Osaka, Japan – March 20, 2018 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approval of partial change application by the Ministry of Health, Labour and Welfare (MHLW) for PRAMIPEXOLE HYDROCHLORIDE Tablets 0.125 mg “SAWAI” / 0.5 mg “SAWAI”.
This approval expands the indication of PRAMIPEXOLE HYDROCHLORIDE Tablets 0.125 mg “SAWAI” / 0.5 mg “SAWAI” to include the same uses as their brand equivalents.
* Brand products : BI･Sifro® Tablets 0.125 mg / 0.5 mg
“Indications and Usage” and “Dosage and Administration” after approvals are as below;
| Indications and Usage (New approval is underlined) |
- Parkinson’s Disease (PD)
- Mild to moderate Restless Legs Syndrome (RLS)
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| Dosage and Administration (New approval is underlined) |
- Parkinson’s Disease (PD)
- In general, for adults, start with 0.25 mg of pramipexole hydrochloride hydrate daily for the first week, and increase to 0.5 mg daily for the second week. Thereafter increase the daily dose by an increment of 0.5 mg at weekly intervals by checking your condition and determine your maintenance dose [standard daily dose: 1.5 - 4.5 mg]. If the daily dose is less than 1.5 mg, divide it into two doses and take each dose after breakfast and dinner. If the daily dose is 1.5 mg or more, divide it into three doses and take each dose after each meal. The dosage may be adjusted according to your age and the severity of symptoms, but the maximum daily dose should not exceed 4.5 mg.
- Mild to moderate Restless Legs Syndrome (RLS)
- In general, for adults, start with 0.25 mg of pramipexole hydrochloride hydrate two to three hours before bedtime. Increase the daily dose by an increment of 0.125 mg at weekly intervals by checking your condition and determine your maintenance dose. The maximum daily dose should not exceed 0.75 mg.
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