METHYLPHENIDATE HYDROCHLORIDE (Page 5 of 6)
16 HOW SUPPLIED/STORAGE AND HANDLING
Methylphenidate Hydrochloride Tablets, USP
Tablets 5 mg: White, round tablets, one side debossed with “W” and other side debossed with “281”.
Bottles of 100 with child-resistant closure, NDC 16729-478-01
Tablets 10 mg with a functional score: White, round tablets, one side debossed with “W282” and other side scored.
Bottles of 100 with child-resistant closure, NDC 16729-479-01
Tablets 20 mg with a functional score: White, round tablets, one side debossed with “W283” and scored on other side.
Bottles of 100 with child-resistant closure, NDC 16729-480-01
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).
Disposal
Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride 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 tablets 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 tablets in the household trash.
17 PATIENT COUNSELING INFORMATION
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 are controlled substances, and they can be abused and lead to dependence. Instruct patients that they should not give methylphenidate hydrochloride tablets to anyone else. Advise patients to store methylphenidate hydrochloride tablets 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 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 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)].
Blood Pressure and Heart Rate Increases
Instruct patients that methylphenidate hydrochloride can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions (5.3)].
Psychiatric Risks
Advise patients that methylphenidate hydrochloride, 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 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. 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 may cause slowing of growth and weight loss [see Warnings and Precautions (5.7)].
Pregnancy Registry
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including methylphenidate hydrochloride during pregnancy [see Use in Specific Populations (8.1)].
Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA
Manufactured By:
WES Pharma Inc.
1221 Tech Court, Westminster,
Maryland (MD) — 21157
United States (USA)
Issued August 2022
Dispense with Medication Guide available at www.accordhealthcare.us/medication-guides
MEDICATION GUIDE Methylphenidate Hydrochloride Tablets CII (meth” il fen’ i date hye” droe klor’ ide) | ||||
What is the most important information I should know about methylphenidate hydrochloride tablets? Methylphenidate hydrochloride tablet is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate hydrochloride tablets in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride tablets may harm others and is against the law.
Tell your doctor if you or your child have abused or been dependent on alcohol, prescription medicines, or street drugs.
The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines: 1. Heart-related problems:
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 tablets. Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride 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 tablets. 2. Mental (psychiatric) problems: All Patients
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 tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. | ||||
What is Methylphenidate hydrochloride tablets?
It is not known if methylphenidate hydrochloride tablets is safe and effective in children under 6 years of age. | ||||
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 doctor about all health conditions (or a family history of), including:
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. 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 doctor will decide whether methylphenidate hydrochloride tablets can be taken with other medicines. Especially tell your doctor if you or your child takes:
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 tablets without talking to your doctor first. | ||||
How should methylphenidate hydrochloride tablets be taken?
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What are the possible side effects of methylphenidate hydrochloride tablets? Methylphenidate hydrochloride tablets may cause serious side effects, including:
Common side effects include: | ||||
• fast heart beat • sweating a lot | • abnormal heartbeat (palpitations) • decreased appetite | • headache • dry mouth | • trouble sleeping • nausea | • nervousness • 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 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 doctor 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. | ||||
What are the ingredients in methylphenidate hydrochloride tablets? Active ingredient: methylphenidate HCl
Inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured For: Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA Manufactured By: WES Pharma Inc. 1221 Tech Court, Westminster, Maryland (MD) — 21157 United States (USA) Issued August 2022 |
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