Pramipexole is a non-ergot dopamine receptor agonist, primarily indicated for the treatment of Parkinson's Disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS).

Indications for Pramipexole

1. Treatment of Parkinson's Disease

(1) Indicated for the symptomatic control of primary Parkinson's Disease, and can be used as monotherapy or in combination with levodopa.

(2) For patients with early-stage Parkinson's Disease, pramipexole may be used as an initial treatment.

(3) For patients with late-stage Parkinson's Disease, combination therapy with levodopa can reduce "off-time" (periods of poor symptom control) and improve motor symptoms.

2. Treatment of Restless Legs Syndrome

(1) Indicated for the relief of symptoms in moderate-to-severe primary Restless Legs Syndrome, which can significantly improve patients' nighttime leg discomfort and sleep quality.

(2) This indication is based on patients presenting with the following typical symptoms: uncomfortable sensations in the legs accompanied by an urge to move, worsening at rest, relief with movement, and exacerbation of symptoms in the evening or at night.

Dosage Form, Strength and Characteristics of Pramipexole

1. Dosage Form and Strength

(1) Tablets, containing pramipexole dihydrochloride monohydrate.(2) Available in 6 strengths: 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg.

2. Appearance Characteristics

(1) 0.125 mg: White, round tablets, engraved with "BI" and "83".

(2) 0.25 mg: White, oval scored tablets, engraved with "BI BI" and "84 84".

(3) 0.5 mg: White, oval scored tablets, engraved with "BI BI" and "85 85".

(4) 0.75 mg: White, oval tablets, engraved with "BI" and "101".

(5) 1 mg: White, round scored tablets, engraved with "BI BI" and "90 90".

(6) 1.5 mg: White, round scored tablets, engraved with "BI BI" and "91 91".

3. Composition

(1) Active Ingredient: Pramipexole dihydrochloride monohydrate.(2) Excipients: Mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate.

Pharmacological Properties

(1) Selectively agonizes the D2 subfamily of dopamine receptors, with the highest affinity for the D3 receptor.

(2) Has a half-life of approximately 8–12 hours and exhibits linear pharmacokinetic characteristics.

(3) Mainly excreted unchanged in urine (90% of the dose).

Storage Method for Pramipexole

1. Temperature Requirement

(1) Store at 20°C to 25°C (68°F to 77°F).

(2) Short-term storage at deviations between 15°C and 30°C (59°F and 86°F) is permitted.

2. Usage Precautions

(1) Store away from light and keep the container tightly closed.

(2) Keep out of the reach and sight of children.

(3) Expired medications should be disposed of properly and must not be flushed down the toilet or poured into drains.

Who can use Sifrol(Pramipexole)?

Approved Uses