Methamphetamine Hydrochloride — Active Pharmaceutical Ingredient

Methamphetamine Hydrochloride is an active pharmaceutical ingredient found in 3 FDA-approved drug products. Forms: TABLET, TABLET, EXTENDED RELEASE. Routes: ORAL.

This content is for informational purposes only. Always consult a healthcare professional.

Methamphetamine Hydrochloride (3 brand names, 2 dosage forms, 1 route)

Available dosage forms: TABLET, TABLET, EXTENDED RELEASE.

Routes of administration: ORAL.

Brand Names

  • DESOXYN
  • METHAMPEX
  • METHAMPHETAMINE HYDROCHLORIDE

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) ].

Indications and Usage

Methamphetamine hydrochloride tablets, USP is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older.

Contraindications

Methamphetamine hydrochloride tablets, USP is contraindicated in patients with: known hypersensitivity to amphetamine, or other components of methamphetamine. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions (6)]. taking monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of the risk of hypertensive crisis [see Drug Interactions (7.1)].

Adverse Reactions

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 [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 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. Fatal cardiorespiratory arrest has been reported, mostly in the context of abuse/misuse Central Nervous System: Psychotic episodes reported at recommended doses. Dizziness, dysphoria, overstimulation, euphoria, insomnia, tremor, restlessness and headache. Exacerbation of motor and verbal tics and Tourette’s syndrome Gastrointestinal: Diarrhea, constipation, dryness of mouth, unpleasant taste, intestinal ischemia, and other gastrointestinal disturbances Hypersensitivity: Urticaria Endocrine: Impotence and changes in l

Overdosage

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.

⚠ Caution
Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.