ROPINIROLE tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)

Tersedia dari:

DIRECT RX

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

1.1 Parkinson’s Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole hydrochloride in pregnant women. In animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the MRHD for Parkinson’s disease. Ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. In pregnant rabbits, ropinirole potentiated the teratogenic effects

Ringkasan produk:

Ropinirole tablets, USP are available as follows: 0.25 mg: White to off white, round, biconvex, film coated tablets debossed with "R6" on one side and plain on other side. 0.5 mg: Yellow, round, biconvex, film coated tablets debossed with "R7" on one side and plain on other side. 1 mg: Green, round, biconvex, film coated tablets debossed with "R1" on one side and plain on other side. 2 mg: Pink, round, biconvex, film coated tablets debossed with "R2" on one side and plain on other side. 3 mg: Purple to light purple, round, biconvex, film coated tablets debossed with "R3" on one side and plain on other side. 4 mg: Brown to pale brown, round, biconvex, film coated tablets debossed with "R4" on one side and plain on other side. 5 mg: Blue, round, biconvex, film coated tablets debossed with "R5" on one side and plain on other side. Storage Store at room temperature between 20°C and 25°C (68°F and 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

ROPINIROLE- ROPINIROLE TABLET, FILM COATED
DIRECT RX
----------
ROPINIROLE
1.1 Parkinson’s Disease
Ropinirole tablets are indicated for the treatment of Parkinson’s
disease.
1.2 Restless Legs Syndrome
Ropinirole tablets are indicated for the treatment of
moderate-to-severe primary
Restless Legs Syndrome (RLS).
2.1 General Dosing Recommendations
Ropinirole tablets can be taken with or without food [see Clinical
Pharmacology (12.3) ] .
If a significant interruption in therapy with ropinirole hydrochloride
has occurred,
retitration of therapy may be warranted.
2.2 Dosing for Parkinson’s Disease
The recommended starting dose of ropinirole hydrochloride for
Parkinson’s disease is
0.25 mg 3 times daily. Based on individual patient therapeutic
response and tolerability, if
necessary, the dose should then be titrated with weekly increments as
described in
Table 1. After Week 4, if necessary, the daily dose may be increased
by 1.5 mg/day on a
weekly basis up to a dose of 9 mg/day, and then by up to 3 mg/day
weekly up to a
maximum recommended total daily dose of 24 mg/day (8 mg 3 times
daily). Doses
greater than 24 mg/day have not been tested in clinical trials.
Table 1. Ascending-Dose Schedule of Ropinirole Hydrochloride for
Parkinson’s Disease
Week
Dosage
Total Daily Dose
1
0.25 mg 3 times daily
0.75 mg
2
0.5 mg 3 times daily
1.5 mg
3
0.75 mg 3 times daily
2.25 mg
4
1 mg 3 times daily
3 mg
Ropinirole tablets should be discontinued gradually over a 7-day
period in patients with
Parkinson’s disease. The frequency of administration should be
reduced from 3 times
daily to twice daily for 4 days. For the remaining 3 days, the
frequency should be
reduced to once daily prior to complete withdrawal of ropinirole
tablets.
Renal Impairment
No dose adjustment is necessary in patients with moderate renal
impairment (creatinine
clearance of 30 to 50 mL/min). The recommended initial dose of
ropinirole for patients
with end-stage renal disease on hemodialysis is 0.25 mg 3 times a day.
Further dose
escalations should be base