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Ropinirole (Ropinirole Hydrochloride)

Trade Name : Ropinirole Hydrochloride

Mylan Pharmaceuticals Inc.

TABLET

Strength 1 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 Hydrochloride) which is also known as Ropinirole Hydrochloride and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 1 mg/1 per ml. Read more

Ropinirole (Ropinirole Hydrochloride) 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

Packaging and Delivery

Validated Cold Chain Shipment

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.

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About GNH

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
  • Dosage and Administration ()u00a0u00a0u00a0u00a0u00a09/2016
  • Warnings and Precautions (, )u00a0u00a0u00a0u00a0u00a09/2016
  • 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 containing ropinirole hydrochloride, USP equivalent to 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg of ropinirole.
  • 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 a 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. ()
  • No data
  • 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.
  • Most common adverse reactions (incidence with ropinirole tablets at least 5% greater than placebo) in the respective indications were:
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 ropinirole 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 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, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(Dipropylamino)ethyl]-2-indolinone 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 white to cream colored crystalline powder with a melting range of 241u00b0 to 245u00b0C and a solubility of 133 mg/mL in water.
  • Each tablet contains 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 anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. In addition, the 0.5 mg tablets also contain D&C Yellow No. 10 Aluminum Lake. The 1 mg tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake. The 2 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 3 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 4 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 5 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Red No. 40 Aluminum Lake.
  • Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2.
  • No data
  • No data
  • No data
  • Ropinirole Tablets, USP are available containing ropinirole hydrochloride, USP equivalent to 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg of ropinirole.
  • The 0.25 mg tablets are white, round, unscored tablets debossed with on one side of the tablet and over on the other side. They are available as follows:
  • NDC 0378-5525-01bottles of 100 tablets
  • The 0.5 mg tablets are yellow, round, unscored tablets debossed with on one side of the tablet and over on the other side. They are available as follows:
  • NDC 0378-5550-01bottles of 100 tablets
  • The 1 mg tablets are green, round, unscored tablets debossed with on one side of the tablet and over on the other side. They are available as follows:
  • NDC 0378-5501-01bottles of 100 tablets
  • The 2 mg tablets are orange, round, unscored tablets debossed with on one side of the tablet and over on the other side. They are available as follows:
  • NDC 0378-5502-01bottles of 100 tablets
  • The 3 mg tablets are lavender, round, unscored tablets debossed with on one side of the tablet and over on the other side. They are available as follows:
  • NDC 0378-5503-01bottles of 100 tablets
  • The 4 mg tablets are grayish beige, round, unscored tablets debossed with on one side of the tablet and over on the other side. They are available as follows:
  • NDC 0378-5504-01bottles of 100 tablets
  • The 5 mg tablets are blue, round, unscored tablets debossed with on one side of the tablet and over on the other side. They are available as follows:
  • NDC 0378-5505-01bottles of 100 tablets
  • Storage: Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from light and moisture.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • Advise the patient to read the FDA-approved patient labeling ().
  • Dosing Instructions:u00a0n- [see ]
  • Ropinirole is the active ingredient in ropinirole tablets (the immediate-release formulation). Ask your patients if they are taking another medication containing ropinirole.
  • Hypersensitivity/Allergic Reactions:n- [see ]
  • Falling Asleep during Activities of Daily Living and Somnolence:
  • 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 tablets or when taking a concomitant medication (e.g., ciprofloxacin) that increases plasma levels of ropinirole .
  • Syncope and Hypotension/Orthostatic Hypotension:u00a0n- [see , ]
  • Hallucinations/Psychotic-like Behavior:u00a0n- [see ].
  • Dyskinesia:u00a0n- [see ]
  • Impulse Control/Compulsive Behaviors:n- [see ]
  • Withdrawal-Emergent Hyperpyrexia and Confusion:n- [see ]
  • Melanoma:n- [see ]
  • Augmentation and Rebound:n- [see ]
  • Nursing Mothers:n- [see ]. n- .
  • Pregnancy:n- [see ]
  • u00a0
  • Patient Information
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Mylan Pharmaceuticals Inc.n
  • Revised: 3/2020RPNL:R11ppb/PL:RPNLP:R8ppb/PL:RPNLR:R8ppb
  • NDC 0378-5525-01
  • rOPINIRolen- Tablets, USPn- 0.25 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each tablet contains ropinirole hydrochloride, USP equivalent to 0.25 mg of ropinirole.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from light and moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM5525A6
  • NDC 0378-5550-01
  • rOPINIRolen- Tablets, USPn- 0.5 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each tablet contains ropinirole hydrochloride, USP equivalent to 0.5 mg of ropinirole.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from light and moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM5550A6
  • NDC 0378-5501-01
  • rOPINIRolen- Tablets, USPn- 1 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each tablet contains ropinirole hydrochloride, USP equivalent to 1 mg of ropinirole.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from light and moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM5501A6
  • NDC 0378-5502-01
  • rOPINIRolen- Tablets, USPn- 2 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each tablet contains ropinirole hydrochloride, USP equivalent to 2 mg of ropinirole.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from light and moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM5502A6
  • NDC 0378-5503-01
  • rOPINIRolen- Tablets, USPn- 3 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each tablet contains ropinirole hydrochloride, USP equivalent to 3 mg of ropinirole.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from light and moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM5503A6
  • NDC 0378-5504-01
  • rOPINIRolen- Tablets, USPn- 4 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each tablet contains ropinirole hydrochloride, USP equivalent to 4 mg of ropinirole.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from light and moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM5504A6
  • NDC 0378-5505-01
  • rOPINIRolen- Tablets, USPn- 5 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each tablet contains ropinirole hydrochloride, USP equivalent to 5 mg of ropinirole.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from light and moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM5505A6

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