Ropinirole (Ropinirole)

Trade Name : Ropinirole

West-Ward Pharmaceuticals Corp.

TABLET

Strength 0.25 mg/1

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

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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 West-Ward Pharmaceuticals Corp.. It is available in strength of 0.25 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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About GNH

No data

Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinsonu2019s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (, )

Parkinsonu2019s Disease:
Restless Legs Syndrome:

rOPINIRole Tablets USP are available for oral administration in the following strengths.
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 mg ()

Ropinirole tablets are contraindicated in patients known to have hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients.
History of hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients ()

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

The following adverse reactions are described in more detail in other sections of the label:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice.n
Parkinsonu2019s Disease
During the premarketing development of ropinirole, patients received ropinirole either without L-dopa (early Parkinsonu2019s disease trials) or as concomitant therapy with L-dopa (advanced Parkinsonu2019s disease trials). Because these two populations may have differential risks for various adverse reactions, this section will in general present adverse reaction data for these two populations separately.
Early Parkinsonu2019s disease (Without L-dopa):
Approximately 24% of patients treated with ropinirole who participated in the double-blind, placebo-controlled early Parkinsonu2019s disease (without L-dopa) trials discontinued treatment due to adverse reactions compared with 13% of patients who received placebo. The most common adverse reactions in patients treated with ropinirole (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation were nausea and dizziness.
Advanced Parkinsonu2019s Disease (with L-dopa):
Approximately 24% of patients who received ropinirole in the double-blind, placebo-controlled advanced Parkinsonu2019s disease (with L-dopa) trials discontinued treatment due to adverse reactions compared with 18% of patients who received placebo. The most common adverse reaction in patients treated with ropinirole (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation was dizziness.
Table 4 lists treatment-emergent adverse reactions that occurred in at least 2% of patients with advanced Parkinsonu2019s disease (with L-dopa) treated with ropinirole who participated in the double-blind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients. In these trials, either ropinirole or placebo was used as an adjunct to L-dopa.
Restless Legs Syndrome
In the double-blind, placebo-controlled trials in patients with RLS, the most commonly observed adverse reactions in patients treated with ropinirole (incidence at least 5% greater than placebo) were nausea, vomiting, somnolence, dizziness, and asthenic condition (i.e., asthenia, fatigue, and/or malaise).
Approximately 5% of patients treated with ropinirole who participated in the double-blind, placebo-controlled trials in the treatment of RLS discontinued treatment due to adverse reactions compared with 4% of patients who received placebo. The most common adverse reaction in patients treated with ropinirole (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation was nausea.
Most common adverse reactions (incidence with ropinirole at least 5% greater than placebo) in the respective indications were:

No data

7.1n- 12.3
7.2n- 12.3

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

The symptoms of overdose with ropinirole 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 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 in cases of overdose included vomiting, increased coughing, fatigue, syncope, vasovagal syncope, dyskinesia, agitation, chest pain, orthostatic hypotension, somnolence and confusional state.

rOPINIRole Tablets USP contain ropinirole hydrochloride USP, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 2-indol-2-one, 4-[2-(dipropylamino)ethyl]-1,3-dihydro-, monohydrochloride and the molecular formula is CHNOu2022HCl. The molecular weight is 296.84 (260.38 as the free base).
The structural formula is:
Ropinirole hydrochloride USP is a pale yellow to green powder, is freely soluble in water, and has a melting range of 243u00b0 to 250u00b0C.
Each tablet 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 USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg, respectively. Inactive ingredients consist of: colloidial silicon dioxide, croscarmellose sodium, lactose (anhydrous), magnesium stearate and microcrystalline cellulose. In addition, the 0.5 mg tablet contains: D&C Yellow #10 Aluminum Lake. The 1 mg tablet contains: Lime Green Lake Blend. The 2 mg tablet contains: FD&C Yellow #6 Aluminum Lake. The 3 mg tablet contains: FD&C Red #40 Aluminum Lake. The 4 mg tablet contains: Brown Lake Blend. The 5 mg tablet contains: FD&C Blue #2 Aluminum Lake.

No data

Carcinogenesis
Two-year carcinogenicity studies of ropinirole were conducted in mice at oral doses of 0, 5, 15, and 50 mg/kg/day and in rats at oral doses of 0, 1.5, 15, and 50 mg/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 for Parkinsonu2019s disease (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 3 times the MRHD on a mg/m basis.
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 doses of 20 mg/kg/day (8 times 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 (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/m basis). No effect on male fertility was observed in rats at doses up to 125 mg/kg/day (50 times the MRHD on a mg/m basis).

No data

The 0.25 mg tablet is supplied as a white to off-white, round biconvex tablet, debossed with u201c54 511u201d on one side and plain on the other side.
The 0.5 mg tablet is supplied as a yellow to speckled-yellow, round biconvex tablet, debossed with u201c54 337u201d on one side and plain on the other side.
The 1 mg tablet is supplied as a green to speckled-green, round biconvex tablet, debossed with u201c54 751u201d on one side and plain on the other side.
The 2 mg tablet is supplied as an orange to speckled-orange, round biconvex tablet, debossed with u201c54 231u201d on one side and plain on the other side.
The 3 mg tablet is supplied as a red to speckled-red, round biconvex tablet, debossed with u201c54 575u201d on one side and plain on the other side.
The 4 mg tablet is supplied as a brown to speckled-brown, round biconvex tablet, debossed with u201c54 273u201d on one side and plain on the other side.
The 5 mg tablet is supplied as a blue to speckled-blue, round biconvex tablet, debossed with u201c54 722u201d on one side and plain on the other side.
Storage
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Protect from light and moisture. Close container tightly after each use.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Dosing Instructions
Instruct patients to take ropinirole only as prescribed. If a dose is missed, advise patients not to double their next dose. Ropinirole can be taken with or without food n .
Ropinirole is the active ingredient in ropinirole tablets. 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 to immediately contact their healthcare professional n .
Falling Asleep During Activities of Daily Living and Somnolence
Alert patients to the potential sedating effects caused by ropinirole, 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 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.
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, etc.) in combination with ropinirole or when taking a concomitant medication (e.g., ciprofloxacin) that increases plasma levels of ropinirole n .
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 ropinirole, 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 ropinirole n .
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 ropinirole. The elderly are at greater risk than younger patients with Parkinsonu2019s disease. This risk is greater in patients who are taking ropinirole with L-dopa or taking higher doses of ropinirole 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
Dyskinesia
Inform patients that ropinirole may cause and/or exacerbate pre-existing dyskinesias n .
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) 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. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking ropinirole n .
Withdrawal-Emergent Hyperpyrexia and Confusion
Advise patients to contact their healthcare provider if they wish to discontinue ropinirole or decrease the dose of ropinirole n .
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 for any indication n .
Augmentation and Rebound
Inform patients with RLS that augmentation and/or rebound may occur after starting treatment with ropinirole n .
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 and any potential adverse effects on the breastfed child from ropinirole or from the underlying maternal condition . Advise patients that ropinirole 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 n
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10004278/09
Revised October 2017

rOPINIRole Tablets USP
(roe pinu2019 i roleu201d)
Rx only
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
If you have Parkinsonu2019s disease, read this side.
If you have Restless Legs Syndrome (RLS), read the other side.
What is the most important information I should know about ropinirole?
Ropinirole can cause serious side effects, including:
What is ropinirole?
Having one of these conditions does not mean you have or will develop the other condition.
You should not be taking more than 1 medicine containing ropinirole. Tell your healthcare provider if you are taking any other medicine containing ropinirole.
It is not known if ropinirole is safe and effective for use in children younger than 18 years of age.
Do not take ropinirole if you:
Before you take ropinirole, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of these medicines may increase your chances of getting side effects while taking ropinirole.
How should I take ropinirole for Parkinsonu2019s disease?
If you are taking ropinirole:
What are the possible side effects of ropinirole?
Ropinirole can cause serious side effects, including:
The most common side effects of ropinirole include:
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all of the possible side effects with ropinirole. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store rOPINIRole Tablets?
Keep ropinirole and all medicines out of the reach of children.
General information about the safe and effective use of ropinirole.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ropinirole for a condition for which it was not prescribed. Do not give ropinirole to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ropinirole that is written for health professionals.
What are the ingredients in rOPINIRole Tablets?
The following ingredients are in rOPINIRole Tablets:
Active ingredient:
Inactive ingredients:
This Patient Information has been approved by the U.S. Food and Drug Administration.
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10004278/09
Revised October 2017
PATIENT INFORMATION
rOPINIRole Tablets USP
(roe pinu2019 i roleu201d)
Rx only
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
If you have Restless Legs Syndrome (RLS), read this side.
If you have Parkinsonu2019s disease, read the other side.
People with RLS should take ropinirole differently than people with Parkinsonu2019s disease (see for the recommended dosing for RLS). A lower dose of ropinirole is generally needed for people with RLS, and is taken once daily before bedtime.
What is the most important information I should know about ropinirole?
Ropinirole can cause serious side effects, including:
What is ropinirole?
Ropinirole is a prescription medicine containing ropinirole used to treat moderate-to-severe primary Restless Legs Syndrome (RLS). It is also used to treat Parkinsonu2019s disease.
Having one of these conditions does not mean you have or will develop the other condition.
You should not be taking more than 1 medicine containing ropinirole. Tell your healthcare provider if you are taking any other medicine containing ropinirole.
It is not known if ropinirole is safe and effective for use in children younger than 18 years of age.
Do not take ropinirole if you:
Before you take ropinirole, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of these medicines may increase your chances of getting side effects while taking ropinirole.
How should I take ropinirole for RLS?
What are the possible side effects of ropinirole?
Ropinirole can cause serious side effects, including:
The most common side effects of ropinirole include:
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all of the possible side effects with ropinirole. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
How should I store rOPINIRole Tablets?
Keep ropinirole and all medicines out of the reach of children.
General information about the safe and effective use of ropinirole.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ropinirole for a condition for which it was not prescribed. Do not give ropinirole to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about ropinirole that is written for healthcare professionals.
What are the ingredients in rOPINIRole Tablets?
The following ingredients are in rOPINIRole Tablets:
Active ingredient:
Inactive ingredients:
This Patient Information has been approved by the U.S. Food and Drug Administration.
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10004278/09
Revised October 2017

rOPINIRole Tablets, .25 mg
0054-0116-25, Rx only

rOPINIRole Tablets, .5 mg
0054-0117-25, Rx only

rOPINIRole Tablets, 1 mg
0054-0118-25, Rx only

rOPINIRole Tablets, 2 mg
0054-0119-25, Rx only

rOPINIRole Tablets, 3 mg
0054-0120-25, Rx only

rOPINIRole Tablets, 4 mg
0054-0121-25, Rx only

rOPINIRole Tablets, 5 mg
0054-0122-25, Rx only

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Ropinirole (Ropinirole)

Trade Name : Ropinirole

TABLET

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

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)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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CONTACT US

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