pharmacopeia
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Boxed warning

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, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing methamphetamine, 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 Precautions ( 5.1 ) and Drug Abuse and Dependence ( 9.2 )] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. 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, can result in overdose and death. ( 5.1 , 9.2 , 10 ): • Before prescribing methamphetamine hydrochloride tablets, assess each patient’s risk for abuse, misuse, and addiction.

Mechanism of action

Sourced from openFDA

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in the treatment of ADHD is not known.

Dopamine UptakeMonoamine OxidaseNorepinephrine Uptake

Indications

Sourced from openFDA
  • Methamphetamine hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older. • Methamphetamine hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older.ICD-10: F90.9

Contraindications

Sourced from openFDA
  • Methamphetamine hydrochloride tablets are contraindicated in patients with: • known hypersensitivity to amphetamine, or other components of methamphetamine hydrochloride tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions ( 6 )] .contraindicated

Dosage & administration

Sourced from openFDA

• Administer methamphetamine hydrochloride tablets orally once daily or in two divided doses daily. Avoid administration late in the evening due to the risk of insomnia. ( 2.2 ) • Recommended starting dosage is 5 mg once or twice daily. ( 2.3 ) • Daily dosage may be increased in 5 mg increments at weekly intervals depending on clinical response. ( 2.3 ) • The recommended dosage range is 20 mg to 25 mg daily. ( 2.3 ) 2.1 Pretreatment Screening Prior to treating patients with methamphetamine hydrochloride tablets, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical examination) [see Warnings and Precautions ( 5.2 )] . • the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating methamphetamine hydrochloride tablets [see Warnings and Precautions ( 5.9 )] . 2.2 Important Dosing Information Administer methamphetamine hydrochloride tablets orally once daily or in two divided doses daily. Avoid taking methamphetamine hydrochloride tablets late in the evening due to the risk of insomnia. 2.3 Recommended Dosage For pediatric patients 6 years of age and older, the recommended starting dosage is 5 mg methamphetamine hydrochloride tablets once or twice daily. The daily dosage may be increased in increments of 5 mg at weekly intervals based on clinical response of the patient. The recommended dosage range is 20 mg to 25 mg daily.

Warnings & precautions

Sourced from openFDA

• Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. ( 5.2 ) • Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. ( 5.3 ) • Psychiatric Adverse Reactions: Prior to initiating methamphetamine hydrochloride tablets, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing methamphetamine hydrochloride tablets. ( 5.4 ) • Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. ( 5.5 ) • Peripheral Vasculopathy, including Raynaud’s Phenomenon: Careful observation for digital changes is necessary during methamphetamine hydrochloride tablets treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy. ( 5.6 ) • Seizures: May lower the convulsive threshold. If a seizure occurs, discontinue methamphetamine hydrochloride tablets. ( 5.7 ) • Serotonin Syndrome: Increased risk when coadministered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situations. If it occurs, discontinue methamphetamine hydrochloride tablets and initiate supportive treatment.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] • Hypersensitivity to amphetamine products or other ingredients of methamphetamine hydrochloride tablets [see Contraindications ( 4 )] • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] • Risks to Patient with Serious Cardiac Disease [see Warnings and Precautions ( 5.2 )] • Increased Blood Pressure and Heart Rate [see Warnings and Precautions ( 5.3 )] • Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.4 )] • Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions ( 5.5 )] • Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions ( 5.6 )] • Seizures [see Warnings and Precautions ( 5.7 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.8 )] • Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.9 )] The following adverse reactions associated with the use of methamphetamine hydrochloride tablets were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: Elevation of blood pressure, tachycardia and palpitation.

Use in specific populations

Sourced from openFDA

• Pregnancy: May cause fetal harm. ( 8.1 ) • Lactation: Breastfeeding not recommended. ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methamphetamine hydrochloride tablets, during pregnancy. Healthcare providers are encouraged to advise patients to register by contacting the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting online at www.womensmentalhealth.org/research/pregnancyregistry/adhd-medications/. Risk Summary Available data from epidemiologic studies and postmarketing reports on use of methamphetamine and amphetamine in pregnant women over decades of use have not identified a drug-associated risk of major birth defects or miscarriage. Neonates exposed to amphetamines in utero are at risk for withdrawal symptoms following delivery. Adverse pregnancy outcomes including premature delivery and low birth weight have been seen in infants born to mothers taking amphetamines during pregnancy (see Clinical Considerations) . In animals, administration of methamphetamine during organogenesis resulted in developmental toxicity, including neonatal death and fetal malformations, at doses equivalent to the maximum recommended human dose (MRHD) on a mg/m 2 basis.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Methamphetamine is absorbed from the gastrointestinal tract. Elimination Metabolism The primary site of metabolism is in the liver by aromatic hydroxylation, N-dealkylation and deamination.

Overdosage

Sourced from openFDA

Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: • Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. • CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. • Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Approval history

Sourced from openFDA
  • Apr 21, 2010ANDAANDA091189Dr Reddys Labs Sa
  • Nov 17, 2015ANDAANDA203846Hikma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,065 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Toxicity To Various Agents26725%
  2. 2Drug Abuse23422%
  3. 3Completed Suicide908.5%
  4. 4Death878.2%
  5. 5Cardiac Arrest716.7%
  6. 6Drug Interaction676.3%
  7. 7Respiratory Arrest656.1%
  8. 8Overdose504.7%
  9. 9Substance Abuse494.6%
  10. 10Cardio-respiratory Arrest474.4%
  11. 11Drug Toxicity393.7%
  12. 12Intentional Drug Misuse343.2%
  13. 13Pulmonary Oedema343.2%
  14. 14Serotonin Syndrome323.0%
  15. 15Respiratory Depression292.7%

Literature

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Recent PubMed references pinned to Methamphetamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 273 ClinicalTrials.gov registrations naming Methamphetamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Methamphetamine work?
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in the treatment of ADHD is not known.
What is Methamphetamine used for?
According to FDA labeling, Methamphetamine carries indications including: Methamphetamine hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older. • Methamphetamine hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Methamphetamine?
Methamphetamine is classified as Centrally acting sympathomimetics, Amphetamine Anorectic, Central Nervous System Stimulant, Dopamine Uptake Inhibitors, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Appetite Suppression, Bronchodilation, Central Nervous System Stimulation, Increased Cerebral Cortex Dopamine Activity, Increased Cerebral Cortex Norepinephrine Activity, Increased Sympathetic Activity.
What are the brand names for Methamphetamine?
Methamphetamine is marketed under brand names including Desoxyn.
What are the contraindications for Methamphetamine?
Methamphetamine labeling lists contraindications including: Methamphetamine hydrochloride tablets are contraindicated in patients with: • known hypersensitivity to amphetamine, or other components of methamphetamine hydrochloride tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions ( 6 )] .. Always consult the full prescribing information and a clinician.
Note. Data for methamphetamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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