Registrants (1)
171714327
Manufacturing Establishments (1)
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products (1)
Methylphenidate Hydrochloride
72162-1636
ANDA090710
ANDA (C73584)
ORAL
December 15, 2023
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
METHYLPHENIDATE HYDROCHLORIDE 5MG TAB #100
RECENT MAJOR CHANGES SECTION
Highlight: Boxed Warning 10/2023
Dosage and Administration (2.1) 10/2023
Warnings and Precautions ( 5.1, 5.2, 5.8,5.9, 5.10) 10/2023
RECENT MAJOR CHANGES
Boxed Warning 10/2023
Dosage and Administration (2.1) 10/2023
Warnings and Precautions ( 5.1, 5.2, 5.8,5.9, 5.10) 10/2023
DESCRIPTION SECTION
11 DESCRIPTION
Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, USP a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths 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. Its molecular weight is 269.77 g/mol.
Each tablet contains 5 mg, 10 mg, or 20 mg of methylphenidate hydrochloride, USP. Inactive ingredients include: lactose monohydrate, magnesium stearate, polyethylene glycol 8000, and talc. In addition, the 5 mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, the 10 mg tablet contains FD&C blue No. 2 aluminum lake and D&C yellow No. 10 aluminum lake and the 20 mg tablet contains FD&C yellow No. 6 aluminum lake.
INDICATIONS & USAGE SECTION
Highlight: Methylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1).
1 INDICATIONS AND USAGE
Methylphenidate hydrochloride tablets are indicated for the treatment of:
- Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults
- Narcolepsy
DOSAGE & ADMINISTRATION SECTION
Highlight: Methylphenidate Hydrochloride Tablets(2.2):
- Pediatric Patients 6 Years and Older: Start with 5 mg twice daily (before breakfast and lunch), titrating the dose weekly in 5- to 10-mg increments. Dosages above 60 mg/day are not recommended.
- Adults: Average daily dosage is 20 mg to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg (2.2).
2 DOSAGE AND ADMINISTRATION
2.1 Pretreatment Screening
Prior to treating patients with methylphenidate hydrochloride tablets, assess:
- for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].
- the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating methylphenidate hydrochloride tablets [see Warnings and Precautions (5.10)].
2.2 General Dosing Information
Methylphenidate Hydrochloride Tablets
Pediatric Patients 6 years and Older:Start with 5 mg orally twice daily (before breakfast and lunch). Increase dosage gradually, in increments of 5- to 10-mg weekly. Daily dosage above 60 mg is not recommended.
Adults:Average dosage is 20 to 30 mg daily. Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
2.3 Dosage Reduction and Discontinuation
If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue methylphenidate hydrochloride tablets. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
DOSAGE FORMS & STRENGTHS SECTION
Highlight: * Tablets: 5 mg, 10 mg, and 20 mg (3)
3 DOSAGE FORMS AND STRENGTHS
Methylphenidate Hydrochloride Tablets, USP
- 5 mg, light purple, round-shaped, flat faced, beveled edge, uncoated tablets, debossed with "228" on one side and S5 on the other side.
- 10 mg, light green, round-shaped, flat faced, beveled edge, uncoated tablets, debossed with "229" on one side and S and 10 on either side of the score line on the other side.
- 20 mg, light peach, round-shaped, flat faced, beveled edge, uncoated tablets, debossed with "230" on one side and S and 20 on either side of the score line on the other side.
CONTRAINDICATIONS SECTION
Highlight: * Known hypersensitivity to methylphenidate or other product components of methylphenidate hydrochloride tablets (4).
- Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days (4).
4 CONTRAINDICATIONS
- Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [ see Adverse Reactions (6.1)].
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [ see Drug Interactions (7.1)].
BOXED WARNING SECTION
WARNING: ABUSE, MISUSE, AND ADDICTION
USE IN SPECIFIC POPULATIONS SECTION
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/.
Risk Summary
Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations).
No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Fetal/Neonatal Adverse Reactions
CNS stimulants, such as methylphenidate hydrochloride tablets, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.
Data
Animal Data
In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the MRHD given to adolescents on a mg/m 2basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2basis), which was also maternally toxic. The no effect level for embryo- fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (approximately 2 times the MRHD given to adolescents on a mg/m 2basis).
8.2 Lactation
Risk Summary
Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methylphenidate hydrochloride tablets and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride tablets or from the underlying maternal condition.
Clinical Considerations
Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
8.4 Pediatric Use
The safety and effectiveness of methylphenidate hydrochloride tablets for the treatment of ADHD have been established in pediatric patients aged 6 to 17 years.
The safety and effectiveness of methylphenidate hydrochloride tablets in pediatric patients aged less than 6 years have not been established.
The long-term efficacy of methylphenidate in pediatric patients has not been established.
Long-Term Suppression of Growth
Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride tablets. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [ see Warnings and Precautions (5.7)] .
Juvenile Animal Toxicity Data
Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 4 times the MRHD of 60 mg/day given to children on a mg/m 2basis.
In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m 2basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the MRHD given to children on a mg/m 2basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 timesthe MRHD given to children on a mg/m 2basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.
8.5 Geriatric Use
Methylphenidate hydrochloride tablets have not been studied in the geriatric population.
ADVERSE REACTIONS SECTION
Highlight: Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain (6).
**To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or **www.fda.gov/medwatch.
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 (9.2,9.3) ]
- Known hypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride tablets [see Contraindications (4)]
- Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications (4), Drug Interactions (7.1)]
- 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)]
- Acute Angle Closure Glaucoma [see Warnings and Precautions (5.8)]
- Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.9)]
- Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions(5.10)]
The following adverse reactions associated with the use of methylphenidate hydrochloride tablets, and other methylphenidate products were identified in clinical trials, spontaneous reports, and literature. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Adverse Reactions Reported with Methylphenidate Hydrochloride Tablets
Infections and Infestations: nasopharyngitis
Blood and the Lymphatic System Disorders: leukopenia, thrombocytopenia, anemia
Immune System Disorders: hypersensitivity reactions, including angioedema, and anaphylaxis
Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of growth during prolonged use in pediatric patients
Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood, depression
Nervous System Disorders: headache, dizziness, tremor, dyskinesia, including choreoatheetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs
Eye Disorders: blurred vision, difficulties in visual accommodation
Cardiac Disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris
Respiratory, Thoracic, and Mediastinal Disorders: cough
Gastrointestinal Disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia
Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury
Skin and Subcutaneous Tissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura
Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis, trismus
Investigations: weight loss (adult ADHD patients)
Additional Adverse Reactions Reported with Other Methylphenidate-Containing Products
The list below shows adverse reactions not listed for methylphenidate hydrochloride tablets that have been reported with other methylphenidate- containing products.
Blood and Lymphatic Disorders: pancytopenia
Immune System Disorders: hypersensitivity reactions, such as auricular swelling, bullous conditions, eruptions, exanthemas
Psychiatric Disorders: affect lability, mania, disorientation, and libido changes
Nervous System Disorders: migraine, motor and verbal tics
Eye Disorders: diplopia, increased intraocular pressure, mydriasis
Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole
Vascular Disorders: peripheral coldness, Raynaud's phenomenon
Respiratory, Thoracic, and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea
Gastrointestinal Disorders: diarrhea, constipation
Skin and Subcutaneous Tissue Disorders: angioneurotic edema, erythema, fixed drug eruption
Musculoskeletal, Connective Tissue, and Bone Disorders: myalgia, muscle twitching
Renal and Urinary Disorders: hematuria
Reproductive System and Breast Disorders: gynecomastia
General Disorders: fatigue, hyperpyrexia
Urogenital Disorders: priapism
OVERDOSAGE SECTION
10 OVERDOSAGE
Clinical 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.
Overdose Management
Consider the possibility of multiple drug ingestion. 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.
SPL MEDGUIDE SECTION
MEDICATION GUIDE
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Methylphenidate Hydrochloride Tablets USP, for oral use, CII (meth" ǝl-fen 'i-dāt) Rx Only |
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What is the most important information I should know about methylphenidate hydrochloride tablets? Methylphenidate hydrochloride tablets****may cause serious side effects, including: ***Abuse, misuse, and addiction.**Methylphenidate hydrochloride tablets has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate hydrochloride 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 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 carefully for heart problems before starting methylphenidate hydrochloride 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 has any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking methylphenidate hydrochloride tablets. *Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride tablets. *Mental (psychiatric) problems: All Patients
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 while taking methylphenidate hydrochloride tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. |
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What are methylphenidate hydrochloride tablets?
**Methylphenidate hydrochloride tablets is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.**Keep methylphenidate hydrochloride tablets in a safe place to protect it from theft. Never give your methylphenidate hydrochloride tablets to anyone else, because it may cause death or harm them. Selling or giving away methylphenidate hydrochloride tablets may harm others and is against the law. |
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Who should not take methylphenidate hydrochloride tablets? *Methylphenidate hydrochloride tablets should not be taken if you or your child:
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Methylphenidate hydrochloride tablets may not be right for you or your child. Before starting methylphenidate hydrochloride tablets, tell your or your child’s healthcare provider about all health conditions (or a family history of), including:
Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Methylphenidate hydrochloride tablets and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking methylphenidate hydrochloride tablets. Your healthcare provider will decide whether methylphenidate hydrochloride tablets can be taken with other medicines. |
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Especially tell your healthcare provider if you or your child takes:
Do not start any new medicine while taking methylphenidate hydrochloride tablets without talking to your healthcare provider first. |
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How should methylphenidate hydrochloride tablets be taken?
Children should have their height and weight checked often while taking methylphenidate hydrochloride tablets. If you or your child take too much methylphenidate hydrochloride tablets, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. |
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What are the possible side effects of methylphenidate hydrochloride tablets? Methylphenidate hydrochloride tablets may cause serious side effects, including:
Tell your healthcare provider if you or your child have, numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes. Call your healthcare provider right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride tablets. ***Slowing of growth (height and weight) in children.**Children should have their height and weight checked often during treatment with methylphenidate hydrochloride tablets. Methylphenidate hydrochloride tablets treatment may be stopped if your child is not growing or gaining weight. ***Eye problems (increased pressure in the eye and glaucoma).**Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness. ***New or worsening tics or worsening Tourette’s syndrome.**Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with methylphenidate hydrochloride tablets. Common side effects include:
Call your doctor for medical advice about side effects.You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store methylphenidate hydrochloride tablets?
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General information about the safe and effective use of methylphenidate hydrochloride tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about methylphenidate hydrochloride tablets that is written for healthcare professionals. Do not use methylphenidate hydrochloride tablets for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them and it is against the law. |
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What are the ingredients in methylphenidate hydrochloride tablets? **Active ingredient:**methylphenidate HCl **Inactive ingredients:**lactose monohydrate, magnesium stearate, polyethylene glycol 8000, and talc. In addition, the 5 mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, the 10 mg tablet contains FD&C blue No. 2 aluminum lake and D&C yellow No. 10 aluminum lake and the 20 mg tablet contains FD&C yellow No. 6 aluminum lake. |
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Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Rev. 11/2023
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HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
Methylphenidate Hydrochloride Tablets, USP 5 mg are ight purple, round-shaped, flat faced, beveled edge, uncoated tablets, debossed with "228" on one side and S5 on the other side.
NDC: 72162-1636-1: 100 Tablets in a BOTTLE
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP controlled room temperature].
Protect from light.
Dispense in tight, light-resistant container (USP) with a child-resistant closure.
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504