METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride_tablet, extended release

Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known. Methylphenidate is a racemic mixture comprised of the d- l-threo d-threo l-threo Cardiac Electrophysiology A formal QT study has not been conducted in patients taking Methylphenidate hydrochloride extended-release tablets. The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of Methylphenidate hydrochloride tablets on the QT interval was evaluated in a double-blind, placebo- and open-label active (moxifloxacin)-controlled study following single doses of dexmethylphenidate XR 40 mg (maximum recommended adult total daily dosage) in 75 healthy volunteers. Electrocardiograms (ECGs) were collected up to 12 hours postdose. Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was less than 5 ms, and the upper limit of the 90% confidence interval (CI) was below 10 ms for all time-matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident exposure response relationship. Absorption Methylphenidate hydrochloride in the extended-release tablets is more slowly but as extensively absorbed as in the regular tablets. Relative bioavailability of the extended-release tablet compared to the Methylphenidate hydrochloride tablet measured by the urinary excretion of Methylphenidate hydrochloride major metabolite (alpha-phenyl-2-piperidine acetic acid) was 105% (49% to 168%) in children and 101% (85% to 152%) in adults. The time to peak rate in children was 1. 4 hours) for the Methylphenidate hydrochloride tablets and 4. 2 hours) for the Methylphenidate hydrochloride extended-release tablets. An average of 67% of extended-release tablet dose was excreted in children as compared to 86% in adults. Effect of Food After a high-fat meal, both area under the curve (AUC) (by 25%) and C max max max max max Distribution Binding to plasma proteins is low (10% to 33%). The volume of distribution was 2. 11 L/kg for d-methylphenidate and 1. 91 L/kg for l-methylphenidate. Elimination The systemic clearance is 0. 12 L/h/kg for d-methylphenidate and 0. 28 L/h/kg for l-methylphenidate. Metabolism Methylphenidate is metabolized primarily by de-esterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity. Excretion After oral administration, 78% to 97% of the dose is excreted in the urine and 1% to 3% in feces in the form of metabolites within 48 to 96 hours. Most of the dose is excreted in the urine as alpha-phenyl-2-piperidine acetic acid (60% to 86%). The cumulative urinary excretion of alpha-phenyl-2-piperidine acetic acid are not significantly different for Methylphenidate hydrochloride extended-release tablets. Studies in Specific Populations Male and Female Patients In a clinical study involving adult subjects who received Methylphenidate hydrochloride extended-release tablets plasma concentrations of Methylphenidate hydrochloride major metabolite appeared to be greater in females than in males. No gender differences were observed for Methylphenidate hydrochloride plasma concentration in the same subjects. Racial or Ethnic Groups There is insufficient experience with the use of Methylphenidate hydrochloride extended-release to detect ethnic variations in pharmacokinetics. Patients with Renal Impairment Methylphenidate hydrochloride has not been studied in renally-impaired patients. Renal impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since less than 1% of a radiolabeled dose is excreted in the urine as unchanged compound, and the major metabolite (ritalinic acid), has little or no pharmacologic activity. Patients with Hepatic Impairment Methylphenidate hydrochloride has not been studied in patients with hepatic impairment. Hepatic impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since it is metabolized primarily to ritalinic acid by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body.

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

Methylphenidate hydrochloride extended-release tablets (2. 2) May switch to Methylphenidate hydrochloride extended-release tablets when the 8-hour dosage of Methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of methylphenidate hydrochloride tablets. Must be swallowed whole and never crushed or chewed Prior to treating pediatric patients and adults with central nervous system (CNS) stimulants, including Methylphenidate hydrochloride extended-release tablets, assess for the presence of cardiac disease (i. , perform a careful history including family history of sudden death or ventricular arrhythmia, and physical examination) [see Warnings and Precautions (5. 2) Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for Methylphenidate hydrochloride extended-release tablets use [see Boxed Warning Warnings and Precautions (5. 1) Drug Abuse and Dependence (9) Methylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, Methylphenidate hydrochloride extended-release tablets may be used in place of methylphenidate hydrochloride tablets when the 8-hour dosage of Methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of methylphenidate hydrochloride tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed. Pharmacological treatment of ADHD may be needed for extended periods. Periodically re-evaluate the long-term use of Methylphenidate hydrochloride extended-release tablets, and adjust dosage as needed. If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue Methylphenidate hydrochloride extended-release tablets. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

The following are discussed in more detail in other sections of the labeling: Abuse and Dependence [see Boxed Warning Warnings and Precautions (5. 1) Drug Abuse and Dependence (9. 3 ) ] Known hypersensitivity to methylphenidate or other ingredients of Methylphenidate hydrochloride extended-release tablets [ see Contraindications (4) Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications (4) Drug Interactions (7. 1) Serious Cardiovascular Reactions [see Warnings and Precautions (5. 2) Blood Pressure and Heart Rate Increases [see Warnings and Precautions (5. 3) Psychiatric Adverse Reactions [see Warnings and Precautions (5. 4) Priapism [see Warnings and Precautions (5. 5) Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions (5. 6) Long-term Suppression of Growth [see Warnings and Precautions (5. 7) The following adverse reactions associated with the use of all Methylphenidate hydrochloride extended-release 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 extended-release tablets Infections and Infestations: Blood and the Lymphatic System Disorders : Immune System Disorders: Metabolism and Nutrition Disorders: Psychiatric Disorders: Nervous System Disorders: Eye Disorders: Cardiac Disorders: Respiratory, Thoracic and Mediastinal Disorders: Gastrointestinal Disorders: Hepatobiliary Disorders: Skin and Subcutaneous Tissue Disorders: Musculoskeletal and Connective Tissue Disorders: Investigations: Additional Adverse Reactions Reported with Other Methylphenidate-Containing Products The list below shows adverse reactions not listed for Methylphenidate hydrochloride extended-release tablets that have been reported with other methylphenidate-containing products. Blood and Lymphatic Disorders: Immune System Disorders: Psychiatric Disorders: Nervous System Disorders: Eye Disorders: Cardiac Disorders: Vascular Disorders: Respiratory, Thoracic and Mediastinal Disorders: Gastrointestinal Disorders: Skin and Subcutaneous Tissue Disorders: Musculoskeletal, Connective Tissue and bone Disorders: Renal and Urinary Disorders: Reproductive System and Breast Disorders: General Disorders: Urogenital Disorders Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc. at 1-877-770-3138 or FDA at 1-800-FDA-1088 or www. gov/medwatch.

Hypersensitivity 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 [ see Adverse Reactions (6) Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [ see Drug Interactions (7. 1) Known hypersensitivity to methylphenidate or other product components of Methylphenidate hydrochloride extended-release tablets. (4) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Methylphenidate hydrochloride extended-release tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth. org/adhd-medications/ Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy [ see Clinical Considerations] No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 (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. 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 therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. Data Animal Data In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 2 2 2 2 2 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. 7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1. 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 extended-release tablets and any potential adverse effects on the breastfed infant from Methylphenidate hydrochloride extended-release tablets or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. The safety and effectiveness of Methylphenidate hydrochloride extended-release tablets for the treatment of ADHD have been established in pediatric patients 6 to 17 years. The safety and effectiveness of Methylphenidate hydrochloride extended-release tablets in pediatric patients less than 6 years have not been established. The long-term efficacy of Methylphenidate hydrochloride extended-release tablets in pediatric patients has not been established. Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including Methylphenidate hydrochloride extended-release 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 2 In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m 2 2 2 Methylphenidate hydrochloride tablet has not been studied in the geriatric population.

Antihypertensive drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed (7) Halogenated anesthetics: Avoid use of Methylphenidate hydrochloride extended-release tablets on the day of surgery if halogenated anesthetics will be used (7) Risperidone: The combined use of methylphenidate with risperidone when there is a change in dose of either or both medications may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS (7) Table 1 presents clinically important drug interactions with Methylphenidate hydrochloride extended-release tablets Table 1: Clinically Important Drug Interactions with Methylphenidate Hydrochloride Extended-Release Tablets Monoamine Oxidase Inhibitors (MAOI) Clinical Impact 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 [ see Contraindications (4) Intervention Concomitant use of Methylphenidate hydrochloride extended-release tablets with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Antihypertensive Drugs Clinical Impact Methylphenidate hydrochloride extended-release tablets may decrease the effectiveness of drugs used to treat hypertension [ see Warnings and Precautions (5. 3) Intervention Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed. Examples Potassium-sparing and thiazide diuretics, calcium channel blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta blockers, centrally acting alpha-2 receptor agonists Halogenated Anesthetics Clinical Impact Concomitant use of halogenated anesthetics and Methylphenidate hydrochloride extended-release tablets may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention Avoid use of Methylphenidate hydrochloride extended-release tablets in patients being treated with anesthetics on the day of surgery. Examples halothane, isoflurane, enflurane, desflurane, sevoflurane Risperidone The combined use of methylphenidate with risperidone when there is a change in dose of either or both medications may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.

WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including Methylphenidate hydrochloride extended-release tablets, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Warnings and Precautions (5. 1) Drug Abuse and Dependence (9. 3 WARNING: ABUSE AND DEPENDANCE See full prescribing information for complete boxed warning. CNS stimulants, including Methylphenidate hydrochloride extended-release tablets, other methylphenidate-containing products, and amphetamine, have a high potential for abuse and dependence ( 5. 3 Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy ( 5.
OVERDOSAGE
Human Experience Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (which may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis. Overdose Management Consult with a Certified Poison Control Center (1-800-222-1222) for the latest recommendations.
NONCLINICAL TOXICOLOGY
Carcinogenesis In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas at a daily dose of approximately 60 mg/kg/day. This dose is approximately 2 times the MRHD of 60 mg/kg/day given to children on mg/m 2 Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 4 times the MRHD (children) on a mg/m 2 In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro in vitro in vitro in vivo Impairment of Fertility No human data on the effect of methylphenidate on fertility are available. Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2.
MEDICATION GUIDE
MEDICATION GUIDE Methylphenidate Hydrochloride Extended-Release Tablets (meth" il fen'' i date hye" droe klor'' ide) What is the most important information I should know about Methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets is a federal controlled substance (CII) because it can be abused or lead to dependence. The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines: 1. Heart-related problems: sudden death in patients who have heart problems or heart defects stroke and heart attack in adults increased blood pressure and heart rate Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting Methylphenidate hydrochloride extended-release tablets. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Methylphenidate hydrochloride extended-release tablets. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Methylphenidate hydrochloride extended-release tablets. Mental (Psychiatric) problems: All Patients new or worse behavior and thought problems new or worse bipolar illness new or worse aggressive behavior or hostility new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Methylphenidate hydrochloride extended-release tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. What is Methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) Methylphenidate hydrochloride extended-release tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. Methylphenidate hydrochloride extended-release tablets is also used in the treatment of a sleep disorder called narcolepsy. It is not known if Methylphenidate hydrochloride extended-release tablets is safe and effective in children under 6 years of age. Who should not take Methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets should not be taken if you or your child: are allergic to methylphenidate hydrochloride, or any of the ingredients in Methylphenidate hydrochloride extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in Methylphenidate hydrochloride extended-release tablets. are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Methylphenidate hydrochloride extended-release tablets may not be right for you or your child. Before starting Methylphenidate hydrochloride extended-release tablets tell you or your child’s doctor about all health conditions (or a family history of) including: heart problems, heart defects, high blood pressure mental problems including psychosis, mania, bipolar illness, or depression circulation problems in fingers or toes if you are pregnant or plan to become pregnant. It is not known if Methylphenidate hydrochloride extended-release tablets will harm your unborn baby. There is a pregnancy registry for females who are exposed to ADHD medications, including Methylphenidate hydrochloride extended-release tablets, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Methylphenidate hydrochloride extended-release tablets and their baby. If you or your child becomes pregnant during treatment with Methylphenidate hydrochloride extended-release tablets talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth. org/adhd­medications/. if you are breastfeeding or plan to breastfeed. Methylphenidate hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Methylphenidate hydrochloride extended-release tablets. Tell your doctor about all of the medicines that you or your child takes including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your doctor will decide whether Methylphenidate hydrochloride extended-release tablets can be taken with other medicines. Especially tell your doctor if you or your child takes: anti-depression medicines including MAOIs blood pressure medicines (anti-hypertensive) Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist. Do not start any new medicine while taking Methylphenidate hydrochloride extended-release tablets without talking to your doctor first. How should Methylphenidate hydrochloride extended-release tablets be taken? Take Methylphenidate hydrochloride extended-release tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child. Take Methylphenidate hydrochloride extended-release tablets 30 to 45 minutes before a meal. The effect of a dose of Methylphenidate hydrochloride extended-release tablets usually lasts about 8 hours. Do not chew or crush Methylphenidate hydrochloride extended-release tablets. From time to time, your doctor may stop Methylphenidate hydrochloride extended-release tablets treatment for a while to check ADHD symptoms. Your doctor may do regular checks of the blood, heart, and blood pressure while taking Methylphenidate hydrochloride extended-release tablets. Children should have their height and weight checked often while taking Methylphenidate hydrochloride extended-release tablets. Methylphenidate hydrochloride extended-release tablets treatment may be stopped if a problem is found during these check-ups. In case of poisoning call your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room. What are the possible side effects of Methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including: What are possible side effects of Methylphenidate hydrochloride extended-release tablets? See “What is the most important information I should know about Methylphenidate hydrochloride extended-release tablets?” painful and prolonged erections (priapism) circulation problems in fingers and toes fingers or toes may feel numb, cool, painful fingers or toes may change color from pale, to blue, to red Tell your doctor if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the 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 hydrochloride extended-release tablets. slowing of growth (height and weight) in children Common side effects include: fast heart beat abnormal heartbeat (palpitations) headache trouble sleeping nervousness sweating a lot decreased appetite dry mouth nausea stomach pain Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Methylphenidate hydrochloride extended-release tablets? Store Methylphenidate hydrochloride extended-release tablets in a safe place and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C). Protect from moisture. Dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Methylphenidate hydrochloride extended-release tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away (discard) Methylphenidate hydrochloride extended-release tablets in the household trash. Keep Methylphenidate hydrochloride extended-release tablets and all medicines out of the reach of children. General information about the safe and effective use of Methylphenidate hydrochloride extended-release tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about Methylphenidate hydrochloride extended-release tablets that is written for healthcare professionals. Do not use Methylphenidate hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give Methylphenidate hydrochloride extended-release tablets to other people, even if they have the same symptoms. It may harm them and it is against the law. What are the ingredients in Methylphenidate hydrochloride extended-release tablets? Active ingredient: Inactive ingredients: Manufactured by: Granules Pharmaceuticals Inc. 3701 Concorde Pkwy Chantilly, VA 20151 Revised: 11/2019 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA This Medication Guide has been approved by the U. Food and Drug Administration Revised November 2019 CII Image.

Golden State Medical Supply, Inc.

METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride_tablet, extended release Product manual source documgent