Pharmaceutical Name

Trade (marketing or proprietary) name: Adderall®

Generic (nonproprietary or active ingredient) name: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets

Indication and Usage

Reason the product has been approved for sale on the market.

FDA has approved this central nervous system stimulant prescription medicine for the treatment of attention deficit hyperactivity disorder (ADHD).

The effectiveness of Adderall® for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Adderall® for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Manufacturer Insert

Ingredients

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, USP, amphetamine sulfate, USP, lactitol, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, and other ingredients.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated states. Known hypersensitivity or idiosyncrasy to amphetamine. Patients with a history of drug abuse. In patients known to be hypersensitive to amphetamine, or other components of Adderall®. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products. Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Other warnings on the insert include hypertension, other cardiovascular conditions, preexisting psychosis, bipolar illness, emergency of new psychotic or manic symptoms, aggression, seizures, peripheral vasculopathy, Raynaud’s phenomenon, serotonin syndrome, and visual disturbances.

The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Adderall® should be used with caution in patients who use other sympathomimetic drugs.

Concerning tics, the manufacturer states the following: Amphetamines have been reported to exacerbate motor and phonic tics and Tourette’s syndrome. Therefore, clinical evaluation for tics and Tourette’s syndrome in children and their families should precede use of stimulant medications.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Adderall can cause: Palpitations, Tachycardia (increased heart rate), Elevation of blood pressure, Sudden death, Myocardial infarction (heart attack), There have been isolated reports of cardiomyopathy associated with chronic amphetamine use, Psychotic episodes at recommended doses, Overstimulation, Restlessness, Irritability, Euphoria, Dyskinesia (involuntary muscle movements), Dysphoria (profound state of unease or dissatisfaction), Depression, Tremor, Tics, Aggression, Anger, Logorrhea (communication disorder that causes excessive wordiness and repetitiveness), Dermatillomania (skin picking), Vision blurred, Mydriasis (dilation of the pupil), Dryness of the mouth, Unpleasant taste, Diarrhea, Constipation, Intestinal ischemia (injury to the large or small intestine occurs due to not enough blood supply), Other gastrointestinal disturbances, Anorexia and weight loss may occur as undesirable effects, Urticaria (hives), Rash/hypersensitivity reactions including angioedema and anaphylaxis, Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported, Impotence (failure of sexual power in the male), Changes in libido, Frequent or prolonged erections, Alopecia (baldness), Rhabdomyolysis (damaged skeletal muscle breaks down rapidly. Symptoms may include muscle pains, weakness, vomiting, and confusion), slowing of growth (height and weight) in children, Nervousness, Decreased appetite

Specific Populations

Pregnancy

There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheo-esophageal fistula, and anal atresia (vater association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d,l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.

Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

Breastfeeding

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric

Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Hyperactivity Disorder.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Analytical Deep Dive

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