ROPINIROLE tablet, film coated ROPINIROLE HYDROCHLORIDE tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Direct_Rx

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 tablets 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 maximum recommended human dose (MRHD) for Parkinson’s disease. Ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. In pregnant rabbits, ropinirole potentia

Ապրանքի ամփոփագիր:

Ropinirole Tablets: Each circular, biconvex, film-coated tablet contains ropinirole as follows: 0.25 mg: white tablets debossed with “H” on one side and “121” on other side bottle of 30 tablets bottle of 100 tablets bottle of 1000 tablets bottle of 5000 tablets 0.5 mg: yellow tablets debossed with “H” on one side and “122” on other side bottle of 30 tablets bottle of 100 tablets bottle of 1000 tablets bottle of 5000 tablets 1 mg: green tablets debossed with “H” on one side and “123” on other side bottle of 30 tablets bottle of 100 tablets bottle of 1000 tablets bottle of 5000 tablets 2 mg: Peach tablets debossed with “H” on one side and “124” on other side bottle of 30 tablets bottle of 100 tablets bottle of 1000 tablets bottle of 5000 tablets 3 mg: Purple tablets debossed with “H” on one side and “125” on other side bottle of 30 tablets bottle of 100 tablets bottle of 1000 tablets bottle of 5000 tablets 4 mg: Pale brown tablets debossed with “H” on one side and “126” on other side bottle of 30 tablets bottle of 100 tablets bottle of 1000 tablets bottle of 5000 tablets 5 mg: Blue tablets debossed with “H” on one side and “127” on other side bottle of 30 tablets bottle of 100 tablets bottle of 1000 tablets bottle of 5000 tablets 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].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

ROPINIROLE- ROPINIROLE TABLET, FILM COATED
ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
DIRECT_RX
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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 have
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
three 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 three 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. 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 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.