Dexedrine Spansule Sustained-Release Capsules Uses

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What is Dexedrine Spansule Sustained-Release Capsules?

Dexedrine Spansule Sustained-Release Capsules 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 Sustained-Release Capsules 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 Sustained-Release Capsules is used as part of a total treatment program that also includes social, educational, and psychological treatment.

Dexedrine Spansule Sustained-Release Capsules 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 Sustained-Release Capsules.

Dexedrine Spansule Sustained-Release Capsules 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 Sustained-Release Capsules is indicated in:

Narcolepsy

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

Dexedrine Spansule Sustained-Release Capsules 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 Dexedrine Spansule Sustained-Release Capsules?

Use Dexedrine Spansule Sustained-Release Capsules sustained-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Dexedrine Spansule Sustained-Release Capsules 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 sustained-release capsules refilled.
  • Take Dexedrine Spansule Sustained-Release Capsules 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 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 sustained-release capsules. Certain fruit juices (eg, grapefruit, apple, orange) may decrease Dexedrine Spansule Sustained-Release Capsules sustained-release capsules's effectiveness.
  • Take Dexedrine Spansule Sustained-Release Capsules sustained-release capsules on a regular schedule to get the most benefit from it. Taking Dexedrine Spansule Sustained-Release Capsules 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 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 sustained-release capsules.

Uses of Dexedrine Spansule Sustained-Release Capsules 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 Sustained-Release Capsules description

Dexedrine Spansule Sustained-Release Capsules is a chiral compound. The racemic mixture can be divided into its optical antipodes: levo- and dextro-amphetamine. Dexedrine Spansule Sustained-Release Capsules 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 Sustained-Release Capsules is a homologue of phenethylamine.

Dexedrine Spansule Sustained-Release Capsules dosage

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.

Narcolepsy

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, Dexedrine Spansule Sustained-Release Capsules 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.

How supplied

Dexedrine Spansule Sustained-Release Capsules (Dexedrine Spansule Sustained-Release Capsules 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

Dexedrine Spansule Sustained-Release Capsules interactions

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What other drugs will affect Dexedrine Spansule Sustained-Release Capsules?

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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.

Dexedrine Spansule Sustained-Release Capsules side effects

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What are the possible side effects of Dexedrine Spansule Sustained-Release Capsules?

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Applies to Dexedrine Spansule Sustained-Release Capsules: oral capsule extended release, oral solution, oral tablet

As well as its needed effects, Dexedrine Spansule Sustained-Release Capsules (the active ingredient contained in Dexedrine Spansule Sustained-Release Capsules) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Dexedrine Spansule Sustained-Release Capsules, check with your doctor immediately:

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 Sustained-Release Capsules, 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 Dexedrine Spansule Sustained-Release Capsules 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
  • 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
  • passing of gas
  • redness of the skin
  • weight loss

Dexedrine Spansule Sustained-Release Capsules contraindications

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What is the most important information I should know about Dexedrine Spansule Sustained-Release Capsules?

Do not use Dexedrine Spansule Sustained-Release Capsules 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 Sustained-Release Capsules before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to Dexedrine Spansule Sustained-Release Capsules, 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 Sustained-Release Capsules, 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 Sustained-Release Capsules can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Dexedrine Spansule Sustained-Release Capsules 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.



Active ingredient matches for Dexedrine Spansule Sustained-Release Capsules:

Dextroamphetamine


List of Dexedrine Spansule Sustained-Release Capsules substitutes (brand and generic names)

Sort by popularity
Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Dextroamphetamine Sulfate 5 mg
Tablet; Oral; Dextroamphetamine Sulfate 10 mg
Tablet; Oral; Dextroamphetamine Sulfate 5 mg
Procentra solution 5 mg/5mL (Independence Pharmaceuticals, LLC (US))
Procentra liquid 5 mg/5mL (FSC Laboratories, Inc (US))

References

  1. 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).
  2. PubChem. "dextroamphetamine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "dextroamphetamine". http://www.drugbank.ca/drugs/DB01576 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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