Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Sandoz Inc
METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Methylphenidate hydrochloride and methylphenidate hydrochloride sustained-release are indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults • Narcolepsy Pregnancy Category C In 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. Teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (MRHD) on a mg/m2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the MRHD on a mg/m2 basis). There was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the MRHD on a mg/m2 basis), which was also maternally toxic. The no effect level for embryo-fetal development
Tablets 5 mg-round, yellow (SZ imprinted on one side and 783 on the other) Bottles of 100.......................................................................NDC 0781-5748-01 Tablets 10 mg-round, pale green, scored (SZ imprinted on one side and 789 on the other) Bottles of 100.......................................................................NDC 0781-5749-01 Tablets 20 mg-round, pale yellow, scored (SZ imprinted on one side and 790 on the other) Bottles of 100.......................................................................NDC 0781-5753-01 Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature] Protect from moisture. Dispense in tight, light-resistant container (USP). SR Tablets 20 mg-round, white to off-white, film coated (SZ and 780 printed in black ink on one side). Bottles of 100.......................................................................NDC 0781-5754-01 Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature]. Protect from moisture. 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 and methylphenidate hydrochloride sustained-release 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 or methylphenidate hydrochloride sustained-release 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 or methylphenidate hydrochloride sustained-release in the household trash.
New Drug Application Authorized Generic
METHYLPHENIDATE HYDROCHLORIDE SR- METHYLPHENIDATE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE Sandoz Inc ---------- MEDICATION GUIDE METHYLPHENIDATE HYDROCHLORIDE (METH-il-FEN-i-date) tablets, USP CII What is the most important information I should know about methylphenidate hydrochloride? Methylphenidate hydrochloride is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate hydrochloride in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride 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. Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride. 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. 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, bipolar illness, or depression. Call your doctor right away if yo Přečtěte si celý dokument
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE SR- METHYLPHENIDATE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METHYLPHENIDATE HYDROCHLORIDE TABLETS CII AND METHYLPHENIDATE HYDROCHLORIDE SUSTAINED-RELEASE TABLETS CII SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE TABLETS CII AND METHYLPHENIDATE HYDROCHLORIDE SUSTAINED-RELEASE TABLETS CII.. METHYLPHENIDATE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII METHYLPHENIDATE HYDROCHLORIDE SUSTAINED-RELEASE TABLETS, FOR ORAL USE, CII INITIAL U.S. APPROVAL: 1955 WARNING: ABUSE AND DEPENDENCE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • RECENT MAJOR CHANGES Boxed Warning 1/2019 Contraindications (4) 1/2019 Warnings and Precautions (5) 1/2019 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): • • _Methylphenidate Hydrochloride Sustained-Release Tablets _(2.2): • • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS CNS stimulants, including methylphenidate hydrochloride and methylphenidate hydrochloride sustained- release, 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) 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 to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maxi Přečtěte si celý dokument