ROPINIROLE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals (USA) Inc.

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ropinirole hydrochloride tablets are indicated for the treatment of Parkinson's disease. Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Ropinirole hydrochloride 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

Product summary:

Ropinirole Hydrochloride Tablets equivalent to 0.25 mg of ropinirole are white-colored, round-shaped, film-coated tablets debossed with "ZF22" on one side and plain on other side and are supplied as follows: NDC 68382-338-01 in bottle of 100 tablets NDC 68382-338-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 0.5 mg of ropinirole are yellow-colored, round-shaped, film-coated tablets, debossed with "ZF23" on one side and plain on the other side and are supplied as follows: NDC 68382-339-01 in bottle of 100 tablets NDC 68382-339-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 1 mg of ropinirole are green-colored, round-shaped, film-coated tablets, debossed with "ZF24" on one side and plain on the other side and are supplied as follows: NDC 68382-340-01 in bottle of 100 tablets NDC 68382-340-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 2 mg of ropinirole are pink-colored, round-shaped, film-coated tablets, debossed with "ZF25" on one side and plain on the other side and are supplied as follows: NDC 68382-341-01 in bottle of 100 tablets NDC 68382-341-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 3 mg of ropinirole are purple-colored, round-shaped, film-coated tablets, debossed with "ZF42" on one side and plain on the other side and are supplied as follows: NDC 68382-342-01 in bottle of 100 tablets NDC 68382-342-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 4 mg of ropinirole are brown-colored, round-shaped, film-coated tablets, debossed with "ZF43" on one side and plain on the other side and are supplied as follows: NDC 68382-343-01 in bottle of 100 tablets NDC 68382-343-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 5 mg of ropinirole are blue-colored, round-shaped, film-coated tablets, debossed with "ZF26" on one side and plain on the other side and are supplied as follows: NDC 68382-344-01 in bottle of 100 tablets NDC 68382-344-10 in bottle of 1000 tablets 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. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS (USA) INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROPINIROLE HYDROCHLORIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ROPINIROLE HYDROCHLORIDE TABLETS.
ROPINIROLE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Ropinirole hydrochloride 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
Ropinirole hydrochloride Tablets can be taken with or without food
(2.1)
Retitration of ropinirole may be warranted if therapy is interrupted
(2.1)
Parkinson's Disease:
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)
Restless Legs Syndrome:
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)
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
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 behaviors (5.4)
May cause or exacerbate dyskinesia (5.5)
May cause problems with impulse control or compulsive behaviors (5.6)
ADVERSE REACTIONS
Most common adverse reactions (incidence with ropinirole at least 5%
greater than place