Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate ER (Page 4 of 9)

6.2 Adverse Reactions Associated with the Use of Amphetamine, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release, or Dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartatemonohydrate, amphetamine sulfate

The following adverse reactions have been identified during post-approval use of amphetamine, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release, or Dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular

Palpitations. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System

Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania, paresthesia (including formication) and bruxism.

Eye Disorders

Vision blurred, mydriasis.

Gastrointestinal

Unpleasant taste, constipation, other gastrointestinal disturbances.

Allergic

Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.

Endocrine

Impotence, changes in libido, frequent or prolonged erections.

Skin

Alopecia.

VascularDisorders

Raynaud’sphenomenon.

Musculoskeletal and Connective Tissue Disorders

Rhabdomyolysis

7 DRUG INTERACTIONS

7.1 Clinically Important Interactions with Amphetamines


Table 4: Drugs Having Clinically Important Interactions with Amphetamines

Monoamine Oxidase Inhibitors (MAOIs)

Clinical Impact

Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.

Intervention

Do not administer Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release concomitantly or within 14 days after discontinuing MAOI [see CONTRAINDICATIONS (4)]

Examples

selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue

Serotonergic Drugs

Clinical Impact

The concomitant use of Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release and serotonergic drugs increases the risk of serotonin syndrome.

Intervention

Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release initiation or dosage increase. If serotonin syndrome occurs, discontinue Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release and the concomitant serotonergic drug(s) [see WARNINGS AND PRECAUTIONS (5.6)].

Examples

selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort

CYP2D6 Inhibitors

Clinical Impact

The concomitant use of Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release and CYP2D6 inhibitors may increase the exposure of Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release compared to the use of the drug alone and increase the risk of serotonin syndrome.

Intervention

Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release initiation and after a dosage increase. If serotonin syndrome occurs, discontinue Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release and the CYP2D6 inhibitor [see WARNINGS AND PRECAUTIONS (5.6) and OVERDOSAGE (10)].

Examples

paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir

Alkalinizing Agents

Clinical Impact

Increase blood levels and potentiate the action of amphetamine.

Intervention

Coadministration of Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release and gastrointestinal or urinary alkalinizing agents should be avoided.

Examples

Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate). Urinary alkalinizing agents (e.g., acetazolamide, some thiazides).

Acidifying Agents

Clinical Impact

Lower blood levels and efficacy of amphetamines.

Intervention

Increase dose based on clinical response.

Examples

Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid). Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).

Tricyclic Antidepressants

Clinical Impact

May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

Intervention

Monitor frequently and adjust or use alternative therapy based on clinical response.

Examples

desipramine, protriptyline

Proton Pump Inhibitors

Clinical Impact

Time to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone.

Intervention

Monitor patients for changes in clinical effect and adjust therapy based on clinical response.

Examples

Omeprazole

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