ROPINIROLE HYDROCHLORIDE tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

SOLCO HEALTHCARE US, LLC

INN (इंटरनेशनल नाम):

ROPINIROLE HYDROCHLORIDE

रचना:

ROPINIROLE 0.25 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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]

उत्पाद समीक्षा:

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 Bottles of 100 – NDC 43547-268-10 Bottles of 500 – NDC 43547-268-50 0.5 mg: yellow tablets debossed “973” on one side and “HH” on the other side Bottles of 100 – NDC 43547-269-10 Bottles of 500 – NDC 43547-269-50 1 mg: green tablets debossed “974” on one side and “HH” on the other side Bottles of 100 – NDC 43547-270-10 Bottles of 500 – NDC 43547-270-50 2 mg: pink tablets debossed “975” on one side and “HH” on the other side Bottles of 100 – NDC 43547-271-10 Bottles of 500 – NDC 43547-271-50 3 mg: purple tablets debossed “976” on one side and “HH” on the other side Bottles of 100 – NDC 43547-272-10 Bottles of 500 – NDC 43547-272-50 4 mg: beige tablets debossed “977” on one side and “HH” on the other side Bottles of 100 – NDC 43547-273-10 Bottles of 500 – NDC 43547-273-50 5 mg: blue tablets debossed “978” on one side and “HH” on the other side Bottles of 100 – NDC 43547-274-10 Bottles of 500 – NDC 43547-274-50 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
SOLCO HEALTHCARE US, LLC
----------
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,
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:
•
•
•
Withdrawal Symptoms (5.8) 7/2021
Melanoma-removal (5.9) 7/2021
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 end-stage renal
disease on hemodialysis. (2.3)
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 hal