ROPINIROLE HYDROCHLORIDE tablet, film coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Aphena Pharma Solutions - Tennessee, LLC

INN（国際名）:

ROPINIROLE HYDROCHLORIDE

構図:

ROPINIROLE 0.25 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Ropinirole hydrochloride tablets are indicated for the treatment of Parkinson's disease. Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Ropinirole hydrochloride is contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, ropinirole has been shown to have adverse effects on embryo-fetal development, including teratogenic effects. Ropinirole hydrochloride should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Oral treatment of pregnant rats with ropinirole during organogenesis resulted in decreased fetal body weight, increased fetal death, and digital malformations at 24, 36, and 60 times, respectively, the maximum recommended human dose (MRHD) for P

製品概要:

Each round biconvex film-coated ropinirole hydrochloride tablet, USP, contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: 0.25 mg: white tablets debossed “972” on one side and “HH” on the other side Bottles of 100 – NDC 43547-268-10 0.5 mg: yellow tablets debossed “973” on one side and “HH” on the other side Bottles of 100 – NDC 43547-269-10 1 mg: green tablets debossed “974” on one side and “HH” on the other side Bottles of 100 – NDC 43547-270-10 2 mg: pink tablets debossed “975” on one side and “HH” on the other side Bottles of 100 – NDC 43547-271-10 3 mg: purple tablets debossed “976” on one side and “HH” on the other side Bottles of 100 – NDC 43547-272-10 4 mg: beige tablets debossed “977” on one side and “HH” on the other side Bottles of 100 – NDC 43547-273-10 5 mg: blue tablets debossed “978” on one side and “HH” on the other side Bottles of 100 – NDC 43547-274-10 Storage Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROPINIROLE HYDROCHLORIDE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROPINIROLE
HYDROCHLORIDE TABLETS.
ROPINIROLE HYDROCHLORIDE TABLETS, USP, FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Dosage and Administration (2.2, 2.3) 8/2014
Warnings and Precautions (5.4, 5.6, 5.9) 8/2014
INDICATIONS AND USAGE
Ropinirole hydrochloride is a non-ergoline dopamine agonist indicated
for the treatment of Parkinson’s disease (PD) and
moderate-to-severe primary Restless Legs Syndrome (RLS) (1.1, 1.2)
DOSAGE AND ADMINISTRATION
Ropinirole Hydrochloride Tablets can be taken with or without food
(2.1)
Retitration of ropinirole hydrochloride tablets may be warranted if
therapy is interrupted (2.1)
Parkinson's Disease:
The recommended starting dose is 0.25 mg taken three times daily;
titrate to a maximum daily dose of 24 mg (2.2)
Renal Impairment: The maximum recommended dose is 18 mg/day in
patients with end-stage renal disease on
hemodialysis (2.2)
Restless Legs Syndrome:
The recommended starting dose is 0.25 mg once daily, 1 to 3 hours
before bedtime, titrate to a maximum
recommended dose of 4 mg daily (2.3)
Renal Impairment: The maximum recommended dose is 3 mg/day in patients
with end-stage renal disease on
hemodialysis (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 mg (3)
CONTRAINDICATIONS
History of hypersensitivity/allergic reaction (including urticaria,
angioedema, rash, pruritus) to ropinirole or to any of the
excipients (4)
WARNINGS AND PRECAUTIONS
Sudden onset of sleep and somnolence may occur (5.1)
Syncope may occur (5.2)
Hypotension, including orthostatic hypotension may occur (5.3)
May cause hallucinations and psychotic-like behaviors (5.4)
May cause or exacerbate dyskinesia (5.5)
May cause problems wit