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 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 of L-dopa whe

Ringkasan produk:

Each circular, beveled edged, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to the labeled amount of ropinirole as follows: • 0.25 mg: white to off-white tablets with ‘2’ over ‘53’ debossed on one side and ‘G’ on the other side NDC 68462-253-01 Bottles of 100 with child-resistant closure NDC 68462-253-10 Bottles of 1000 NDC 68462-253-11 Unit-dose pack of 100 (10 x 10 unit-dose) • 0.5 mg: pale yellow to yellow tablets with ‘2’ over ‘54’ debossed on one side and ‘G’ on the other side NDC 68462-254-01 Bottles of 100 with child-resistant closure NDC 68462-254-10 Bottles of 1000 NDC 68462-254-11 Unit-dose pack of 100 (10 x 10 unit-dose) • 1 mg: pale green to green tablets with ‘2’ over ‘55’ debossed on one side and ‘G’ on the other side NDC 68462-255-01 Bottles of 100 with child-resistant closure NDC 68462-255-10 Bottles of 1000 NDC 68462-255-11 Unit-dose pack of 100 (10 x 10 unit-dose) • 2 mg: pale pink to pink tablets with ‘2’ over ‘56’ debossed on one side and ‘G’ on the other side NDC 68462-256-01 Bottles of 100 with child-resistant closure NDC 68462-256-10 Bottles of 1000 NDC 68462-256-11 Unit-dose pack of 100 (10 x 10 unit-dose) • 3 mg: purple tablets with ‘2’ over ‘57’ debossed on one side and ‘G’ on the other side NDC 68462-257-01 Bottles of 100 with child-resistant closure NDC 68462-257-10 Bottles of 1000 • 4 mg: pale brown to brown tablets with ‘2’ over ‘58’ debossed on one side and ‘G’ on the other side NDC 68462-258-01 Bottles of 100 with child-resistant closure NDC 68462-258-10 Bottles of 1000 • 5 mg: blue tablets with ‘2’ over ‘59’ debossed on one side and ‘G’ on the other side NDC 68462-259-01 Bottles of 100 with child-resistant closure NDC 68462-259-10 Bottles of 1000 NDC 68462-259-11 Unit-dose pack of 100 (10 x 10 unit-dose)

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 tablets has
occurred, retitration of
therapy may be warranted.
2.2 Dosing for Parkinson's Disease
The recommended starting dose of ropinirole tablets 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 Tablets 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 [see Warnings and Precautions (5.8)]. 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 s