ROPINIROLE tablet, film coated, extended release

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Sandoz Inc

INN (International Adı):

ROPINIROLE HYDROCHLORIDE

Kompozisyon:

ROPINIROLE 2 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 ris

Ürün özeti:

Ropinirole exended-release tablets are biconvex, capsule-shaped, film-coated tablets that contain ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: Storage  Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

ROPINIROLE- ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE
SANDOZ 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 Behavior (5.7)
7/2021
Warnings and Precautions, Withdrawal Symptoms (5.9)
7/2021
Warnings and Precautions, Melonoma-removal (5.10)
7/2021
INDICATIONS AND USAGE
Ropinirole extended-release tablets are a non-ergoline dopamine
agonist indicated for the treatment of
Parkinson’s disease. (1)
DOSAGE AND ADMINISTRATION
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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
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ADVERSE REACTIONS
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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. The maximum
recommended dose of ropinirole
extended-release tablets is 24 mg/day. (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;