Dexedrine Spansule 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.
Dexedrine Spansule 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. Dexedrine Spansule is used as part of a total treatment program that also includes social, educational, and psychological treatment.
Dexedrine Spansule 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 Dexedrine Spansule.
Dexedrine Spansule indications
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.
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Dexedrine Spansule Sulfate Tablets USP are indicated for:
1. Narcolepsy.
2. Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) 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.
How should I use Dexedrine Spansule?
Use Dexedrine Spansule sustained-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Dexedrine Spansule sustained-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dexedrine Spansule sustained-release capsules refilled.
Take Dexedrine Spansule sustained-release capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Swallow Dexedrine Spansule sustained-release capsules whole. Do not break, crush, or chew before swallowing.
Do not drink fruit juice at the same time that you take Dexedrine Spansule sustained-release capsules. Certain fruit juices (eg, grapefruit, apple, orange) may decrease Dexedrine Spansule sustained-release capsules's effectiveness.
Take Dexedrine Spansule sustained-release capsules on a regular schedule to get the most benefit from it. Taking Dexedrine Spansule sustained-release capsules at the same time each day will help you remember to take it.
If you miss a dose of Dexedrine Spansule 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 Dexedrine Spansule sustained-release capsules.
Uses of Dexedrine Spansule 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.
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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.
Dexedrine Spansule description
Dexedrine Spansule is a chiral compound. The racemic mixture can be divided into its optical antipodes: levo- and dextro-amphetamine. Dexedrine Spansule 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. Dexedrine Spansule is a homologue of phenethylamine.
Dexedrine Spansule dosage
Dexedrine Spansule Dosage
Applies to the following strength(s): 5 mg; 10 mg; 15 mg; 5 mg/5 mL; 2.5 mg; 7.5 mg; 20 mg; 30 mg
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
Narcolepsy
Usual Pediatric Dose for:
Attention Deficit Disorder
Narcolepsy
Additional dosage information:
Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments
Usual Adult Dose for Narcolepsy
-Initial Dose: 10 mg orally per day
-Maintenance Dose: May raise daily dose in 10 mg increments at weekly intervals until optimal response is obtained.
Comments:
-The usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
-IR: Give the first dose on awakening; give 1 to 2 additional doses at intervals of 4 to 6 hours.
-ER/SR: May use this formulation for once-a-day dosage wherever appropriate.
Use: Narcolepsy treatment
Usual Pediatric Dose for Attention Deficit Disorder
Immediate-Release (IR):
Age 3 to 5 Years:
-Initial Dose: 2.5 mg orally per day
-Maintenance Dose: May raise daily dose in 2.5 mg increments at weekly intervals until optimal response is obtained.
IR and Extended-Release (ER)/Sustained-Release (SR):
Age 6 to 17 Years:
-Initial Dose: 5 mg orally 1 or 2 times a day
-Maintenance Dose: May raise daily dose in 5 mg increments at weekly intervals until optimal response is obtained.
-Maximum Dose: Only in rare cases will it be necessary to exceed 40 mg per day.
Comments:
-IR: Give the first dose on awakening; give 1 to 2 additional doses at intervals of 4 to 6 hours.
-ER/SR: May use this formulation for once-a-day dosage wherever appropriate.
-Where possible, occasionally interrupt drug administration to determine if continued therapy is required.
Use: As part of a total treatment program for Attention Deficit Hyperactivity Disorder (ADHD).
Usual Pediatric Dose for Narcolepsy
Age 6 to 11 Years:
-Initial Dose: 5 mg orally per day
-Maintenance Dose: May raise daily dose in 5 mg increments at weekly intervals until optimal response is obtained.
Age 12 Years and Older:
-Initial Dose: 10 mg orally per day
-Maintenance Dose: May raise daily dose in 10 mg increments at weekly intervals until optimal response is obtained.
Comments:
-The usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
-IR: Give the first dose on awakening; give 1 to 2 additional doses at intervals of 4 to 6 hours.
-ER/SR: May use this formulation for once-a-day dosage wherever appropriate.
-Narcolepsy rarely occurs in children under 12 years of age.
-Due to the high abuse potential, this drug should be prescribed/dispensed sparingly and particular attention should be paid to subjects possibly obtaining this drug for non-therapeutic use or distribution to others.
-Administering this drug for prolonged periods of time should be avoided as it may lead to drug dependence.
-Drug misuse may cause sudden death and serious cardiovascular adverse events.
Long-term effects of amphetamines in children have not been well established.
-For ADHD treatment, the IR formulations are not recommended in patients younger than 3 years and the ER/SR formulation is not recommended in patients younger than 6 years.
-For narcolepsy treatment, all formulations of this drug are not recommended in patients younger than 6 years.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule II
Dialysis
Data not available.
Other Comments
Administration Advice:
-Avoid late evening doses because of the potential for insomnia.
-Administer this drug at the lowest effective dosage, and individually adjust dosage.
-Take tablet doses at the same times on each day preferably with or immediately after meals.
Storage Requirements:
-Store this drug between 20 to 25 degrees Celsius (68 to 77 Fahrenheit) and dispense in a tight, light-resistant container.
General:
-Individual patient response to amphetamines varies widely: toxic symptoms can occur at doses as low as 2 mg but 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.
-Overdosage: Management is largely symptomatic and may include gastric lavage, activated charcoal, a cathartic, and sedation; insufficient data is available to recommend the use of hemodialysis or peritoneal dialysis.
Monitoring:
-Cardiovascular: Blood pressure, heart rate, changes in fingers and toes
-Psychiatric: New or worsening psychiatric disorders, including aggressive behavior/hostility, depression, psychosis, mania, and suicidal thoughts or behavior
Patient Advice:
-Avoid driving and other potentially dangerous activities such as operating machinery until you know how this drug affects you.
-Contact your healthcare provider if you experience any of the following on your fingers or toes during treatment: unexplained wounds, new numbness, pain, skin color change, or temperature sensitivity.
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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 amphetamine 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 amphetamine 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-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated MAO inhibitors - MAO antidepressants, as well as a metabolite of furazolidone, slow amphetamine 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 amphetamine 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, amphetamine 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.
In addition to its needed effects, some unwanted effects may be caused by Dexedrine Spansule (the active ingredient contained in Dexedrine Spansule). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Dexedrine Spansule:
Rare
Agitation
delusions
seeing, hearing, or feeling things that are not there
Incidence not known:
Blurred vision
chest discomfort or pain
difficulty breathing
dizziness
faintness
false or unusual sense of well-being
fast, pounding, or irregular heartbeat or pulse
headache
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
troubled breathing
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 Dexedrine Spansule, get emergency help immediately:
Symptoms of overdose:
Change in consciousness
dark-colored urine
diarrhea
discouragement
feeling sad or empty
fever
irritability
lack of appetite
loss of consciousness
loss of interest or pleasure
mood or mental changes
muscle cramps or spasms
muscle pain or stiffness
nausea
panic state
physical attempt to injure
rapid breathing
seizures
stomach cramps
sweating
trouble concentrating
violent actions
vomiting
Minor Side Effects
Some of the side effects that can occur with Dexedrine Spansule may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Incidence not known:
Bad, unusual, or unpleasant (after) taste
change in taste
constipation
decreased interest in sexual intercourse
dry mouth
hives or welts, itching, or skin rash
inability to have or keep an erection
indigestion
loss in sexual ability, desire, drive, or performance
Do not use Dexedrine Spansule 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 Dexedrine Spansule before the MAO inhibitor has cleared from your body.
Do not use this medication if you are allergic to Dexedrine Spansule, 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 Dexedrine Spansule, 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 Dexedrine Spansule can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.
Dexedrine Spansule 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).
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