METHAMPHETAMINE HYDROCHLORIDE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

METHAMPHETAMINE HYDROCHLORIDE (UNII: 997F43Z9CV) (METHAMPHETAMINE - UNII:44RAL3456C)

Saatavilla:

Hikma Pharmaceuticals USA Inc.

INN (Kansainvälinen yleisnimi):

METHAMPHETAMINE HYDROCHLORIDE

Koostumus:

METHAMPHETAMINE HYDROCHLORIDE 5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

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

Valmisteyhteenveto

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