Methamphetamine

FDA label, Dr. Reddy's Laboratories Inc, oral, effective 2025-11-07. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Boxed warning

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. 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, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of each drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Drug interactions

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Label text (8 paragraphs)

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 . Table 1: Clinically Important Drug Interactions with methamphetamine hydrochloride tablets, USP Monoamine Oxidase Inhibitors (MAOI) Clinical Impact: MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.

Intervention: Concomitant use of methamphetamine hydrochloride tablets, USP with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment is contraindicated [see Contraindications (4)]. Serotonergic Drugs Clinical Impact: The concomitant use of amphetamines, including methamphetamine hydrochloride tablets, USP , and serotonergic drugs increases the risk of serotonin syndrome. Intervention: Initiate methamphetamine hydrochloride tablets, USP with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during methamphetamine hydrochloride tablets, USP initiation or dosage increase.

If serotonin syndrome occurs, discontinue methamphetamine hydrochloride tablets, USP and the concomitant serotonergic drug(s) [see Warnings and Precautions 5.8]. AlkalinizingAgents Clinical Impact: Alkalinizing agents may increase exposure to amphetamines and potentiate the action of amphetamine. Intervention Avoid co-administration of methamphetamine hydrochloride tablets, USP and gastrointestinal and urinary alkalinizing agents. Acidifying Agents Clinical Impact: Acidifying agents lower blood levels and efficacy of amphetamines. Intervention Increase dose of methamphetamine hydrochloride tablets, USP based on clinical response.

Tricyclic Antidepressants Clinical Impact: May enhance the activity of tricyclic or sympathomimetic agents causing sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Intervention Monitor frequently and adjust methamphetamine hydrochloride tablets, USP dose or use alternative therapy based on clinical response. CYP2D6 Inhibitors Clinical Impact: Concomitant use of methamphetamine hydrochloride tablets, USP and CYP2D6 inhibitors may increase the exposure of methamphetamine hydrochloride tablets, USP compared to the use of the drug alone, and increase the risk of serotonin syndrome.

Intervention Start with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during methamphetamine hydrochloride tablets, USP initiation and after a dosage increase. If serotonin syndrome occurs, discontinue methamphetamine hydrochloride tablets, USP and the CYP2D6 inhibitor [see Warnings and Precautions 5.8]. Gastric pH Modulators Clinical Impact: Time to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone. Intervention Monitor patients for changes in clinical effect and use alternative therapy based on clinical response.

Guanethidine Clinical Impact: Methamphetamine may decrease the hypotensive effect ofguanethidine. Intervention Monitor patients and adjust therapy based on clinicalresponse. Insulin requirements in diabetes mellitus may be altered in association with the use of methamphetamine and the concomitant dietary regimen.

7.2 Drug/Laboratory Test Interactions Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

Contraindications

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 )]. 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 )].

Known hypersensitivity to amphetamine, or other components of methamphetamine hydrochloride tablets, USP. ( 4 ) Concomitant use of monoamine oxidase inhibitors (MAOIs), or use of an MAOI within the preceding 14 days. ( 4 )

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