ROPINIROLE tablet, film coated, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Alembic Pharmaceuticals Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 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 population, the estimated background r

Produkto santrauka:

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 62332-107-30                bottle of 30 tablets NDC 62332-107-90                bottle of 90 tablets NDC 62332-107-31                bottle of 100 tablets NDC 62332-107-71                bottle of 500 tablets NDC 62332-107-91                bottle of 1000 tablets NDC 62332-107-10                carton of 100 (10X10) unit dose tablets 4 mg: light brown tablets debossed with ‘L193’ NDC 62332-108-30                bottle of 30 tablets NDC 62332-108-90                bottle of 90 tablets NDC 62332-108-31                bottle of 100 tablets NDC 62332-108-71                bottle of 500 tablets NDC 62332-108-91                bottle of 1000 tablets NDC 62332-108-10                carton of 100 (10X10) unit dose tablets 6 mg: white to off white tablets debossed with ‘L321’ NDC 62332-109-30                bottle of 30 tablets NDC 62332-109-90                bottle of 90 tablets NDC 62332-109-31                bottle of 100 tablets NDC 62332-109-71                bottle of 500 tablets NDC 62332-109-91                bottle of 1000 tablets NDC 62332-109-10                carton of 100 (10X10) unit dose tablets 8 mg: dark brown to red tablets debossed with ‘L194’ NDC 62332-110-30                bottle of 30 tablets NDC 62332-110-90                bottle of 90 tablets NDC 62332-110-31                bottle of 100 tablets NDC 62332-110-71                bottle of 500 tablets NDC 62332-110-91                bottle of 1000 tablets NDC 62332-110-10                carton of 100 (10X10) unit dose tablets 12 mg: light green tablets debossed with ‘L195’ NDC 62332-111-30                bottle of 30 tablets NDC 62332-111-90                bottle of 90 tablets NDC 62332-111-31                bottle of 100 tablets NDC 62332-111-71                bottle of 500 tablets NDC 62332-111-91                bottle of 1000 tablets NDC 62332-111-10                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.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ROPINIROLE - ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE
ALEMBIC PHARMACEUTICALS INC.
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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
Warnings and Precautions, Hallucinations/Psychotic-Like Behavior (5.5)
7/2021
Warnings and Precautions, Impulse Control/Compulsive Behaviors (5.7)
7/2021
Warnings and Precautions, Withdrawal Symptoms (5.9) 7/2021
Warnings and Precautions, Melanoma-removal (5.10) 7/2021
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 hypersensitiv