pregabalin reference
Reference image
(pregabalin · DailyMed)
Registered Rwanda · Rwanda FDA

PREGALIN

PREGABALIN USP

RWANDA-FDA25/HM/0730/0107 Hard Gelatin Capsules - INN generic

What it does

Pregabalin is a medication used to treat nerve pain and certain types of seizures. It helps calm overactive nerves in the brain.

Commonly used for: nerve pain (neuropathic pain), seizures (epilepsy), anxiety disorders

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
RWANDA-FDA25/HM/0730/0107
Registration date
27/05/2026
Expiry date
26/05/2031
Status
Registered
Active ingredient
PREGABALIN USP
Dosage form
Hard Gelatin Capsules
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Ctx Lifesciences
Country of origin
India

Source: Rwanda Food and Drugs Authority · fetched 2026-06-02 06:15:19 · updated 2026-09-14 02:30:15

Drug Interactions

65
Check interactions

Pharmacodynamic Warnings

Pregabalin appears in TABLE 11: Drugs with CNS depressant effects

Severe (7)

Antiepileptics - decreases absorption

Iron chelators (dexrazoxane) might decrease the absorption of antiepileptics (fosphenytoin, phenytoin). Avoid.

Severe Theoretical

Antiepileptics - decreases exposure

Lumacaftor is predicted to decrease the exposure to antiepileptics (carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone). Avoid.

Severe Theoretical

Antiepileptics - decreases concentration

St John’s wort is predicted to decrease the concentration of antiepileptics (fosphenytoin, phenobarbital, phenytoin, primidone). Avoid.

Severe Theoretical

Antiepileptics - increases risk of overheating and dehydration

Hydroxyzine potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Severe Theoretical

Antiepileptics - increases risk of overheating and dehydration

Haloperidol potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Severe Theoretical

Antiepileptics - decreases absorption

Dexrazoxane might decrease the absorption of antiepileptics (fosphenytoin, phenytoin). Avoid.

Severe Theoretical

Antiepileptics - increases risk of overheating and dehydration

Oxybutynin potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Severe Theoretical

Moderate (25)

Antiepileptics - increases concentration

Intravenous chloramphenicol increases the concentration of antiepileptics (fosphenytoin, phenytoin) and antiepileptics (fosphenytoin, phenytoin) affect the concentration of intravenous chloramphenicol

Moderate Study

Antiepileptics - decreases concentration

Diazoxide decreases the concentration of antiepileptics (fosphenytoin, phenytoin) and antiepileptics (fosphenytoin, phenytoin) are predicted to decrease the effects of diazoxide. Monitor concentration

Moderate Anecdotal

Antiepileptics - increases concentration

Disulfiramincreasestheconcentrationofantiepileptics (fosphenytoin,phenytoin).Monitorconcentrationandadjust dose.rStudy →AlsoseeTABLE12p.1520

Moderate Study

Antiepileptics - increases concentration

Fluorouracilincreasestheconcentrationofantiepileptics (fosphenytoin,phenytoin).Monitorconcentrationandadjust dose.rAnecdotal 1xidneppA|snoitcaretnI A1 https://www.facebook.c (Books-Courses-Medic

Moderate Anecdotal

Antiepileptics - decreases concentration

Folates are predicted to decrease the concentration of antiepileptics (fosphenytoin, phenobarbital, phenytoin, primidone). Monitor concentration and adjust dose.

Moderate Study

Unknown (33)

Antiepileptics - increases risk of overheating and dehydration

Acetazolamide potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Unknown Theoretical

Antiepileptics - increases risk of visual disturbances

Alcohol potentially increases the risk of visual disturbances when given with antiepileptics (retigabine).

Unknown Study

Antiepileptics - decreases exposure

Enzalutamide is predicted to slightly decrease the exposure to antiepileptics (brivaracetam).

Unknown Theoretical

Antiepileptics - decreases exposure

Apalutamidepotentiallydecreasestheexposureto antiepileptics(valproate).nTheoretical

Unknown Theoretical

Antiepileptics - increases concentration

Capecitabine increases the concentration of antiepileptics (fosphenytoin, phenytoin).

Unknown Anecdotal

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: class

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Pregabalin is a medication used to treat nerve pain and certain types of seizures. It helps calm overactive nerves in the brain.

What it treats

  • nerve pain (neuropathic pain)
  • seizures (epilepsy)
  • anxiety disorders

How it works

Pregabalin works by reducing the number of signals sent by nerves to the brain, which helps decrease pain and seizure activity.

Who it's for

Pregabalin is suitable for adults and some children who have nerve pain or epilepsy.

Drug class

Antiepileptics

Cautions

  • • Be careful if you are taking other medications that can cause drowsiness or slow down brain activity.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Pregabalin

BNF-referenced

Pregabalin is an anticonvulsant medication that is structurally related to gamma-aminobutyric acid (GABA). It is primarily used for the management of epilepsy, neuropathic pain, and generalized anxiety disorder. Pregabalin modulates the release of excitatory neurotransmitters by binding to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system, which contributes to its antiseizure and analgesic effects. It does not interact directly with GABA receptors but may enhance GABAergic activity indirectly.

Indications

  • Epilepsy
  • Neuropathic pain
  • Generalized anxiety disorder

Dosage

Adults: The usual starting dose is 150 mg daily, divided into two or three doses. The dose may be increased to a maximum of 600 mg daily based on clinical response and tolerability. Refer to the BNF for specific dosing adjustments in

Mechanism of action

Pregabalin binds presynaptically to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system. This binding modulates the release of several excitatory neurotransmitters, including glutamate, substance P, norepinephrine, and calcitonin gene-related peptide. By preventing the trafficking of the alpha2-delta subunit from the dorsal root ganglia to the spinal dorsal horn, pregabalin contributes to its anticonvulsant and analgesic effects.

Pharmacodynamics

Pregabalin increases the density of GABA transporters in cultured neurons but does not bind directly to GABA-A, GABA-B, or benzodiazepine receptors. It does not affect dopamine, serotonin, or opiate receptors, nor does it modulate sodium channels or cyclooxygenase activity. Its primary action is through the inhibition of excitatory neurotransmitter release, which helps in controlling seizures and alleviating neuropathic pain.

Pharmacokinetics

Pregabalin is rapidly absorbed after oral administration, with peak plasma concentrations usually reached within 1 hour. It has a bioavailability of approximately 90%, and its plasma concentration does not significantly change with increasing doses. Pregabalin is not extensively metabolized; it is primarily excreted unchanged in the urine. The elimination half-life is about 6 hours, and dose adjustments may be necessary in patients with renal impairment.

Adverse effects

  • Dizziness
  • Somnolence
  • Dry mouth
  • Edema
  • Weight gain
  • Blurred vision
  • Difficulty concentrating
  • Euphoria
  • Depression
  • Angioedema

Interactions

  • CNS depressants may enhance the sedative effects of pregabalin
  • Concurrent use with opioids may increase the risk of respiratory depression
  • Antiepileptic drugs may have additive effects

Precautions

  • Use with caution in patients with a history of substance abuse
  • Monitor for signs of angioedema, especially in patients with a history of angioedema
  • Caution in patients with renal impairment, as dosage adjustments may be necessary

Pregnancy

Pregabalin is classified as category C. Animal studies have shown adverse effects, and there are no well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Pregabalin is excreted in breast milk. The effects on a nursing infant are unknown, and caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg
  • Oral solution: 20 mg/mL
  • Chewable tablets: 50 mg
BNF 85 (British National Formulary) p.377 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Pregabalin

PubChem CID 5486971

Molecular formula: C8H17NO2

Mechanism of action

Although the mechanism of action has not been fully elucidated, studies involving structurally related drugs suggest that presynaptic binding of pregabalin to voltage-gated calcium channels is key to the antiseizure and antinociceptive effects observed in animal models. By binding presynaptically to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system, pregabalin modulates the release of several excitatory neurotransmitters including glutamate, substance-P, norepinephrine, and calcitonin gene related peptide. In addition, pregabalin prevents the alpha2-delta subunit from being trafficked from the dorsal root ganglia to the spinal dorsal horn, which may also contribute to the mechanism of action. Although pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), it does not bind directly to GABA or benzodiazepine receptors. Pregabalin is an anticonvulsant that is structurally related to the inhibitory CNS neurotransmitter gamma-aminobutyric acid (GABA). Pregabalin also has demonstrated analgesic activity. Although pregabalin was developed as a structural analog of GABA, the drug does not bind directly to GABA-A, GABA-B, or benzodiazepine receptors; does not augment GABA-A responses in cultured neurons; and does not alter brain concentrations of GABA in rats or affect GABA uptake or degradation. However, in cultured neurons, prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in CNS tissues. ... In vitro, pregabalin reduces the calcium-dependent release of several neurotransmitters, including glutamate, norepinephrine, and substance P, possibly by modulation of calcium channel function. Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake. Pregabalin is a potent ligand for the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system that exhibits potent anticonvulsant, analgesic, and anxiolytic activity in a range of animal models. ... Potent binding to the alpha-2-delta site reduces depolarization-induced calcium influx with a consequential modulation in excitatory neurotransmitter release. Pregabalin has no demonstrated effects on GABAergic mechanisms. ... For more Mechanism of Action (Complete) data for PREGABALIN (6 total), please visit the HSDB record page.

Pharmacodynamics

Although the structure of pregabalin is similar to gamma-aminobutyric acid (GABA), it does not bind to GABA receptors. Instead, it binds the alpha2-delta subunit of presynaptic voltage-gated calcium channels in the central nervous system. Pregabalin does not modulate dopamine receptors, serotonin receptors, opiate receptors, sodium channels or cyclooxygenase activity.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.