ROPINIROLE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 is 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 when th

Product summary:

Each modified oval shaped, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to the labeled amount of ropinirole as follows: 0.25 mg: white to off white coloured, modified oval shaped, biconvex, film-coated tablet debossed with “105” on one side and “RH” on the other side in bottles of 100 (NDC 69452-356-20), with a child-resistant closure. 0.5 mg: pale yellow coloured, modified oval shaped, biconvex, film-coated tablet debossed with “106” on one side and “RH” on the other side in bottles of 100 (NDC 69452-357-20), with a child-resistant closure. 1 mg: pale green coloured, modified oval shaped, biconvex, film-coated tablet debossed with “107” on one sideand “RH” on the other side in bottles of 30 (NDC 72189-494-30), with a child-resistant closure. 2 mg: pink coloured, modified oval shaped, biconvex, film-coated tablet debossed with “110” on one side and “RH” on the other side in bottles of 100 (NDC 69452-359-20), with a child-resistant closure. 3 mg: purple coloured, modified oval shaped, biconvex, film-coated tablet debossed with “112” on one side and “RH” on the other side in bottles of 100 (NDC 69452-360-20), with a child-resistant closure. 4 mg: brown coloured, modified oval shaped, biconvex, film-coated tablet debossed with “114” on one side and “RH” on the other side in bottles of 100 (NDC 69452-361-20), with a child-resistant closure. 5 mg: pale blue coloured, modified oval shaped, biconvex, film-coated tablet debossed with “115” on one side and“RH” on the other side in bottles of 100 (NDC 69452-362-20), with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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 can be taken with or without food [see Clinical
Pharmacology (12.3)].
If a significant interruption in therapy with ropinirole has occurred,
retitration of therapy
may be warranted.
2.2 Dosing for Parkinson’s Disease
The recommended starting dose of ropinirole 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 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 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.
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 based on tolerability and need for effi