ROPINIROLE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

West-Ward Pharmaceuticals Corp.

INN (Mezinárodní Name):

ROPINIROLE HYDROCHLORIDE

Složení:

ROPINIROLE 0.25 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Ropinirole is indicated for the treatment of Parkinson’s disease. Ropinirole is 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 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 potentiated the teratogenic effects of L-dopa when these drugs were administered in combination [se

Přehled produktů:

The 0.25 mg tablet is supplied as a white to off-white, round biconvex tablet, debossed with “54 511” on one side and plain on the other side. The 0.5 mg tablet is supplied as a yellow to speckled-yellow, round biconvex tablet, debossed with “54 337” on one side and plain on the other side. The 1 mg tablet is supplied as a green to speckled-green, round biconvex tablet, debossed with “54 751” on one side and plain on the other side. The 2 mg tablet is supplied as an orange to speckled-orange, round biconvex tablet, debossed with “54 231” on one side and plain on the other side. The 3 mg tablet is supplied as a red to speckled-red, round biconvex tablet, debossed with “54 575” on one side and plain on the other side. The 4 mg tablet is supplied as a brown to speckled-brown, round biconvex tablet, debossed with “54 273” on one side and plain on the other side. The 5 mg tablet is supplied as a blue to speckled-blue, round biconvex tablet, debossed with “54 722” on one side and plain on the other side. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Close container tightly after each use.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ROPINIROLE- ROPINIROLE TABLET
WEST-WARD PHARMACEUTICALS CORP.
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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)
04/2020
Warnings and Precautions, Impulse Control/Compulsive Behaviors (5.6)
04/2020
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 at least 5%
greater than placebo) in the respective indications
we re :
•
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WEST-WARD
PHARMACEUTICALS CORP. AT 1-800-962-8364
Ropinirole can be taken with or without food. (2.1)
Retitration of ropinirole may be warranted if therapy is interrupted.
(2.1)
The recommended starting dose is 0.25 mg taken three times daily;
titrate to 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 end-stage renal disease on
hemodialysis. (2.3)
Sudden onset of sleep and somnolence may occu