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Ropinirole 2 mg Tablet, Film Coated, Extended Release, 90-count

by Alembic Pharmaceuticals Inc. · 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-107-90)

NDC 62332-0107-90

🏷️ FDA NDC (as labeled) 62332-107-90 billing pads the product segment with a zero

This package

Contains90-count Cost per ea$0.3788 NADAC Per package$34.09 / 90 tablets Pack sizes6 compare ↓

Also priced by: Part D plans $0.9817/unit — full pricing hub ↓

Also comes in: 30 tablets 62332-0107-30 100 tablets 62332-0107-10 100 tablets 62332-0107-31 500 tablets 62332-0107-71 1000 tablets 62332-0107-91

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 62332-107-90

Product NDC 62332-107

11-digit billing NDC 62332010790

NCPDP billing unit EA — each (per item)

RxCUI 799054, 799055, 799056, 824959, 848582

UNII D7ZD41RZI9

UPC 0362332107308, 0362332111305, 0362332110308, 0362332109302

Application # ANDA202786

SPL Set ID 54fb15b7-da35-4841-ba5d-ee3712cd94f3

Established class (EPC) Nonergot Dopamine Agonist

Mechanism of action Dopamine Agonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2020-06-20

Route ORAL

Dosage form TABLET, FILM COATED, EXTENDED RELEASE

Substance ROPINIROLE HYDROCHLORIDE

GPI-14 73203070107520

GPI class rOPINIRole HCl ER

GCN Seq No 063858

GCN 99570

HICL code 012182

Ingredient (HICL) Ropinirole Hcl

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H6

Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain

HIC3 code H6A

Therapeutic class — specific (HIC3) Antiparkinsonism Drugs,Other

AHFS code 28:36.20.08

AHFS class Nonergot-Deriv.dopamine Receptor Agonist

FDB label name ROPINIROLE HCL ER 2 MG TABLET

FDB brand name Ropinirole Er

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 62332-107-90 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62332-0107-90. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Nonergot Dopamine Agonist class.

Pharmacologic class Nonergot Dopamine Agonist

Drug family (ATC) Dopamine agonists

How it works Dopamine Agonists

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAlembic Pharmaceuticals Inc.

Application holderALEMBIC PHARMACEUTICALS LTD

FDA applicationANDA202786 (ANDA)

Labeler code62332

First marketedJun 2020

Product typeHuman Prescription Drug

Portfolio491 products on file

🔎 All NDCs from Alembic Pharmaceuticals Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ROPINIROLE HCL ER 2 MG TABLET Ingredient Ropinirole Hcl

📖 What it is MedlinePlus · NLM

Ropinirole is used to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance), including shaking of parts of the body, stiffness, slowed movements, and problems with balance. Ropinirole is also used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Ropinirole is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance in the...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Ropinirole treats two different conditions. The regular tablets are approved for Parkinson's disease and for moderate-to-severe Restless Legs Syndrome — that uncomfortable, irresis...
Yes, and it's one of the most important things to know. Some people taking ropinirole have fallen asleep suddenly during everyday activities — including while driving — sometimes w...
I heard this medication can make you fall asleep out of nowhere. Is that true?
It can, and this is something to watch for carefully. Some people develop strong, hard-to-control urges — like gambling, overeating, compulsive shopping, or increased sexual intere...

📖 Read our full Ropinirole guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Ropinirole — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Ropinirole (101 interactions) — ranked by severity →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Pink / Brown / White / Green

ShapeCapsule

ImprintL195

Size12 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
UNII H3UP11403C
Ethylcellulose is a plant-derived polymer that thickens and forms protective coatings on tablets and capsules. It slows medicine release into the body and protects the contents from moisture and air.
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII ZF94AP8MEY
Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII 30IQX730WE
Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

12 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.379	$34.09 / 90 tablets
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.9817	$88.35 / 90 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 37% over the last 24 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ropinirole 2 mg 00228-3658-03	Actavis	30 tablets	$0.379	AB	Availability likely	—
Ropinirole 2 mg 43547-0554-03	Solco	30 tablets	$0.379	AB	Availability likely	—
Ropinirole 2 mgthis 62332-0107-90	Alembic	90 tablets	$0.379	AB	Availability likely	—
Ropinirole 2 mg 64850-0250-30	Elite	30 tablets	$0.379	AB	Availability likely	—
Ropinirole Hydrochloride 2 mg 42291-0713-30	AvKARE	30 tablets	—	AB	FDA listed	—
Ropinirole 2 mg 46708-0262-10	Alembic	100 tablets	—	AB	FDA listed	—
Ropinirole 2 mg 55111-0659-05	Dr.	500 tablets	—	AB	FDA listed	—
Ropinirole 2 mg 72162-2602-03	Bryant	30 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2020

On the market since

Jun 2020

📍

2026

Currently FDA-listed

6 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

30 tablets62332-0107-30 154 Rx · $6,420

100 tablets62332-0107-10 No Medicaid data

100 tablets62332-0107-31 No Medicaid data

500 tablets62332-0107-71 No Medicaid data

90 tablets this page62332-0107-90 No Medicaid data

1000 tablets62332-0107-91 No Medicaid data

Drug total (last 4 qtrs): 154 Rx · 10,650 units · $6,420 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ROPINIROLE — the ingredient across all brands.

Top reported reactions

Fall1,253

Fatigue1,193

Nausea1,149

Dizziness908

Hallucination886

Pain793

Dyspnoea788

Age at onset

Child1

Adolescent5

Adult1,291

Elderly1,698

Reporter sex

Male · 37%

Female · 63%

Unknown · 0%

Serious outcomes

Hospitalization5,589

Life-threatening443

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
62332-0107-10	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (62332-107-10)	—	—	2020-06-20	Active
62332-0107-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-107-30)	$0.3788 / ea	$11.36	2020-06-20	Active
62332-0107-31	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-107-31)	—	—	2020-06-20	Active
62332-0107-71	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-107-71)	—	—	2020-06-20	Active
62332-0107-90 You're viewing this	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-107-90)	$0.3788 / ea	$34.09	2020-06-20	Active
62332-0107-91	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-107-91)	—	—	2020-06-20	Active

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.3788 NADAC).

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 62332-0107-90?

NDC 62332-0107-90 is a 90-count package — 90 tablet, film coated, extended release in 1 bottle.

What is the difference between NDC 62332-0107-90 and NDC 62332-0107-30?

Both are Ropinirole 2 mg Tablet, Film Coated, Extended Release — the drug itself is identical. NDC 62332-0107-90 is the 90-count package, while NDC 62332-0107-30 is the 30 tablets package.

What NDC number is used to bill for this package of Ropinirole 2 mg Tablet, Film Coated, Extended Release?

Bill NDC 62332-0107-90 — the 11-digit billing format is 62332010790. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 30 words ▾

1 INDICATIONS AND USAGE Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease. Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease. (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION · Ropinirole extended-release tablets are taken once daily, with or without food; tablets must be swallowed whole and not be chewed, crushed, or divided. (2.1) · The recommended starting dose is 2 mg taken once daily for 1 to 2 weeks; the dose should be increased by 2 mg/day at 1 week or longer intervals. The maximum recommended dose of ropinirole extended-release tablets are 24 mg/day.

(2.2, 14.2) · Renal Impairment: In patients with end-stage renal disease on hemodialysis, the maximum recommended dose is 18 mg/day. (2.2) · If ropinirole extended-release tablets must be discontinued, it should be tapered gradually over a 7-day period; retitration of ropinirole extended-release tablets may be warranted if therapy is interrupted. (2.1, 2.2) · Patients may be switched directly from immediate-release ropinirole to ropinirole extended-release tablets; the initial switching dose of ropinirole extended-release tablets should approximately match the total daily dose of immediate-release ropinirole.

(2.3)

2.1General Dosing Recommendations · Ropinirole extended-release tablets are taken once daily, with or without food [see Clinical Pharmacology (12.3)] . · Tablets must be swallowed whole and must not be chewed, crushed, or divided. · If a significant interruption in therapy with ropinirole extended-release tablets has occurred, retitration of therapy may be warranted.

2.2Dosing for Parkinson's Disease The recommended starting dose of ropinirole extended-release tablets is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at weekly or longer intervals, based on therapeutic response and tolerability. Monitor patients at least weekly during dose titration. Too rapid a rate of titration may lead to the selection of a dose that does not provide additional benefit, but increases the risk of adverse reactions.

In fixed-dose studies designed to characterize the dose response to ropinirole extended-release tablets, there was no additional therapeutic benefit shown in patients with advanced stage Parkinson’s disease taking daily doses greater than 8 mg/day, or with early stage Parkinson’s disease taking doses greater than 12 mg/day [see Clinical Studies (14.1 and 14.2)] . Although the maximum recommended dose of ropinirole extended-release tablets is 24 mg, patients with advanced Parkinson’s disease should generally be maintained at daily doses of 8 mg or lower and patients with early Parkinson’s disease should generally be maintained at daily doses 12 mg or lower.

Ropinirole extended-release tablets should be discontinued gradually over a 7-day period [see Warnings and Precautions (5.9)]. Renal Impairment No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The recommended initial dose of ropinirole extended-release tablets for patients with end-stage renal disease on hemodialysis is 2 mg once daily.

Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 18 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required.

The use of ropinirole extended-release tablets in patients with severe renal impairment without regular dialysis has not been studied.

2.3Switching from Immediate-Release Ropinirole Tablets to Extended-Release Ropinirole Tablets Patients may be switched directly from immediate-release ropinirole to extended-release ropinirole tablets. The initial dose of ropinirole extended-release tablets should approximately match the total daily dose of the immediate-release formulation of ropinirole, as shown in Table 1. Table 1.

Conversion from Immediate-Release Ropinirole Tablets to Extended-Release Ropinirole Tablets Immediate-Release Ropinirole Tablets Total Daily Dose (mg) Extended-Release Ropinirole Tablets Total Daily Dose (mg) 0.75 to 2.25 2 3 to 4.5 4 6 6 7.5 to 9 8 12 12 15 16 18 18 21 20 24 24 Following conver…

💊 Dosage Forms and Strengths 134 words ▾

3 DOSAGE FORMS AND STRENGTHS Ropinirole extended-release tablets, USP are available as below: • 2 mg, pink, capsule shaped, film coated tablet, debossed with ‘L191’ on one side and plain on other side. • 4 mg, light brown, capsule shaped, film coated tablet, debossed with ‘L193’ on one side and plain on other side. • 6 mg, white to off white, capsule shaped, film coated tablet, debossed with ‘L321’ on one side and plain on other side. • 8 mg, dark brown to red, capsule shaped, film coated tablet, debossed with ‘L194’ on one side and plain on other side. • 12 mg, light green, capsule shaped, film coated tablet, debossed with ‘L195’ on one side and plain on other side.

Tablets: 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg (3)

⛔ Contraindications 46 words ▾

4 CONTRAINDICATIONS 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 (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS •Sudden onset of sleep and somnolence may occur (5.1) •Syncope may occur (5.2) •Hypotension, including orthostatic hypotension may occur (5.3) •Elevation of blood pressure and changes in heart rate may occur (5.4) •May cause hallucinations and psychotic-like behaviors (5.5) •May cause or exacerbate dyskinesia (5.6) •May cause problems with impulse control or compulsive behaviors (5.7)

5.1Falling Asleep during Activities of Daily Living and Somnolence Patients treated with ropinirole extended-release tablets have reported falling asleep while engaged in activities of daily living, including driving or operating machinery, which sometimes resulted in accidents. Although many of these patients reported somnolence while on ropinirole, some perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some have reported these events more than 1 year after initiation of treatment.

Among the 613 patients who received ropinirole extended-release tablets in flexible-dose clinical trials (Study 1 and Study 3), <1% of patients reported sudden onset of sleep and <1% of patients reported a motor vehicle accident in which it is not known if falling asleep was a contributing factor. In a placebo-controlled fixed-dose trial in patients with advanced Parkinson’s disease (Study 2), sudden onset of sleep was reported in 4% of 276 patients on ropinirole extended-release tabletscompared with 3% of 74 patients on placebo.

In a placebo-controlled fixed-dose trial in patients with early Parkinson’s disease (Study 4), sudden onset of sleep was reported in 5% of 146 patients on ropinirole extended-release tabletscompared with 0% of 40 patients on placebo [see Adverse Reactions (6.1)] . The incidence of sudden onset of sleep was not dose-related in either trial. During a placebo-controlled flexible-dose trial in patients with advanced Parkinson’s disease (Study 1), somnolence was reported in 7% of 202 patients on ropinirole extended-release tablets compared with 4% of 191 patients on placebo.

During a flexible-dose, active-control, crossover trial in early Parkinson’s disease (Study 3), somnolence was reported in 11% of 140 patients on ropinirole extended-release tablets compared with 15% of 149 patients on an immediate-release formulation of ropinirole tablets [see Adverse Reactions (6.1)]. In a placebo-controlled fixed-dose trial in patients with advanced Parkinson’s disease (Study 2), somnolence was reported in 8% of 276 patients on ropinirole extended-release tablets compared with 5% of 74 patients on placebo.

In a placebo-controlled fixed-dose trial in patients with early Parkinson’s disease (Study 4), somnolence was reported in 10% of 146 patients on ropinirole extended-release tablets compared with 5% of 40 patients on placebo [see Adverse Reactions (6.1)] . The frequency of reported somnolence was not dose-related. It has been reported that falling asleep while engaged in activities of daily living usually occurs in a setting of pre-existing somnolence, although patients may not give such a history.

For this reason, prescribers should reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities. Before initiating treatment with ropinirole extended-release tablets, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with ropinirole extended-release tablets such as concomitant sedating medications or alcohol, the presence of sleep disorders, and concomitant medications that increase ropinirole plasma levels (e.g., ciprofloxacin) [see Drug Interactions (7.1)] .

If a patient develops significant daytime sleepiness or episodes of fallin…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the label: • Hypersensitivity [see Contraindications (4)] • Falling asleep during activities of daily living and somnolence [see Warnings and Precautions (5.1)] • Syncope [see Warnings and Precautions (5.2)] • Hypotension/ orthostatic hypotension [see Warnings and Precautions (5.3)] • Elevation of blood pressure and changes in heart rate [see Warnings and Precautions (5.4)] • Hallucinations/ psychotic-like behavior [see Warnings and Precautions (5.5)] • Dyskinesia [see Warnings and Precautions (5.6)] • Impulse control/compulsive behaviors [see Warnings and Precautions (5.7)] • Withdrawal-emergent hyperpyrexia and confusion [see Warnings and Precautions (5.8)] • Withdrawal symptoms [see Warnings and Precautions (5.9)] • Fibrotic complications [see Warnings and Precautions (5.10)] • Retinal pathology [see Warnings and Precautions (5.11)] · Most common adverse reactions (incidence for ropinirole extended-release tablets all doses at least 5% greater than placebo in either a flexible- or fixed-dose study) in patients with advanced Parkinson’s disease were nausea, dyskinesia, dizziness, and hallucination.

(6.1) · Most common adverse reactions (incidence for ropinirole extended-release tablets all doses at least 5% greater than placebo in fixed-dose study) in patients with early Parkinson’s disease not taking L-dopa were nausea, somnolence, sudden onset of sleep, hypertension, and headache. In a flexible-dose study in patients with early Parkinson's, the most common adverse reactions (at least 5% incidence for ropinirole extended-release tablets) were nausea, somnolence, abdominal pain/discomfort, dizziness, headache, and constipation.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience 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. During the premarketing development of ropinirole extended-release tablets, patients with advanced Parkinson’s disease received ropinirole extended-release tablets or placebo as adjunctive therapy with L-dopa in a flexible-dose clinical trial.

In a flexible-dose trial, patients with early Parkinson’s disease were treated with ropinirole extended-release tablets or the immediate-release formulation of ropinirole tablets without L-dopa. In addition, placebo-controlled, fixed-dose, postmarketing trials evaluated the dose response of ropinirole extended-release tablets in patients with advanced Parkinson’s disease taking L-dopa and in patients with early Parkinson’s disease without concomitant L-dopa. Advanced Parkinson’s Disease (with L-dopa) Study 1 was a 24-week, double-blind, placebo-controlled, flexible-dose trial in patients with advanced Parkinson’s disease.

In Study 1, the most commonly observed adverse reactions in patients treated with ropinirole extended-release tablets (incidence at least 5% greater than placebo) were dyskinesia, nausea, dizziness, and hallucinations. In Study 1, approximately 6% of patients treated with ropinirole extended-release tablets discontinued treatment due to adverse reactions, compared with 5% of patients who received placebo. The most common adverse reaction in patients treated with ropinirole extended-release tablets causing discontinuation of treatment with ropinirole extended-release tablets in Study 1 was hallucination (2%) Table 2 lists adverse reactions that occurred in at least 2% (and were numerically greater than placebo) of patients with advanced Parkinson’s disease treated with ropinirole extended-release tablets who participated in St…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS · Inhibitors or inducers of CYP1A2: May alter the clearance of ropinirole; dose adjustment of ropinirole extended-release tablets may be required. (7.1, 12.3) · Hormone replacement therapy (HRT): Starting or stopping HRT treatment may require dose adjustment of ropinirole extended-release tablets. (7.2, 12.3) · Dopamine antagonists (e.g., neuroleptics metoclopramide): May reduce efficacy of ropinirole extended-release tablets. (7.3)

7.1Cytochrome P450 1A2 Inhibitors and Inducers In vitro metabolism studies showed that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of ropinirole. There is thus the potential for inducers or inhibitors of this enzyme to alter the clearance of ropinirole. Therefore, if therapy with a drug known to be a potent inducer or inhibitor of CYP1A2 is stopped or started during treatment with ropinirole extended-release tablets, adjustment of the dose of ropinirole extended-release tablets may be required.

Coadministration of ciprofloxacin, an inhibitor of CYP1A2, with immediate-release ropinirole increases the AUC and C max of ropinirole [see Clinical Pharmacology (12.3)] . Cigarette smoking is expected to increase the clearance of ropinirole since CYP1A2 is known to be induced by smoking [see Clinical Pharmacology (12.3)] .

7.2Estrogens Population pharmacokinetic analysis revealed that higher doses of estrogens (usually associated with hormone replacement therapy) reduced the clearance of ropinirole. Starting or stopping hormone replacement therapy may require adjustment of dosage of ropinirole extended-release tablets [see Clinical Pharmacology (12.3)].

7.3Dopamine Antagonists Because ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes) or metoclopramide may reduce the efficacy of ropinirole extended-release tablets.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. (8.1)

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole extended-release tablets in pregnant women. In animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the MRHD for Parkinson’s disease. Ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity.

In pregnant rabbits, ropinirole potentiated the teratogenic effects of L-dopa when these drugs were administered in combination [see Data] . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage in the indicated populations is unknown.

Data Animal Data: Oral administration of ropinirole (0, 20, 60, 90, 120, or 150 mg/kg/day) to pregnant rats during organogenesis resulted in embryolethality, increased incidence of fetal malformations (digit, cardiovascular, and neural tube defects) and variations, and decreased fetal weight at the 2 highest doses. These doses were also associated with maternal toxicity. The highest no-effect dose for adverse effects on embryofetal development (90 mg/kg/day) is approximately 36 times the MRHD for Parkinson’s disease (24 mg/day) on a body surface area (mg/m 2 ) basis.

No effect on embryofetal development was observed in rabbits when ropinirole was administered alone during organogenesis at oral doses of 0, 1, 5, or 20 mg/kg/day (up to 16 times the MRHD on a mg/m 2 basis). In pregnant rabbits, there was a greater incidence and severity of fetal malformations (primarily digit defects) when ropinirole (10 mg/kg/day) was administered orally during gestation in combination with L-dopa (250 mg/kg/day) than when L-dopa was administered alone. This drug combination was also associated with maternal toxicity.

Oral administration of ropinirole (0, 0.1, 1, or 10 mg/kg/day) to rats during late gestation and continuing throughout lactation resulted in neurobehavioral impairment (decreased startle response) and decreased body weight in offspring at the highest dose. The no-effect dose of 1 mg/kg/day is less than the MRHD on a mg/m 2 basis.

8.2Lactation Risk Summary There are no data on the presence of ropinirole in human milk, the effects of ropinirole on the breastfed infant, or the effects of ropinirole on milk production. However, inhibition of lactation is expected because ropinirole inhibits secretion of prolactin in humans. Ropinirole or metabolites, or both, are present in rat milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ropinirole extended-release tablets and any potential adverse effects on the breastfed infant from ropinirole or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Dose adjustment is not necessary in elderly (65 years and older) patients, as the dose of ropinirole extended-release tablets are individually titrated to clinical therapeutic response and tolerability. Pharmacokinetic trials conducted in patients demonstrated that oral clearance of ropinirole is reduced by 15% in patients older than 65 years compared with younger patients [see Clinical Pharmacology (12.3)] . In flexible-dose clinical trials of ropinirole extended-release tablets, 387 patients were 65 years and older and 107 patients were 75 years and older.

Among patients receiving ropinirole extended-release tablets, hallucination was more common in elderly patients (10%) compared with non-elderly patients (2%). In these trials, the incidence of ove…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 183 words ▾

Among patients receiving ropinirole extended-release tablets, hallucination was more common in elderly patients (10%) compared with non-elderly patients (2%). In these trials, the incidence of overall adverse reactions increased with increasing age for both patients receiving ropinirole extended-release tablets and placebo. In the fixed-dose clinical trials of ropinirole extended-release tablets, 176 patients were 65 years and older and 73 were 75 and older.

Among patients with advanced Parkinson’s disease receiving ropinirole extended-release tablets, vomiting and nausea were more common in patients greater than 65 years (5% and 9%, respectively) compared with patients less than 65 (1% and 7%, respectively).

🆘 Overdosage 124 words ▾

10 OVERDOSAGE 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ropinirole is a non-ergoline dopamine agonist. The precise mechanism of action of ropinirole as a treatment for Parkinson’s disease is unknown, although it is thought to be related to its ability to stimulate dopamine D 2 receptors within the caudate-putamen in the brain.

12.2Pharmacodynamics Clinical experience with dopamine agonists, including ropinirole, suggests an association with impaired ability to regulate blood pressure resulting in orthostatic hypotension, especially during dose escalation. In some subjects in clinical trials, blood pressure changes were associated with the emergence of orthostatic symptoms, bradycardia, and, in one case in a healthy volunteer, transient sinus arrest with syncope [see Warnings and Precautions (5.2, 5.3)]. The mechanism of orthostatic hypotension induced by ropinirole is presumed to be due to a D 2 -mediated blunting of the noradrenergic response to standing and subsequent decrease in peripheral vascular resistance.

Nausea is a common concomitant symptom of orthostatic signs and symptoms. At oral doses as low as 0.2 mg, ropinirole suppressed serum prolactin concentrations in healthy male volunteers. Immediate-release ropinirole had no dose-related effect on electrocardiogram wave form and rhythm in young, healthy, male volunteers in the range of 0.01 to 2.5 mg.

Immediate-release ropinirole had no dose- or exposure-related effect on mean QTc intervals in healthy male and female volunteers titrated to doses up to 4 mg/day. The effect of ropinirole on QTc intervals at higher exposures achieved either due to drug interactions, hepatic impairment, or at higher doses has not been systematically evaluated.

12.3Pharmacokinetics Increase in systemic exposure of ropinirole following oral administration of 2 to 12 mg of ropinirole extended-release tablets was approximately dose proportional. For ropinirole extended-release tablets, steady-state concentrations of ropinirole are expected to be achieved within 4 days of dosing. Absorption In clinical trials with immediate-release ropinirole, more than 88% of a radiolabeled dose was recovered in urine, and the absolute bioavailability was 45% to 55%, indicating approximately 50% first-pass effect.

The bioavailability of ropinirole extended-release tablets is similar to that of immediate-release ropinirole tablets. In a repeat-dose trial in subjects with Parkinson’s disease using ropinirole extended-release tablets 8 mg, the dose-normalized AUC (0-24) and C min for ropinirole extended-release tablets and immediate-release ropinirole were similar. Dose-normalized C max was, on average, 12% lower for ropinirole extended-release tablets than for the immediate-release formulation and the median time to peak concentration was 6 to 10 hours.

In a single-dose trial, administration of ropinirole extended-release tablets to healthy volunteers with food (i.e., high-fat meal) increased AUC by approximately 30% and C max by approximately 44% compared with dosing under fasted conditions. In a repeat-dose trial in patients with Parkinson’s disease, food (i.e., high-fat meal) increased AUC by approximately 20% and C max by approximately 44%; T max was prolonged by 3 hours (median prolongation) compared with dosing under fasted conditions [see Dosage and Administration (2)] .

Distribution Ropinirole is widely distributed throughout the body, with an apparent volume of distribution of

7.5L/kg. It is up to 40% bound to plasma proteins and has a blood-to-plasma ratio of 1:1. Metabolism Ropinirole is extensively metabolized by the liver.

The major metabolic pathways are N-despropylation and hydroxylation to form the inactive N-despropyl metabolite and hydroxy metabolites. The N-despropyl metabolite is converted to carbamyl glucuronide, carboxylic acid, and N-despropyl hydroxy metabolites. The hydroxy metabolite of ropinirole is rapidly glucuronidated.

In vitro studies indicate that the major cytochrome P450 enzyme inv…

🧬 Mechanism of Action 47 words ▾

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Each capsule shaped, film coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: 2 mg: pink tablets debossed with ‘L191’ NDC 62332-107-30 bottle of 30 tablets with child-resistant closure NDC 62332-107-90 bottle of 90 tablets with child-resistant closure NDC 62332-107-31 bottle of 100 tablets with child-resistant closure NDC 62332-107-71 bottle of 500 tablets NDC 62332-107-91 bottle of 1000 tablets NDC 62332-107-10 carton of 100 (10X10) unit dose tablets 4 mg: light brown tablets debossed with ‘L193’ NDC 62332-108-30 bottle of 30 tablets with child-resistant closure NDC 62332-108-90 bottle of 90 tablets with child-resistant closure NDC 62332-108-31 bottle of 100 tablets with child-resistant closure NDC 62332-108-71 bottle of 500 tablets NDC 62332-108-91 bottle of 1000 tablets NDC 62332-108-10 carton of 100 (10X10) unit dose tablets 6 mg: white to off white tablets debossed with ‘L321’ NDC 62332-109-30 bottle of 30 tablets with child-resistant closure NDC 62332-109-90 bottle of 90 tablets with child-resistant closure NDC 62332-109-31 bottle of 100 tablets with child-resistant closure NDC 62332-109-71 bottle of 500 tablets NDC 62332-109-91 bottle of 1000 tablets NDC 62332-109-10 carton of 100 (10X10) unit dose tablets 8 mg: dark brown to red tablets debossed with ‘L194’ NDC 62332-110-30 bottle of 30 tablets with child-resistant closure NDC 62332-110-90 bottle of 90 tablets with child-resistant closure NDC 62332-110-31 bottle of 100 tablets with child-resistant closure NDC 62332-110-71 bottle of 500 tablets NDC 62332-110-91 bottle of 1000 tablets NDC 62332-110-10 carton of 100 (10X10) unit dose tablets 12 mg: light green tablets debossed with ‘L195’ NDC 62332-111-30 bottle of 30 tablets with child-resistant closure NDC 62332-111-90 bottle of 90 tablets with child-resistant closure NDC 62332-111-31 bottle of 100 tablets with child-resistant closure NDC 62332-111-71 bottle of 500 tablets NDC 62332-111-91 bottle of 1000 tablets NDC 62332-111-10 carton of 100 (10X10) unit dose tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP.

📋 Description 165 words ▾

11 DESCRIPTION Ropinirole extended-release tablets, USP 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 empirical formula is C 16 H 24 N 2 O•HCl. The molecular weight is 296.84 (260.38 as the free base).

The structural formula is: Ropinirole hydrochloride, USP 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 capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, ethylcellulose, hydrogenated castor oil, hypromellose, magnesium stearate, and one or more of the following: FD&C Blue No.

2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, povidone, pregelatinized starch, talc, titanium dioxide. FDA approved dissolution test specifications differ from USP. Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Dosing Instructions Instruct patients to take ropinirole extended-release tablets only as prescribed. If a dose is missed, advise patients not to double their next dose.

Ropinirole extended-release tablets can be taken with or without food. Inform patients to swallow ropinirole extended-release tablets whole and not to chew, crush, or divide the tablets [see Dosage and Administration (2.1)] . Ropinirole is the active ingredient in both ropinirole extended-release tablets and ropinirole 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 ropinirole tablets or ropinirole extended-release tablets, to immediately contact their healthcare professional [see Contraindications (4)] .

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) 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 ropinirole extended-release tablets or when taking a concomitant medication (e.g., ciprofloxacin) that increases plasma levels of ropinirole [see Warnings and Precautions (5.1)] .

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 extended-release tablets, 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 extended-release tablets [see Warnings and Precautions (5.2, 5.3)] . 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 [see Warnings and Precautions (5.4)] . Hallucinations/Psychotic…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyskinesia: Involuntary, uncontrolled movements of the face, arms, legs, or body.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

electrocardiogram: A quick, painless test that records the heart's electrical activity to check its rhythm and rate.

end-stage renal disease: The most advanced, permanent stage of kidney failure, usually needing dialysis or a kidney transplant.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

hallucination: Seeing, hearing, feeling, or smelling something that is not actually there.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

lactation: The making and release of milk from a mother's breasts after giving birth.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neural tube defects: Serious birth defects of a baby's brain or spine that form very early in pregnancy.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

orthostatic hypotension: A drop in blood pressure when you stand up from sitting or lying down, which can cause brief dizziness.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

pruritus: Itching of the skin.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 62332-0104-30 · Alembic 62332-0108-10 · Alembic →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Ropinirole 2 mg Tablet, Film Coated, Extended Release, 90-count

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