ROPINIROLE HYDROCHLORIDE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Alembic Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

ROPINIROLE HYDROCHLORIDE

Σύνθεση:

ROPINIROLE 0.25 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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. Risk Summary 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 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 ad

Περίληψη προϊόντος:

Ropinirole Tablets: Each circular, biconvex, film-coated tablet contains ropinirole as follows: 0.25 mg: white tablets debossed with “H” on one side and “121” on other side NDC 62332-030-30     bottle of 30 tablets NDC 62332-030-31     bottle of 100 tablets   0.5 mg: yellow tablets debossed with “H” on one side and “122” on other side NDC 62332-031-30    bottle of 30 tablets NDC 62332-031-31    bottle of 100 tablets 1 mg: green tablets debossed with “H” on one side and “123” on other side NDC 62332-032-30     bottle of 30 tablets NDC 62332-032-31     bottle of 100 tablets 2 mg: Peach tablets debossed with “H” on one side and “124” on other side NDC 62332-033-30     bottle of 30 tablets NDC 62332-033-31     bottle of 100 tablets 3 mg: Purple tablets debossed with “H” on one side and “125” on other side NDC 62332-034-30     bottle of 30 tablets NDC 62332-034-31     bottle of 100 tablets 4 mg: Pale brown tablets debossed with “H” on one side and “126” on other side NDC 62332-035-30     bottle of 30 tablets NDC 62332-035-31     bottle of 100 tablets 5 mg: Blue tablets debossed with “H” on one side and “127” on other side NDC 62332-036-30     bottle of 30 tablets NDC 62332-036-31     bottle of 100 tablets STORAGE: Protect from light and moisture. Close container tightly after each use. Store at controlled room temperature 20°-25°C (68°-77°F) [see USP].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ROPINIROLE HYDROCHLORIDE - ROPINIROLE HYDROCHLORIDE TABLET, FILM
COATED
ALEMBIC PHARMACEUTICALS INC.
----------
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,
Withdrawal Symptoms (5.8) 7/2021
Melanoma-removal (5.9) 7/2021
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). (1)
DOSAGE AND ADMINISTRATION
· Ropinirole tablets can be taken with or without food. (2.1) (2)
· Retitration of ropinirole tablets may be warranted if therapy is
interrupted. (2.1) (2)
Parkinson’s Disease: (2)
· The recommended starting dose is 0.25 mg taken three times daily;
titrate to a maximum daily
dose of 24 mg. (2.2) (2)
· Renal Impairment: The maximum recommended dose is 18 mg/day in
patients with end-stage
renal disease on hemodialysis. (2.2) (2)
Restless Legs Syndrome: (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) (2)
· Renal Impairment: The maximum recommended dose is 3 mg/day in
patients with end-stage
renal disease on hemodialysis. (2.3) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 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 and somnolence may occur (5.1) (5)
· Syncope may occur (5.2) (5)
· Hypotension, including orthostatic hypotension may occur (5.3) (5)
· May cause hallucinations and psychotic-like behaviors (5.4) (5)
· May cause or exacerbate dyskinesia (5.5) (5)
· May cause problems