely seizures); longer taper (2–4 weeks) if used for extended periods
Misuse potential — Euphoria is a recognised effect; exercise caution in patients with substance use history; regular reassessment for signs of dependence recommended
Renal dosing is critical — Unlike gabapentin, pregabalin has more predictable pharmacokinetics, but renal excretion means dose must be adjusted based on CrCl; use CrCl-based table for dosing
CHF patients at risk — Pregabalin causes fluid retention and weight gain; avoid or use with extreme caution in NYHA Class III–IV heart failure; monitor for worsening symptoms

Version

RxIndia v1.1 — 09 Apr 2025

Reference

CDSCO Product Information
Indian Pharmacopoeia (IP)
API Textbook of Medicine
AIIMS Formulary / Treatment Protocols
ICMR Guidelines for Epilepsy Management
Indian Association for Study of Pain — Neuropathic Pain Guidelines
Indian Psychiatric Society Consensus Statements (GAD off-label use reference)
Goodman & Gilman's The Pharmacological Basis of Therapeutics
Harrison's Principles of Internal Medicine
Cochrane Reviews and Meta-analyses on Pregabalin in Fibromyalgia and GAD (off-label evidence only)

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Clinical Responsibility

This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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