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METHYLPHENIDATE HYDROCHLORIDE 20 mg Tablet, 50-count

by AvPAK · 50 BLISTER PACK in 1 BOX (50268-529-15) / 1 TABLET in 1 BLISTER PACK (50268-529-11)
NDC 50268-0529-15
🏷️ FDA NDC (as labeled) 50268-529-15 billing pads the product segment with a zero
Rx only Generic Discontinued CII ⚠ Discontinued by firm
🗂️ Data synced Jul 16, 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

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

⚠️
Other active recalls for Methylphenidate Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 7, 2022 — Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind. (RISING PHARMACEUTICALS) · FDA recall D-0573-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through May 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 50268-529-15
Product NDC 50268-529
11-digit billing NDC 50268052915
NCPDP billing unit EA — each (per item)
RxCUI 1091150, 1091392
UNII 4B3SC438HI
Application # ANDA207416
SPL Set ID 9e7967c8-d323-160d-e053-2995a90a323e
Established class (EPC) Central Nervous System Stimulant
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through May 2026)
Marketing start 2020-02-13
Route ORAL
Dosage form TABLET
Substance METHYLPHENIDATE HYDROCHLORIDE
GPI-14 61400020100315
GPI class Methylphenidate HCl
GCN Seq No 004027
GCN 15920
HICL code 001682
Ingredient (HICL) Methylphenidate Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2V
Therapeutic class — specific (HIC3) Tx For Attention Deficit-Hyperact(Adhd)/Narcolepsy
AHFS code 28:20.32.00
AHFS class Respiratory And Cns Stimulants
FDB label name METHYLPHENIDATE 20 MG TABLET
FDB brand name Methylphenidate Hcl
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 50268-529-15 — 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 → 50268-0529-15. 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 Central Nervous System Stimulant class.

Pharmacologic class Central Nervous System Stimulant
Drug family (ATC) Centrally acting sympathomimetics
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

LabelerAvPAK
Application holderASCENT PHARMACEUTICALS INC
FDA applicationANDA207416 (ANDA)
Labeler code50268
First marketedFeb 2020
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio346 products on file
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 METHYLPHENIDATE 20 MG TABLET Ingredient Methylphenidate Hcl
📖 What it is MedlinePlus · NLM

Methylphenidate is used to control symptoms of attention deficit hyperactivity disorder (ADHD; condition that makes it hard to pay attention, control your behavior, and remain still or quiet) and to treat narcolepsy (condition that causes people to be very sleepy during the day and to fall asleep suddenly). Methylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by changing the amounts of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Methylphenidate helps boost two brain chemicals — dopamine and norepinephrine — that play a big role in attention, focus, and impulse control. When those chemicals are more availab...
  • What exactly is methylphenidate supposed to do for my ADHD?
  • Methylphenidate is a controlled substance, and it does have a real potential for abuse and dependence — that's something the FDA takes seriously enough to put a boxed warning on th...
  • The most common ones — decreased appetite, some trouble sleeping, headache, and a slightly faster heartbeat — are annoying but usually manageable and tend to improve over time. For...
📖 Read our full Methylphenidate guide →
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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.210 $10.51 / 50 tablet
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 $0.2171 $10.86 / 50 tablet
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.233 $0.143
▲ Up 18% 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methylphenidate Hydrochloride 20 mg 00115-1802-01 Amneal 100 tablets $0.210 — Availability likely —
Methylphenidate Hydrochloride 20 mg 00406-1146-01 SpecGx 100 tablets $0.210 AB Availability likely —
Methylphenidate Hydrochloride 20 mg 10702-0102-01 KVK-TECH, 100 tablets $0.210 AB Availability likely —
Methylphenidate Hydrochloride 20 mg 16729-0480-01 Accord 100 tablets $0.210 AB Availability likely —
Methylphenidate Hydrochloride 20 mg 31722-0175-01 Camber 100 tablets $0.210 AB Availability likely —
Methylphenidate hydrochloride 20 mg 43547-0488-10 Solco 100 tablets $0.210 AB Availability likely —
Methylphenidate Hydrochloride 20 mgthis 50268-0529-15 AvPAK 50 tablets $0.210 AB Discontinued —
Methylphenidate Hydrochloride 20 mg 67877-0618-01 Ascend 100 tablets $0.210 AB Availability likely —
Methylphenidate Hydrochloride 20 mg 75834-0326-01 Nivagen 100 tablets $0.210 AB Availability likely —
Methylphenidate Hydrochloride 20 mg 43386-0575-01 Lupin 100 tablets $0.227 AB FDA listed +8%
Ritalin 20 mg 00078-0441-05 Novartis 100 tablets $1.633 AB Discontinued +677%
Ritalin 20 mg 66758-0275-01 Sandoz 100 tablets $1.633 AB Availability likely +677%
Methylphenidate Hydrochloride 20 mg 13107-0382-01 Aurolife 100 tablets — — FDA listed —
Methylphenidate Hydrochloride 20 mg 55466-0103-12 Neolpharma, 100 tablets — AB Discontinued —
Methylphenidate Hydrochloride 20 mg 57664-0230-08 Sun 100 tablets — AB FDA listed —
Methylphenidate Hydrochloride 20 mg 71335-1219-01 Bryant 30 tablets — AB FDA listed —
Methylphenidate Hydrochloride 20 mg 72162-2087-01 Bryant 100 tablets — — FDA listed —
Methylphenidate Hydrochloride 20 mg 72162-2430-01 Bryant 100 tablets — AB FDA listed —
Methylphenidate Hydrochloride 20 mg 72865-0124-01 XLCare 100 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
Feb 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.

🔬 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 Methylphenidate hydrochloride — the ingredient across all brands.

Top reported reactions

Fatigue3,184
Headache2,966
Nausea2,963
Anxiety2,813
Depression2,349
Insomnia2,163
Somnolence1,900

Age at onset

Neonate57
Infant37
Child2,084
Adolescent1,299
Adult4,503
Elderly537

Reporter sex

58,909 reports

Serious outcomes

Death2,604
Disabling1,320
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,818 0
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 NDCDescription Marketing startStatus
50268-0529-15 You're viewing this 50 BLISTER PACK in 1 BOX (50268-529-15) / 1 TABLET in 1 BLISTER PACK (50268-529-11) 2020-02-13 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 50268-529-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50268-0529-15, written without dashes as 50268052915. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50268-0529-15, the first segment (50268) is the labeler code FDA assigned to AvPAK; the middle segment (0529) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
AvPAK is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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.
🚨 Boxed Warning 🎯 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 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 111 words ▾

WARNING: ABUSE AND DEPENDENCE CNS stimulants, including methylphenidate hydrochloride tablets, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)] . WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning.

CNS stimulants, including m ethylphenidate hydrochloride tablets , other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence (5.1, 9.2, 9.3). Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy (5.1, 9.2)

🎯 Indications and Usage 49 words ▾

1. INDICATIONS AND USAGE Methylphenidate hydrochloride tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults Narcolepsy Methylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy

⏱️ Dosage and Administration ~2 min read ▾

2. DOSAGE AND ADMINISTRATION Methylphenidate hydrochloride Tablets, USP (2.2) : Pediatric Patients 6 years and older: Start with 5 mg twice daily (before breakfast and lunch), titrating the dose weekly in 5 to 10 mg increments. Dosages above 60 mg/day are not recommended. Adults: Average daily dosage is 20 to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg.

2.1Pretreatment Screening Prior to treating pediatric patients and adults with central nervous system (CNS) stimulants, including methylphenidate hydrochloride tablets, assess for the presence of cardiac disease (i.e., perform a careful history including family history of sudden death or ventricular arrhythmia, and physical examination) [see Warnings and Precautions (5.2)] . Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for methylphenidate hydrochloride tablets use [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9)].

2.2General Dosing Information Methylphenidate hydrochloride Tablets Pediatric Patients 6 years and Older: Start with 5 mg orally twice daily (before breakfast and lunch). Increase dosage gradually, in increments of 5 to 10 mg weekly. Daily dosage above 60 mg is not recommended.

Adults: Average dosage is 20 to 30 mg daily. Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg.

Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m. Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of methylphenidate hydrochloride tablets, and adjust dosage as needed.

2.3Dose Reduction and Discontinuation If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue methylphenidate hydrochloride tablets. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

💊 Dosage Forms and Strengths 98 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets • 5 mg, Light yellow, round, biconvex, beveled edge tablets de-bossed with ‘T’ on one side and ‘173’ on the other side. • 10 mg, White to off white, round, flat, beveled edge tablets de-bossed with ‘T’ and ‘174’ with a functional score line on one side and plain on the other side. • 20 mg, Light yellow, round, flat, beveled edge tablets de-bossed with ‘T’ and ‘175’ with a functional score line on one side and plain on the other side. • Tablets: 5 mg, 10 mg, and 20 mg (3)

⛔ Contraindications 93 words ▾

4 CONTRAINDICATIONS Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions (6.1)]. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions (7.1)].

Known hypersensitivity to methylphenidate or other product components of methylphenidate hydrochloride tablets (4) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serious Cardiovascular Events : Sudden death has been reported in association with CNS-stimulant treatment at usual doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm arrhythmias, or coronary artery disease (5.2).

Blood Pressure and Heart Rate Increases : Monitor blood pressure and pulse. Consider the benefits and risk in patients for whom an increase in blood pressure or heart rate would be problematic (5.3) Psychiatric Adverse Reactions : Use of stimulants may cause psychotic or manic symptoms in patients with no prior history or exacerbation of symptoms in patients with preexisting psychiatric illness. Evaluate for preexisting psychotic or bipolar disorder prior to methylphenidate hydrochloride tablets use (5.4).

Priapism : Cases of painful and prolonged penile erections, and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed (5.5). Peripheral Vasculopathy, including Raynaud’s Phenomenon : Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon.

Careful observation for digital changes is necessary during treatment with ADHD stimulants (5.6). Long-Term Suppression of Growth : Monitor height and weight at appropriate intervals in pediatric patients (5.7).

5.1Potential for Abuse and Dependence CNS stimulants, including methylphenidate hydrochloride, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence (9.2, 9.3)].

5.2Serious Cardiovascular Reactions Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems.

Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during methylphenidate hydrochloride treatment.

5.3Blood Pressure and Heart Rate Increases CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

5.4Psychiatric Adverse Reactions Exacerbation of Preexisting Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g. comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing methylphenidate hydrochloride. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse and Dependence [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3 ) ] Known hypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride tablets [see Contraindications (4)] Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications (4), Drug Interactions (7.1)] Serious Cardiovascular Reactions [see Warnings and Precautions (5.2)] Blood Pressure and Heart Rate Increases [see Warnings and Precautions (5.3)] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4)] Priapism [see Warnings and Precautions (5.5)] Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions (5.6)] Long-term Suppression of Growth [see Warnings and Precautions (5.7)] The following adverse reactions associated with the use of all methylphenidate hydrochloride tablets and other methylphenidate products were identified in clinical trials, spontaneous reports, and literature.

Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Adverse Reactions Reported with methylphenidate hydrochloride Infections and Infestations: nasopharyngitis Blood and the Lymphatic System Disorders : leukopenia, thrombocytopenia, anemia Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of growth during prolonged use in pediatric patients Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood Nervous System Disorders: headache, dizziness, tremor, dyskinesia including choreoatheetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs Eye Disorders: blurred vision, difficulties in visual accommodation Cardiac Disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris Respiratory, Thoracic and Mediastinal Disorders: cough Gastrointestinal Disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury Skin and Subcutaneous Tissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis Investigations: weight loss (adult ADHD patients) Additional Adverse Reactions Reported With Other Methylphenidate-Containing Products The list below shows adverse reactions not listed for methylphenidate hydrochloride that have been reported with other methylphenidate-containing products.

Blood and Lymphatic Disorders: pancytopenia Immune System Disorders: hypersensitivity reactions such as auricular swelling, bullous conditions, eruptions, exanthemas Psychiatric Disorders: affect lability, mania, disorientation and libido changes Nervous System Disorders: migraine Eye Disorders: diplopia, mydriasis Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole Vascular Disorders: peripheral coldness, Raynaud's phenomenon Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea Gastrointestinal Disorders: diarrhea, constipation Skin and Subcutaneous Tissue Disorders: angioneurotic edema, erythema, fixed drug eruption Musculoskeletal, Connective Tissue and bone Disorders: myalgia, muscle twitching Renal and Urinary Disorders: hematuria Reproductive System and Breast Disorders: gynecomastia Gene…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Antihypertensive drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed (7) Halogenated anesthetics: Avoid use of methylphenidate hydrochloride tablets on the day of surgery if halogenated anesthetics will be used (7)

7.1Clinically Important Interactions with methylphenidate hydrochloride Table 1 presents clinically important drug interactions with methylphenidate hydrochloride tablets Table 1: Clinically Important Drug Interactions with methylphenidate hydrochloride Monoamine Oxidase Inhibitors (MAOI) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications (4)].

Intervention Concomitant use of methylphenidate hydrochloride with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment is contraindicated. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Antihypertensive Drugs Clinical Impact Methylphenidate hydrochloride may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions (5.3)] . Intervention Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.

Examples Potassium-sparing and thiazide diuretics, calcium channel blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta blockers, centrally acting alpha-2 receptor agonists Halogenated Anesthetics Clinical Impact Concomitant use of halogenated anesthetics and methylphenidate hydrochloride may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention Avoid use of methylphenidate hydrochloride in patients being treated with anesthetics on the day of surgery.

Examples halothane, isoflurane, enflurane, desflurane, sevoflurane

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/ Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents.

A decrease in pup body weight was observed in a pre and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants, such as methylphenidate hydrochloride tablets, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

Data Animal Data In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the MRHD given to adolescents on a mg/m 2 basis).

There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), but no other effects on postnatal development were observed.

The no effect level for pre and postnatal development in rats was 15 mg/kg/day (~2 times the MRHD given to adolescents on a mg/m 2 basis).

8.2Lactation Risk Summary Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects o…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/ Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents.

A decrease in pup body weight was observed in a pre and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants, such as methylphenidate hydrochloride tablets, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

Data Animal Data In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the MRHD given to adolescents on a mg/m 2 basis).

There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), but no other effects on postnatal development were observed.

The no effect level for pre and postnatal development in rats was 15 mg/kg/day (~2 times the MRHD given to adolescents on a mg/m 2 basis).

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of methylphenidate hydrochloride for the treatment of ADHD have been established in pediatric patients 6 to 17 years. The safety and effectiveness of methylphenidate hydrochloride in pediatric patients less than 6 years have not been established. The long-term efficacy of methylphenidate hydrochloride in pediatric patients has not been established.

Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.7)] . Juvenile Animal Toxicity Data Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood.

A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis. In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10).

When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the MRHD given to children on a mg/m 2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the MRHD given to children on a mg/m 2 basis).

The clinical significance of the long-term behavioral effects observed in rats is unknown.

🧓 Geriatric Use 13 words ▾

8.5Geriatric Use Methylphenidate hydrochloride has not been studied in the geriatric population.

🆘 Overdosage 81 words ▾

10 OVERDOSAGE Human Experience Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (which may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis.

Overdose Management Consult with a Certified Poison Control Center (1-800-222-1222) for the latest recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Methylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known.

12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Cardiac Electrophysiology A formal QT study has not been conducted in patients taking methylphenidate hydrochloride tablets. The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of methylphenidate hydrochloride on the QT interval was evaluated in a double-blind, placebo and open-label active (moxifloxacin)-controlled study following single doses of dexmethylphenidate XR 40 mg (maximum recommended adult total daily dosage) in 75 healthy volunteers. Electrocardiograms (ECGs) were collected up to 12 hours postdose.

Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was less than 5 ms, and the upper limit of the 90% confidence interval (CI) was below 10 ms for all time-matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident exposure response relationship.

12.3Pharmacokinetics Absorption Methylphenidate hydrochloride in the extended release tablets is more slowly but as extensively absorbed as in the regular tablets. Relative bioavailability of the extended-release tablet compared to the methylphenidate hydrochloride tablet, measured by the urinary excretion of methylphenidate hydrochloride major metabolite (α-phenyl-2-piperidine acetic acid) was 105% (49% to 168%) in children and 101% (85% to 152%) in adults. The time to peak rate in children was 1.9 hours (0.3 to 4.4 hours) for the methylphenidate hydrochloride tablets and 4.7 hours (1.3 to 8.2 hours) for the methylphenidate hydrochloride extended-release tablets.

An average of 67% of extended-release tablet dose was excreted in children as compared to 86% in adults. Effect of Food After a high-fat meal, both area under the curve (AUC) (by 25 %) and C max (by 27 %) are higher. Time to C max (T max ) is faster after a high-fat meal (median T max : 2.5 hours) as compared to without food (median T max : 3 hours).

Distribution Binding to plasma proteins is low (10% to 33%). The volume of distribution was 2.65 ±

1.11L/kg for d- methylphenidate and 1.80 ±

0.91L/kg for 1- methylphenidate. Elimination The systemic clearance is 0.40 ±

0.12L/h/kg for d-methylphenidate and 0.73 ±

0.28L/h/kg for 1-methylphenidate. Metabolism Methylphenidate is metabolized primarily by de-esterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity. Excretion After oral administration, 78% to 97% of the dose is excreted in the urine and 1% to 3% in feces in the form of metabolites within 48 to 96 hours.

Most of the dose is excreted in the urine as alpha-phenyl-2-piperidine acetic acid (60% to 86%). The cumulative urinary excretion of alpha-phenyl-2-piperidine acetic acid are not significantly different for methylphenidate hydrochloride extended release tablets. Studies in Specific Populations Male and Female Patients In a clinical study involving adult subjects who received methylphenidate hydrochloride extended release, plasma concentrations of methylphenidate hydrochloride’s major metabolite appeared to be greater in females than in males.

No gender differences were observed for methylphenidate hydrochloride plasma concentration in the same subjects. Racial or Ethnic Groups There is insufficient experience with the use of methylphenidate hydrochloride tablets to detect ethnic variations in pharmacokinetics. Patients with Renal Impairment Methylphenidate hyd…

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 5 mg Tablets - Light yellow, round, biconvex, beveled edge tablets de-bossed with ‘ T ’ on one side and ‘ 173 ’ on the other side. 10 mg Tablets – White to off white, round, flat, beveled edge tablets de-bossed with ‘ T ’ and ‘ 174 ’ with a functional score line on one side and plain on the other side. NDC 50268-528-15 (10 tablets per card, 5 cards per carton) 20 mg Tablets - Light yellow, round, flat, beveled edge tablets de-bossed with ‘ T ’ and ‘ 175 ’ with a functional score line on one side and plain on the other side.

NDC 50268-529-15 (10 tablets per card, 5 cards per carton) Store at 20° to 25°C (68° to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Protect from light. Dispensed in Unit Dose Package.

For Institutional Use Only. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride tablets by a medicine take-back program or by an authorized collector registered with the Drug Enforcement Administration.

If no take-back program or authorized collector is available, mix methylphenidate hydrochloride tablets with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard methylphenidate hydrochloride tablets in the household trash.

📋 Description 120 words ▾

11 DESCRIPTION Methylphenidate hydrochloride tablets, USP is a central nervous system (CNS) stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α- phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is a white to off white, odorless, fine crystalline powder.

Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol.

Methylphenidate hydrochloride tablets, USP contain the following inactive ingredients: compressible sugar, colloidal silicon dioxide, D&C yellow no. 10 (5 mg and 20 mg tablets), lactose monohydrate, magnesium stearate, and microcrystalline cellulose. image description

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Controlled Substance Status/High Potential for Abuse and Dependence Advise patients that methylphenidate hydrochloride tablets are controlled substances, and they can be abused and lead to dependence. Instruct patients that they should not give methylphenidate hydrochloride tablets to anyone else.

Advise patients to store methylphenidate hydrochloride tablets in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired methylphenidate hydrochloride tablets by a medicine take-back program if available [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.1, 9.2, 9.3), How Supplied/Storage and Handling (16)] .

Serious Cardiovascular Risks Advise patients that there is a potential serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension with methylphenidate hydrochloride tablets use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)]. Blood Pressure and Heart Rate Increases Instruct patients that methylphenidate hydrochloride tablets can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions (5.3)] .

Psychiatric Risks Advise patients that methylphenidate hydrochloride tablets at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)]. Priapism Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct them to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5)] .

Circulation Problems in Fingers and Toes [Peripheral vasculopathy, Including Raynaud’s Phenomenon] Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride tablets.

Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)] . Suppression of Growth Advise patients that methylphenidate hydrochloride tablets may cause slowing of growth and weight loss [see Warnings and Precautions (5.7)]. Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including methylphenidate hydrochloride, during pregnancy [see Use in Specific Populations (8.1)] . \Manufactured for: AvKARE Pulaski, TN 38478 Mfg.

Rev. 01/20 AV Rev. 07/20 (P) AvPAK

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE MEDICATION GUIDE Methylphenidate hydrochloride tablets, USP CII (meth'' il fen' i date hye'' droe klor' ide) What is the most important information I should know about methylphenidate hydrochloride tablets? Methylphenidate hydrochloride is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate hydrochloride tablets in a safe place to prevent misuse and abuse.

Selling or giving away methylphenidate hydrochloride tablets may harm others and is against the law. Tell your doctor if you or your child have abused or been dependent on alcohol, prescription medicines or street drugs. The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.

1. Heart-related problems : sudden death in patients who have heart problems or heart defects stroke and heart attack in adults increased blood pressure and heart rate Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting methylphenidate hydrochloride tablets.

Your doctor should check you or your childs blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride tablets. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking methylphenidate hydrochloride tablets. 2.

Mental (Psychiatric) problems : All Patients new or worse behavior and thought problems new or worse bipolar illness new or worse aggressive behavior or hostility new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking methylphenidate hydrochloride tablets , especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What are methylphenidate hydrochloride tablets? Methylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

Methylphenidate hydrochloride tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Methylphenidate hydrochloride tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. Methylphenidate hydrochloride tablets are also used in the treatment of a sleep disorder called narcolepsy.

It is not known if methylphenidate hydrochloride tablets are safe and effective in children under 6 years of age. Who should not take methylphenidate hydrochloride tablets? Methylphenidate hydrochloride tablets should not be taken if you or your child: are allergic to methylphenidate hydrochloride, or any of the ingredients in methylphenidate hydrochloride tablets.

See the end of this Medication Guide for a complete list of ingredients in methylphenidate hydrochloride tablets. are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Methylphenidate hydrochloride tablets may not be right for you or your child. Before starting methylphenidate hydrochloride tablets, tell your or your child’s doctor about all health conditions (or a family history of) including: heart problems, heart defects, high blood pressure mental problems including psychosis, mania, bipolar illness, or depression circulation problems in fingers or toes if you are pregnant or plan to become pregnant.

It is not known if methylphenidate hydrochloride tablets will harm your unborn baby. There is a pregnancy registr…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50268-0528-15 · AvPAK 50268-0530-15 · AvPAK →
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.