R428 Pill — GRAY CAPSULE, 16mm — Lamotrigine
| Imprint | R428 |
|---|---|
| Colour | GRAY |
| Shape | CAPSULE |
| Size | 16 |
| Strength | LAMOTRIGINE 300 mg |
| Dosage form | Tablet, Extended Release |
| Manufacturer | NorthStar Rx LLC |
| NDC | 16714-627 |
| Schedule | — |
| Availability | Prescription only |
| Ingredients | LAMOTRIGINE[LAMOTRIGINE] |
What does this imprint mean?
The imprint "R428" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.
Active ingredient
Lamotrigine
Uses and warnings
BOXED WARNING: "Serious Rashes" - life-threatening rashes, including "Stevens-Johnson syndrome" and "toxic epidermal necrolysis," have been reported, occurring in approximately "0.8%" of pediatric patients and "0.3%" of adults on adjunctive therapy; risk is increased with rapid dose escalation and concomitant valproate. Lamotrigine is contraindicated in patients with known hypersensitivity to the drug. Other major warnings include multiorgan hypersensitivity reactions (DRESS) that "can be fatal or life-threatening," blood dyscrasias (neutropenia, thrombocytopenia, pancytopenia), aseptic meningitis, and the class-wide warning that "antiepileptic drugs increase the risk of suicidal thoughts or behavior."
Lamotrigine tablets are indicated for: - "Adjunctive therapy" in patients ≥2 years for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome - "Conversion to monotherapy" in adults with partial seizures who are receiving treatment with a single other AED - "Maintenance treatment of Bipolar I Disorder" in adults, "to delay the time to occurrence of mood episodes."
How to identify this pill
- • Check the imprint matches exactly: "R428".
- • Confirm the colour (GRAY) and shape (CAPSULE).
- • Compare the size (16) against a ruler if possible.
- • When in doubt, confirm with a pharmacist before taking any medication.
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Official references
Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 082f023d-60ab-5baa-cbae-b1f8e80c6b91.xml