ROPINIROLE- ropinirole tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Ropinirole Hydrochloride (UNII: D7ZD41RZI9) (Ropinirole - UNII:030PYR8953)

Tilgjengelig fra:

Apotex Corp.

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Sammensetning:

ROPINIROLE 0.25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 hydrochloride is 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 hydrochloride 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 dr

Produkt oppsummering:

Ropinirole Tablet, USP 0.25 mg are white pentagonal tablets engraved “ROP” over “.25” on one side, “APO” on the other side. They are supplied as follows: Bottles of 30s: NDC 60505-2865-3 Bottles of 60s: NDC 60505-2865-6 Bottles of 90s: NDC 60505-2865-9 Bottles of 100s: NDC 60505-2865-1 Bottles of 500s: NDC 60505-2865-5 Bottles of 1,000s: NDC 60505-2865-8 Ropinirole Tablet, USP 0.5 mg are yellow pentagonal tablets engraved “ROP” over “.5” on one side, “APO” on the other side. They are supplied as follows: Bottles of 30s: NDC 60505-2866-3 Bottles of 60s: NDC 60505-2866-6 Bottles of 90s: NDC 60505-2866-9 Bottles of 100s: NDC 60505-2866-1 Bottles of 500s: NDC 60505-2866-5 Bottles of 1,000s: NDC 60505-2866-8 Ropinirole Tablet, USP 1 mg are green pentagonal tablets engraved “ROP” over “1” on one side, “APO” on the other side. They are supplied as follows: Bottles of 30s: NDC 60505-2867-3 Bottles of 60s: NDC 60505-2867-6 Bottles of 90s: NDC 60505-2867-9 Bottles of 100s: NDC 60505-2867-1 Bottles of 500s: NDC 60505-2867-5 Bottles of 1,000s: NDC 60505-2867-8 Ropinirole Tablet, USP 2 mg are pink pentagonal tablets engraved “ROP” over “2” on one side, “APO” on the other side. They are supplied as follows Bottles of 30s: NDC 60505-2868-3 Bottles of 60s: NDC 60505-2868-6 Bottles of 90s: NDC 60505-2868-9 Bottles of 100s: NDC 60505-2868-1 Bottles of 500s: NDC 60505-2868-5 Bottles of 1,000s: NDC 60505-2868-8 Ropinirole Tablet, USP 3 mg are purple pentagonal tablets engraved “ROP” over “3” on one side, “APO” on the other side. They are supplied as follows: Bottles of 30s: NDC 60505-2869-3 Bottles of 60s: NDC 60505-2869-6 Bottles of 90s: NDC 60505-2869-9 Bottles of 100s: NDC 60505-2869-1 Bottles of 500s: NDC 60505-2869-5 Bottles of 1,000s: NDC 60505-2869-8 Ropinirole Tablet, USP 4 mg are pale brown pentagonal tablets engraved “ROP” over “4” on one side, “APO” on the other side. They are supplied as follows: Bottles of 30s: NDC 60505-2870-3 Bottles of 60s: NDC 60505-2870-6 Bottles of 90s: NDC 60505-2870-9 Bottles of 100s: NDC 60505-2870-1 Bottles of 500s: NDC 60505-2870-5 Bottles of 1,000s: NDC 60505-2870-8 Ropinirole Tablet, USP 5 mg are blue pentagonal tablets engraved “ROP” over “5” on one side, “APO” on the other side. They are supplied as follows: Bottles of 30s: NDC 60505-2871-3 Bottles of 60s: NDC 60505-2871-6 Bottles of 90s: NDC 60505-2871-9 Bottles of 100s: NDC 60505-2871-1 Bottles of 500s: NDC 60505-2871-5 Bottles of 1,000s: NDC 60505-2871-8 STORAGE Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ROPINIROLE- ROPINIROLE TABLET, FILM COATED
APOTEX CORP.
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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
Dosage and Administration (2.3) 9/2016
Warnings and Precautions (5.7, 5.9) 9/2016
INDICATIONS AND USAGE
Ropinirole tablet is 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 hydrochloride 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 hy