ROPINIROLE HYDROCHLORIDE tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

A-S Medication Solutions

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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]

Produkto santrauka:

Product: 50090-4810 NDC: 50090-4810-0 30 TABLET, FILM COATED in a BOTTLE

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
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
wi