ROPINIROLE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Solco Healthcare US, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease. Ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients. Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole extended-release 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] . In the U.S. general population, the estimated background ris

Product summary:

Each biconvex, round, film-coated tablet contains ropinirole hydrochloride, USP, equivalent to the labeled amount of ropinirole as follows: Storage Store at 20°C to 25°C (68°F-77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ROPINIROLE- ROPINIROLE TABLET, EXTENDED RELEASE
Solco Healthcare US, LLC
----------
PATIENT INFORMATION
Ropinirole Tablets, USP
(roe pin’ i role”)
Ropinirole Extended-Release Tablets
(roe pin’ i role”)
Dispense with Patient Information available at:
www.solcohealthcare.com/medguide/ropinirole-er-tablets.pdf
If you have Parkinson’s disease, read this side.
If you have Restless Legs Syndrome (RLS), read the other side.
Important Note: Ropinirole extended-release tablets have not been
studied in RLS and are not approved for
the treatment of RLS. However, an immediate-release form of ropinirole
is approved for the treatment of
moderate to severe primary RLS (see other side of this leaflet).
What is the most important information I should know about ropinirole
tablets and ropinirole extended-
release tablets?
Ropinirole tablets and ropinirole extended-release tablets can cause
serious side effects including:
•
Falling asleep during normal activities. You may fall asleep while
doing normal activities such as
driving a car, doing physical tasks, or using hazardous machinery
while taking ropinirole tablets or
ropinirole extended-release tablets. You may suddenly fall asleep
without being drowsy or without
warning. This may result in having accidents. Your chances of falling
asleep while doing normal
activities while taking ropinirole tablets or ropinirole
extended-release tablets are greater if you take
other medicines that cause drowsiness. Tell your healthcare provider
right away if this happens. Before
starting ropinirole tablets or ropinirole extended-release tablets, be
sure to tell your healthcare provider
if you take any medicines that make you drowsy.
•
Fainting. Fainting can happen, and sometimes your heart rate may be
decreased. This can happen
especially when you start taking ropinirole tablets or ropinirole
extended-release tablets or your dose is
increased. Tell your healthcare provider if you faint, feel dizzy, or
feel light-headed.
•
Decrease in blood pressure. Ropinirole tablets and ropini

Summary of Product characteristics

ROPINIROLE- ROPINIROLE TABLET, EXTENDED RELEASE
SOLCO HEALTHCARE US, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROPINIROL EEXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ROPINIROLE
EXTENDED-RELEASE TABLETS.
ROPINIROLE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Warnings and Precautions, Hallucinations/Psychotic-Like Behavior (5.5)
7/2021
Warnings and Precautions, Impulse Control/Compulsive Behaviors (5.7)
7/2021
Warnings and Precautions, Withdrawal Symptoms (5.9) 7/2021
Warnings and Precautions, Melanoma-removal (5.10) 7/2021
INDICATIONS AND USAGE
Ropinirole extended-release tablets are a non-ergoline dopamine
agonist indicated for the treatment of
Parkinson’s disease. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg, 4 mg, 6 mg, 8 mg, and 12 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
•
•
Ropinirole extended-release tablets are taken once daily, with or
without food; tablets must be
swallowed whole and not be chewed, crushed, or divided. (2.1)
The recommended starting dose is 2 mg taken once daily for 1 to 2
weeks; the dose should be
increased by 2 mg/day at 1 week or longer intervals. The maximum
recommended dose of ropinirole
extended-release tablets is 24 mg/day. (2.2, 14.2)
Renal Impairment: In patients with end-stage renal disease on
hemodialysis, the maximum
recommended dose is 18 mg/day. (2.2)
If ropinirole extended-release tablets must be discontinued, it should
be tapered gradually over a 7-
day period; retitration of ropinirole extended-release tablets may be
warranted if therapy is
interrupted. (2.1, 2.2)
Patients may be switched directly from immediate-release ropinirole to
ropinirole extended-release
tabl