ROPINIROLE 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:

Trigen Laboratories, 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 popul

Product summary:

Each capsule shaped, film coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:  2 mg: pink tablets debossed with 'L191' NDC 13811-639-30    bottle of 30 tablets NDC 13811-639-90    bottle of 90 tablets NDC 13811-639-10    bottle of 100 tablets NDC 13811-639-50    bottle of 500 tablets NDC 13811-639-01    bottle of 1000 tablets NDC 13811-639-11    carton of 100 (10X10) unit dose tablets 4 mg: light brown tablets debossed with 'L193' NDC 13811-640-30    bottle of 30 tablets NDC 13811-640-90    bottle of 90 tablets NDC 13811-640-10    bottle of 100 tablets NDC 13811-640-50    bottle of 500 tablets NDC 13811-640-01    bottle of 1000 tablets NDC 13811-640-11    carton of 100 (10X10) unit dose tablets 6 mg: white to off white tablets debossed with 'L321' NDC 13811-641-30    bottle of 30 tablets NDC 13811-641-90    bottle of 90 tablets NDC 13811-641-10    bottle of 100 tablets NDC 13811-641-50    bottle of 500 tablets NDC 13811-641-01    bottle of 1000 tablets NDC 13811-641-11    carton of 100 (10X10) unit dose tablets 8 mg: dark brown to red tablets debossed with 'L194' NDC 13811-642-30    bottle of 30 tablets NDC 13811-642-90    bottle of 90 tablets NDC 13811-642-10    bottle of 100 tablets NDC 13811-642-50    bottle of 500 tablets NDC 13811-642-01    bottle of 1000 tablets NDC 13811-642-11    carton of 100 (10X10) unit dose tablets 12 mg: light green tablets debossed with 'L195' NDC 13811-643-30    bottle of 30 tablets NDC 13811-643-90    bottle of 90 tablets NDC 13811-643-10    bottle of 100 tablets NDC 13811-643-50    bottle of 500 tablets NDC 13811-643-01    bottle of 1000 tablets NDC 13811-643-11    carton of 100 (10X10) unit dose tablets Storage Store at 20° to 25°C (68° to 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 - ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE
TRIGEN LABORATORIES, LLC
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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) (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) (2)
· 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 are 24 mg/day. (2.2,
14.2) (2)
· Renal Impairment: In patients with end-stage renal disease on
hemodialysis, the maximum recommended dose is 18
mg/day. (2.2) (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) (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) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg (3) (3)
CONTRAINDICATIONS
History of hypersensitivity/ allergic reaction (including urticaria,
angioedema, rash, pruritus) to ropinirole or to any of the
excipients (4) (4)
WARNINGS AND PRECAUTIONS
•Sudden onset of sleep