Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
METHAMPHETAMINE HYDROCHLORIDE (UNII: 997F43Z9CV) (METHAMPHETAMINE - UNII:44RAL3456C)
Hikma Pharmaceuticals USA Inc.
METHAMPHETAMINE HYDROCHLORIDE
METHAMPHETAMINE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Attention Deficit Disorder with Hyperactivity: Methamphetamine hydrochloride tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. In patients known to be hypersensitive to amphetamine, or other components of methamphetamine hydrochloride tablets, hypersensitivity reactions such as angioedema and anaphylactic reactions have been re
Methamphetamine Hydrochloride Tablets, USP 5 mg tablets are supplied as a round, white to off-white, biconvex, debossed tablet with "54" on one side and "681" on the other side. NDC 0054-0389-25: Bottle of 100 tablets Recommended Storage: Store at 20ºC to 25ºC (68ºF to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light resistant, child-resistant container as defined in the USP/NF. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000760/03 Revised October 2023
Abbreviated New Drug Application
METHAMPHETAMINE HYDROCHLORIDE- METHAMPHETAMINE HYDROCHLORIDE TABLET Hikma Pharmaceuticals USA Inc. ---------- MEDICATION GUIDE Methamphetamine Hydrochloride Tablets USP, CII (meth″ am fet′ a meen hye″ droe klor′ ide) Rx only What is the most important information I should know about methamphetamine hydrochloride tablets? Methamphetamine hydrochloride tablets may cause serious side effects, including: • Abuse, misuse, and addiction. Methamphetamine hydrochloride tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methamphetamine hydrochloride tablets, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of methamphetamine hydrochloride tablets or when it is used in ways that are not approved, such as snorting or injection. o Your healthcare provider should check your child’s risk for abuse, misuse, and addiction before starting treatment with methamphetamine hydrochloride tablets and will monitor your child during treatment. o Methamphetamine hydrochloride tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give methamphetamine hydrochloride tablets to anyone else. See “What are methamphetamine hydrochloride tablets?” for more information. o Keep methamphetamine hydrochloride tablets in a safe place and properly dispose of any unused medicine. See “How should I store methamphetamine hydrochloride tablets?” for more information. o Tell your healthcare provider if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs. • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your child’s healthcare provider should check your child carefully for heart problems before starting treatment with methamphetamin Prečítajte si celý dokument
METHAMPHETAMINE HYDROCHLORIDE- METHAMPHETAMINE HYDROCHLORIDE TABLET HIKMA PHARMACEUTICALS USA INC. ---------- METHAMPHETAMINE HYDROCHLORIDE TABLETS, USP CII RX ONLY WARNING: ABUSE, MISUSE, AND ADDICTION METHAMPHETAMINE HAS A HIGH POTENTIAL FOR ABUSE AND MISUSE, WHICH CAN LEAD TO THE DEVELOPMENT OF A SUBSTANCE USE DISORDER, INCLUDING ADDICTION. MISUSE AND ABUSE OF CNS STIMULANTS, INCLUDING METHAMPHETAMINE HYDROCHLORIDE TABLETS, CAN RESULT IN OVERDOSE AND DEATH (SEE OVERDOSAGE), AND THIS RISK IS INCREASED WITH HIGHER DOSES OR UNAPPROVED METHODS OF ADMINISTRATION, SUCH AS SNORTING OR INJECTION. BEFORE PRESCRIBING METHAMPHETAMINE HYDROCHLORIDE TABLETS, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION. EDUCATE PATIENTS AND THEIR FAMILIES ABOUT THESE RISKS, PROPER STORAGE OF THE DRUG, AND PROPER DISPOSAL OF ANY UNUSED DRUG. THROUGHOUT METHAMPHETAMINE TREATMENT, REASSESS EACH PATIENT’S RISK OF ABUSE, MISUSE, AND ADDICTION AND FREQUENTLY MONITOR FOR SIGNS AND SYMPTOMS OF ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS AND DRUG ABUSE AND DEPENDENCE). DESCRIPTION Methamphetamine hydrochloride, USP, chemically known as (αS)-α- Methylbenzeneethan-(N-methyl)-amine Hydrochloride, is a member of the amphetamine group of sympathomimetic amines. It has the following structural formula: Methamphetamine hydrochloride tablets, USP contain 5 mg of methamphetamine hydrochloride, USP for oral administration. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone and purified water. CLINICAL PHARMACOLOGY Methamphetamine is a sympathomimetic amine with CNS stimulant activity. Peripheral actions include elevation of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action. Other central nervous system actions, or metabolic effects, may be involved, for example. The mechanism of action involved in producing the beneficial behavioral changes seen in hyperkinetic children receiving methamphetamine is unknow Prečítajte si celý dokument