ROPINIROLE HYDROCHLORIDE 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:

Bryant Ranch Prepack

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Ropinirole tablets are indicated for the treatment of Parkinson's disease. 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. 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 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 these drugs were administered in combination [see Data]

Ringkasan produk:

Each round biconvex film-coated ropinirole 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 NDC: 71335-0587-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-0587-2 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-0587-3 28 TABLET, FILM COATED in a BOTTLE NDC: 71335-0587-4 100 TABLET, FILM COATED in a BOTTLE 1 mg: green tablets debossed “974” on one side and “HH” on the other side NDC: 71335-1434-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-1434-2 28 TABLET, FILM COATED in a BOTTLE NDC: 71335-1434-3 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-1434-4 60 TABLET, FILM COATED in a BOTTLE 2 mg: pink tablets debossed “975” on one side and “HH” on the other side NDC: 71335-1626-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-1626-2 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-1626-3 90 TABLET, FILM COATED in a BOTTLE Storage Store at room temperature between 20°C and 25°C (68°F and 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROPINIROLE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ROPINIROLE TABLETS.
ROPINIROLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Warnings and Precautions, Hallucinations/Psychotic- Like Behavior
(5.4) 4/2020
Warnings and Precautions, Impulse Control/Compulsive Behaviors (5.6)
4/2020
INDICATIONS AND USAGE
Ropinirole tablets are 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
•
•
Parkinson's Disease:
•
•
Restless Legs Syndrome:
•
•
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
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence with ropinirole tablets at
least 5% greater than placebo) in the
respective indications were:
•
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE U. S.,
LLC AT 1-866-
257-2597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
Ropinirole tablets can be taken with or without food (2.1)
Retitration of ropinirole tablets may be warranted if therapy is
interrupted (2.1)
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)
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 e