Desoxyn

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Overview

What is Desoxyn?

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.

What does Desoxyn look like?

What are the available doses of Desoxyn?

Sorry No records found.

What should I talk to my health care provider before I take Desoxyn?

Sorry No records found

How should I use Desoxyn?

Attention Deficit Disorder with Hyperactivity:

Exogenous Obesity:

The limited usefulness of DESOXYN tablets (see ) should be weighed against possible risks inherent in use of the drug, such as those described below.

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:

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

For Obesity:

What interacts with Desoxyn?

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 ).

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 and ). 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.

What are the warnings of Desoxyn?

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Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued (see ).

Serious Cardiovascular Events

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

Hypertension and other Cardiovascular Conditions:

Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications:

Psychiatric Adverse Events

Pre-existing Psychosis:

Bipolar Illness:

Emergence of New Psychotic or Manic Symptoms:

Aggression:

Long-Term Suppression of Growth:

Seizures:

Peripheral Vasculopathy, including Raynaud’s phenomenon:

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 ). 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 ). 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 ).

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 ).

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:

Children and Adolescents:

Adults:

What are the precautions of Desoxyn?

Instruct patients beginning treatment with DESOXYN 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.
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Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking DESOXYN.

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 .

DESOXYN should not be used concurrently with (see ).

Concurrent administration of and indirect-acting sympathomimetic amines such as the amphetamines, should be closely supervised and dosage carefully adjusted.

Phenothiazines

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pregnancy

Usage in Nursing Mothers:

Geriatric Use:

What are the side effects of Desoxyn?

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

Cardiovascular:

Central Nervous System:

Gastrointestinal:

Hypersensitivity:

Endocrine:

Musculoskeletal:

Miscellaneous:

Skin and Subcutaneous Tissue Disorders:

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

What should I look out for while using Desoxyn?

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 ).

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 and ). 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.

Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued (see ).

Serious Cardiovascular Events

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

Hypertension and other Cardiovascular Conditions:

Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications:

Psychiatric Adverse Events

Pre-existing Psychosis:

Bipolar Illness:

Emergence of New Psychotic or Manic Symptoms:

Aggression:

Long-Term Suppression of Growth:

Seizures:

Peripheral Vasculopathy, including Raynaud’s phenomenon:

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 ). 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 ). 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 ).

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 ).

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:

What might happen if I take too much Desoxyn?

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.

How should I store and handle Desoxyn?

Risperidone oral solution should be stored at controlled room temperature 15°- 25°C (59°-77°F). Protect from light and freezing.Keep out of reach of children.Risperidone oral solution should be stored at controlled room temperature 15°- 25°C (59°-77°F). Protect from light and freezing.Keep out of reach of children.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 20-25°C (68-77°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.Revised: May 2017 MS-04347-R2.0DESOXYN (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 20-25°C (68-77°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.Revised: May 2017 MS-04347-R2.0DESOXYN (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 20-25°C (68-77°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.Revised: May 2017 MS-04347-R2.0DESOXYN (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 20-25°C (68-77°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.Revised: May 2017 MS-04347-R2.0DESOXYN (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 20-25°C (68-77°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.Revised: May 2017 MS-04347-R2.0DESOXYN (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 20-25°C (68-77°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.Revised: May 2017 MS-04347-R2.0

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

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. Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics”. It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved, for example.

Adult obese subjects instructed in dietary management and treated with “anorectic” drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The origins of the increased weight loss due to the various possible drug effects are not established. The amount of weight loss associated with the use of an “anorectic” drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

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.

Non-Clinical Toxicology

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 ).

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 and ). 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.

Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued (see ).

Serious Cardiovascular Events

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

Hypertension and other Cardiovascular Conditions:

Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications:

Psychiatric Adverse Events

Pre-existing Psychosis:

Bipolar Illness:

Emergence of New Psychotic or Manic Symptoms:

Aggression:

Long-Term Suppression of Growth:

Seizures:

Peripheral Vasculopathy, including Raynaud’s phenomenon:

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 ). 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 ). 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 ).

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 ).

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:

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 .

DESOXYN should not be used concurrently with (see ).

Concurrent administration of and indirect-acting sympathomimetic amines such as the amphetamines, should be closely supervised and dosage carefully adjusted.

Phenothiazines

General:

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.

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

Cardiovascular:

Central Nervous System:

Gastrointestinal:

Hypersensitivity:

Endocrine:

Musculoskeletal:

Miscellaneous:

Skin and Subcutaneous Tissue Disorders:

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Disclaimer:

Overview

What is Desoxyn?

What does Desoxyn look like?

What are the available doses of Desoxyn?

What should I talk to my health care provider before I take Desoxyn?

How should I use Desoxyn?

What interacts with Desoxyn?

What are the warnings of Desoxyn?

What are the precautions of Desoxyn?

What are the side effects of Desoxyn?

What should I look out for while using Desoxyn?

What might happen if I take too much Desoxyn?

How should I store and handle Desoxyn?

Clinical Information

Chemical Structure

Clinical Pharmacology

Non-Clinical Toxicology

Reference

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Desoxyn

Overview

What is Desoxyn?

What does Desoxyn look like?

What are the available doses of Desoxyn?

What should I talk to my health care provider before I take Desoxyn?

How should I use Desoxyn?

What interacts with Desoxyn?

What are the warnings of Desoxyn?

What are the precautions of Desoxyn?

What are the side effects of Desoxyn?

What should I look out for while using Desoxyn?

What might happen if I take too much Desoxyn?

How should I store and handle Desoxyn?

Clinical Information

Chemical Structure

Clinical Pharmacology

Non-Clinical Toxicology

Reference

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

Review

Rate this treatment and share your opinion

Helpful tips to write a good review:

Reason for Taking This Treatment

Click the stars to rate this treatment

Effectiveness (required)

Ease of Use (required)

Satisfaction (required)

Write a brief description of your experience with this treatment:

Optional Information

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Professional

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