FDA

Methamphetamine Hydrochloride

Approved 17 Nov 2015OralTablet

The FDA lists this product in 6 strengths and forms.

Indications

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. ( 1 )

Contraindications

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 )] .
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. ( 4 )
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use of an MAOI within the preceding 14 days. ( 4 )

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, 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 )

Indications

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. ( 1 )

Contraindications

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 )] .
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. ( 4 )
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use of an MAOI within the preceding 14 days. ( 4 )

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, 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 )

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 )

7.1Drugs Having Clinically Important Interactions with Methamphetamine Hydrochloride Tablets Table

1 presents clinically important drug interactions with methamphetamine hydrochloride tablets. Table 1: Clinically Important Drug Interactions with Methamphetamine Hydrochloride Tablets 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 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, and serotonergic drugs increases the risk of serotonin syndrome.

Intervention: Initiate methamphetamine hydrochloride tablets with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during methamphetamine hydrochloride tablets initiation or dosage increase. If serotonin syndrome occurs, discontinue methamphetamine hydrochloride tablets and the concomitant serotonergic drug(s) [see Warnings and Precautions ( 5.8 )] . Alkalinizing Agents Clinical Impact: Alkalinizing agents may increase exposure to amphetamines and potentiate the action of amphetamine.

Intervention: Avoid co-administration of methamphetamine hydrochloride tablets 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 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 dose or use alternative therapy based on clinical response. CYP2D6 Inhibitors Clinical Impact: Concomitant use of methamphetamine hydrochloride tablets and CYP2D6 inhibitors may increase the exposure of methamphetamine 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 initiation and after a dosage increase.

If serotonin syndrome occurs, discontinue methamphetamine hydrochloride tablets and the CYP2D6 inhibitor [see Warnings and Precautions ( 5.8 )] . Gastric pH Modulators Clinical Impact: Time to maximum concentration (T max ) 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 of guanethidine .

Intervention: Monitor patients and adjust therapy based on clinical response. Insulin requirements in diabetes mellitus may be altered in association with the use of methamphetamine and the concomitant dietary regimen.

7.2Drug/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.

Pregnancy and breastfeeding

8.1Pregnancy 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. Oral administration of methamphetamine to rats during pregnancy, pregnancy and lactation, or lactation resulted in developmental toxicity in the offspring, including, neonatal mortality and delayed development, at a maternal dose similar to the MRHD on a mg/m 2 basis.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Amphetamines, such as methamphetamine, cause vasoconstriction and thereby decrease placental perfusion.

In addition, amphetamines can stimulate uterine contractions, increasing the risk of premature delivery. Infants born to mothers taking amphetamines during pregnancy have an increased risk of premature delivery and low birth weight. Monitor infants born to mothers taking methamphetamine for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness. Data Animal Data Based on published data, methamphetamine administration during the period of organogenesis caused malformations and pup mortality in mammals at doses equivalent to the maximum recommended human dose (MRHD) on a mg/m 2 basis.

Oral administration of methamphetamine (0, or 3.75 mg/kg) to pregnant rats during gestation, throughout gestation and lactation, or only during lactation resulted in an increase in neonatal pup mortality. Delayed somatic development (pinna unfolding and eye opening) and impairments in neurobehavioral development (righting reflex, incline plane test, and forelimb grip strength) were observed in the pups. The dose with adverse effects was equivalent to the MRHD of 25 mg on a mg/m 2 basis.

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 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. 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 libido; frequent or prolonged erections Musculoskeletal: Rhabdomyolysis Metabolism and Nutrition Disorders: Suppression of growth has been reported with the long-term use of stimulants in pediatric patients Skin and Subcutaneous Tissue Disorders: Alopecia The following additional adverse reactions have been identified during post approval use of amphetamines: Allergic: Rash, hypersensitivity reactions, including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Cardiovascular: Dyspnea, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use Central Nervous System: dyskinesia, fatigue, aggression, anger, logorrhea, dermatillomania, and paresthesia (including formication) Eye Disorders: Mydriasis Vascular Disorders: Raynaud’s phenomenon Common adverse reactions include: palpitation, dizziness, insomnia, tremor, headache, diarrhea, dryness of mouth. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Methamphetamine Hydrochloride

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Methamphetamine Hydrochloride

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Abuse, Misuse, and Addiction

5.2Risks to Patients with Serious Cardiac Disease

5.3Increased Blood Pressure and Heart Rate

5.4Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis

5.5Long-Term Suppression of Growth in Pediatric Patients

5.6Peripheral

5.7Seizures

5.8Serotonin Syndrome

Interactions

7.1Drugs Having Clinically Important Interactions with Methamphetamine Hydrochloride Tablets Table

7.2Drug/Laboratory Test Interactions

Pregnancy and breastfeeding

8.1Pregnancy Pregnancy Exposure Registry

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance