Pregabalin

What it is and how it works

Mechanism of Action Pregabalin binds with high affinity to the alpha 2 -delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha 2 -delta subunit may be involved in pregabalin’s anti-nociceptive and antiseizure effects in animals.

Indications

Pregabalin capsules are indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropathy • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) • Postherpetic neuralgia (PHN) • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older • Fibromyalgia • Neuropathic pain associated with spinal cord injury

Dosage and administration (summary)

• For adult indications, begin dosing at 150 mg/day. For partial-onset seizure dosing in pediatric patients 1 month of age and older, refer to section 2.4. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) • Dosing recommendations: INDICATION Dosing Regimen Maximum Dose DPN Pain 3 divided doses per day 300 mg/day within 1 week. PHN 2 or 3 divided doses per day 300 mg/day within 1 week. Maximum dose of 600 mg/day. Adjunctive Therapy for Partial-Onset Seizures in Adult Patients Weighing 30 kg or More 2 or 3 divided doses per day Maximum dose of 600 mg/day.

Contraindications

Pregabalin capsules are contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy . • Known hypersensitivity to pregabalin or any of its components.

Warnings and precautions

• Angioedema (e.g., swelling of the throat, head, and neck) can occur, and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue pregabalin capsules immediately in these cases. • Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue pregabalin capsules immediately in these patients. • Antiepileptic drugs, including pregabalin, the active ingredient in pregabalin capsules, increase the risk of suicidal thoughts or behavior. • Abrupt or rapid discontinuation may increase the risk for seizures.

Pregnancy

Pregnancy Risk Summary Observational studies on the use of pregabalin capsules during pregnancy suggest a possible small increase in the rate of overall major birth defects, but there was no consistent or specific pattern of major birth defects identified (see Data).

Storage and supply

25 mg capsules: Caramel/white, opaque hard gelatin capsule printed with black ink “554” on the cap, “25 mg” on the body; available in: Bottles of 90: NDC 43547-506-09 Bottles of 1,000: NDC 43547-506-11 50 mg capsules: Caramel/white, opaque hard gelatin capsule printed with black ink “555” on the cap, “50 mg” on the body.

Source: Pregabalin (Pregabalin) — US FDA prescribing information, 2026-03-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.