OVERDOSAGE SECTION.

OVERDOSAGE. 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.TreatmentConsult with Certified Poison Control Center for up to date guidance and advice.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 55292-104-01 100 Tablets Desoxyn (R) (methamphetamine hydrochloride tablets, USP) mg CII Rx only DISPENSE THE ENCLOSED MEDICATION GUIDE WITH EACH PRESCRIPTION. GO TO www.recordatirarediseases.com Each tablet contains mg methamphetamine hydrochloride. See package insert for full prescribing information. Store at 20-25C (68-77F). See USP controlled room temperature. Dispense in 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 Desoxyn (methamphetamine hydrochloride tablets, USP) mg label.

DESCRIPTION SECTION.

DESCRIPTION. DESOXYN (R) (methamphetamine hydrochloride tablets, USP), chemically known as (S)-N,-dimethylbenzeneethanamine hydrochloride, is member of the amphetamine group of sympathomimetic amines. It has the following structural formula: DESOXYN tablets contain mg of methamphetamine hydrochloride for oral administration.Inactive Ingredients:Corn starch, lactose, sodium paraminobenzoate, stearic acid and talc.. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. 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 years or older with behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity: an initial dose of mg DESOXYN once or twice day is recommended. Daily dosage may be raised in increments of 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 recurrence of behavioral symptoms sufficient to require continued therapy.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. 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 Tourettes 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.

BOXED WARNING SECTION.

METHAMPHETAMINE HAS HIGH POTENTIAL FOR ABUSE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING METHAMPHETAMINE FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUG SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF METHAMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Data are not available on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Methamphetamine is 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 to 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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. 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 history of drug abuse.

NONTERATOGENIC EFFECTS SECTION.

Nonteratogenic effects: Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation and significant lassitude.

DRUG & OR LABORATORY TEST INTERACTIONS SECTION.

Drug/Laboratory Test Interactions: Literature reports suggest that amphetamines may be associated with significant elevation of plasma corticosteroids. This should be considered if determination of plasma corticosteroid levels is desired in person receiving amphetamines. Acidifying AgentsLower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).Alkalinizing AgentsIncrease blood levels and potentiate the action of amphetamine. Co-administration of DESOXYN and gastrointestinal alkalinizing agents should be avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) and urinary alkalinizing agents (e.g., acetazolamide, some thiazides).Tricyclic AntidepressantsMay enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Monitor frequently and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, Protriptyline.CYP2D6 InhibitorsThe concomitant use of DESOXYN and CYP2D6 inhibitors may increase the exposure of DESOXYN compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during DESOXYN initiation and after dosage increase. If serotonin syndrome occurs, discontinue DESOXYN and the CYP2D6 inhibitor (see WARNINGS, OVERDOSAGE). Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. Serotonergic DrugsThe concomitant use of DESOXYN and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during DESOXYN initiation or dosage increase. If serotonin syndrome occurs, discontinue DESOXYN and the concomitant serotonergic drug(s) (see WARNINGS and PRECAUTIONS). Examples of serotonergic drugs include selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. Johns Wort. MAO InhibitorsConcomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer DESOXYN concomitantly or within 14 days after discontinuing MAOI (see CONTRAINDICATIONS and WARNINGS). Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. Proton Pump InhibitorsTime to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone. Monitor patients for changes in clinical effect and adjust therapy based on clinical response. An example of proton pump inhibitor is omeprazole.

DRUG ABUSE AND DEPENDENCE SECTION.

DRUG ABUSE AND DEPENDENCE. 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.

DRUG INTERACTIONS SECTION.

Drug Interactions: Insulin requirements in diabetes mellitus may be altered in association with the use of methamphetamine and the concomitant dietary regimen. Methamphetamine may decrease the hypotensive effect of guanethidine. DESOXYN should not be used concurrently with monoamine oxidase inhibitors (see CONTRAINDICATIONS). Concurrent administration of tricyclic antidepressants and indirect-acting sympathomimetic amines such as the amphetamines, should be closely supervised and dosage carefully adjusted. Phenothiazines are reported in the literature to antagonize the CNS stimulant action of the amphetamines.

GENERAL PRECAUTIONS SECTION.

General: DESOXYN tablets should be used with caution in patients with even mild hypertension. Methamphetamine should not be used to combat fatigue or to replace rest in normal persons.Prescribing and dispensing of methamphetamine should be limited to the smallest amount that is feasible at one time in order to minimize the possibility of overdosage.

GERIATRIC USE SECTION.

Geriatric Use: Clinical Studies of DESOXYN did not include sufficient numbers of subjects age 65 years and over to determine whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy observed in this population.

HOW SUPPLIED SECTION.

HOW SUPPLIED. DESOXYN (methamphetamine hydrochloride tablets, USP) is supplied as white tablets imprinted with the letter on one side and the number 12 on the opposite side, containing mg methamphetamine hydrochloride in bottles of 100 (NDC 55292-104-01).Recommended Storage: Store at 20C to 25C (68F to 77F). See USP controlled room temperature. Dispense in 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. (R) 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. RECORDATI RARE DISEASES Logo.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Attention Deficit Disorder with Hyperactivity: DESOXYN tablets are indicated as an integral part of total treatment program which typically includes other remedial measures (psychological, educational, social) for stabilizing effect in children over years of age with 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 diagnosis of central nervous system dysfunction may or may not be warranted.

INFORMATION FOR PATIENTS SECTION.

Information for Patients: The patient should be informed that methamphetamine may impair the ability to engage in potentially hazardous activities, such as, operating machinery or driving motor vehicle. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynauds phenomenon]Instruct patients beginning treatment with DESOXYN about the risk of peripheral vasculopathy, including Raynauds 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 DESOXYN.Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients. The patient should be cautioned not to increase dosage, except on advice of the physician.Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methamphetamine and should counsel them in its appropriate use. patient Medication Guide is available for DESOXYN. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is available at www.recordatirarediseases.com. Instruct patients beginning treatment with DESOXYN about the risk of peripheral vasculopathy, including Raynauds 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 DESOXYN.. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

PEDIATRIC USE SECTION.

Pediatric Use: Long-term effects of methamphetamine in children have not been established (see WARNINGS). Drug treatment is not indicated in all cases of the behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity. It should be considered only in light of the complete history and evaluation of the child. The decision to prescribe DESOXYN tablets should depend on the physicians assessment of the chronicity and severity of the childs symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.When these symptoms are associated with acute stress reactions, treatment with DESOXYN tablets is usually not indicated. Clinical experience suggests that in psychotic children, administration of DESOXYN tablets may exacerbate symptoms of behavior disturbance and thought disorder.Amphetamines have been reported to exacerbate motor and phonic tics and Tourettes syndrome. Therefore, clinical evaluation for tics and Tourettes syndrome in children and their families should precede use of stimulant medications.

PRECAUTIONS SECTION.

PRECAUTIONS. General: DESOXYN tablets should be used with caution in patients with even mild hypertension. Methamphetamine should not be used to combat fatigue or to replace rest in normal persons.Prescribing and dispensing of methamphetamine should be limited to the smallest amount that is feasible at one time in order to minimize the possibility of overdosage.. Information for Patients: The patient should be informed that methamphetamine may impair the ability to engage in potentially hazardous activities, such as, operating machinery or driving motor vehicle. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynauds phenomenon]Instruct patients beginning treatment with DESOXYN about the risk of peripheral vasculopathy, including Raynauds 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 DESOXYN.Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients. The patient should be cautioned not to increase dosage, except on advice of the physician.Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methamphetamine and should counsel them in its appropriate use. patient Medication Guide is available for DESOXYN. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is available at www.recordatirarediseases.com. Instruct patients beginning treatment with DESOXYN about the risk of peripheral vasculopathy, including Raynauds 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 DESOXYN.. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients. Drug Interactions: Insulin requirements in diabetes mellitus may be altered in association with the use of methamphetamine and the concomitant dietary regimen. Methamphetamine may decrease the hypotensive effect of guanethidine. DESOXYN should not be used concurrently with monoamine oxidase inhibitors (see CONTRAINDICATIONS). Concurrent administration of tricyclic antidepressants and indirect-acting sympathomimetic amines such as the amphetamines, should be closely supervised and dosage carefully adjusted. Phenothiazines are reported in the literature to antagonize the CNS stimulant action of the amphetamines. Drug/Laboratory Test Interactions: Literature reports suggest that amphetamines may be associated with significant elevation of plasma corticosteroids. This should be considered if determination of plasma corticosteroid levels is desired in person receiving amphetamines. Acidifying AgentsLower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).Alkalinizing AgentsIncrease blood levels and potentiate the action of amphetamine. Co-administration of DESOXYN and gastrointestinal alkalinizing agents should be avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) and urinary alkalinizing agents (e.g., acetazolamide, some thiazides).Tricyclic AntidepressantsMay enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Monitor frequently and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, Protriptyline.CYP2D6 InhibitorsThe concomitant use of DESOXYN and CYP2D6 inhibitors may increase the exposure of DESOXYN compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during DESOXYN initiation and after dosage increase. If serotonin syndrome occurs, discontinue DESOXYN and the CYP2D6 inhibitor (see WARNINGS, OVERDOSAGE). Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. Serotonergic DrugsThe concomitant use of DESOXYN and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during DESOXYN initiation or dosage increase. If serotonin syndrome occurs, discontinue DESOXYN and the concomitant serotonergic drug(s) (see WARNINGS and PRECAUTIONS). Examples of serotonergic drugs include selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. Johns Wort. MAO InhibitorsConcomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer DESOXYN concomitantly or within 14 days after discontinuing MAOI (see CONTRAINDICATIONS and WARNINGS). Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. Proton Pump InhibitorsTime to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone. Monitor patients for changes in clinical effect and adjust therapy based on clinical response. An example of proton pump inhibitor is omeprazole.. Carcinogenesis, Mutagenesis, Impairment of Fertility: Data are not available on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility. Pregnancy Teratogenic effects: Pregnancy Category C. Methamphetamine has been shown to have teratogenic and embryocidal effects in mammals given high multiples of the human dose. There are no adequate and well-controlled studies in pregnant women. DESOXYN tablets should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects: Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation and significant lassitude. Usage in Nursing Mothers: Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing. Pediatric Use: Long-term effects of methamphetamine in children have not been established (see WARNINGS). Drug treatment is not indicated in all cases of the behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity. It should be considered only in light of the complete history and evaluation of the child. The decision to prescribe DESOXYN tablets should depend on the physicians assessment of the chronicity and severity of the childs symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.When these symptoms are associated with acute stress reactions, treatment with DESOXYN tablets is usually not indicated. Clinical experience suggests that in psychotic children, administration of DESOXYN tablets may exacerbate symptoms of behavior disturbance and thought disorder.Amphetamines have been reported to exacerbate motor and phonic tics and Tourettes syndrome. Therefore, clinical evaluation for tics and Tourettes syndrome in children and their families should precede use of stimulant medications.. Geriatric Use: Clinical Studies of DESOXYN did not include sufficient numbers of subjects age 65 years and over to determine whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy observed in this population.

PREGNANCY SECTION.

Pregnancy Teratogenic effects: Pregnancy Category C. Methamphetamine has been shown to have teratogenic and embryocidal effects in mammals given high multiples of the human dose. There are no adequate and well-controlled studies in pregnant women. DESOXYN tablets should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects: Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation and significant lassitude.

SPL MEDGUIDE SECTION.

MEDICATION GUIDE CII Desoxyn (R) (Pronounced De-soks-in) (methamphetamine hydrochloride tablets, USP) Read the Medication Guide that comes with DESOXYN (R) before you or your child starts taking it and each time you get refill. There may be new information. This Medication Guide does not take the place of talking to your or your childs doctor about your or your childs treatment with DESOXYN.What is the most important information should know about DESOXYN The following have been reported with use of methamphetamine hydrochloride and other stimulant medicines. 1. Heart-related problems: sudden death in patients who have heart problems or heart defectsstroke and heart attack in adultsincreased blood pressure and heart rateTell your or your childs doctor if you or your child have any heart problems, heart defects, high blood pressure, or family history of these problems. Your or your childs doctor should check you or your child carefully for heart problems before starting DESOXYN. Your or your childs doctor should check you or your childs blood pressure and heart rate regularly during treatment with DESOXYN. Call your or your childs doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking DESOXYN. 2. Mental (Psychiatric) problems: All Patients new or worse behavior and thought problemsnew or worse bipolar illnessnew or worse aggressive behavior or hostilityChildren and Teenagersnew psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptomsTell your or your childs doctor about any mental problems you or your child have, or about family history of suicide, bipolar illness, or depression. Call your or your childs doctor right away if you or your child have any new or worsening mental symptoms or problems while taking DESOXYN, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. 3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynauds phenomenon]: fingers or toes may feel numb, cool, painfulfingers or toes may change color from pale, to blue, to redTell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Call you your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking DESOXYN. What is DESOXYNDESOXYN is 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 part of total treatment program for ADHD that may include counseling or other therapies.DESOXYN is federally controlled substance (CII) because it can be abused or lead to dependence. Keep DESOXYN in safe place to prevent misuse and abuse. Selling or giving away DESOXYN may harm others, and is against the law. Tell your or your childs doctor if you or your child have (or have family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs. Who should not take DESOXYNDESOXYN should not be taken if you or your child:have heart disease or hardening of the arterieshave moderate to severe high blood pressurehave hyperthyroidismhave an eye problem called glaucomaare agitatedhave history of drug abuseare taking or have taken within the past 14 days an antidepression medicine called monoamine oxidase inhibitor or MAOI.are sensitive to, allergic to, or had reaction to other stimulant medicinesDESOXYN is not recommended for use in children less than years old in the treatment of ADHD.DESOXYN may not be right for you or your child. Before starting DESOXYN tell your or your childs doctor about all health conditions (or family history of) including:heart problems, heart defects, high blood pressuremental problems including psychosis, mania, bipolar illness or depressiontics or Tourettes syndromethyroid problemsdiabetesseizures or have had an abnormal brain wave test (EEG)circulation problems in fingers and toesTell your or your childs doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.Can DESOXYN be taken with other medicinesTell your or your childs 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 childs doctor will decide whether DESOXYN can be taken with other medicines.Especially tell your or your childs doctor if you or your child takes:anti-depression medicines including MAOIsanti-psychotic medicinesblood pressure medicinesinsulinseizure medicinesKnow the medicines that you or your child takes. Keep 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 childs doctor first.How should DESOXYN be takenTake DESOXYN exactly as prescribed. Your or your childs doctor may adjust the dose until it is right for you or your child. DESOXYN is usually taken or times each day.From time to time, your or your childs doctor may stop DESOXYN treatment for while to check ADHD symptoms.Your or your childs 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 problem is found during these check-ups.If you or your child takes too much DESOXYN or overdoses, call your or your childs doctor or poison control center right away, or get emergency treatment.What are possible side effects of DESOXYNSee What is the most important information should know about DESOXYN for information on reported heart and mental problems. Other serious side effects include:slowing of growth (height and weight) in childrenseizures, mainly in patients with history of seizureseyesight changes or blurred visionCommon side effects include:fast heart beat decreased appetitetremors headachetrouble sleeping dizzinessstomach upset weight lossdry mouthDESOXYN may affect your or your childs ability to drive or do other dangerous activities.Talk to your or your childs doctor if you or your child has side effects that are bothersome or do not go away.This is not complete list of possible side effects. Ask your or your childs doctor or pharmacist for more information.Call your or your childs doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should store DESOXYNStore DESOXYN in safe place at 20C to 25C (68F to 77F). Protect from light.Keep DESOXYN and all medicines out of the reach of children.General information about DESOXYNMedicines are sometimes prescribed for purposes other than those listed in Medication Guide. Do not use DESOXYN for 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 childs doctor. You can ask your or your childs 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 DESOXYNActive 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. (R) Trademark of Recordati Rare Diseases Inc.Revised: March 2019 MS-04347-R3.0. sudden death in patients who have heart problems or heart defects. stroke and heart attack in adults. increased blood pressure and heart rate. new or worse behavior and thought problems. new or worse bipolar illness. new or worse aggressive behavior or hostility. new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms. fingers or toes may feel numb, cool, painful. fingers or toes may change color from pale, to blue, to red. 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 history of drug abuse. are taking or have taken within the past 14 days an antidepression medicine called monoamine oxidase inhibitor or MAOI.. are sensitive to, allergic to, or had reaction to other stimulant medicines. heart problems, heart defects, high blood pressure. mental problems including psychosis, mania, bipolar illness or depression. tics or Tourettes syndrome. thyroid problems. diabetes. seizures or have had an abnormal brain wave test (EEG). circulation problems in fingers and toes. anti-depression medicines including MAOIs. anti-psychotic medicines. blood pressure medicines. insulin. seizure medicines. Take DESOXYN exactly as prescribed. Your or your childs doctor may adjust the dose until it is right for you or your child. DESOXYN is usually taken or times each day.. From time to time, your or your childs doctor may stop DESOXYN treatment for while to check ADHD symptoms.. Your or your childs 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 problem is found during these check-ups.. If you or your child takes too much DESOXYN or overdoses, call your or your childs doctor or poison control center right away, or get emergency treatment.. slowing of growth (height and weight) in children. seizures, mainly in patients with history of seizures. eyesight changes or blurred vision. fast heart beat decreased appetite. tremors headache. trouble sleeping dizziness. stomach upset weight loss. dry mouth. Store DESOXYN in safe place at 20C to 25C (68F to 77F). Protect from light.. Keep DESOXYN and all medicines out of the reach of children.. RECORDATI RARE DISEASES Logo.

SPL UNCLASSIFIED SECTION.

Desoxyn (R) (methamphetamine hydrochloride tablets, USP) Rx only. CII.

TERATOGENIC EFFECTS SECTION.

Teratogenic effects: Pregnancy Category C. Methamphetamine has been shown to have teratogenic and embryocidal effects in mammals given high multiples of the human dose. There are no adequate and well-controlled studies in pregnant women. DESOXYN tablets should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

WARNINGS SECTION.

WARNINGS. Serious Cardiovascular EventsSudden 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 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 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 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 careful history (including assessment for 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 prompt cardiac evaluation. Psychiatric Adverse EventsPre-existing Psychosis: Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with 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 mixed/manic episode in such patients. Prior to initiating treatment with stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include detailed psychiatric history, including 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 prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In 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 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 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 days per week throughout the year) have temporary slowing in growth rate (on average, total of about cm less growth in height and 2.7 kg less growth in weight over years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause 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 history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued. Peripheral Vasculopathy, including Raynauds phenomenon: Stimulants, including DESOXYN, used to treat ADHD are associated with peripheral vasculopathy, including Raynauds 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 Raynauds 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 SyndromeSerotonin syndrome, 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. Johns 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 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. 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 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 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.