54 231 Pill — ORANGE ROUND, 1mm — Ropinirole

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Imprint54 / 231
ColourORANGE
ShapeROUND
Size1
StrengthROPINIROLE HYDROCHLORIDE 2 mg
Dosage formTablet
ManufacturerAphena Pharma Solutions - Tennessee, LLC
NDC43353-911
Schedule—
Availability—
IngredientsROPINIROLE HYDROCHLORIDE[ROPINIROLE]

What does this imprint mean?

The imprint "54 231" 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

Ropinirole

Uses and warnings

No boxed warning. Contraindicated in patients "known to have hypersensitivity to the product." Key warnings include falling asleep during daily activities - patients have reported "falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents"; syncope, reported in "11.5% (18 of 157)" of early-PD patients on ropinirole versus "1.4% (2 of 147)" on placebo; symptomatic/orthostatic hypotension, since dopamine agonists "appear to impair the systemic regulation of blood pressure"; and hallucinations, reported in "5.2% (8 of 157)" of early Parkinson's patients treated with ropinirole.

Ropinirole hydrochloride tablets are indicated for: - Treatment of "the signs and symptoms of idiopathic Parkinson's disease," effective both in early-stage patients not on L-dopa and in advanced patients on concomitant L-dopa - Treatment of "moderate-to-severe primary Restless Legs Syndrome (RLS)," characterized by "an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations."

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 8992cc1b-9f28-40a5-8c95-06acb3b851b6.xml