Dispense in a tight, light resistant, child-resistant container as defined in the USP/NF.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Abuse, Misuse, and Addiction

Educate patients and their families about the risks of abuse, misuse, and addiction of methamphetamine hydrochloride tablets, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise patients to store methamphetamine hydrochloride tablets in a safe place, preferably locked, and instruct patients to not give methamphetamine hydrochloride tablets to anyone else.

Risks to Patients with Serious Cardiac Disease

Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death with methamphetamine hydrochloride tablets use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

Increased Blood Pressure and Heart Rate

Instruct patients that methamphetamine hydrochloride tablets can cause elevations of their blood pressure and pulse rate and they should be monitored for such effects [see Warnings and Precautions (5.3)].

Psychiatric Adverse Risks

Advise patients that methamphetamine hydrochloride tablets, at recommended doses, may cause psychotic or manic symptoms even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

Long-Term Suppression of Growth in Pediatric Patients

Advise patients, family members, and caregivers that methamphetamine hydrochloride tablets may cause slowing of growth including weight loss [see Warnings and Precautions (5.5)].

Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon)

Instruct patients beginning treatment with methamphetamine hydrochloride tablets about the risk of peripheral vasculopathy, including Raynaud's Phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking methamphetamine hydrochloride tablets. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)].

Seizures

Caution patient that methamphetamine hydrochloride tablets may lower the convulsive threshold. Advise patients to contact their healthcare provider immediately and to discontinue methamphetamine hydrochloride tablets if a seizure occurs [see Warnings and Precautions (5.7)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with concomitant use of methamphetamine hydrochloride tablets and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see Contraindications (4), Warnings and Precautions (5.8) and Drug Interactions (7.1)]. Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.

Motor and Verbal Tics, and Worsening of Tourette's Syndrome

Advise patients that motor and verbal tics and worsening of Tourette's syndrome may occur during treatment with methamphetamine hydrochloride tablets. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette's syndrome occurs [see Warnings and Precautions (5.9)].

Concomitant Medications

Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see Drug Interactions (7.1)].

Pregnancy

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to methamphetamine hydrochloride tablets during pregnancy. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with methamphetamine hydrochloride tablets. Advise patients of the potential fetal effects from the use of methamphetamine hydrochloride tablets during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise patients not to breastfeed if they are taking methamphetamine hydrochloride tablets [see Use in Specific Populations (8.2)].