Ropinirole (Ropinirole)

Trade Name : ropinirole

Sandoz Inc

TABLET, FILM COATED, EXTENDED RELEASE

Strength 2 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 (Ropinirole) which is also known as ropinirole and Manufactured by Sandoz Inc. It is available in strength of 2 mg/1 per ml. Read more

Ropinirole (Ropinirole) 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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Ropinirole extended-release tablets are indicated for the treatment of Parkinsonu2019s disease.
Ropinirole extended-release tabletsu00a0are a non-ergoline dopamine agonist indicated for the treatment of Parkinsonu2019s disease. ()

No data

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Tablets: 2u00a0mg, 4 mg, 6u00a0mg, 8 mg, and 12 mg ()

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.
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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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Pregnancy: Based on animal data, may cause fetal harm. ()

The symptoms of overdose with ropinirole extended-release tablets 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 435 mg taken over a 7-day period (62.1 mg/day). Of patients who received a dose greater than 24 mg/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.

Ropinirole extended-release tablets contain ropinirole, a non-ergoline 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 molecular 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 cream colored crystalline powder with a melting range of 241u00b0 to 245u00b0C and a solubility of 134u00a0mg/mL in water.
Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2u00a0mg, 4 mg, 6u00a0mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength).

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 (1.5 mg/kg/day) is less than the MRHD (24 mg/day) on a mg/mbasis. 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 50 mg/kg/day. The highest dose not associated with this finding (15 mg/kg/day) is three times the MRHD on a mg/mbasis.
Mutagenesis
Ropinirole was not mutagenic or clastogenic in (Ames, chromosomal aberration in human lymphocytes, mouse lymphoma ) assays, or in the 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 20 mg/kg/day (8 times the MRHD on a mg/mbasis) 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 (5 mg/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 100 mg/kg/day (40 times the MRHD on a mg/mbasis). No effect on male fertility was observed in rats at oral doses up to 125 mg/kg/day (50 times the MRHD on a mg/mbasis).

The effectiveness of ropinirole was initially established with the immediate-release formulation (ropinirole tablets) for the treatment of early and advanced Parkinsonu2019s disease in threeu00a0randomized, double-blind, placebo-controlled trials.
The effectiveness of ropinirole extended-release tablets in the treatment of Parkinsonu2019s disease was supported by two randomized, double-blind, multicenter, flexible-dose clinical trials and clinical pharmacokinetic considerations. One trial conducted in patients with advanced Parkinsonu2019s disease compared ropinirole extended-release tablets with placebo as adjunctive therapy to L-dopa (Study 1). A second trial compared ropinirole extended-release tablets with ropinirole immediate-release in patients with early Parkinsonu2019s disease not receiving L-dopa (Study 3). Ropinirole extended-release tablets 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, and 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.

Ropinirole exended-release tablets are biconvex, capsule-shaped, film-coated tablets that contain ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:
Storageu00a0
Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [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).
Arrayn- Dosing Instructions
Arrayn- Hypersensitivity/Allergic Reactions
Arrayn- Falling Asleep during Activities of Daily Living and Somnolence
Alert patients to the potential sedating effects caused by ropinirole extended-release tablets, 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 ropinirole extended-release tablets 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, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician.
Arrayn- Syncope and Hypotension/Orthostatic Hypotension
Arrayn- Elevation of Blood Pressure and Changes in Heart Rate
Alert patients to the possibility of increases in blood pressure during treatment with ropinirole extended-release tablets. 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 ropinirole extended-release tablets n n
Arrayn- Hallucinations/Psychotic-like Behavior
Inform patients that they may experience hallucinations (unreal visions, sounds, or sensations) and other psychotic-like behavior can occur while taking ropinirole extended-release tablets. The elderly are at greater risk than younger patients with Parkinsonu2019s disease. This risk is greater in patients who are taking ropinirole extended-release tablets with L-dopa or taking higher doses of ropinirole extended-release tablets, 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 n n
Arrayn- Dyskinesia
Inform patients that ropinirole extended-release tablets may cause and/or exacerbate pre-existing dyskinesias n n n n n
Arrayn- 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 ropinirole extended-release tablets) 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 ropinirole extended-release tablets. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking ropinirole extended-release tablets n n
Arrayn- Withdrawal-Emergent Hyperpyrexia and Confusion
Advise patients to contact their healthcare provider if they wish to discontinue ropinirole extended-release tablets or decrease the dose of ropinirole extended-release tablets n n
Arrayn- 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 ropinirole extended-release tablets n n
Arrayn- 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 ropinirole extended-release tablets and any potential adverse effects on the breastfed child from ropinirole or from the underlying maternal conditionn n Advise patients that ropinirole extended-release tablets could inhibit lactation because ropinirole inhibits prolactin secretion.
Arrayn- 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 n
The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.
Manufactured in India by Sandoz Private Ltd.
for Sandoz Inc., Princeton NJ 08540
Rev.: April 2017

PATIENT INFORMATION
Ropinirole Extended-release Tablets
(roe-PIN-ih-role)

NDC 0781-5780-31
rOPINIRole Extended-Release Tablets
2 mg*
Rx Only
30 Tablets

NDC 0781-5782-31
rOPINIRole Extended-Release Tablets
4 mg*
Rx Only
30 Tablets

NDC 0781-5784-31
rOPINIRole Extended-Release Tablets
6 mg*
Rx Only
30 Tablets

NDC 0781-5786-31
rOPINIRole Extended-Release Tablets
8 mg*
Rx Only
30 Tablets

NDC 0781-5788-31
rOPINIRole Extended-Release Tablets
12 mg*
Rx Only
30 Tablets

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Ropinirole (Ropinirole)

Trade Name : ropinirole

TABLET, FILM COATED, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Ropinirole (Ropinirole)

Trade Name : ropinirole

TABLET, FILM COATED, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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Fluoxetine Hydrochloride (Fluoxetine)

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Disclaimer

Browse from other international pharmaceuticals

General

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NZ Drugs

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