REQUIP- ropinirole tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

REQUIP is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of REQUIP was demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). REQUIP is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS. REQUIP is contraindicated for patients k

Product summary:

Each pentagonal film-coated TILTAB® tablet with beveled edges contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: 0.25 mg: white tablets imprinted with “SB” and “4890” in bottles of 100 (NDC 0007-4890-20). 0.5 mg: yellow tablets imprinted with “SB” and “4891” in bottles of 100 (NDC 0007-4891-20). 1 mg: green tablets imprinted with “SB” and “4892” in bottles of 100 (NDC 0007-4892-20). 2 mg: pale yellowish-pink tablets imprinted with “SB” and “4893” in bottles of 100 (NDC 0007-4893-20). 3 mg: pale to moderate reddish-purple tablets, imprinted with “SB” and“4895” in bottles of 100 (NDC 0007-4895-20). 4 mg: pale brown tablets imprinted with “SB” and “4896” in bottles of 100 (NDC 0007-4896-20). 5 mg: blue tablets imprinted with “SB” and “4894” in bottles of 100 (NDC 0007-4894-20). 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]. GlaxoSmithKline Research Triangle Park, NC 27709 REQUIP and TILTAB are registered trademarks of GlaxoSmithKline. SINEMET is a registered trademark of Merck & Co., Inc. ©2009, GlaxoSmithKline. All rights reserved. May 2009 REP:3PI PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT PATIENT INFORMATION REQUIP® ( ropinirole tablets) If you have Restless Legs Syndrome (RLS, also known as Ekbom Syndrome), read this side Read this information completely before you start taking REQUIP . Read the information each time you get more medicine. There may be new information. This leaflet provides a summary about REQUIP. It does not include everything there is to know about your medicine. This information should not take the place of discussions with your doctor about your medical condition or REQUIP. What is REQUIP? REQUIP is a prescription medicine to treat moderate-to-severe primary Restless Legs Syndrome. It is sometimes used to treat Parkinson's disease. Having one of these conditions does not mean you have or will develop the other. What is the most important information I should know about REQUIP? Unusual urges: Some patients taking REQUIP or REQUIP XL get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider. Who should not take REQUIP? You should not take REQUIP if you are allergic to the active ingredient ropinirole or to any of the inactive ingredients. Your doctor and pharmacist have a list of the inactive ingredients. What should I tell my doctor? Be sure to tell your doctor if: How should I take REQUIP for RLS? What are the possible side effects of REQUIP? Some patients taking REQUIP get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider. This is not a complete list of side effects and should not take the place of discussions with your healthcare providers. Your doctor or pharmacist can give you a more complete list of possible side effects. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Other Information about REQUIP This leaflet summarizes important information about REQUIP. Medicines are sometimes prescribed for purposes other than those listed in this leaflet. Do not take REQUIP for a condition for which it was not prescribed. For more information, talk with your doctor or pharmacist. They can give you information about REQUIP that is written for healthcare professionals. PATIENT INFORMATION REQUIP® ( ropinirole tablets) If you have Parkinson's disease, read this side Read this information completely before you start taking REQUIP . Read the information each time you get more medicine. There may be new information. This leaflet provides a summary about REQUIP. It does not include everything there is to know about your medicine. This information should not take the place of discussions with your doctor about your medical condition or REQUIP. What is REQUIP? REQUIP is a prescription medicine used to treat Parkinson's disease. It is also used to treat moderate-to-severe primary Restless Legs Syndrome. Having one of these conditions does not mean you have or will develop the other. What is the most important information I should know about REQUIP? Unusual urges: Some patients taking REQUIP or REQUIP XL get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider. Who should not take REQUIP? You should not take REQUIP if you are allergic to the active ingredient ropinirole or to any of the inactive ingredients. Your doctor and pharmacist have a list of the inactive ingredients. What should I tell my doctor? Be sure to tell your doctor if: How should I take REQUIP for Parkinson's disease? What are the possible side effects of REQUIP? Some patients taking REQUIP get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider. This is not a complete list of side effects and should not take the place of discussions with your healthcare providers. Your doctor or pharmacist can give you a more complete list of possible side effects. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Other Information about REQUIP This leaflet summarizes important information about REQUIP. Medicines are sometimes prescribed for purposes other than those listed in this leaflet. Do not take REQUIP for a condition for which it was not prescribed. For more information, talk with your doctor or pharmacist. They can give you information about REQUIP that is written for healthcare professionals. GlaxoSmithKline Research Triangle Park, NC 27709 ©2009, GlaxoSmithKline. All rights reserved. April 2009 REP:2PIL

Authorization status:

New Drug Application

Summary of Product characteristics

REQUIP- ROPINIROLE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
REQUIP
(ROPINIROLE TABLETS)
PATIENT INFORMATION INCLUDED
DESCRIPTION
REQUIP (ropinirole) is an orally administered non-ergoline dopamine
agonist. It is the hydrochloride
salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one
monohydrochloride and has an empirical
formula of C
H N O•HCl. The molecular weight is 296.84 (260.38 as the free base).
The structural formula is:
Ropinirole hydrochloride is a white to yellow solid with a melting
range of 243° to 250°C and a
solubility of 133 mg/mL in water.
Each pentagonal film-coated TILTAB tablet with beveled edges contains
0.29 mg, 0.57 mg, 1.14 mg,
2.28 mg, 3.42 mg, 4.56 mg, or 5.70 mg ropinirole hydrochloride
equivalent to ropinirole, 0.25 mg,
0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist
of: croscarmellose sodium,
hydrous lactose, magnesium stearate, microcrystalline cellulose, and
one or more of the following:
carmine, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum
lake, hypromellose, iron
oxides, polyethylene glycol, polysorbate 80, titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
REQUIP is a non-ergoline dopamine agonist with high relative in vitro
specificity and full intrinsic
activity at the D and D dopamine receptor subtypes, binding with
higher affinity to D than to D or
D receptor subtypes.
Ropinirole has moderate in vitro affinity for opioid receptors.
Ropinirole and its metabolites have
negligible in vitro affinity for dopamine D , 5-HT , 5-HT ,
benzodiazepine, GABA, muscarinic,
alpha -, alpha -, and beta-adrenoreceptors.
_PARKINSON’S DISEASE:_ The precise mechanism of action of REQUIP as
a treatment for Parkinson’s
disease is unknown, although it is believed to be due to stimulation
of postsynaptic dopamine D -type
receptors within the caudate-putamen in the brain. This conclusion is
supported by studies that show that
ropinirole improves motor function in various animal models of
Parkinson’s disease. In particular,
ropinir