Methamphetamine (Desoxyn) Full Prescribing Information
Brand Name: Desoxyn
Generic Name: Methamphetamine
Desoxyn patient information (in plain English)
DESOXYN (methamphetamine hydrochloride tablets, USP), chemically known as (S)-N, (alpha)-dimethylbenzeneethanamine hydrochloride, is a member of the amphetamine group of sympathomimetic amines.
Desoxyn is used to treat ADHD and Exogenous Obesity.
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.
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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.
Treatment of 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.
Exogenous Obesity --as a short-term (i.e., a few weeks) adjunct in a regimen of weight reduction based on caloric restriction, for patients in whom obesity is refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs.
Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).
Amphetamines should not be used for weight loss or weight control or to combat unusual tiredness or weakness or replace rest. When used for these purposes, they may be dangerous to your health.
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. THEY SHOULD THUS BE TRIED ONLY IN WEIGHT REDUCTION PROGRAMS FOR PATIENTS IN WHOM ALTERNATIVE THERAPY HAS BEEN INEFFECTIVE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME IN OBESITY MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
These medicines are available only with a doctor's prescription. Prescriptions cannot be refilled. A new prescription must be obtained from your doctor each time you or your child needs this medicine.
When tolerance to the "anorectic" effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.
Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension.
The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
The presence of tics or Tourette's syndrome should be ruled out before administering amphetamines to children.
Pregnancy and Withdrawl: Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.
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.
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.
Pediatric Use: Amphetamines are not recommended for use in Attention-Deficit Hyperactivity Disorder in children under 6 years of age. Long-term effects of amphetamines in children have not been well established.
Chronic administration of amphetamines may be associated with growth inhibition; growth should be monitored during treatment.
Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the child.
Clinical experience suggests that in psychotic children, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder.
Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in children and their families should precede use of stimulant medications.
Data are inadequate to determine whether chronic administration of amphetamines may be associated with growth inhibition; therefore, growth should be monitored during treatment.
The decision to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity of the child's 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 amphetamines is usually not indicated.
Interference with Cognitive or Motor Performance: Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.
Caution should be exercised when co-prescribing amphetamines and other drugs since clinically significant interactions with a number of drugs have been reported. In some instances, potentiations of CNS and cardiac effects could be life threatening. Dosages should be closely monitored.
Insulin requirements in diabetes mellitus may be altered in association with the use of methamphetamine and the concomitant dietary regimen.
BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes furazolidone, guanethidine, urinary alkalinizers, and medicine for depression. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.
Cardiovascular: Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Central Nervous System: Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome.
Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects when amphetamines are used for other than the anorectic effect.
Endocrine: Impotence, changes in libido.
Desoxyn is a Schedule II controlled substance.
Amphetamines have 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 amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.
Signs and Symptoms
Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe reactions, yet doses of 400 to 500 mg are not necessarily fatal.
Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rhabdomyolysis, rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states.
Fatigue and depression usually follow the central stimulation.
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.
If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.
Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion. If acute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine (Regitine, CIBA) has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.
Do not exceed the recommended dosage or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may cause serious side effects. Keep all doctor and laboratory appointments while you are using this medicine.
IF YOU ARE TAKING THIS MEDICINE for ADHD or ADD and your symptoms do not improve or if they become worse, check with your doctor.
- Follow the directions for using this medicine provided by your doctor.
- Store this medicine at room temperature, in a tightly-closed container, away from heat and light.
- Take your last dose of the day 4 to 6 hours before bedtime unless your doctor tells you differently.
- If you miss a dose of this medicine and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.
Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.
Not recommended for this use in children under 6 years of age.
Regardless of indication, amphetamines should be administered at the lowest effective dosage, and dosage should be individually adjusted.
In children 6 years of age or older, 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.
Not recommended for this use in children under 6 years of age.
Most hyperactive children require medication for several years, although once symptoms have been controlled, it may be possible to reduce dosage or to interrupt drug therapy during the summer months and at other times when the child is under less stress. Hyperkinetic children appear to be able to tolerate comparatively high dosages of Desoxyn with few adverse reactions, possibly because they excrete the drug more rapidly than other patients.
Adults: At first, 5 milligrams (mg) one to three times a day. Your doctor may increase your dose if needed.
Adults: One 5 mg tablet should be taken one-half hour before each meal. Treatment should not exceed a few weeks in duration.
Children: Methamphetamine is not recommended for use as an anorectic agent in children under 12 years of age.
If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Spansule capsules may be used for once-a-day dosage wherever appropriate. With tablets, give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
DESOXYN (methamphetamine hydrochloride tablets, USP) is supplied as white tablets imprinted with the Abbott logo and two letter Abbo-Code designation, TE, containing 5 mg methamphetamine hydrochloride in bottles of 100.
Desoxyn Patient Information (plain English)
The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 3/03.
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- Created: 04 January 2009
- Last Updated: 02 September 2014
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