A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Requip Indications, Dosage, Storage, Stability - Ropinirole
Requip Indications, Dosage, Storage, Stability - Ropinirole
INDICATIONS AND USES
Requip (ropinirole hydrochloride) is indicated for the treatment of the signs
and symptoms of idiopathic Parkinson's disease.
The effectiveness of Requip was demonstrated in randomized, controlled
trials in patients with early Parkinson's disease who were not receiving concomitant
L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa
(see CLINICAL PHARMACOLOGY , Clinical Trials ).
DOSAGE AND ADMINISTRATION
In all clinical studies, dosage was initiated at a subtherapeutic level and
gradually titrated to therapeutic response. The dosage should be increased to
achieve a maximum therapeutic effect, balanced against the principal side effects
of nausea, dizziness, somnolence and dyskinesia.
Requip should be taken three times daily. Requip can be taken
with or without food. Since ingestion with food reduces the maximum concentration
(C max ) of Requip , patients should be advised that taking
Requip with food may reduce the occurrence of nausea. However, this has
not been established in controlled clinical trials.
The recommended starting dose is 0.25 mg three times daily. Based on individual
patient response, dosage should then be titrated with weekly increments as described
in the table below. After week 4, if necessary, daily dosage may be increased
by 1.5 mg per day on a weekly basis up to a dose of 9 mg per day, and then by
up to 3 mg per day weekly to a total dose of 24 mg per day.
Ascending-Dose Schedule of Requip
| Week |
Dosage |
Total Daily Dose |
| 1 |
0.25 mg three times daily |
0.75 mg |
| 2 |
0.5 mg three times daily |
1.5 mg |
| 3 |
0.75 mg three times daily |
2.25 mg |
| 4 |
1.0 mg three times daily |
3.0 mg |
Doses greater than 24 mg/day have not been tested in clinical trials.
When Requip is administered as adjunct therapy to L-dopa, the concurrent
dose of L-dopa may be decreased gradually as tolerated. L-dopa dosage reduction
was allowed during the advanced Parkinson's disease (with L-dopa) study if dyskinesias
or other dopaminergic effects occurred. Overall, reduction of L-dopa dose was
sustained in 87% of Requip -treated patients and in 57% of patients on
placebo. On average the L-dopa dose was reduced by 31% in Requip -treated
patients.
Requip should be discontinued gradually over a 7-day period. The frequency
of administration should be reduced from three 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 Requip (ropinirole hydrochloride).
HOW SUPPLIED
Tablets: Each pentagonal film-coated Tiltab® tablet with
beveled edges contains ropinirole hydrochloride as follows: 0.25 mg-white imprinted
with SB and 4890; 0.5 mg-yellow imprinted with SB and 4891; 1.0 mg-green imprinted
with SB and 4892; 2.0 mg-pale yellowish pink imprinted with SB and 4893; 4.0
mg-pale brown imprinted with SB and 4896; 5.0 mg-blue imprinted with SB and
4894.
0.25 mg SUP 30's: NDC 0007-4890-14
0.25 mg bottles of 100: NDC 0007-4890-20
0.5 mg SUP 30's: NDC 0007-4891-14
0.5 mg bottles of 100: NDC 0007-4891-20
1 mg SUP 30's: NDC 0007-4892-14
1 mg bottles of 100: NDC 0007-4892-20
2 mg SUP 30's: NDC 0007-4893-14
2 mg bottles of 100: NDC 0007-4893-20
3 mg bottles of 100: NDC 0007-4895-20
4 mg bottles of 100: NDC 0007-4896-20
5 mg SUP 30's: NDC 0007-4894-14
5 mg bottles of 100: NDC 0007-4894-20
STORAGE
Protect from light and moisture. Close container tightly after each use.
Store at controlled room temperature 20°-25°C (68°-77°F) [see USP].
Manufactured in Crawley, UK by SmithKline Beecham Pharmaceuticals ,
for
SmithKline Beecham Pharmaceuticals , Philadelphia, PA 19101
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