ROPINIROLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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] . In the U.

Product summary:

Ropinirole Tablets, USP are available containing ropinirole hydrochloride, USP equivalent to 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg of ropinirole. The 0.25 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and N over 25 on the other side. They are available as follows: NDC 0378-5525-01 bottles of 100 tablets The 0.5 mg tablets are yellow, round, unscored tablets debossed with M on one side of the tablet and N over 5 on the other side. They are available as follows: NDC 0378-5550-01 bottles of 100 tablets The 1 mg tablets are green, round, unscored tablets debossed with M on one side of the tablet and N over 10 on the other side. They are available as follows: NDC 0378-5501-01 bottles of 100 tablets The 2 mg tablets are orange, round, unscored tablets debossed with M on one side of the tablet and N over 20 on the other side. They are available as follows: NDC 0378-5502-01 bottles of 100 tablets The 3 mg tablets are lavender, round, unscored tablets debossed with M on one side of the tablet and N over 30 on the other side. They are available as follows: NDC 0378-5503-01 bottles of 100 tablets The 4 mg tablets are grayish beige, round, unscored tablets debossed with M on one side of the tablet and N over 40 on the other side. They are available as follows: NDC 0378-5504-01 bottles of 100 tablets The 5 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and N over 50 on the other side. They are available as follows: NDC 0378-5505-01 bottles of 100 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPINIROLE- ROPINIROLE TABLET
MYLAN PHARMACEUTICALS INC.
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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,
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 hallucinations and psychotic-like behavi