Methamphetamine Hydrochloride
Generic Name: methamphetamine hydrochloride
Brand Names:
Methamphetamine Hydrochloride
11. DESCRIPTION Methamphetamine hydrochloride tablets, USP contain methamphetamine, a central nervous system stimulant, in the form of hydrochloride salt. Methamphetamine hydrochloride is chemically known as (S) N,α dimethylbenzeneethanamine hydrochloride with molecular formula of C10H15N.HCl and molecular weight of 185.73 g/mol It has the following structural formula: Methamphetamine hydrochloride tablets, USP contain 5 mg of methamphetamine hydrochloride, USP for oral administration.
Overview
11. DESCRIPTION Methamphetamine hydrochloride tablets, USP contain methamphetamine, a central nervous system stimulant, in the form of hydrochloride salt. Methamphetamine hydrochloride is chemically known as (S) N,α dimethylbenzeneethanamine hydrochloride with molecular formula of C10H15N.HCl and molecular weight of 185.73 g/mol It has the following structural formula: Methamphetamine hydrochloride tablets, USP contain 5 mg of methamphetamine hydrochloride, USP for oral administration.
Uses
1. 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. Methamphetamine hydrochloride tablets, USP is 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.
Dosage
2. DOSAGE & ADMINISTRATION Administer methamphetamine hydrochloride tablets, USP 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 a 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, USP, 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 )].
Side Effects
6. 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 Precautio...
Interactions
7. DRUG INTERACTIONS Acidifying and Alkalinizing Agents: Agents that alter GI and urinary pH can alter blood levels of amphetamine. Acidifying agents can decrease amphetamine blood levels, while alkalinizing agents can increase amphetamine blood levels. ( 7.1 ) 7.1 Drugs Having Clinically Important Interactions with methamphetamine hydrochloride tablets, USP Table 1 presents clinically important drug interactions with methamphetamine hydrochloride tablets, USP .
Warnings
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, 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. 5. WARNINGS AND PRECAUTIONS 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, USP, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing methamphetamine hydrochloride tablets, USP (5 .4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. 4. 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 )].
Storage
16. HOW SUPPLIED /STORAGE AND HANDLING How Supplied Methamphetamine hydrochloride tablets, USP are available containing 5 mg of methamphetamine hydrochloride, USP. The 5 mg tablets are white, round, unscored tablets debossed with 115 on one side of the tablet and blank on the other side.
Frequently Asked Questions
What is Methamphetamine Hydrochloride used for?▼
1. 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. Methamphetamine hydrochloride tablets, USP is 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.
What are the side effects of Methamphetamine Hydrochloride?▼
6. 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 Precautio...
What are the important warnings for Methamphetamine Hydrochloride?▼
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, 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. 5. WARNINGS AND PRECAUTIONS 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, USP, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing methamphetamine hydrochloride tablets, USP (5 .4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. 4. 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 )].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.