Country: United States
Language: English
Source: NLM (National Library of Medicine)
Methylphenidate Hydrochloride (UNII: 4B3SC438HI) (Methylphenidate - UNII:207ZZ9QZ49)
Mayne Pharma
Methylphenidate Hydrochloride
Methylphenidate Hydrochloride 20 mg
ORAL
PRESCRIPTION DRUG
Methylphenidate hydrochloride extended-release capsules (LA) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of methylphenidate hydrochloride extended-release capsules (LA) in the treatment of ADHD was established in 1 controlled trial of children aged 6 to 12 who met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor
Methylphenidate Hydrochloride Extended-Release Capsules (LA) 10 mg: white/light green (imprinted 199 on both the body and cap) Methylphenidate Hydrochloride Extended-Release Capsules (LA) 20 mg: white/white (imprinted 200 on both the body and cap) Methylphenidate Hydrochloride Extended-Release Capsules (LA) 30 mg: white/light blue (imprinted 201 on both the body and cap) Methylphenidate Hydrochloride Extended-Release Capsules (LA) 40 mg: white/dark blue (imprinted 202 on both the body and cap) Methylphenidate Hydrochloride Extended-Release Capsules (LA) 60 mg: light yellow/dark yellow (imprinted A602 on both the body and cap) Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] Dispense in tight container (USP).
Abbreviated New Drug Application
METHYLPHENIDATE HYDROCHLORIDE (LA)- METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE Mayne Pharma ---------- MEDICATION GUIDE METHYLPHENIDATE HYDROCHLORIDE (METH-il-FEN-i-date HYE-droe-KLOR-ide) EXTENDED- RELEASE CAPSULES (LA) CII Rx Only Read the Medication Guide that comes with methylphenidate hydrochloride extended-release capsules (LA) before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child's treatment with methylphenidate hydrochloride extended-release capsules (LA). What is the most important information I should know about Methylphenidate Hydrochloride Extended- Release Capsules (LA)? 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 capsules (LA). Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release capsules (LA). 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 (LA). 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 Children and Teenagers • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your doctor ab Read the complete document
METHYLPHENIDATE HYDROCHLORIDE (LA)- METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE MAYNE PHARMA ---------- METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA) CII ONCE DAILY RX ONLY PRESCRIBING INFORMATION DESCRIPTION Methylphenidate hydrochloride, USP is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules (LA) are an extended-release formulation of methylphenidate with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule (LA) contains half the dose as immediate-release beads and half as enteric- coated, delayed-release beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. Methylphenidate hydrochloride extended-release 10, 20, 30, 40, and 60 mg capsules (LA) provide in a single dose the same amount of methylphenidate as dosages of 5, 10, 15, or 20, or 30 mg of methylphenidate hydrochloride tablets given twice a day. The active substance in methylphenidate hydrochloride extended-release capsules (LA) is methyl α- phenyl-2-piperidineacetate hydrochloride, and its structural formula is 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. Its molecular weight is 269.77. INACTIVE INGREDIENTS: sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10 mg capsule contains FD&C Green #3, FD&C Red #40, and FD&C Yellow #6. The 30 and 40 mg capsules contain D&C Red #28 and FD&C Blue #1. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black impr Read the complete document