dextroamphetamine sulfate


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dextroamphetamine sulfate

Dexedrine Spansule, DextroStat

Pharmacologic class: Amphetamine

Therapeutic class: Sympathomimetic amine, CNS stimulant

Controlled substance schedule II

Pregnancy risk category C

FDA Box Warning

• Drug has high abuse potential. Prolonged use may lead to drug dependence. Stay alert for possibility of patient obtaining drug for nontherapeutic use or distribution. Drug should be prescribed sparingly.

• Misuse may cause sudden death and serious cardiovascular events.

Action

Produces CNS and respiratory stimulation by promoting release of norepinephrine from nerve terminals

Availability

Capsules (sustained-release): 5 mg, 10 mg, 15 mg

Oral solution: 5 mg/ml

Tablets: 5 mg, 10 mg

Indications and dosages

Attention deficit hyperactivity disorder

Adults: 5 to 60 mg P.O. daily in divided doses until optimal response is obtained

Children ages 6 and older: 5 mg (capsules, oral solution, or tablets) P.O. once or twice daily, increased by 5 mg at weekly intervals until optimal response is obtained

Children ages 3 to 5: 2.5 mg (oral solution) P.O. daily, increased by 2.5 mg at weekly intervals until optimal response is obtained

Narcolepsy

Adults: 5 to 60 mg P.O. daily as a single dose or in divided doses

Children ages 12 and older: 10 mg P.O. daily, increased by 10 mg at weekly intervals until desired response occurs or adult dosage is reached

Children ages 6 to 11: 5 mg P.O. daily, increased by 5 mg at weekly intervals until desired response occurs or adult dosage is reached

Contraindications

• Hypersensitivity to drug or tartrazine
• Glaucoma
• Psychotic disorders, agitated states
• Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension
• Hyperthyroidism
• MAO inhibitor use within past 14 days
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• cardiovascular disease, hypertension, diabetes mellitus
• history of substance abuse
• elderly patients.

Administration

• Make sure patient swallows sustained-release capsules whole without chewing or crushing.
• Before starting therapy, perform complete cardiac evaluation, including ECG and echocardiogram.
• Give last daily dose at least 6 hours before patient's bedtime.

Don't give within 14 days of MAO inhibitor, because potentially fatal reaction may occur.

Adverse reactions

CNS: hyperactivity, insomnia, restlessness, tremor, depression, dizziness, headache, irritability

CV: palpitations, tachycardia, hypertension, hypotension, arrhythmias

GI: nausea, vomiting, constipation, diarrhea, abdominal cramps, dry mouth

GU: erectile dysfunction, increased libido

Skin: urticaria

Other: metallic taste, decreased appetite, physical or psychological drug dependence

Interactions

Drug-drug.Acetazolamide, sodium bicarbonate: urine alkalization, leading to increased dextroamphetamine effects

Adrenergic blockers: additive effects

Ammonium chloride, ascorbic acid (large doses): urine acidification, leading to decreased dextroamphetamine effects

Beta-adrenergic blockers, tricyclic antidepressants: increased risk of adverse cardiovascular effects

Guanethidine: reversal of hypotensive effect

MAO inhibitors: hypertensive crisis

Phenothiazines: decreased dextroamphetamine effects

Selective serotonin reuptake inhibitors: increased risk of serotonin syndrome

Drug-diagnostic tests.Plasma corticosteroids: increased levels

Drug-food.Caffeine: increased stimulant effect

Drug-herbs.Caffeine-containing herbs, ephedra (ma huang): increased stimulant effect

Patient monitoring

• Interrupt therapy or reduce dosage periodically to assess drug efficacy in patients with behavior disorders.
• Monitor patient for new or worsening aggressive behavior.
• Monitor blood and urine glucose levels carefully in diabetic patient. Drug may alter regular insulin requirements.

Patient teaching

• Tell patient to swallow sustained-release capsules whole with liquid without chewing or crushing.
• Advise patient to take drug early in day to avoid insomnia.

Instruct patient to immediately notify prescriber if chest pain, irregular pulse, or worsening aggressive behavior occurs.
• Instruct patient to avoid driving and other hazardous activities until he knows how drug affects him.
• Caution patient not to stop therapy abruptly but to taper dosage gradually.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and herbs mentioned above.

dextroamphetamine sulfate

[deks′trō·amfet′əmēn]
a central nervous system stimulant.
indications It is prescribed in the treatment of narcolepsy, hyperkinetic disorders, and attention deficit disorder in children and as an anorexiant in treating exogenous obesity.
contraindications Cardiovascular disease, glaucoma, hypertension, hyperthyroidism, agitation, history of drug abuse, concomitant administration of a monoamine oxidase inhibitor within 14 days, or known hypersensitivity to this drug prohibits its use.
adverse effects Among the more serious adverse reactions are manifestations of central nervous system excitation, increased blood pressure, arrhythmias and other cardiovascular effects, nausea, anorexia, and drug dependence.

dex·tro·am·phet·a·mine sul·fate

(deks'trō-am-fet'ă-mēn sul'fāt)
Agent similar in action to racemic amphetamine sulfate, but more stimulating to the central nervous system; sympathomimetic and appetite depressant.
Synonym(s): dextroamphetamine sulphate.

dex·tro·am·phet·a·mine sul·fate

(deks'trō-am-fet'ă-mēn sul'fāt)
A sympathomimetic and appetite depressant.

dextroamphetamine sulfate

n brand names: Dexedrine, Oxydess II;
drug class: amphetamine, Controlled Substance Schedule II;
action: increases release of norepinephrine and dopamine in the cerebral cortex to the reticular activating system;
uses: narcolepsy, attention deficit disorder with hyperactivity.
dextromethorphan hydrobromide
(dek´strōməthor´fan hī´drōbrō´mīd),
n brand names: Benylin DM, Robitussin Pediatric, Vicks Formula 44;
drug class: antitussive, nonnarcotic;
action: depresses cough center in medulla;
use: nonproductive cough.
References in periodicals archive ?
The company said Dextroamphetamine Sulfate Extended-release Capsules, 5 mg, 10 mg, and 15 mg is the generic version of Amedra Pharmaceuticals LLC's Dexedrine.
According to the company, it has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dextroamphetamine Sulfate, which is indicated in narcolepsy and attention deficit disorder with hyperactivity as an integral part of a total treatment programme that typically includes other measures (psychological, educational, social) for patients (ages six years to 16 years) with this syndrome.
The company said dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, are indicated for the treatment of attention deficit hyperactivity disorder (ADHD).
The statement adds that these consequences can include arrhythmias (irregular heartbeat) and low blood pressure, in the case of propafenone HCI; fainting and low blood pressure, in the case of isosorbide mononitrate; respiratory depression (difficulty or lack of breathing) and low blood pressure, in the case of morphine sulfate; and rapid heart rate and high blood pressure, in the case of dextroamphetamine sulfate.
The company said Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (mixed salts of a single entity amphetamine product), 5 mg, 7.
According to the company, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets' NDA has passed the final approval from the US Food and Drug Administration (FDA) for the treatment of attention deficit hyperactivity disorder (ADHD).
M2 EQUITYBITES-July 12, 2013-Tris Pharma's generic pharmaceuticals business launches Dextroamphetamine Sulfate Oral Solution in US(C)2013 M2 COMMUNICATIONS http://www.
M2 PHARMA-July 12, 2013-Tris Pharma's generic pharmaceuticals business launches Dextroamphetamine Sulfate Oral Solution in US(C)2013 M2 COMMUNICATIONS
It has received approval for dextroamphetamine sulfate tablets USP 5 mg and 10 mg, the generic equivalent of Dextrosat, indicated for narcolepsy and attention deficit disorder with hyperactivity.