מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Accord Healthcare, Inc.
ORAL
PRESCRIPTION DRUG
Methylphenidate hydrochloride tablets are indicated for the treatment of: - Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults - Narcolepsy - 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)] . 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. Heal
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.
Abbreviated New Drug Application
Accord Healthcare, Inc. ---------- 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: • 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 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 • 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, bi קרא את המסמך השלם
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET ACCORD HEALTHCARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METHYLPHENIDATE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII INITIAL U.S. APPROVAL: 1955 WARNING: ABUSE AND DEPENDENCE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ CNS STIMULANTS, INCLUDING METHYLPHENIDATE HYDROCHLORIDE, OTHER METHYLPHENIDATE- CONTAINING PRODUCTS, AND AMPHETAMINES, HAVE A HIGH POTENTIAL FOR ABUSE AND DEPENDENCE (5.1, 9.2, 9.3). ASSESS THE RISK OF ABUSE PRIOR TO PRESCRIBING, AND MONITOR FOR SIGNS OF ABUSE AND DEPENDENCE WHILE ON THERAPY (5.1, 9.2) INDICATIONS AND USAGE Methylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy ( 1). DOSAGE AND ADMINISTRATION _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. DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 10 mg, and 20 mg ( 3) CONTRAINDICATIONS 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). WARNINGS AND PRECAUTIONS _Serious Cardiovascular Events_: Sudden death has been reported in association with CNS-stimulant treatment at usual doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myo קרא את המסמך השלם