METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Solution, 500 mL — NDC 70752-0132-14 package photo

METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Solution, 500 mL

by QUAGEN PHARMACEUTICALS LLC · 500 mL in 1 BOTTLE, PLASTIC (70752-132-14)
NDC 70752-0132-14
🏷️ FDA NDC (as labeled) 70752-132-14 billing pads the product segment with a zero
Rx only Generic On market CII
🗂️ 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 →
⚠️
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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 70752-132-14
Product NDC 70752-132
11-digit billing NDC 70752013214
NCPDP billing unit ML — per mL (volume)
RxCUI 1091133, 1091341
UNII 4B3SC438HI
Application # ANDA213567
SPL Set ID 59de488c-c3f8-415d-9e9f-9102c090aac8
Established class (EPC) Central Nervous System Stimulant
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-04
Route ORAL
Dosage form SOLUTION
Substance METHYLPHENIDATE HYDROCHLORIDE
GPI-14 61400020102030
GPI class Methylphenidate HCl
GCN Seq No 054680
GCN 22686
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 10 MG/5 ML SOL
FDB brand name Methylphenidate Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 70752-132-14 — 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 → 70752-0132-14. 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

LabelerQUAGEN PHARMACEUTICALS LLC
Application holderQUAGEN PHARMACEUTICALS LLC
FDA applicationANDA213567 (ANDA)
Labeler code70752
First marketedJun 2020
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio50 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 10 MG/5 ML SOL 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.

💊 What it looks like

FlavorGrape
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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII OJ4Z5Z32L4
    A synthetic polymer made by linking ethylene glycol units together. It serves as a solvent, humectant to retain moisture, and film-forming agent in tablets and coatings to improve texture and drug delivery.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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 DailyMedingredient 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.119 $59.45 / 500 ml
Medicaid paysCMS SDUD · 12 mo $0.1682 $84.10 / 500 ml
Medicare drug plans payPart D · Q2 2026 $0.1476 $73.80 / 500 ml
NADAC price history (per mL) — tap or hover for the price & month
Sep 2021 Sep 2022 Jan 2026 Aug 2026 $0.206 $0.111
▼ Down 18% over the last 22 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 10 mg/5mL 27808-0059-01 Cranbury 500 ml $0.119 AA Availability likely
Methylphenidate Hydrochloride 10 mg/5mLthis 70752-0132-14 QUAGEN 500 ml $0.119 AA Availability likely
Methylphenidate Hydrochloride 10 mg/5mL 71930-0025-52 Eywa 500 ml $0.119 AA Availability likely
Methylphenidate 10 mg/5mL 10702-0164-50 KVK-Tech, 500 ml $0.151 AA FDA listed +27%
Methylin 10 mg/5mL 59630-0755-50 SHIONOGI 500 ml $0.232 AA Availability likely +95%
Methylphenidate HCl 10 mg/5mL 39328-0154-50 Patrin 500 ml AA FDA listed
Methylphenidate Hydrochloride 10 mg/5mL 43386-0931-05 Lupin 500 ml AA FDA listed
Methylphenidate Hydrochloride 10 mg/5mL 43602-0178-05 Ascent 500 ml AA FDA listed
Methylphenidate Hydrochloride 10 mg/5mL 63629-1176-01 Bryant 500 ml AA FDA listed
Methylphenidate Hydrochloride 10 mg/5mL 67877-0603-91 Ascend 500 ml AA FDA listed
Methylphenidate Hydrochloride 10 mg/5mL 72162-1993-05 Bryant 500 ml AA FDA listed
Methylphenidate Hydrochloride 10 mg/5mL 72162-2041-05 Bryant 500 ml AA 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 & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70752-0132-14, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
9.5K
Units reimbursed last 4 qtrs
2.6M
Gross reimbursed last 4 qtrs
$440.2K
Avg / prescription
$46.52
Avg / unit
$0.1682
Latest quarter Q4 2025
2.7KRx
Medicaid pays / mL
$0.1682
gross reimbursed
vs
NADAC / mL
$0.1189
acquisition cost
=
Spread
+$0.0493
+41% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
33% FFS 67% MCO
Fee-for-service · 3,077 Rx Managed care · 6,386 Rx
State Medicaid map
Alaska: no data reported AK Maine: 13,888 units · 996 per 100k residents ME Washington: 33,493 units · 429 per 100k residents WA Idaho: 4,885 units · 249 per 100k residents ID Montana: no data reported MT North Dakota: 13,137 units · 1,678 per 100k residents ND Minnesota: 50,065 units · 873 per 100k residents MN Wisconsin: 8,510 units · 144 per 100k residents WI Michigan: 36,110 units · 360 per 100k residents MI New York: 180,337 units · 921 per 100k residents NY Vermont: 4,050 units · 626 per 100k residents VT New Hampshire: 3,993 units · 285 per 100k residents NH Oregon: 28,992 units · 685 per 100k residents OR Nevada: 10,600 units · 332 per 100k residents NV Wyoming: no data reported WY South Dakota: 10,565 units · 1,150 per 100k residents SD Iowa: 6,400 units · 200 per 100k residents IA Illinois: 14,482 units · 115 per 100k residents IL Indiana: 147,221 units · 2,145 per 100k residents IN Ohio: 122,701 units · 1,041 per 100k residents OH Pennsylvania: 270,041 units · 2,083 per 100k residents PA New Jersey: 75,400 units · 812 per 100k residents NJ Massachusetts: 98,887 units · 1,412 per 100k residents MA California: 128,237 units · 329 per 100k residents CA Utah: no data reported UT Colorado: 30,179 units · 513 per 100k residents CO Nebraska: 15,915 units · 805 per 100k residents NE Missouri: 48,528 units · 783 per 100k residents MO Kentucky: 25,620 units · 566 per 100k residents KY West Virginia: 36,010 units · 2,034 per 100k residents WV Virginia: 140,210 units · 1,609 per 100k residents VA Maryland: 46,793 units · 757 per 100k residents MD Connecticut: 4,460 units · 123 per 100k residents CT Rhode Island: 32,615 units · 2,979 per 100k residents RI Arizona: 10,980 units · 148 per 100k residents AZ New Mexico: 14,033 units · 664 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 55,042 units · 772 per 100k residents TN North Carolina: 125,509 units · 1,158 per 100k residents NC South Carolina: 195,172 units · 3,632 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 22,678 units · 496 per 100k residents LA Mississippi: no data reported MS Alabama: 56,240 units · 1,101 per 100k residents AL Georgia: 222,907 units · 2,021 per 100k residents GA D.C.: 8,808 units · 1,297 per 100k residents DC Hawaii: no data reported HI Texas: 25,690 units · 84.2 per 100k residents TX Florida: 237,663 units · 1,051 per 100k residents FL
Units reimbursed · per 100k residents
84.23,632
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 South Carolina 3,632 /100k
2 Rhode Island 2,979 /100k
3 Indiana 2,145 /100k
4 Pennsylvania 2,083 /100k
5 West Virginia 2,034 /100k
6 Georgia 2,021 /100k
7 North Dakota 1,678 /100k
8 Virginia 1,609 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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
70752-0132-14 You're viewing this 500 mL in 1 BOTTLE, PLASTIC (70752-132-14) 2020-06-04 Active

📄 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 96 words

DRUG ABUSE AND DEPENDENCE Methylphenidate HCl Oral Solution should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative. Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse.

Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked. Long-term follow-up may be required because of the patient’s basic personality disturbances.

🎯 Indications and Usage ~2 min read

INDICATIONS AND USAGE Attention Deficit Disorders, Narcolepsy Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate HCl Oral Solution is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test.

Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired.

The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis.

Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.

Attention Deficit Disorders, Narcolepsy Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate HCl Oral Solution is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG.

Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated…

⏱️ Dosage and Administration 206 words

DOSAGE AND ADMINISTRATION Dosage should be individualized according to the needs and responses of the patient. Adults Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily.

Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

Children (6 years and over) Methylphenidate HCl Oral Solution should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug. Methylphenidate HCl Oral Solution should be periodically discontinued to assess the child's condition.

Improvement may be sustained when the drug is either temporarily or permanently discontinued. Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.

Contraindications 87 words

CONTRAINDICATIONS Marked anxiety, tension, and agitation are contraindications to Methylphenidate HCl Oral Solution, since the drug may aggravate these symptoms. Methylphenidate HCl Oral Solution is contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette's syndrome. Methylphenidate HCl Oral Solution is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

⚠️ Warnings ~3 min read

WARNINGS Serious Cardiovascular Events Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems Children and Adolescents – Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

Adults – Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.

Hypertension and Other Cardiovascular Conditions Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.

Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events Pre-Existing Psychosis – Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Bipolar Illness – Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Emergence of New Psychotic or Manic Symptoms – Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patien…

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy; libido changes; and rhabdomyolysis.

There have been rare reports of Tourette’s syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to severe hepatic injury; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; a few instances of scalp hair loss; serotonin syndrome in combination with serotonergic drugs.

Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten year old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.

🔄 Drug Interactions 63 words

Drug Interactions Methylphenidate HCl Oral Solution may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents. Human pharmacologic studies have shown that Methylphenidate HCl Oral Solution may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine).

Downward dosage adjustments of these drugs may be required when given concomitantly with Methylphenidate HCl Oral Solution.

🤰 Pregnancy 135 words

Usage in Pregnancy Adequate animal reproduction studies to establish safe use of Methylphenidate HCl Oral Solution during pregnancy have not been conducted. However, in a recently conducted study, methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 167 times and 78 times the maximum recommended human dose on a mg/kg and a mg/m 2 basis, respectively. In rats, teratogenic effects were not seen when the drug was given in doses of 75 mg/kg/day, which is approximately 62.5 and 13.5 times the maximum recommended human dose on a mg/kg and a mg/m 2 basis, respectively.

Therefore, until more information is available, methylphenidate should not be prescribed for women of childbearing age unless, in the opinion of the physician, the potential benefits outweigh the possible risks.

🆘 Overdosage 169 words

OVERDOSAGE Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, dryness of mucous membranes, and rhabdomyolysis. Consult with a Certified Poison Control Center regarding treatment for up-to-date guidance and advice.

Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage.

In the presence of severe intoxication, use a carefully titrated dosage of a short-acting barbiturate before performing gastric lavage. Other measures to detoxify the gut include administration of activated charcoal and a cathartic. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.

Efficacy of peritoneal dialysis or extracorporeal hemodialysis for methylphenidate overdosage has not been established.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY 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 HCl is a central nervous system (CNS) stimulant.

The mode of therapeutic action in humans is not completely understood, but methylphenidate presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. There is neither specific evidence which clearly establishes the mechanism whereby Methylphenidate HCl Oral Solution produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

Pharmacokinetics Absorption Methylphenidate HCl Oral Solution is readily absorbed. Following oral administration of Methylphenidate HCl Oral Solution, peak plasma methylphenidate concentrations are achieved at 1 to 2 hours. Methylphenidate HCl Oral Solution has been shown to be bioequivalent to Ritalin ® tablet.

The mean C max following a 20 mg dose is approximately 9 ng/mL. Food Effect In a study in adult volunteers to investigate the effects of a high-fat meal on the bioavailability of Methylphenidate HCl Oral Solution at a dose of 20 mg, the presence of food delayed the peak by approximately 1 hour (1.7 hours, fasted and 2.7 hours, fed). Overall, a high-fat meal increased the C max of Methylphenidate HCl Oral Solution by about 13% and the AUC by about 25%, on average.

Through a cross-study comparison, the magnitude of increase in C max and AUC is found to be comparable between the Methylphenidate HCl Oral Solution and Ritalin, the immediate release tablet. Metabolism and Excretion In humans, methylphenidate is metabolized primarily via deesterification to alpha-phenylpiperidine acetic acid (PPA, ritalinic acid). The metabolite has little or no pharmacologic activity.

After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was PPA, accounting for approximately 80% of the dose. The pharmacokinetics of the Methylphenidate HCl Oral Solution have been studied in healthy adult volunteers.

The mean terminal half-life (t ½ ) of methylphenidate following administration of 20 mg Methylphenidate HCl Oral Solution (t ½ = 2.7 hours) is comparable to the mean terminal t ½ following administration of Ritalin (methylphenidate hydrochloride immediate-release tablets) (t ½ = 2.8h) in healthy adult volunteers. Special Populations Gender – The effect of gender on the pharmacokinetics of methylphenidate after Methylphenidate HCl Oral Solution administration has not been studied. Race – The influence of race on the pharmacokinetics of methylphenidate after Methylphenidate HCl Oral Solution administration has not been studied.

Age – The pharmacokinetics of methylphenidate after Methylphenidate HCl Oral Solution administration have not been studied in pediatrics. Renal Insufficiency There is no experience with the use of Methylphenidate HCl Oral Solution in patients with renal insufficiency. After oral administration of radiolabeled methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioactivity was excreted in the urine in the form of ritalinic acid.

Since renal clearance is not an important route of methylphenidate clearance, renal insufficiency is expected to have little effect on the pharmacokinetics of Methylphenidate HCl Oral Solution. Hepatic Insufficiency There is no experience with the use of Methylphenidate HCl Oral Solution in patients with hepatic insufficiency.

📦 How Supplied / Storage and Handling 93 words

HOW SUPPLIED Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 70752-131-14 Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.

Bottles of 500 mL . . . . . . . . NDC 70752-132-14 Dispense in tight container with child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Ritalin is a registered trademark of Novartis Corporation.

📋 Description 137 words

DESCRIPTION Methylphenidate HCl Oral Solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is a 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. Each mL of Methylphenidate HCl Oral Solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of Methylphenidate HCl Oral Solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP.

In addition, Methylphenidate HCl Oral Solution also contains the following inactive ingredients: diluted hydrochloric acid, glycerin, natural & artificial grape flavor, Polyethylene Glycol 1450 and purified water. image description

💬 Medication Guide ~3 min read

MEDICATION GUIDE Methylphenidate (METH-il-FEN-i-date) Hydrochloride Oral Solution, 5 mg/5 mL and 10 mg/5 mL CII Read the Medication Guide that comes with Methylphenidate HCl Oral Solution before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child's treatment with Methylphenidate HCl Oral Solution.

What is the most important information I should know about Methylphenidate HCl Oral Solution? The following have been reported with use of methylphenidate HCl oral solution 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 HCl Oral Solution. Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with Methylphenidate HCl Oral Solution.

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 HCl Oral Solution. 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 Children and Teenagers 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 HCl Oral Solution, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. 3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Methylphenidate HCl Oral Solution. What Is Methylphenidate HCl Oral Solution?

Methylphenidate HCl Oral Solution is a central nervous system stimulant prescription medicine. Methylphenidate HCl Oral Solution is a liquid form of medication that you take by mouth. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

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

Methylphenidate HCl Oral Solution is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methylphenidate HCl Oral Solution in a safe place to prevent misuse and abuse. Selling or giving away Methylphenidate HCl Oral Solution may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs. Who should not take Methylphenidate HCl Oral Solution? Methylphenidate HCl Oral Solution should not be taken if you or your child: are very anxious, tense, or agitated have an eye problem called glaucoma have tics or Tourette's syndrome, or…

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