Dexampex is used to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy (uncontrollable desire for sleep or a sudden attack of deep sleep). It belongs to the group of medicines called central nervous system (CNS) stimulants.
Dexampex works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. Dexampex is used as part of a total treatment program that also includes social, educational, and psychological treatment.
Dexampex is 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 Dexampex.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Dexampex is indicated in:
Attention Deficit Disorder with Hyperactivity
As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM-IV characteristics.
Need for Comprehensive Treatment Program
Dexampex is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.
How should I use Dexampex?
Use Dexampex sustained-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Dexampex sustained-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dexampex sustained-release capsules refilled.
Take Dexampex sustained-release capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Swallow Dexampex sustained-release capsules whole. Do not break, crush, or chew before swallowing.
Do not drink fruit juice at the same time that you take Dexampex sustained-release capsules. Certain fruit juices (eg, grapefruit, apple, orange) may decrease Dexampex sustained-release capsules's effectiveness.
Take Dexampex sustained-release capsules on a regular schedule to get the most benefit from it. Taking Dexampex sustained-release capsules at the same time each day will help you remember to take it.
If you miss a dose of Dexampex sustained-release capsules, 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.
Ask your health care provider any questions you may have about how to use Dexampex sustained-release capsules.
Uses of Dexampex in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Attention-deficit/hyperactivity disorder: Treatment of attention-deficit/hyperactivity disorder as part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients 3 to 16 years (IR tablet, oral solution) or 6 to 16 years (ER capsule).
Narcolepsy: Treatment of narcolepsy.
Dexampex is a chiral compound. The racemic mixture can be divided into its optical antipodes: levo- and dextro-Dexampex. Dexampex is the parent compound of its own structural class, comprising a broad range of psychoactive derivatives, e.g., MDMA (Ecstasy) and the N-methylated form, methamphetamine. Dexampex is a homologue of phenethylamine.
Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.
Usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
Narcolepsy seldom occurs in pediatric patients under 12 years of age; however, when it does, Dexampex sulfate may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until an optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
Attention Deficit Disorder with Hyperactivity
Not recommended for pediatric patients under 3 years of age.
In pediatric patients 3 to 5 years of age, start with 2.5 mg daily, by tablet; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.
In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.
Dexampex (Dexampex sulfate tablets, USP) is supplied as follows:
2.5 mg: White, square tablet, debossed "2.5" on one side and "MIA" on the other side in bottles of 100 tablets, NDC 24338-850-10.
5 mg: Pink, oval tablet, debossed "5" on one side and "MIA" score on the other side in bottles of 100 tablets, NDC 24338-851-10.
7.5 mg: Light green, triangle tablet, debossed "7.5" on one side and "MIA" on the other side in bottles of 100 tablets, NDC 24338-852-10.
10 mg: Peach, round tablet, double scored on one side and debossed "10" over "MIA" on the other side in bottles of 100 tablets, NDC 24338-853-10.
15 mg: Light blue, pentagon tablet, debossed "15" on one side and "MIA" on the other side in bottles of 100 tablets, NDC 24338-854-10.
20 mg: Purple, capsule-shaped tablet, debossed "20" on one side and "MIA" on the other side in bottles of 100 tablets, NDC 24338-855-10.
30 mg: Light yellow, hexagon tablet, debossed "30" on one side and "MIA" on the other side in bottles of 100 tablets, NDC 24338-856-10. Dispense in well-closed containers as defined in the USP.
Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F). DEA Order Form Required.
Pharmacist: Medication Guide to be dispensed to Patients.
Manufactured by Mikart Inc. Atlanta, GA 30318 for Arbor Pharmaceuticals LLC, Atlanta, GA 30328. Made in USA. Revised: Jan 2014
Acidifying agents - Gastrointestinal acidifying agents (guanethidine,reserpine, glutamic acid HCl,ascorbic acid, fruit juices, etc.) lower absorption of amphetamines Urinary acidifying agents -(ammonium chloride, sodium acid phosphate, etc.) Increase the concentration of the ionized species of the Dexampex Primary excretion - Both Groups of agents lower blood levels and efficacy of amphetamines Adrenergic blockers - Adrenergic blockers are inhibited by amphetamines Alkalinizing agents -Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.)increase absorption of amphetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the Dexampex molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentate the actions of amphetamines Antidepressants, tricyclic - Ferndexs may enhance the activity of tricyclic or sympathomimetic agents; d-Dexampex with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-Dexampex in the brain; cardiovascular effects can be potentiated MAO inhibitors - MAO antidepressants, as well as a metabolite of furazolidone, slow Dexampex metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings, this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results Antihistamines - Ferndexs may counteract the sedative effect of antihistamines Antihypertensives - Ferndexs may antagonize the hypotensive effects of antihypertensives Chlorpromazine - Chlorpromazine blocks dopamine and norepinephrine receptors, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat Dexampex poisoning Ethosuximide - Ferndexs may delay intestinal absorption of ethosuximide Haloperidol - Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amphetamines Lithium carbonate - The anorectic and stimulatory effects of amphetamines may be inhibited by lithium carbonate Meperidine - Ferndexs pone the analgesic effect of meperidine Methenamine therapy - Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy Norepinephrine - Ferndexs enhance the adrenergic effect of norepinephrine Phenobarbital - Ferndexs may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action Phenytoin - Ferndexs may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action Propoxyphene - In cases of propoxyphene overdose, Dexampex CNS stimulation is potentiated and fatal convulsions can occur Veratrum alkaloids - Ferndexs inhibit the hypotensive effect of veratrum alkaloids Drug/Laboratory Test Interaction Ferndexs can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening Ferndexs may interfere with urinary steroid determinations.
As well as its needed effects, Dexampex (the active ingredient contained in Dexampex) may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking Dexampex, check with your doctor immediately:
seeing, hearing, or feeling things that are not there
Incidence not known:
chest discomfort or pain
false or unusual sense of well-being
fast, pounding, or irregular heartbeat or pulse
pounding in the ears
shakiness in the legs, arms, hands, or feet
swelling of the feet or lower legs
trembling or shaking of the hands or feet
twitching, twisting, or uncontrolled repetitive movements of tongue, lips, face, arms, or legs
unable to sleep
uncontrolled vocal outbursts and/or tics (uncontrolled repeated body movements)
unusual tiredness or weakness
If any of the following symptoms of overdose occur while taking Dexampex, get emergency help immediately:
Symptoms of overdose:
Change in consciousness
feeling sad or empty
lack of appetite
loss of consciousness
loss of interest or pleasure
mood or mental changes
muscle cramps or spasms
muscle pain or stiffness
physical attempt to injure
Minor Side Effects
Some Dexampex side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
Incidence not known:
Bad, unusual, or unpleasant (after) taste
change in taste
decreased interest in sexual intercourse
hives or welts, itching, or skin rash
inability to have or keep an erection
loss in sexual ability, desire, drive, or performance
Do not use Dexampex if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take Dexampex before the MAO inhibitor has cleared from your body.
Do not use this medication if you are allergic to Dexampex, or if you have hardened arteries (arteriosclerosis), heart disease, moderate to severe high blood pressure (hypertension), overactive thyroid, glaucoma, severe anxiety or agitation, or a history of drug or alcohol addiction.
Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking Dexampex, tell your doctor if you have any type of heart problems.
Do not give this medication to a child younger than 3 years old without the advice of a doctor.
Long-term use of Dexampex can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.
Dexampex is a drug of abuse and may be habit-forming. Keep track of the amount of medicine used from each new bottle. You should be aware if anyone is using your medicine improperly or without a prescription. Using this medication improperly can cause death or serious side effects on the heart.
DailyMed. "DEXTROAMPHETAMINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DailyMed. "AMPHETAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Dexampex are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Dexampex. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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Information checked by Dr. Sachin Kumar, MD Pharmacology