Methylphenidate Hydrochloride 27 mg Tablet, Extended Release, 100-count
Other active recalls for Methylphenidate Hydrochloride (different manufacturers) — 1 · tap to view
Past resolved recalls for this product (1)
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Central Nervous System Stimulant class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- 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...
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Supplement & herbal interactions
Some supplements/herbs that may interact with Methylphenidate Hydrochloride — tap one for details:
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💊 What it looks like
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🧪 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.
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UNII 3J2P07GVB6
Cellulose acetate is a plant-derived polymer made by chemically modifying cellulose fibers. In medications, it serves as a film-coating material for tablets and capsules to protect the drug, control release, and improve appearance.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII E4GA8884NN
Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII 11628IH70O
Polyethylene oxide is a synthetic polymer derived from ethylene. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
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UNII 3IG9032SAH
A synthetic polymer derived from ethylene that forms a thick, gel-like substance in water. It acts as a binder and thickener in medications, helping hold solid forms together and controlling how quickly the medicine releases into your body.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII AB6MNQ6J6L
Succinic acid is an organic acid derived from natural sources or chemical synthesis. In medications, it functions as a buffer to help maintain the proper pH level and may also serve as a preservative or flavor enhancer in formulations.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
17 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.645 | $64.46 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $1.15 | $114.79 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $2.92 | $292.47 / 100 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Methylphenidate Hydrochloride 27 mgthis 13811-0707-10 | Trigen | 100 tablets | $0.645 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 27 mg 31722-0953-01 | Camber | 100 tablets | $0.645 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 27 mg 50268-0546-12 | AvPAK | 1 tablet | $0.645 | AB | Discontinued | — |
| Methylphenidate Hydrochloride 27 mg 60687-0543-21 | American | 1 tablet | $0.645 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 27 mg 62037-0734-01 | Actavis | 100 tablets | $0.645 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 27 mg 62175-0311-37 | Lannett | 100 tablets | $0.645 | BX | Availability likely | — |
| Methylphenidate Hydrochloride Extended-Release 27 mg 00406-0127-01 | SpecGx | 100 tablets | $0.645 | — | Availability likely | — |
| Methylphenidate Hydrochloride 27 mg 00527-3311-37 | Lannett | 100 tablets | $0.760 | AB | FDA listed | +18% |
| Methylphenidate Hydrochloride 27 mg 57664-0607-88 | Sun | 100 tablets | $0.760 | — | Discontinued | +18% |
| Relexxii 27 mg 68025-0096-10 | Vertical | 100 tablets | $11.478 | — | Availability likely | +1681% |
| Concerta 27 mg 50458-0588-01 | Janssen | 100 tablets | $12.653 | AB | Availability likely | +1863% |
| Methylphenidate Hydrochloride 27 mg 51407-0925-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Methylphenidate Hydrochloride 27 mg 72865-0134-01 | XLCare | 100 tablets | — | AB | FDA listed | — |
| Methylphenidate Hydrochloride 27 mg 72162-2395-01 | Bryant | 100 tablets | — | BX | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 13811-0707-10 You're viewing this | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-707-10) | 2017-08-14 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride extended-release tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with a higher dosage or unapproved methods of administration, such as snorting or injection. Before prescribing methylphenidate hydrochloride extended-release tablets, assess each patient’s risk for abuse, misuse, and addiction.
Educate patients and their families about these risks, proper storage of methylphenidate hydrochloride extended-release tablets, and proper disposal of any unused drug. Throughout methylphenidate hydrochloride extended-release tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ) and Drug Abuse and Dependence ( 9.1 , 9.2 )] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning.
Methylphenidate hydrochloride extended-release tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing methylphenidate hydrochloride extended-release tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of methylphenidate hydrochloride extended-release tablets, and proper disposal of any unused drug.
Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of methylphenidate hydrochloride extended-release tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), and Use in Specific Populations ( 8.4 )].
Methylphenidate hydrochloride extended-release tablets are a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old ( 1 ). Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Prior to initiating methylphenidate hydrochloride extended-release tablets treatment assess for ( 2.1 ): the presence of cardiac disease for family history of tics or Tourette’s syndrome and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome Administer once daily in the morning with or without food. Swallow whole with liquids; do not chew, divide, or crush ( 2.2 ). Recommended dosage in pediatric patients 6 to 17 years of age new to methylphenidate: starting dosage is 18 mg once daily.
May be increased weekly in 18 mg increments. Maximum dosage for pediatric patients ( 2.3 ): 6 to 12 years: 54 mg once daily 13 to 17 years: 72 mg once daily Recommended dosage in adults (up to 65 years of age) new to methylphenidate: starting dosage is 18 mg or 36 mg once daily. May be increased weekly in 18 mg increments, up to 72 mg once daily ( 2.3 ).
Patients currently using immediate-release methylphenidate: starting methylphenidate hydrochloride extended-release tablets dosage is based on current dosage regimen ( 2.4 ).
2.1Pretreatment Screening Prior to treating patients with methylphenidate hydrochloride extended-release tablets, assess: For the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )] . The family history for tics or Tourette’s syndrome and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome [see Warnings and Precautions ( 5.11 )] .
2.2Important Administration Instructions Administer methylphenidate hydrochloride extended-release tablets orally once daily in the morning with or without food. Swallow methylphenidate hydrochloride extended-release tablets whole with liquids. Do not split, crush, or chew the extended-release tablets because doing so will compromise the extended-release characteristics of methylphenidate hydrochloride extended-release tablets and may compromise the effectiveness or safety of methylphenidate hydrochloride extended-release tablets.
2.3Recommended Methylphenidate Hydrochloride Extended-Release Tablets Dosage in Patients New to Methylphenidate See Table 1 for the recommended once-daily dosage of methylphenidate hydrochloride extended-release tablets in patients who were not taking a methylphenidate product. In patients who have not achieved an optimal response at a lower dosage, increase the methylphenidate hydrochloride extended-release tablets dosage in 18 mg increments at weekly intervals. However, if a slower titration is recommended for patients who have not achieved an optimal response taking 18 mg of methylphenidate hydrochloride extended-release tablets once daily, increase their daily dosage to 27 mg once per day.
Table 1: Recommended Methylphenidate Hydrochloride Extended-Release Tablets Dosage in Patients New to Methylphenidate Patient Population Recommended Starting Dosage Dosage Range Pediatric patients 6 to 12 years of age 18 mg once daily 18 mg to 54 mg once daily Pediatric patients 13 to 17 years of age 18 mg once daily 18 mg to 72 mg once daily (not to exceed 2 mg/kg/day) Adults 18 to 65 years of age 18 or 36 mg once daily 18 mg to 72 mg once daily
2.4Recommended Methylphenidate Hydrochloride Extended-Release Tablets Dosage in Patients Switching from Another Methylphenidate Product See Table 2 for the recommended starting dosage of methylphenidate hydrochloride extended-release tablets in patients switching from an immediate-release methylphenidate product administered twice daily or three times daily (total daily dosage of 10 to 60 mg/day). Table 2: Recommended Starting Dosage in Patients Switching from Another Methylphenidate Product Previous Immediate-release Methylphenidate Daily Dosage Recommended Methylphenidate Hydrochloride Extended-Release Tablets Starting Dosage 5 mg twice daily or three times daily 18 mg every morning 10 mg twice daily or three times daily 36 mg every…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Extended-Release Tablets: 18 mg tablets are yellow with “TL706” imprinted in black ink 27 mg tablets are gray with “TL707” imprinted in black ink 36 mg tablets are white with “TL708” imprinted in black ink 54 mg tablets are pink with “TL709” imprinted in black ink 72 mg tablets are blue with “TL710” imprinted in black ink Extended-release tablets: 18, 27, 36, 54, and 72 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Methylphenidate hydrochloride extended-release tablets are contraindicated in patients: Known to be hypersensitive to methylphenidate or other components of methylphenidate hydrochloride extended-release tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate hydrochloride extended-release tablets. [see Adverse Reactions ( 6 )] . Receiving concomitant monoamine oxidase inhibitors (MAOIs), and within 14 days following discontinuation of treatment with a MAO inhibitor because of the risk of a hypertensive crisis [see Drug Interactions ( 7 )] .
Known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release tablets ( 4 ) Receiving concomitant monoamine oxidase inhibitors and within 14 days following discontinuation of treatment with a MAO inhibitor ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease ( 5.2 ). Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse ( 5.3 ). Psychiatric Adverse Reactions : Prior to initiating methylphenidate hydrochloride extended-release tablets, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing methylphenidate hydrochloride extended-release tablets ( 5.4 ). Priapism : If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention ( 5.5 ). Peripheral Vasculopathy, including Raynaud’s Phenomenon : Carefully assess for digital changes during methylphenidate hydrochloride extended-release tablets treatment.
Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy ( 5.6 ). Long-Term Suppression of Growth in Pediatric Patients : Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their methylphenidate hydrochloride extended-release tablets treatment interrupted ( 5.7 ).
Risk of Gastrointestinal (GI) Obstruction in Patients with GI Narrowing : Only use in patients able to swallow the extended-release tablet whole, and should not ordinarily be used in patients with pre-existing severe GI narrowing ( 5.8 ). Acute Angle Closure Glaucoma: methylphenidate hydrochloride extended-release tablets-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist ( 5.9 ). Increased Intraocular Pressure (IOP) and Glaucoma : Prescribe methylphenidate hydrochloride extended-release tablets to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.
Closely monitor patients with a history of increased IOP or open angle glaucoma ( 5.10 ). Motor and Verbal Tics, and Worsening of Tourette’s Syndrome : Before initiating methylphenidate hydrochloride extended-release tablets, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome.
Discontinue methylphenidate hydrochloride extended-release tablets treatment if clinically appropriate ( 5.11 ).
5.1Abuse, Misuse, and Addiction Methylphenidate hydrochloride extended-release tablets have a high potential for abuse and misuse. The use of methylphenidate hydrochloride extended-release tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction [see Drug Abuse and Dependence ( 9.1 , 9.2 )] . Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher dosage or unapproved methods of administration, such as snorting or injection.
Before prescribing methylphenidate hydrochloride extended-release tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store methylphenidate hydrochloride extended-release tablets in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride extended-release tablets to anyone else.
Throughout methylphenidate hydrochloride extended-release tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
5.2 Risks…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 )] Hypersensitivity Reactions [see Contraindications ( 4 ) ] Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7 )] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions ( 5.2 )] Increased Blood Pressure and Heart Rate [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 in Pediatric Patients [see Warnings and Precautions ( 5.7 )] Risks of Gastrointestinal Obstruction in Patients with Gastrointestinal Narrowing [see Warnings and Precautions ( 5.8 )] Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.9 )] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions ( 5.10 )] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.11 )] The most common adverse reactions (>5%) in double-blind clinical trials were: Pediatric patients 6 to 17 years: upper abdominal pain ( 6.1 ).
Adults up to 65 years of age: decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, tachycardia, and hyperhidrosis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Trigen Laboratories, LLC at 1-800-444-5164 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. The data below is based on a total of 3,906 patients in clinical studies who received methylphenidate hydrochloride extended-release tablets. Patients aged 6 up to 65 years old with ADHD were evaluated in 6 controlled clinical studies and 11 open-label clinical studies [see Table 3] .
Table 3: Methylphenidate Hydrochloride Extended-Release Tablets-treated Patients in Double-Blind and Open-Label Clinical Studies Patient Population N Dosage Range Pediatric patients 6 to 12 years of age 2,216 18 to 54 mg once daily Adolescents 502 18 to 72 mg once daily Adults up to 65 years of age 1,188 18 to 108 mg once daily The most common adverse reactions (≥5%) in double-blind clinical trials were: Pediatric patients: upper abdominal pain [see Table 4] . Adults: decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, tachycardia, and hyperhidrosis [see Table 5] .
The most common adverse reactions associated with methylphenidate hydrochloride extended-release tablets discontinuation (≥1%) from the pediatric and adult clinical trials were anxiety, irritability, insomnia, and increased blood pressure. Most Common Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials: Adverse reactions in either the pediatric or adult double-blind adverse reactions tables may be relevant for both patient populations. Adverse Reactions in Pediatric Patients Aged 6 years and Older Table 4 displays adverse reactions reported in 2% or more of methylphenidate hydrochloride extended-release tablets-treated pediatric patients ages 6 and older with ADHD in 4 placebo-controlled, double-blind clinical trials.
Table 4: Most Common Adverse Reactions 1 in Pediatric Patients 6 Years of Age and Older with ADHD in 4 Placebo-Controlled, Double-Blind Clinical Trials Methylphenidate Hydrochloride Extended-Release Tablets (n=321) Placebo (n=318) Upper abdominal pain 6% 4% Insomnia 2 3% 1% Nasopharyngitis 3% 2% Vomiting 3% 2% Pyrexia 2% 1% 1 Reported in ≥2% of methylphenidate hydrochlor…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 6 describes clinically significant drug interactions with methylphenidate hydrochloride extended-release tablets. Table 6: Clinically Significant Drug Interactions Monoamine Oxidase Inhibitors Prevention or Management Concomitant use of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, with MAOIs or within 14 days after discontinuing an MAOI is contraindicated [see Contraindications ( 4 )] . Mechanism and Clinical Effect(s) Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can cause hypertensive crisis.
Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Antihypertensive Drugs Prevention or Management Increase monitoring for blood pressure and adjust the dosage of the antihypertensive drug, as needed. Mechanism and Clinical Effect(s) Methylphenidate hydrochloride extended-release tablets may decrease effectiveness of drugs used to treat hypertension [see Warnings and Precautions 5.3 ] .
Halogenated Anesthetics Prevention or Management Avoid use of methylphenidate hydrochloride extended-release tablets in patients being treated with anesthetics on the day of surgery. Mechanism and Clinical Effect(s) Concomitant use of halogenated anesthetics and methylphenidate hydrochloride extended-release tablets may increase the risk of sudden blood pressure and heart rate increase during surgery. Risperidone Prevention or Management Monitor for signs of extrapyramidal symptoms.
Mechanism and Clinical Effect(s) The risk of risperidone-associated extrapyramidal symptoms may increase in patients taking concomitant methylphenidate hydrochloride extended-release tablets when there is a change in the methylphenidate hydrochloride extended-release tablets or risperidone dosage. Antihypertensive drugs : Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ( 7 ).
See additional clinically significant drug interactions, in the DRUG INTERACTIONS section ( 7 ).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Caution should be exercised if administered to nursing mothers ( 8.3 ) Safety and efficacy has not been established in children less than six years old or elderly patients greater than 65 years of age ( 8.4 and 8.5 )
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including methylphenidate hydrochloride extended-release tablets, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ . Risk Summary Published studies and post-marketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
There are risks to the fetus associated with the use of central nervous system (CNS) stimulants 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 throughout organogenesis at doses up to 4 and 16 times, respectively, the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 54 times the MRHD given to adults.
A slight decrease in body weight was observed in pregnant rats at the highest dose of 30 mg/kg/day (4 times the MRHD given to adults). In a pre- and postnatal development study in which rats were treated with oral administration of methylphenidate throughout pregnancy and lactation, a decrease in pup body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD given to adults on a mg/m 2 basis) (see Data) . The background risk of major birth defects and miscarriage in those with ADHD is unknown.
All pregnancies have a background risk of birth defects, 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 extended-release tablets, can cause vasoconstriction and thereby decrease placental perfusion.
No fetal and/or neonatal adverse reactions have been reported with the use of a therapeutic dosage 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 up to 30 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 54 times the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis.
The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (16 times the MRHD given to adults on a mg/m 2 basis). There was no evidence of changes in morphological development in rats, although a reduction in maternal body weight was observed at the highest dose of 30 mg/kg/day (4 times the MRHD of 72 mg/day given to adults (on a mg/m 2 basis). The no effect level for maternal body weight in rats is 5 mg/day (equal to the MRHD for adults on a mg/m 2 basis); and the no effect level for embryo-fetal development is 30 mg/kg/day (4 times the MRHD for adults on a mg/m 2 basis).
When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 30 mg/kg/day, decreases in offspring body weight, alterati…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including methylphenidate hydrochloride extended-release tablets, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ . Risk Summary Published studies and post-marketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
There are risks to the fetus associated with the use of central nervous system (CNS) stimulants 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 throughout organogenesis at doses up to 4 and 16 times, respectively, the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 54 times the MRHD given to adults.
A slight decrease in body weight was observed in pregnant rats at the highest dose of 30 mg/kg/day (4 times the MRHD given to adults). In a pre- and postnatal development study in which rats were treated with oral administration of methylphenidate throughout pregnancy and lactation, a decrease in pup body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD given to adults on a mg/m 2 basis) (see Data) . The background risk of major birth defects and miscarriage in those with ADHD is unknown.
All pregnancies have a background risk of birth defects, 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 extended-release tablets, can cause vasoconstriction and thereby decrease placental perfusion.
No fetal and/or neonatal adverse reactions have been reported with the use of a therapeutic dosage 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 up to 30 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 54 times the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis.
The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (16 times the MRHD given to adults on a mg/m 2 basis). There was no evidence of changes in morphological development in rats, although a reduction in maternal body weight was observed at the highest dose of 30 mg/kg/day (4 times the MRHD of 72 mg/day given to adults (on a mg/m 2 basis). The no effect level for maternal body weight in rats is 5 mg/day (equal to the MRHD for adults on a mg/m 2 basis); and the no effect level for embryo-fetal development is 30 mg/kg/day (4 times the MRHD for adults on a mg/m 2 basis).
When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 30 mg/kg/day, decreases in offspring body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD of 72 mg/day, given to adults on a mg/m 2 basis). The no effect level for pre- and post-natal developm…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of methylphenidate hydrochloride extended-release tablets for the treatment of ADHD have been established in pediatric patients 6 years of age and older. The safety and effectiveness of methylphenidate hydrochloride extended-release tablets have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage.
Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth (weight and height) should be monitored in pediatric patients during treatment with CNS stimulants, including methylphenidate hydrochloride extended-release tablets.
Pediatric patients who are not growing or gaining weight as expected may need to have their methylphenidate hydrochloride extended-release tablets 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 54 mg/day given to pediatric patients 6 to 12 years of age 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 54 mg/day given to pediatric patients 6 to 12 years of age 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 (9 times the MRHD given to pediatric patients 6 to 12 years of age on a mg/m 2 basis).
The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.4 times the MRHD given to pediatric patients 6 to 12 years of age on a mg/m 2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.
🧓 Geriatric Use ▾
8.5Geriatric Use Methylphenidate hydrochloride extended-release tablets are not indicated for use in patients greater than 65 years of age.
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop.
CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop.
10.2Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of methylphenidate hydrochloride extended-release tablets should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful.
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Methylphenidate is a central nervous system (CNS) stimulant. The mode of therapeutic action of methylphenidate in the treatment of ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of methylphenidate hydrochloride extended-release tablets has not been fully characterized.
12.3Pharmacokinetics Absorption Following oral administration of methylphenidate hydrochloride extended-release tablets, plasma methylphenidate concentrations reached an initial maximum concentration at about 1 hour, followed by gradual ascending concentrations over the next 5 to 9 hours, after which a gradual decrease begins. Mean times to reach peak plasma concentrations across all doses of methylphenidate hydrochloride extended-release tablets occurred between 6 and 10 hours. Methylphenidate hydrochloride extended-release tablets once daily minimizes the fluctuations between peak and trough concentrations associated with immediate-release methylphenidate three times daily [ see Figure 1 ].
No clinically significant difference in methylphenidate exposures was observed following the administration of either methylphenidate hydrochloride extended-release tablets once daily and immediate-release methylphenidate three times daily in adults. Figure 1. Mean Methylphenidate Plasma Concentrations Following a Single 18 mg Methylphenidate Hydrochloride Extended-Release Tablets dose and Immediate-release Methylphenidate 5 mg Doses (Three Doses Administered Every 4 Hours) The mean single-dose pharmacokinetic parameters in 36 healthy adults following the administration of one 18 mg methylphenidate hydrochloride extended-release tablets dose and three 5 mg methylphenidate doses every four hours are summarized in Table 7.
Table 7: Methylphenidate Pharmacokinetic Parameters (Mean ± SD) After Methylphenidate Hydrochloride Extended-Release Tablets and Immediate-release Methylphenidate Dosing in Healthy Adults Parameters Methylphenidate Hydrochloride Extended-Release Tablets (18 mg single dose) (n=36) Immediate-release Methylphenidate (Three 5 mg doses every four hours) (n=35) C max (ng/mL) 3.7 ± 1.0 4.2 ±
1.0T max (h) 6.8 ± 1.8 6.5 ±
1.8AUC inf (ng∙h/mL) 41.8 ± 13.9 38.0 ± 11.0 t 1/2 (h) 3.5 ± 0.4 3.0 ±
0.5The methylphenidate pharmacokinetics were evaluated in healthy adults following single- and multiple-doses (steady state) of methylphenidate hydrochloride extended-release tablets (up to 144 mg/day (up to 2 times the maximum recommended dose)). The mean half-life was about 3.6 hours. No differences in the pharmacokinetics of methylphenidate hydrochloride extended-release tablets were noted following single and repeated once-daily methylphenidate hydrochloride extended-release tablets dosing, indicating no significant drug accumulation.
The AUC and t 1/2 following repeated once-daily dosing are similar to those following a single 18 to 144 mg dose of methylphenidate hydrochloride extended-release tablets. Dose Proportionality Following administration of methylphenidate hydrochloride extended-release tablets in single doses of 18, 36, and 54 mg/day to healthy adults, C max and AUC (0–inf) of d-methylphenidate were dose proportional, whereas l-methylphenidate C max and AUC (0–inf) increased disproportionately with respect to dose. Following administration of methylphenidate hydrochloride extended-release tablets, plasma concentrations of the l-isomer were approximately 1/40 the plasma concentrations of the d-isomer.
In healthy adults, single and multiple doses (once-daily) methylphenidate hydrochloride extended-release…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Methylphenidate is a central nervous system (CNS) stimulant. The mode of therapeutic action of methylphenidate in the treatment of ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate hydrochloride extended-release tablets, USP are available in 18, 27, 36, 54, and 72 mg strengths. 18 mg tablets are yellow with “TL706” imprinted in black ink 27 mg tablets are gray with “TL707” imprinted in black ink 36 mg tablets are white with “TL708” imprinted in black ink 54 mg tablets are pink with “TL709" imprinted in black ink 72 mg tablets are blue with “TL710” imprinted in black ink. The tablets are supplied: 18 mg 100-count bottle NDC 13811-706-10 27 mg 100-count bottle NDC 13811-707-10 36 mg 100-count bottle NDC 13811-708-10 54 mg 100-count bottle NDC 13811-709-10 72 mg 30-count bottle NDC 13811-710-30 Storage and Handling Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] .
Protect from humidity.
📋 Description ▾
11 DESCRIPTION Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in five tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, 54, or 72 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect.
Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate HCl USP is a white, odorless 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.
Methylphenidate hydrochloride extended-release tablets, USP also contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. In addition, 18 mg tablets contain: iron oxide red, iron oxide yellow 27 mg tablets contain: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake 54 mg tablets contain: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake 72 mg tablets contain: FD&C Blue #1 Aluminum Lake FDA approved dissolution test specifications differ from USP structural formula
11.1System Components and Performance Methylphenidate hydrochloride extended-release tablets use osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components.
There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core.
As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the drug layer of core of methylphenidate hydrochloride extended-release tablets.
The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of methylphenidate hydrochloride extended-release tablets, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.1 , 9.2 ), Overdosage ( 10 )] . Advise patients to store methylphenidate hydrochloride extended-release tablets in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride extended-release tablets to anyone else.
Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with methylphenidate hydrochloride extended-release 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 )] . Increased Blood Pressure and Heart Rate Advise patients and their caregivers that methylphenidate hydrochloride extended-release tablets can cause elevations in blood pressure and heart rate [see Warnings and Precautions ( 5.3 )] .
Psychiatric Risks Advise patients and their caregivers that methylphenidate hydrochloride extended-release tablets, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [see Warnings and Precautions ( 5.4 )] . Priapism Advise patients, caregivers, and family members of methylphenidate hydrochloride extended-release tablets-treated males of the possibility of priapism. Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions ( 5.5 )] .
Peripheral Vasculopathy, including Raynaud’s Phenomenon Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms; to report to their healthcare provider any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes; to call their healthcare provider immediately with any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride extended-release tablets [see Warnings and Precautions ( 5.6 )] .
Long-term Suppression of Growth in Pediatric Patients Advise patients, caregivers, and family members that methylphenidate hydrochloride extended-release tablets may cause slowing of growth and weight loss in pediatric patients [see Warnings and Precautions ( 5.7 )] . Glaucoma and Increased Intraocular Pressure Advise patients that increased intraocular pressure and glaucoma may occur during methylphenidate hydrochloride extended-release tablets treatment [see Warnings and Precautions ( 5.10 )] . Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during methylphenidate hydrochloride extended-release tablets treatment.
Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions ( 5.11 )] . Administration Instructions Instruct patients to swallow methylphenidate hydrochloride extended-release tablets whole with liquids, and not to split, crush, or chew, the extended-release tablets. Advise patients not to be concerned if they occasionally notice a tablet-appearing substance in their stool.
Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to methylphenidate hydrochloride extended-release tablets during pregnancy [see Use in Specific Populations ( 8.1 )]. Lactation Advise methylphenidate hydrochloride extended-release tablets-treat…
💬 Medication Guide ▾
MedGuide MEDICATION GUIDE Methylphenidate hydrochloride extended-release tablets USP CII (METH-il-FEN-i-date) What is the most important information I should know about methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including: Abuse, misuse, and addiction. Methylphenidate hydrochloride extended-release tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction.
Misuse and abuse of methylphenidate hydrochloride extended-release tablets, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of methylphenidate hydrochloride extended-release tablets or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with methylphenidate hydrochloride extended-release tablets and will monitor you or your child during treatment.
Methylphenidate hydrochloride extended-release tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give methylphenidate hydrochloride extended-release tablets to anyone else. See “ What are methylphenidate hydrochloride extended-release tablets? ” for more information.
Keep methylphenidate hydrochloride extended-release tablets in a safe place and properly dispose of any unused medicine. See “ How should I store methylphenidate hydrochloride extended-release tablets? ” for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with methylphenidate hydrochloride extended-release tablets.
Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems, such as chest pain, shortness of breath, or fainting during treatment with methylphenidate hydrochloride extended-release tablets. Increased blood pressure and heart rate.
Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release tablets. Mental (psychiatric) problems, including: new or worse behavior or thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression .
Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with methylphenidate hydrochloride extended-release tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. See "What are the possible side effects of methylphenidate hydrochloride extended-release tablets?" for more information about side effects. What are methylphenidate hydrochloride extended-release tablets?
Methylphenidate hydrochloride extended-release tablets are a central nervous system (CNS) stimulant prescription medicine used for the treatment of attention deficit hyperactivity disorder (ADHD) in people 6 to 65 years of age. Methylphenidate hydrochloride extended-release tablets may help increase attention and decrease impulsiveness and hyperactivity in people with AD…