Complete SPL Sections#
WARNING: ABUSE AND DEPENDENCE
BOXED WARNING SECTION
C N S stimulants, including methylphenidate hydrochloride extended-release capsules , other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] .
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies ( 14 )] .
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
10 mg extended-release capsules light brown opaque cap and white opaque body, imprinted TEVA on the cap and 5345 on the body 20 mg extended-release capsules white opaque cap and white opaque body, imprinted TEVA on the cap and 5346 on the body 30 mg extended-release capsules ivory opaque cap and ivory opaque body, imprinted TEVA on the cap and 5347 on the body 40 mg extended-release capsules light brown opaque cap and light brown opaque body, imprinted TEVA on the cap and 5348 on the body
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [ s ee 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 [ s ee Drug Interactions ( 7.1 )].
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following are discussed in more detail in other sections of the labeling: Abuse and Dependence [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] Known hypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride extended-release capsules [see Contraindications ( 4 )] Hypertensive crisis when used concomitantly with 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 )]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules 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/.
9 DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
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.
11 DESCRIPTION
DESCRIPTION SECTION
Methylphenidate Hydrochloride Extended-Release Capsules contain methylphenidate hydrochloride, USP, a CNS stimulant. Methylphenidate Hydrochloride Extended-Release Capsules are an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each Methylphenidate Hydrochloride Extended-Release Capsule contains pellets, with half the dose as immediate-release and half as delayed-release, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in Methylphenidate Hydrochloride Extended-Release Capsules is methyl α-phenyl-2-piperidineacetate hydrochloride. Its structural formula is as follows: M.W. 269.77 Methylphenidate hydrochloride, USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each capsule, for oral administration, has the following inactive ingredients: ammonio methacrylate copolymer, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze (modified), sugar spheres, talc, titanium dioxide and triethyl citrate. The 10 mg and 40 mg capsule shell contains FD&C blue no. 1, FD&C red no. 40 and FD&C yellow no. 6. The 30 mg capsule shell contains D&C red no. 33 and D&C yellow no. 10.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg are available as two-piece, hard gelatin capsules, with light brown opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5345 on the body, containing 10 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5345-01). Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg are available as two-piece, hard gelatin capsules, with white opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5346 on the body, containing 20 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5346-01). Methylphenidate Hydrochloride Extended-Release Capsules, 30 mg are available as two-piece, hard gelatin capsules, with ivory opaque cap and ivory opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5347 on the body, containing 30 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5347-01). Methylphenidate Hydrochloride Extended-Release Capsules, 40 mg are available as two-piece, hard gelatin capsules, with light brown opaque cap and light brown opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5348 on the body, containing 40 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5348-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride extended-release capsules with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard methylphenidate hydrochloride extended-release capsules in the household trash.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Controlled Substance Status/High Potential for Abuse and Dependence Advise patients that methylphenidate hydrochloride extended-release capsules are a controlled substance, and they can be abused and lead to dependence. Instruct patients that they should not give methylphenidate hydrochloride extended-release capsules to anyone else. Advise patients to store methylphenidate hydrochloride extended-release capsules in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules by a medicine take-back program if available [see Boxed Warning, Warnings and Precautions (5.1 ), Drug Abuse and Dependence ( 9.1 , 9.2 , 9.3 ), How Supplied/Storage and Handling ( 16 )] . Serious Cardiovascular Risks Advise patients that there is a potential serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension with methylphenidate hydrochloride extended-release capsules 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 [s ee Warnings and Precautions ( 5.2 )]. Blood Pressure and Heart Rate Increases Instruct patients that methylphenidate hydrochloride extended-release capsules can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions ( 5.3 )] . Psychiatric Risks Advise patients that methylphenidate hydrochloride extended-release capsules, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [ see Warnings and Precautions ( 5.4 )]. Priapism Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct them to seek immediate medical attention in the event of priapism [see Warnings and Precautions ( 5.5 )] . Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon] Instruct patients beginning treatment with methylphenidate hydrochloride extended-release capsules about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride extended-release capsules. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions ( 5.6 )] . Suppression of Growth Advise patients that methylphenidate hydrochloride extended-release capsules may cause slowing of growth and weight loss [see Warnings and Precautions ( 5.7 )]. Alcohol Effect Advise patients to avoid alcohol while taking methylphenidate hydrochloride extended-release capsules. Consumption of alcohol while taking methylphenidate hydrochloride extended-release capsules may result in a more rapid release of the dose of methylphenidate [ see Clinical Pharmacology ( 12.3 ) ] . Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to methylphenidate hydrochloride extended-release capsules during pregnancy [see Use in Specific Populations ( 8.1 )] . Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. F 12/2019
MEDICATION GUIDE
SPL MEDGUIDE SECTION
Methylphenidate Hydrochloride (meth″ il fen′ i date hye″ droe klor′ ide) Extended-Release Capsules LA CII Wh a t is the most important information I should know about methylphenidate hydrochloride extended-release capsules ? Methylphenidate hydrochloride extended-release capsules are a federal controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate hydrochloride extended-release capsules in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride extended-release capsules m a y harm others, and is against the law. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Th e following have been reported with use of methylphenidate hydrochloride and other stimulant medicines: Hea r t-relat e d problems: sudde n 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 capsules. Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release capsules. 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 capsules . Mental (Psychiatric) problems: Al l Patients n e w or worse behavior and thought problems n e w or worse bipolar illness n e w or worse aggressive behavior or hostility n e w 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 capsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. Wha t are methylphenidate hydrochloride extended-release capsules ? Methylphenidate hydrochloride extended-release capsules are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Methylphenidate hydrochloride extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Methylphenidate hydrochloride extended-release capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. It is not known if methylphenidate hydrochloride extended-release capsules are safe and effective in children under 6 years of age. Who should not take methylphenidate hydrochloride extended-release capsules ? Methylphenidate hydrochloride extended-release capsules should not be taken if you or your child: are allergic to methylphenidate hydrochloride, or any of the ingredients in methylphenidate hydrochloride extended-release capsules. See the end of this Medication Guide for a complete list of ingredients in methylphenidate hydrochloride extended-release capsules. 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 capsules may not be right for you or your child. Before starting methylphenidate hydrochloride extended-release capsules, tell your or your child’s doctor about all health conditions (or a family history of) including: heart problems, heart defects, high blood pressure mental problems including psychosis, mania, bipolar illness, or depression circulation problems in fingers or toes if you are pregnant or plan to become pregnant. It is not known if methylphenidate hydrochloride will harm your unborn baby. There is a pregnancy registry for females who are exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules during pregnancy. The purpose of the registry is to collect information about the health of females exposed to methylphenidate hydrochloride extended-release capsules and their baby. If you or your child becomes pregnant during treatment with methylphenidate hydrochloride extended-release capsules, 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/adhd-medications/. 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 the baby during treatment with methylphenidate hydrochloride extended-release capsules. Tell your doctor about all of the medicines that you or your child take including prescription and over- the-counter medicines, vitamins, and herbal supplements. Methylphenidate hydrochloride extended-release capsules 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 extended-release capsules. Your doctor will decide whether methylphenidate hydrochloride extended-release capsules can be taken with other medicines. Especiall y 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 capsules without talking to your doctor first. How should methylphenidate hydrochloride extended-release capsules be taken? Take methylphenidate hydrochloride extended-release capsules exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child. Take methylphenidate hydrochloride extended-release capsules once a day in the morning. Methylphenidate hydrochloride extended-release capsules are an extended-release capsule. D o not chew or crush methylphenidate hydrochloride extended-release capsules or the medicine inside the capsule. Swallow methylphenidate hydrochloride extended-release capsules whole with water or other liquids. If you cannot swallow the capsule whole, open it and sprinkle the medicine over a spoonful of applesauce. Swallow the applesauce and medicine mixture without chewing. Follow with a drink of water or other liquid. You should avoid drinking alcohol during treatment with methylphenidate hydrochloride extended-release capsules. This may cause a faster release of methylphenidate hydrochloride extended-release capsules. From time to time, your doctor may stop methylphenidate hydrochloride extended-release capsule 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 capsules. Children should have their height and weight checked often while taking methylphenidate hydrochloride extended-release capsules. Methylphenidate hydrochloride extended-release capsules 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 possible side effects of methylphenidate hydrochloride extended-release capsules? See “What is the most important information I should know about methylphenidate hydrochloride extended-release capsules?” for informat...
Package/Label Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0093-5346-01 CII Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg Once-Daily PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 100 CAPSULES
Package/Label Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0093-5347-01 CII Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg Once-Daily PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 100 CAPSULES
Package/Label Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0093-5348-01 CII Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg Once-Daily PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 100 CAPSULES
