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Ropinirole Hydrochloride - Xl (Requip)

Trade Name : REQUIP

GlaxoSmithKline LLC

TABLET, FILM COATED, EXTENDED RELEASE

Strength 12 mg/1

ROPINIROLE HYDROCHLORIDE Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ropinirole Hydrochloride - Xl (Requip) which is also known as REQUIP and Manufactured by GlaxoSmithKline LLC. It is available in strength of 12 mg/1 per ml. Read more

Ropinirole Hydrochloride - Xl (Requip) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • REQUIP XL is indicated for the treatment of Parkinsonu2019s disease.
  • REQUIPu00a0XL is a non-ergoline dopamine agonist indicated for the treatment of Parkinsonu2019s disease. ()
  • No data
  • 2.2n- 14.2
  • 2.1n- 2.2
  • Tablets: 2u00a0mg, 4u00a0mg, 6 mg, 8u00a0mg, and 12 mg ()
  • REQUIP XL is contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients.
  • History of hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients ()
  • No data
  • The following adverse reactions are described in more detail in other sections of the label:
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • 7.1n- 12.3
  • 7.2n- 12.3
  • Pregnancy: Based on animal data, may cause fetal harm. ()
  • The symptoms of overdose with REQUIP XL are related to its dopaminergic activity. General supportive measures are recommended. Vital signs should be maintained, if necessary.
  • In clinical trials, there have been patients who accidentally or intentionally took more than their prescribed dose of ropinirole. The largest overdose reported with immediate-release ropinirole in clinical trials was 435u00a0mg taken over a 7-day period (62.1u00a0mg/day). Of patients who received a dose greater than 24u00a0mg/day, reported symptoms included adverse events commonly reported during dopaminergic therapy (nausea, dizziness), as well as visual hallucinations, hyperhidrosis, claustrophobia, chorea, palpitations, asthenia, and nightmares. Additional symptoms reported for overdoses included vomiting, increased coughing, fatigue, syncope, vasovagal syncope, dyskinesia, agitation, chest pain, orthostatic hypotension, somnolence, and confusional state.
  • REQUIPu00a0XL contains ropinirole, a nonu2011ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is CHNOu2022HCl. 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 243u00b0C to 250u00b0C and a solubility of 133u00a0mg/mL in water.
  • REQUIPu00a0XL extended-release tablets are formulated as a 3-layered tablet with a central, active-containing, slow-release layer, and 2 placebo outer layers acting as barrier layers that control the surface area available for drug release. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, glyceryl behenate, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mannitol, povidone, and one or more of the following: FD&C Yellow No. 6 aluminum lake, FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 400, titanium dioxide.
  • No data
  • Carcinogenesis
  • Two-year carcinogenicity studies of ropinirole were conducted in mice at oral doses of 0, 5, 15, and 50u00a0mg/kg/day and in rats at oral doses of 0, 1.5, 15, and 50u00a0mg/kg/day.
  • In rats, there was an increase in testicular Leydig cell adenomas at all doses tested. The lowest dose tested (1.5u00a0mg/kg/day) is less than the MRHD (24u00a0mg/day) on a mg/m basis. The endocrine mechanisms believed to be involved in the production of these tumors in rats are not considered relevant to humans.
  • In mice, there was an increase in benign uterine endometrial polyps at a dose of 50u00a0mg/kg/day. The highest dose not associated with this finding (15u00a0mg/kg/day) is 3 times the MRHD on a mg/m basis.
  • Mutagenesis
  • Ropinirole was not mutagenic or clastogenic in in vitro (Ames, chromosomal aberration in human lymphocytes, mouse lymphoma ) assays, or in the in vivo mouse micronucleus test.
  • Impairment of Fertility
  • When administered to female rats prior to and during mating and throughout pregnancy, ropinirole caused disruption of implantation at oral doses of 20u00a0mg/kg/day (8u00a0times the MRHD on a mg/m basis) or greater. This effect in rats is thought to be due to the prolactin-lowering effect of ropinirole. In rat studies using a low oral dose (5u00a0mg/kg) during the prolactin-dependent phase of early pregnancy (gestation days 0 to 8), ropinirole did not affect female fertility at oral doses up to 100u00a0mg/kg/day (40u00a0times the MRHD on a mg/m basis). No effect on male fertility was observed in rats at oral doses up to 125u00a0mg/kg/day (50u00a0times the MRHD on a mg/m basis).
  • The effectiveness of ropinirole was initially established with the immediate-release formulation (REQUIP tablets) for the treatment of early and advanced Parkinsonu2019s disease in 3 randomized, double-blind, placebo-controlled trials.
  • The effectiveness of REQUIPu00a0XL in the treatment of Parkinsonu2019s disease was supported by 2 randomized, double-blind, multicenter, flexible-dose clinical trials and clinical pharmacokinetic considerations. One trial conducted in patients with advanced Parkinsonu2019s disease compared REQUIPu00a0XL with placebo as adjunctive therapy to L-dopa (Study 1). A second trial compared REQUIPu00a0XL with REQUIP tablets in patients with early Parkinsonu2019s disease not receiving L-dopa (Study 3). REQUIP XL has also been evaluated in 2 postmarketing, randomized, double-blind, multicenter, fixed-dose, dose-response clinical trials conducted in advanced and early Parkinsonu2019s disease patients (Study 2 and Study 4, respectively).
  • In these trials a variety of measures were used to assess the effects of treatment (e.g., Unified Parkinsonu2019s Disease Rating Scale [UPDRS] scores, patient diaries recording time u201conu201d and u201coff,u201d tolerability of L-dopa dose reductions). The UPDRS is a multi-item rating scale intended to evaluate mentation (Part I), activities of daily living (Part II), motor performance (Part III), and complications of therapy (Part IV). Part III of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings in patients with Parkinsonu2019s disease (e.g., tremor, rigidity, bradykinesia, postural instability) scored for different body regions and has a maximum (worst) score of 108.
  • Each biconvex, capsule-shaped, film-coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:
  • Storage
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0-30u00b0C (59u00b0-86u00b0F) [see USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Dosing Instructions
  • Instruct patients to take REQUIPu00a0XL only as prescribed. If a dose is missed, advise patients not to double their next dose. REQUIPu00a0XL can be taken with or without food. Inform patients to swallow REQUIP XL tablets whole and not to chew, crush, or divide the tablets .
  • Ropinirole is the active ingredient in both REQUIPu00a0XL and REQUIP tablets (the immediate-release formulation). Ask your patients if they are taking another medication containing ropinirole.
  • Hypersensitivity/Allergic Reactions
  • Advise patients about the potential for developing a hypersensitivity/allergic reaction including manifestations such as urticaria, angioedema, rash, and pruritus when taking any ropinirole product. Inform patients who experience these or similar reactions after starting REQUIP or REQUIP XL, to immediately contact their healthcare professional .
  • Falling Asleep during Activities of Daily Living and Somnolence
  • Alert patients to the potential sedating effects caused by REQUIPu00a0XL, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Because somnolence is a frequent adverse reaction with potentially serious consequences, patients should not drive a car, operate machinery, or engage in other potentially dangerous activities until they have gained sufficient experience with REQUIPu00a0XL to gauge whether or not it adversely affects their mental and/or motor performance. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., conversations, eating, driving a motor vehicle) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician.
  • Advise patients of possible additive effects when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants) in combination with REQUIPu00a0XL or when taking a concomitant medication (e.g., ciprofloxacin) that increases plasma levels of ropinirole.
  • Syncope and Hypotension/Orthostatic Hypotension
  • Advise patients that they may experience syncope and may develop hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating while taking REQUIP XL, especially if they are elderly. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). Postural/orthostatic symptoms may be related to sitting up or standing. Accordingly, caution patients against standing rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with REQUIPu00a0XL .
  • Elevation of Blood Pressure and Changes in Heart Rate
  • Alert patients to the possibility of increases in blood pressure during treatment with REQUIP XL. Exacerbation of hypertension may occur. Medication dose adjustment may be necessary if elevation of blood pressure is sustained over multiple evaluations. Alert patients with cardiovascular disease who may not tolerate marked changes in heart rate to the possibility that they may experience significant increases or decreases in heart rate during treatment with REQUIPu00a0XL .
  • Hallucinations/Psychotic-Like Behavior
  • Inform patients that they may experience hallucinations (unreal visions, sounds, or sensations), and that other psychotic-like behavior can occur while taking REQUIP XL. The elderly are at greater risk than younger patients with Parkinsonu2019s disease. This risk is greater in patients who are taking REQUIP XL with L-dopa or taking higher doses of REQUIP XL, and may also be further increased in patients taking any other drugs that increase dopaminergic tone. Tell patients to report hallucinations or psychotic-like behavior to their healthcare provider promptly should they develop .
  • Dyskinesia
  • Inform patients that REQUIP XL may cause and/or exacerbate pre-existing dyskinesias .
  • Impulse Control/Compulsive Behaviors
  • Advise patients that they may experience impulse control and/or compulsive behaviors while taking 1 or more of the medications (including REQUIP XL) that increase central dopaminergic tone, that are generally used for the treatment of Parkinsonu2019s disease. Advise patients to inform their physician or healthcare provider if they develop new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with REQUIP XL. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking REQUIP XL .
  • Withdrawal-Emergent Hyperpyrexia and Confusion
  • Advise patients to contact their healthcare provider if they wish to discontinue REQUIP XL or decrease the dose of REQUIP XL .
  • Melanoma
  • Advise patients with Parkinsonu2019s disease that they have a higher risk of developing melanoma. Advise patients to have their skin examined on a regular basis by a qualified healthcare provider (e.g., dermatologist) when using REQUIP XL .
  • Nursing Mothers
  • Because of the possibility that ropinirole may be excreted in breast milk, discuss the developmental and health benefits of breastfeeding along with the motheru2019s clinical need for REQUIP XL and any potential adverse effects on the breastfed child from ropinirole or from the underlying maternal condition . Advise patients that REQUIP XL could inhibit lactation because ropinirole inhibits prolactin secretion.
  • Pregnancy
  • Because experience with ropinirole in pregnant women is limited and ropinirole has been shown to have adverse effects on embryofetal development in animals, including teratogenic effects, advise patients of this potential risk. Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy n
  • Trademarks are owned by or licensed to the GSK group of companies.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92018 GSK group of companies or its licensor.
  • RXL:8PI
  • No data
  • PRINCIPAL DISPLAY PANEL
  • Arrayn- NDC 0007-4885-13
  • REQUIP XLn
  • (ropinirole extended-release tablets)
  • 2 mg
  • R only
  • Arrayn- 30 Tablets
  • Each tablet contains 2.28 mg ropinirole HCl equivalent to 2 mg ropinirole.
  • Dosage:
  • Do not use if safety seal under cap is broken or missing.
  • Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature].
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in Ireland
  • Rev. 1/17
  • 10000000143772
  • PRINCIPAL DISPLAY PANEL
  • Arrayn- NDC 0007-4887-13
  • REQUIP XLn
  • (ropinirole extended-release tablets)
  • 4 mg
  • R only
  • Arrayn- 30 Tablets
  • Each tablet contains 4.56 mg ropinirole HCl equivalent to 4 mg ropinirole.
  • Dosage:
  • Do not use if safety seal under cap is broken or missing.
  • Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature].
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in Ireland
  • Rev. 11/16
  • 10000000143774
  • PRINCIPAL DISPLAY PANEL
  • Arrayn- NDC 0007-4883-13
  • REQUIP XLn
  • (ropinirole extended-release tablets)
  • 6 mg
  • R only
  • Arrayn- 30 Tablets
  • Each tablet contains 6.84 mg ropinirole HCl equivalent to 6 mg ropinirole.
  • Dosage:
  • Do not use if safety seal under cap is broken or missing.
  • Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature].
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in Ireland
  • Rev. 1/17
  • 10000000143773
  • PRINCIPAL DISPLAY PANEL
  • Arrayn- NDC 0007-4888-13
  • REQUIP XLn
  • (ropinirole extended-release tablets)
  • 8 mg
  • R only
  • Arrayn- 30 Tablets
  • Each tablet contains 9.12 mg ropinirole HCl equivalent to 8 mg ropinirole.
  • Dosage:
  • Do not use if safety seal under cap is broken or missing.
  • Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature].
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in Ireland
  • Rev. 12/16
  • 10000000143771
  • PRINCIPAL DISPLAY PANEL
  • Arrayn- NDC 0007-4882-13
  • REQUIP XLn
  • (ropinirole extended-release tablets)
  • 12 mg
  • R only
  • Arrayn- 30 Tablets
  • Each tablet contains 13.68 mg ropinirole HCl equivalent to 12 mg ropinirole.
  • Dosage:
  • Do not use if safety seal under cap is broken or missing.
  • Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature].
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in Ireland
  • Rev. 12/16
  • 10000000143775

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