ROPINIROLE HYDROCHLORIDE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Wockhardt USA LLC.

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE 2 mg

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 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 L-dopa when these drugs were administered in combination [see Data] . In the U.S. general populat

Product summary:

Each ropinirole extended-release biconvex, circular-shaped, film-coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: 2 mg: Pink, coated, circular shaped tablets with beveled edge, debossed with 'W' on one side and plain on other side                                                              771 and are supplied as follows: Bottle of 30                             NDC 64679-771-01 Bottle of 500                           NDC 64679-771-03 Unit dose packages of 100     NDC 64679-771-04 4 mg: Light brown, coated, circular shaped tablets with beveled edge, debossed with 'W' on one side and plain on other side.                                                                        773 and are supplied as follows: Bottle of 30                             NDC 64679-773-01 Bottles of 500                                     NDC 64679-773-03 Unit dose packages of 100     NDC 64679-773-04 6 mg: White, coated, circular shaped tablets with beveled edge, debossed with 'W' on one side and plain on other side.                                                               776 and are supplied as follows: Bottles of 30                           NDC 64679-776-01 Bottles of 500                                     NDC 64679-776-03 Unit dose packages of 100     NDC 64679-776-04 8 mg: Brown, coated, circular shaped tablets with beveled edge, debossed with 'W' on one side and plain on other side.                                                                774 and are supplied as follows: Bottles of 30                           NDC 64679-774-01 Bottles of 500                                     NDC 64679-774-03 Unit dose packages of 100     NDC 64679-774-04 12 mg: Green, coated, circular shaped tablets with beveled edge, debossed with 'W' on one side and plain on other side.                                                                 775 and are supplied as follows: Bottles of 30                           NDC 64679-775-01 Bottles of 500                                     NDC 64679-775-03 Unit dose packages of 100     NDC 64679-775-04 Storage: Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
WOCKHARDT USA LLC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROPINIROLE EXTENDED-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
Dosage and Administration (2.2) 3/2017
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6) 3/2017
INDICATIONS AND USAGE
Ropinirole extended-release tablets are non-ergoline dopamine agonist
indicated for the treatment of Parkinson's disease.
(1)
DOSAGE AND ADMINISTRATION
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. (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 tablets; the initial
switching dose of ropinirole extended-release tablets should
approximately match the total daily dose of immediate-
release ropinirole. (2.3)
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
Sudden onset of sleep and somnolence may occur (5.1)
Syncope may occur (5.2)
Hypotension, including orthostatic hypotension may occur (5