Desoxyn ®                   
(methamphetamine hydrochloride tablets, USP)

Rx only

DESOXYN ® (methamphetamine hydrochloride tablets, USP), chemically known as (S)-N,α-dimethylbenzeneethanamine hydrochloride, is a member of the amphetamine group of sympathomimetic amines. It has the following structural formula:

DESOXYN tablets contain 5 mg of methamphetamine hydrochloride for oral administration.

Inactive Ingredients:

Corn starch, lactose, sodium paraminobenzoate, stearic acid and talc.

Methamphetamine is a sympathomimetic amine with CNS stimulant activity. Peripheral actions include elevation of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action. Other central nervous system actions, or metabolic effects, may be involved, for example.

The mechanism of action involved in producing the beneficial behavioral changes seen in hyperkinetic children receiving methamphetamine is unknown.

In humans, methamphetamine is rapidly absorbed from the gastrointestinal tract. The primary site of metabolism is in the liver by aromatic hydroxylation, N-dealkylation and deamination. At least seven metabolites have been identified in the urine. The biological half-life has been reported in the range of 4 to 5 hours. Excretion occurs primarily in the urine and is dependent on urine pH. Alkaline urine will significantly increase the drug half-life. Approximately 62% of an oral dose is eliminated in the urine within the first 24 hours with about one-third as intact drug and the remainder as metabolites.

Attention Deficit Disorder with Hyperactivity: DESOXYN tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

In patients known to be hypersensitive to amphetamine, or other components of DESOXYN. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products (see ADVERSE REACTIONS).

Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis (see WARNINGS and DRUG INTERACTIONS). It is also contraindicated in patients with glaucoma, advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism or known hypersensitivity or idiosyncrasy to sympathomimetic amines. Methamphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.

Serious Cardiovascular Events

Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems:

• Children and Adolescents: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
• Adults: Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.

Hypertension and other Cardiovascular Conditions: Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.

Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications: Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events

Pre-existing Psychosis: Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Bipolar Illness: Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Emergence of New Psychotic or Manic Symptoms: Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

Aggression: Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Long-Term Suppression of Growth: Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Seizures: There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Peripheral Vasculopathy, including Raynaud’s phenomenon: Stimulants, including DESOXYN, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Serotonin Syndrome

Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort (see DRUG INTERACTIONS). Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism (see CLINICAL PHARMACOLOGY). The potential for a pharmacokinetic interaction exists with the co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to DESOXYN. In these situations, consider an alternative nonserotonergic drug or an alternative drug that does not inhibit CYP2D6 (see DRUG INTERACTIONS).

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Concomitant use of DESOXYN with MAOI drugs is contraindicated (see CONTRAINDICATIONS).

Discontinue treatment with DESOXYN and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of DESOXYN with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate DESOXYN with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.

Visual Disturbance: Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

The following are adverse reactions in decreasing order of severity within each category that have been reported:

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 have been rarely reported at recommended doses. Dizziness, dysphoria, overstimulation, euphoria, insomnia, tremor, restlessness and headache. Exacerbation of motor and phonic tics and Tourette’s syndrome.

Gastrointestinal: Diarrhea, constipation, dryness of mouth, unpleasant taste and other gastrointestinal disturbances.

Hypersensitivity: Urticaria.

Endocrine: Impotence and changes in libido; frequent or prolonged erections.

Musculoskeletal: Rhabdomyolysis.

Miscellaneous: Suppression of growth has been reported with the long-term use of stimulants in children (see WARNINGS).

Skin and Subcutaneous Tissue Disorders: Alopecia.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Controlled Substance: DESOXYN tablets are subject to control under DEA schedule II.

Abuse: Methamphetamine has been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with methamphetamine include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis often clinically indistinguishable from schizophrenia. Abuse and/or misuse of methamphetamine have resulted in death. Fatal cardiorespiratory arrest has been reported in the context of abuse and/or misuse of methamphetamine.

Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Serotonin syndrome has also been reported. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Treatment

Consult with a Certified Poison Control Center for up to date guidance and advice.

DESOXYN tablets are given orally.

Methamphetamine should be administered at the lowest effective dosage, and dosage should be individually adjusted. Late evening medication should be avoided because of the resulting insomnia.

Attention Deficit Disorder with Hyperactivity: For treatment of children 6 years or older with a behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity: an initial dose of 5 mg DESOXYN once or twice a day is recommended. Daily dosage may be raised in increments of 5 mg at weekly intervals until an optimum clinical response is achieved. The usual effective dose is 20 to 25 mg daily. The total daily dose may be given in two divided doses daily.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

DESOXYN (methamphetamine hydrochloride tablets, USP) is supplied as white tablets imprinted with the letter R on one side and the number 12 on the opposite side, containing 5 mg methamphetamine hydrochloride in bottles of 100 (NDC 55292-104-01).

Recommended Storage: Store at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.

Dispense in a USP tight, light resistant container.

Manufactured by:

UPM Pharmaceuticals

510 5th Street, Bristol, TN 37620, U.S.A.

For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.

® Trademark of Recordati Rare Diseases Inc.

This product label may have been updated. For the most recent prescribing information, please visit www.recordatirarediseases.com.

Revised: March 2019 MS-04347-R3.0

Desoxyn ®

(Pronounced Dĕ-sŏks-ĭn)

(methamphetamine hydrochloride tablets, USP)

Read the Medication Guide that comes with DESOXYN ® before you or your child starts taking it and each time you get a refill.

There may be new information. This Medication Guide does not take the place of talking to your or your child’s doctor about your or your child’s treatment with DESOXYN.

What is DESOXYN?

DESOXYN is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder; (ADHD). DESOXYN may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

DESOXYN should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Who should not take DESOXYN?

DESOXYN should not be taken if you or your child:

• have heart disease or hardening of the arteries
• have moderate to severe high blood pressure
• have hyperthyroidism
• have an eye problem called glaucoma
• are agitated
• have a history of drug abuse
• are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
• are sensitive to, allergic to, or had a reaction to other stimulant medicines

DESOXYN is not recommended for use in children less than 6 years old in the treatment of ADHD.

DESOXYN may not be right for you or your child. Before starting DESOXYN tell your or your child’s doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness or depression
• tics or Tourette’s syndrome
• thyroid problems
• diabetes
• seizures or have had an abnormal brain wave test (EEG)
• circulation problems in fingers and toes

Tell your or your child’s doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can DESOXYN be taken with other medicines?

Tell your or your child’s doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.

DESOXYN and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking DESOXYN.

Your or your child’s doctor will decide whether DESOXYN can be taken with other medicines.

Especially tell your or your child’s doctor if you or your child takes:

• anti-depression medicines including MAOIs
• anti-psychotic medicines
• blood pressure medicines
• insulin
• seizure medicines

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking DESOXYN without talking to your or your child’s doctor first.

How should DESOXYN be taken?

• Take DESOXYN exactly as prescribed. Your or your child’s doctor may adjust the dose until it is right for you or your child.
• DESOXYN is usually taken 1 or 2 times each day.
• From time to time, your or your child’s doctor may stop DESOXYN treatment for a while to check ADHD symptoms.
• Your or your child’s doctor may do regular checks of the blood, heart, and blood pressure while taking DESOXYN. Children should have their height and weight checked often while taking DESOXYN. DESOXYN treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much DESOXYN or overdoses, call your or your child’s doctor or poison control center right away, or get emergency treatment.

What are possible side effects of DESOXYN?

See “What is the most important information I should know about DESOXYN?” for information on reported heart and mental problems.

Other serious side effects include:

• slowing of growth (height and weight) in children
• seizures, mainly in patients with a history of seizures
• eyesight changes or blurred vision

Common side effects include:

• fast heart beat • decreased appetite
• tremors • headache
• trouble sleeping • dizziness
• stomach upset • weight loss
• dry mouth

DESOXYN may affect your or your child’s ability to drive or do other dangerous activities.

Talk to your or your child’s doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your or your child’s doctor or pharmacist for more information.

Call your or your child’s doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store DESOXYN?

• Store DESOXYN in a safe place at 20°C to 25°C (68°F to 77°F). Protect from light.
• Keep DESOXYN and all medicines out of the reach of children.

General information about DESOXYN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DESOXYN for a condition for which it was not prescribed. Do not give DESOXYN to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about DESOXYN. If you would like more information, talk with your or your child’s doctor. You can ask your or your child’s doctor or pharmacist for information about DESOXYN that was written for healthcare professionals.

For more information about DESOXYN, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or visit www.recordatirarediseases.com.

What are the ingredients in DESOXYN?

Active Ingredient: methamphetamine hydrochloride

Inactive Ingredients: corn starch, lactose, sodium paraminobenzoate, stearic acid and talc

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Recordati Rare Diseases Inc.

Lebanon, NJ 08833, U.S.A.

® Trademark of Recordati Rare Diseases Inc.

Revised: March 2019 MS-04347-R3.0

NDC 55292-104-01
100 Tablets
Desoxyn ®
(methamphetamine hydrochloride tablets, USP)
5 mg CII
Rx only
DISPENSE THE ENCLOSED MEDICATION GUIDE WITH EACH PRESCRIPTION.
GO TO www.recordatirarediseases.com

Each tablet contains 5 mg methamphetamine hydrochloride.
See package insert for full prescribing information.
Store at 20-25°C (68-77°F). See USP controlled room temperature.
Dispense in a USP tight, light-resistant container.
Do not accept if seal over bottle opening is broken or missing.
Manufactured by:
UPM Pharmaceuticals
For: Recordati Rare Diseases Inc.
Lebanon, NJ 08833, U.S.A.
MS-04346 R1.0

NDC 55292-102-01

100 Tablets

Desoxyn ®
(methamphetamine hydrochloride tablets, USP)

5 mg CII

Rx only

DISPENSE THE ENCLOSED MEDICATION GUIDE WITH EACH PRESCRIPTION.

GO TO www.recordatirarediseases.com

Each tablet contains 5 mg methamphetamine hydrochloride.

See package insert for full prescribing information.

Store below 86°F (30°C).

Dispense in a USP tight, light-resistant container.

Do not accept if seal over bottle opening is broken or missing.

Manufactured by: AbbVie LTD

For: Recordati Rare Diseases Inc.
Lebanon, NJ 08833, U.S.A.

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