What Adderall potentiates

Adderall

  • Generic name: amphetamine, dextroamphetamine mixed salts
  • Brand Name: Adderall
Drug description

What is Adderall and how is it used?

Adderall is a prescription drug used to treat symptoms of hyperactivity and for impulse control. Adderall can be used alone or with other medicines.


Adderall is a central nervous system stimulant.



It is not known whether Adderall is safe or effective in children under 3 years of age.



What are the possible side effects of Adderall?

Adderall can cause serious side effects, including:

  • Chest pain,
  • Difficulty breathing
  • Drowsiness,
  • Hallucinations,
  • new behavior problems,
  • Aggression,
  • Paranoia,
  • Hostility,
  • Deafness,
  • Pain,
  • freeze,
  • unexplained wounds,
  • Skin color changes on fingers or toes,
  • Fits (convulsions)
  • Muscle twitches (tics),
  • Visual disturbances,

Get medical help right away if you have any of the symptoms listed above.



The most common side effects of Adderall are:

  • Stomach pain,
  • Nausea,
  • Loss of appetite,
  • Weight loss,
  • Mood changes, including nervousness or irritability,
  • fast heart rate,
  • A headache,
  • Dizziness,
  • Difficulty sleeping (insomnia),
  • dry mouth ,

Let the doctor know if you have any side effects that bothers you or that do not go away.

These are not all of the possible side effects of Adderall. Please contact your doctor or pharmacist for more information.



Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

ADDERALL
(Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) tablets

AMPHETAMINS HAVE A HIGH POTENTIAL FOR ABUSE. Administration of amphetamines for long periods of time can lead to drug addiction and must be avoided. Particular attention should be paid to the possibility of obtaining items containing AMPHETAMINE for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.

AMPHETAMINE ABUSE CAN CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR SIDE EVENTS.

DESCRIPTION

A single unit amphetamine product that combines the neutral sulfate salts of dextroamphetamine and amphetamine with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate.

EACH TABLET CONTAINS5 mg7.5 mg10 mg12.5 mg15 mg20 mg30 mg
Dextroamphetamine saccharate1.25 mg1.875 mg2.5 mg3.125 mg3.75 mg5 mg7.5 mg
Amphetamine aspartate monohydrate1.25 mg1.875 mg2.5 mg3.125 mg3.75 mg5 mg7.5 mg
Dextroamphetamine sulfate, USP1.25 mg1.875 mg2.5 mg3.125 mg3.75 mg5 mg7.5 mg
Amphetamine sulfate, USP1.25 mg1.875 mg2.5 mg3.125 mg3.75 mg5 mg7.5 mg
Total equivalence of the amphetamine base3.13 mg4.7 mg6.3 mg7.8 mg9.4 mg12.6 mg18.8 mg

Inactive ingredients: lactitol, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate and other ingredients.

Colours:

Adderall 5 mg is a white to off-white tablet that does not contain any added coloring.
Adderall 7.5 mg and 10 mg contain FD&C Blue # 1.
Adderall 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow # 6 as a coloring additive.

Indications

INDICATIONS

Adderall is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.

Attention deficit hyperactivity disorder (ADHD)

A diagnosis of attention deficit hyperactivity disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and that appeared before the age of 7. Symptoms must cause clinically significant impairment, e.g. Relating to social, academic or professional functions, and be present in two or more environments, e.g. B. at school (or at work) and at home. The symptoms cannot be better explained by another mental disorder. For the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to detail / careless mistakes; Lack of sustained attention; poor listener; Failure to perform tasks; bad organization; avoids tasks that require sustained mental exertion; loses things; easily distracted; forgetful. For the hyperactive-impulsive type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting / squirming; Leave seat; inadequate walking / climbing; Difficulty with quiet activities; 'on the way;' excessive talking; bursting answers; I can't wait to get my turn. intrusive. For the combined type, both inattentive and hyperactive-impulsive criteria must be met.

Special diagnostic considerations

The specific etiology of this syndrome is unknown and there is no single diagnostic test. An adequate diagnosis requires not only the use of medical, but also special psychological, educational and social resources. Learning may or may not be impaired. The diagnosis must be based on a complete medical history and evaluation of the child, not just the presence of the required number of DSM-IV features.

Need for a comprehensive treatment program

Adderall is indicated as an integral part of an overall treatment program for ADHD, which may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be appropriate for all children with this syndrome. Stimulants are not intended for use in children who have symptoms attributable to environmental factors and / or other primary psychiatric disorders, including psychosis. Adequate educational internship is essential and psychosocial interventions are often helpful. If remedial measures alone are not enough, the decision to prescribe a stimulant will depend on the doctor's assessment of the chronicity and severity of the child's symptoms.

Long-term use

The effectiveness of Adderall for long-term use has not been systematically assessed in controlled studies. Therefore, the doctor who elects to use Adderall for extended periods of time should periodically reassess the long-term usefulness of the drug for the individual patient.

dosage

DOSAGE AND APPLICATION

Regardless of the indication, amphetamines should be administered at the lowest effective dose, and the dose should be individually tailored to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia.

Attention Deficit Hyperactivity Disorder

Not recommended for children under 3 years of age. For children 3 to 5 years of age, start with 2.5 mg daily; The daily dosage can be increased in 2.5 mg increments at weekly intervals until an optimal response is achieved.

For children 6 years and older, start with 5 mg once or twice a day. The daily dosage can be increased in 5 mg increments at weekly intervals until an optimal response is achieved. Only in rare cases does a total of 40 mg per day have to be exceeded. Give the first dose when you wake up; additional doses (1 or 2) at 4 to 6 hour intervals.

If possible, drug administration should be occasionally interrupted to determine if behavioral symptoms recur sufficient to warrant continued therapy.

Narcolepsy

Usual dose 5 mg to 60 mg per day in divided doses, depending on the patient's individual response.

Narcolepsy rarely occurs in children under 12 years of age; In this case, however, dextroamphetamine sulfate can be used. The recommended starting dose for patients 6 to 12 years of age is 5 mg per day; The daily dose can be increased in 5 mg increments at weekly intervals until an optimal response is achieved. For patients 12 years of age or older, start with 10 mg daily. The daily dosage can be increased in 10 mg increments at weekly intervals until an optimal response is achieved. If bothersome side effects occur (e.g. insomnia or anorexia), the dosage should be reduced. When you wake up, give the first dose; additional doses (1 or 2) at 4 to 6 hour intervals.

AS DELIVERED

Adderall 5 mg : A round, flat, bevelled edge, white to off-white tablet, “5” partially cut in half on one side and “AD” embossed on the other side, supplied as follows:

100 tablets unit of use NDC 0555-0762-02

Adderall 7.5 mg : An oval, convex, blue tablet, '7.5' partially halved on one side and 'AD' debossed fully and partially halved on the other side, supplied as follows:

100 tablets unit of use NDC 0555-0763-02

Adderall 10 mg : A round, convex, blue tablet, debossed with “10” on one side, fully and partially bisected and debossed with “AD” on the other side, provided as follows:

100 tablets unit of use NDC 0555-0764-02

Adderall 12.5 mg : A round, flat, bevelled edge, orange tablet, debossed with “12.5” on one side and “AD” on the other side with a full and partial bisection, supplied as follows:

100 tablets unit of use NDC 0555-0765-02

Adderall 15 mg : An oval, convex, orange tablet, '15' partially halved on one side and 'AD' debossed fully and partially halved on the other side, supplied as follows:

100 tablets unit of use NDC 0555-0766-02

Adderall 20 mg : A round, convex, orange tablet, debossed with “20” on one side, fully and partially bisected and debossed with “AD” on the other side, provided as follows:

100 tablets unit of use NDC 0555-0767-02

Adderall 30 mg : A round, flat, bevelled edge, orange tablet, embossed “30” on one side with a full and partial bisection and “AD” embossed on the other side, supplied as follows:

100 tablets unit of use NDC 0555-0768-02

Place in a tight, light-resistant container.

Store at 20 to 25 ° C [see USP-controlled room temperature ].

Teva Select Brands, Horsham, PA 19044 Division of Teva Pharmaceuticals USA

Side effects

SIDE EFFECTS

Cardiovascular

Palpitations, tachycardia, increase in blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathies associated with chronic amphetamine use.

Central nervesystem

Psychotic episodes in recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremors, tics, aggression, anger, logorrhea, dermatillomania.

Eye diseases

Visual disturbances, mydriasis.

Gastrointestinal

Dry mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disorders. Anorexia and weight loss can occur as undesirable effects.

Allergic

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

Endocrine

Impotence, changes in libido, frequent or persistent erections.

skin

Alopecia.

Musculoskeletal system

Rhabdomyolysis.

Substance abuse and addiction

Adderall (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets) is a Schedule II Controlled Substance.

Amphetamines have been abused extensively. Tolerance, extreme psychological dependence, and severe social disability have occurred. There have been reports of patients who increased the dosage to levels many times higher than recommended. Sudden discontinuation after prolonged administration of high doses leads to extreme tiredness and mental depression. Changes are also noted in the sleep EEG. Manifestations of chronic amphetamine intoxication include severe dermatosis, pronounced insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic poisoning is psychosis, which is often clinically indistinguishable from schizophrenia.

Drug interactions

INTERACTIONS WITH OTHER DRUGS

Acidulants

Lower blood levels and effectiveness of amphetamines. Increase the dose based on clinical response. Examples of acidulants include gastrointestinal acidulants (e.g. guanethidine, reserpine, glutamic acid-HCl, ascorbic acid) and uric acidulants (e.g. ammonium chloride, sodium acid phosphate, methenamine salts).

Adrenergic blockers

Adrenergic blockers are inhibited by amphetamines.

Alkalizing agents

Increase blood levels and potentiate the effects of amphetamine. Simultaneous use of Adderall and gastrointestinal alkalizing agents should be avoided. Examples of alkalizing agents include gastrointestinal alkalizing agents (e.g. sodium bicarbonate) and urine alkalizing agents (e.g. acetazolamide some thiazides).

Tricyclic antidepressants

May increase the activity of tricyclic or sympathomimetic agents, which leads to a noticeable and persistent increase in the concentration of d-amphetamine in the brain; cardiovascular effects can be intensified. Frequently monitor and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, protriptyline.

CYP2D6 inhibitors

Concomitant use of Adderall and CYP2D6 inhibitors may increase the exposure of Adderall compared to using the drug alone and may increase the risk of serotonin syndrome. Start with lower doses and monitor patients for signs and symptoms of serotonin syndrome, especially during Adderall initiation and after a dose increase. If serotonin syndrome occurs, discontinue Adderall and the CYP2D6 inhibitor [see WARNINGS , Overdose ]. Examples of CYP2D6 inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir.

Serotonergic drugs

Using Adderall and serotonergic medicines at the same time increases the risk of serotonin syndrome. Start with lower doses and monitor patients for signs and symptoms of serotonin syndrome, especially during Adderall initiation or dose escalation. If serotonin syndrome occurs, discontinue Adderall and its accompanying serotonergic drug (s) [see WARNINGS and PRECAUTIONS ]. Examples of serotonergic drugs include selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort.

MAO inhibitors

Simultaneous use of MAOs and CNS stimulants can lead to a hypertensive crisis. Possible outcomes are death, stroke, myocardial infarction, aortic dissection, ophthalmic complications, eclampsia, pulmonary edema, and kidney failure. Do not administer Adderall at the same time or within 14 days of MAOI discontinuation [see CONTRAINDICATIONS and WARNINGS ]. Examples of MAOs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue.

Antihistamines

Amphetamines can counteract the sedative effects of antihistamines.

Antihypertensive drugs

Amphetamines can antagonize the blood pressure lowering effects of antihypertensive drugs.

Chlorpromazine

Chlorpromazine blocks dopamine and norepinephrine receptors and thus inhibits the central stimulatory effects of amphetamines. It can be used to treat amphetamine poisoning.

Ethosuximide

Amphetamines can delay the intestinal absorption of ethosuximide.

Haloperidol

Haloperidol blocks dopamine receptors and thus inhibits the central stimulating effect of amphetamines.

Lithium carbonate

The anorectic and stimulatory effects of amphetamines can be inhibited by lithium carbonate.

Meperidine

Amphetamines increase the analgesic effect of meperidine.

What are the ingredients in methadone
Methenamine therapy

The excretion of amphetamines in the urine is increased and its effectiveness is decreased by acidulants used in methenamine therapy.

Norepinephrine

Amphetamines enhance the adrenergic effects of norepinephrine.

phenobarbital

Amphetamines Can Delay Intestinal Absorption of Phenobarbital ;; Concomitant administration of phenobarbital can produce a synergistic anticonvulsant effect.

Phenytoin

Amphetamines can delay the intestinal absorption of phenytoin. Concomitant administration of phenytoin can produce a synergistic anticonvulsant effect.

Propoxyphene

An overdose of propoxyphene increases amphetamine CNS stimulation and fatal convulsions can occur.

Proton pump inhibitors

The time to maximum concentration (Tmax) of amphetamine is shortened compared to administration alone. Monitor patients for changes in clinical effect and adjust therapy based on clinical response. An example of a proton pump inhibitor is omeprazole.

Veratrum alkaloids

Amphetamines inhibit the antihypertensive effects of veratrum alkaloids.

Interactions between drugs and laboratory tests

Amphetamines can cause significant increases in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines can interfere with the determination of steroids in the urine.

Warnings

WARNINGS

Serious Cardiovascular Events

Sudden death and pre-existing structural heart malformations or other serious heart problems

Children and adolescents

Sudden death has been reported in association with treatment with CNS stimulants at normal doses in children and adolescents with structural heart abnormalities or other serious heart problems. Although some structural heart problems alone can put an increased risk of sudden death, stimulants should generally not be used in children or adolescents with known structural heart abnormalities, cardiomyopathy, serious heart rhythm problems, or other serious heart problems that may increase susceptibility to the sympathomimetic effects of a person Stimulant [see CONTRAINDICATIONS ].

Adults

Sudden deaths, strokes, and myocardial infarctions have been reported in adults taking stimulants at the usual doses for ADHD. Although the role of stimulants in adults in these cases is also unknown, adults are more likely than children to have serious structural heart abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other serious heart problems. Adults with such abnormalities should also generally not be treated with stimulants [see CONTRAINDICATIONS ].

Hypertension and other cardiovascular diseases

Stimulants cause a slight increase in the average blood pressure (approx. 2 to 4 mmHg) and the average heart rate (approx. 3 to 6 beats per minute) [see SIDE EFFECTS ], and individuals can have larger increases. While the mean changes alone should not have any short-term consequences, all patients should be monitored for major changes in heart rate and blood pressure. Caution should be exercised when treating patients whose underlying medical conditions could be affected by increases in blood pressure or heart rate, such as: B. Patients with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia [see CONTRAINDICATIONS ].

Assessment of cardiovascular status in patients treated with stimulant drugs

Children, adolescents, or adults considered for stimulant treatment should have a careful medical history (including assessing a family history of sudden death or ventricular arrhythmia) and physical examination to assess the presence of heart disease, and should receive additional cardiac examination. if there is evidence of such a condition (e.g. electrocardiogram and echocardiogram). Patients who experience symptoms such as strenuous chest pain, unexplained syncope, or other symptoms suggestive of heart disease during treatment with stimulants should have a cardiac evaluation immediately.

Psychiatric Adverse Events

Pre-existing psychosis

Administration of stimulants can worsen behavioral and thought disorders symptoms in patients with pre-existing psychotic disorders.

Bipolar disease

Particular caution should be exercised when using stimulants to treat ADHD patients with comorbid bipolar disorder, as such patients may be concerned about the possible induction of a mixed / manic episode. Before initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately evaluated to determine whether they are at risk for bipolar disorder. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Development of new psychotic or manic symptoms

The treatment of any psychotic or manic symptoms that occur, e.g. B. Hallucinations, delusions, or mania in children and adolescents without a history of psychotic illness or mania, can be caused by stimulants in normal doses. If such symptoms occur, a possible causal role for the stimulant should be considered and treatment discontinuation may be appropriate. In a pooled analysis of multiple placebo-controlled short-term studies, such symptoms occurred in approximately 0.1% (4 patients with events out of 3482 who were exposed to methylphenidate or amphetamine at usual doses for several weeks) of stimulant-treated patients compared to 0 in placebo- treated patients.

aggression

Aggressive behavior or hostility is commonly seen in children and adolescents with ADHD and has been reported in clinical trials and after the marketing of some drugs used to treat ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients starting treatment for ADHD should be monitored for the appearance or worsening of aggressive behavior or hostility.

Long-term suppression of growth

Careful follow-up of weight and height in children 7-10 years of age who were randomized to either methylphenidate or non-drug treatment groups over a 14-month period, as well as naturalistic subsets of newly treated methylphenidate and non-drug treated children over 36 Years Months (up to the age of 10 to 13 years) suggest that consistently drugged children (i.e., treatment 7 days a week throughout the year) have a temporary slowdown in growth rate (on average about 2 cm less overall growth in size and 2.7 kg less weight gain over 3 years), with no signs of growth recovery during this development phase. Published data are insufficient to determine whether chronic use of amphetamines can cause similar growth suppression. However, it is expected that they are likely to have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining weight as expected may need to discontinue treatment.

Seizures

There is some clinical evidence that stimulants may lower the seizure threshold in patients with a history of seizures, in patients with previous EEG abnormalities without seizures, and very rarely in patients without a history of seizures and without a history of EEG seizures. In the event of seizures, the drug should be discontinued.

Peripheral vasculopathy, including Raynaud's phenomenon

Stimulants, including Adderall, used to treat ADHD, have been linked to peripheral vasculopathy, including Raynaud's phenomenon. The signs and symptoms are usually intermittent and mild; However, very rare consequences are digital ulcerations and / or the breakdown of soft tissue. The effects of peripheral vasculopathy, including Raynaud's phenomenon, have been observed in post-marketing reports at varying times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reducing the dose or discontinuing the drug. Careful observation of digital changes is required during treatment with ADHD stimulants. Another clinical assessment (e.g. referral to rheumatology) may be appropriate for certain patients.

Serotonin Syndrome

Serotonin syndrome, a potentially life-threatening reaction, can occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems, such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs) )), Triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John's wort [see INTERACTIONS WITH OTHER DRUGS ]. It is known that amphetamines and amphetamine derivatives are metabolized to some extent by cytochrome P450 2D6 (CYP2D6) and slightly inhibit CYP2D6 metabolism [see CLINICAL PHARMACOLOGY ]. The potential for a pharmacokinetic interaction exists with concomitant use of CYP2D6 inhibitors, which may increase the risk with increased exposure to Adderall. In these situations you should consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see INTERACTIONS WITH OTHER DRUGS ].

Symptoms of serotonin syndrome may include changes in mental status (e.g. agitation, hallucinations, delirium and coma), autonomic instability (e.g. tachycardia, unstable blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms ( e.g. tremors, rigidity). Myoclonus, hyperreflexia, incoordination), seizures and / or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).

Concomitant use of Adderall with MAOI drugs is contraindicated [see CONTRAINDICATIONS ].

Immediately discontinue Adderall and all associated serotonergic agents if the above symptoms occur and institute supportive symptomatic treatment. If concomitant use of Adderall with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Adderall at lower doses, monitor patients for serotonin syndrome during initiation or titration of the drug, and inform patients of this increased risk of serotonin syndrome.

Visual disturbance

Difficulties in accommodation and blurring of vision have been reported with stimulant treatment.

Precautions

PRECAUTIONS

General

The lowest possible amount of amphetamine should be prescribed or dispensed at the same time to minimize the possibility of overdose. Adderall should be used with caution in patients using other sympathomimetics.

Tics

Amphetamines have been reported to exacerbate motor and phonetic tics and Tourette's syndrome. Therefore, clinical evaluation of tics and Tourette's syndrome in children and their families should precede stimulant use.

Information for patients

Amphetamines can affect the patient's ability to engage in potentially hazardous activities such as using machines or vehicles. The patient should therefore be warned accordingly.

Prescribers or other health professionals should educate patients, their families, and their caregivers about the benefits and risks of amphetamine or dextroamphetamine treatment and advise them on appropriate use. A patient Guide to medication is available for Adderall.

The prescribing doctor or health care professional should instruct patients, their families, and their caregivers to read this Guide to medication and should help them understand its content. Patients should be given the opportunity to discuss the content of the medication guide and receive answers to any questions they may have. The full text of the Guide to medication is printed at the end of this document.

Circulatory problems in fingers and toes [peripheral vasculopathy, including Raynaud's phenomenon]
  • Educate patients starting Adderall treatment of the risk of peripheral vasculopathy, including Raynaud's phenomenon, and its associated signs and symptoms: fingers or toes may feel numb, cool, painful, and / or their color may change Change from pale to blue to red.
  • Instruct patients to report any new numbness, pain, changes in skin color, or sensitivity to temperature in their fingers or toes to their doctor.
  • Instruct patients to call their doctor right away if any signs of unexplained sores on fingers or toes appear while they are taking Adderall.
  • Another clinical assessment (e.g. referral to rheumatology) may be appropriate for certain patients.

Carcinogenesis / Mutagenesis and Impairment of Fertility

No evidence of carcinogenicity was found in studies in which d, l-amphetamine (enantiomeric ratio of 1: 1) was administered to mice and rats in the diet for 2 years at doses up to 30 mg / kg / day in male mice. 19 mg / kg / day in female mice and 5 mg / kg / day in male and female rats. These doses are approximately 2.4, 1.5 and 0.8 times the recommended maximum human dose of 30 mg / day [child], based on the body surface area of ​​mg / m².

Amphetamine was not clastogenic at the enantiomeric ratio (immediate release) present in Adderall (d to l ratio of 3: 1) in the mouse bone marrow micronucleus test in vivo and was negative when tested in the E. coli Part of the Ames test in vitro . It has been reported that d, l-amphetamine (1: 1 enantiomeric ratio) produced a positive reaction in the mouse bone marrow micronucleus test, an equivocal reaction in the Ames test, and negative reactions in the mouse in vitro Sister chromatid exchange and chromosomal aberration tests.

Amphetamine at the enantiomeric ratio (immediate release) present in Adderall (ratio of d to l of 3: 1) did not adversely affect fertility or early embryonic development in rats at doses up to 20 mg / kg / day (approximately five times the recommended Maximum dose in humans of 30 mg / day, based on the body surface area of ​​mg / m²).

pregnancy

Teratogenic effects

Pregnancy Category C.

Amphetamine at the enantiomeric ratio present in Adderall (d to l ratio of 3: 1) had no apparent effect on the morphological development or survival of the embryo fetal when given to pregnant rats and rabbits at doses of up to Oral administration was 6 or 16 mg / kg / day. These doses are approximately 1.5 and 8 times the recommended maximum human dose of 30 mg / day [child], based on the body surface area of ​​mg / m². Fetal malformations and deaths have been reported in mice after parenteral administration of d-amphetamine doses of 50 mg / kg / day (approximately 6 times a human dose of 30 mg / day [child] on a mg / m² basis) or more to pregnant animals. Administration of these doses was also associated with severe maternal toxicity.

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

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

Non-teratogenic effects

Babies born to mothers who depend on amphetamines are at increased risk of premature birth and low birth weight. In addition, these infants may experience withdrawal symptoms as evidenced by dysphoria, including restlessness, and significant fatigue.

Use in nursing mothers

Amphetamines are excreted in breast milk.Mothers taking amphetamines should be advised not to breastfeed.

Pediatric use

Long-term effects of amphetamines in children are not well documented. Amphetamines are not recommended for use in children under 3 years of age with the attention deficit hyperactivity disorder described below INDICATIONS AND USE .

Geriatric use

Adderall has not been studied in the geriatric population.

Overdose

OVERDOSE

Manifestations of amphetamine overdose include restlessness, tremors, hyperreflexia, rapid breathing, confusion, assault, hallucinations, panic conditions, hyperpyrexia, and rhabdomyolysis. Fatigue and depression usually follow stimulation of the central nervous system. Serotonin syndrome has also been reported. The cardiovascular effects include arrhythmias, high blood pressure or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

treatment

Contact a certified poison control center for up-to-date guidance and advice.

Contraindications

CONTRAINDICATIONS

Advanced atherosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, glaucoma.

Excited states.

Known hypersensitivity or peculiarity to amphetamine.

Patients with a history of substance abuse.

In patients known to be hypersensitive to amphetamines or other ingredients of Adderall. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see SIDE EFFECTS ].

Patients taking monoamine oxidase inhibitors (MAOIs) or methylene blue within 14 days of discontinuation of MAOIs (including MAOIs such as linezolid or intravenous) because of an increased risk of hypertensive crisis [see WARNINGS and INTERACTIONS WITH OTHER DRUGS ].

Clinical pharmacology

CLINICAL PHARMACOLOGY

Pharmacodynamics

Amphetamines are sympathomimetic non-catecholamine amines with CNS stimulating activity. The nature of the therapeutic effects for attention deficit hyperactivity disorder (ADHD) is unknown. It is believed that amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Pharmacokinetics

Adderall tablets contain D-amphetamine and L-amphetamine salts in a 3: 1 ratio. After a single dose of 10 or 30 mg of Adderall was administered to healthy subjects under fasting conditions, peak plasma concentrations occurred approximately 3 hours after the dose for both d-amphetamine and for l-amphetamine on. The mean elimination half-life (t½) for d-amphetamine was shorter than that of t½. of the l-isomer (9.77 to 11 hours versus 11.5 to 13.8 hours). The PK parameters (Cmax, AUC0-inf) of d- and l-amphetamine increased approximately three-fold from 10 mg to 30 mg, suggesting dose-proportional pharmacokinetics.

The effect of food on the bioavailability of Adderall has not been studied.

Metabolism and excretion

It is reported that amphetamine is oxidized at the 4-position of the benzene ring to form 4-hydroxyamphetamine or at the side chain α- or β-carbons to form alpha-hydroxyamphetamine and norephedrine, respectively. Norephedrine and 4-hydroxyamphetamine are both active and are then each oxidized to 4-hydroxynorephedrine. Alpha-hydroxyamphetamine is deaminated to form phenylacetone, which ultimately forms benzoic acid and its glucuronide, as well as the glycine conjugate hippuric acid. Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved in the formation of 4-hydroxyamphetamine. Since CYP2D6 is genetically polymorphic, population fluctuations in amphetamine metabolism are possible.

Amphetamine is known to inhibit monoamine oxidase, while the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated. In vitro Experiments with human microsomes show a slight inhibition of CYP2D6 by amphetamine and a slight inhibition of CYP1A2, 2D6 and 3A4 by one or more metabolites. Due to the likelihood of auto-inhibition and the lack of information on the concentration of these metabolites in relation to in vivo Concentrations, no evidence of the potential of amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes in vivo can be done.

At normal urinary pH levels, approximately half of an administered amphetamine dose can be recovered in the urine as a derivative of alpha-hydroxy-amphetamine and approximately another 30% to 40% of the dose can be recovered in the urine as amphetamine itself. Since amphetamine has a pKa of 9.9, amphetamine recovery in urine is highly dependent on pH and urine flow rates. Urinary alkaline pH values ​​result in less ionization and decreased renal elimination, and acidic pH values ​​and high flow rates result in increased renal elimination with intervals greater than glomerular filtration rates, suggesting the involvement of active secretion . Urinary amphetamine recovery has been reported to be between 1% and 75% depending on urinary pH, with the remaining portion of the dose being metabolized by the liver. Consequently, both liver and kidney dysfunction can inhibit the elimination of amphetamine and lead to prolonged exposure. In addition, drugs that affect urinary pH are known to alter the way amphetamines are excreted. A reduction in amphetamine metabolism, which can occur due to drug interactions or genetic polymorphisms, is rather clinically significant in the case of reduced renal excretion [see PRECAUTIONS ].

Guide to medication

INFORMATION ABOUT THE PATIENT

Adderall
(ADD-ur-all)
(Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) tablets

Read the Adderall Medication Guide that came with it before you or your child start taking it and each time you receive a refill. New information may be available. This medication guide is not a substitute for talking to your doctor about you or your child's treatment with Adderall.

What is the most important information I should know about Adderall?

The following have been reported with the use of Adderall and other stimulants.

1. Heart problems:

  • sudden death in patients with heart problems or defects
  • Stroke and heart attack in adults
  • increased blood pressure and heart rate

Let your doctor know if you or your child has heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should carefully examine you or your child for heart problems before starting Adderall.

Your doctor should check your or your child's blood pressure and heart rate regularly while they are being treated with Adderall.

Call your doctor right away if you or your child have signs of heart problems such as chest pain, shortness of breath, or fainting while taking Adderall.

2. Mental (psychiatric) problems: All patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and adolescents

  • New psychotic symptoms (such as hearing voices, believing in things that are not true are suspicious) or new manic symptoms

Tell your doctor about any mental health problems you or your child have, or any family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child has new or worsening psychological symptoms or problems while taking Adderall, especially if you see or hear things that are not real, think things are not real, or are suspicious .

3. Circulatory disorders in fingers and toes Peripheral vasculopathy, including Raynaud's phenomenon

  • Fingers or toes may feel numb, cool, painful, and / or change color from pale to blue to red

Tell your doctor if you or your child experiences numbness, pain, changes in skin color, or sensitivity to temperature in their fingers or toes.

Call your doctor right away if you or your child has any signs of unexplained sores on your fingers or toes while you are taking Adderall.

What is adderall

Adderall is a prescription drug used to stimulate the central nervous system. It is used to treat attention deficit hyperactivity disorder (ADHD). Adderall can help increase alertness and decrease impulsivity and hyperactivity in patients with ADHD.

Adderall should be used as part of an overall treatment program for ADHD that may include counseling or other therapies.

Adderall is also used to treat a sleep disorder called narcolepsy.

Adderall is a state controlled substance (CII) because it can be abused or become addictive. Keep Adderall in a safe place to prevent abuse and abuse. Selling or giving away Adderall could harm others and is against the law.

Let your doctor know if you or your child have ever had (or have had a family history of) abuse, or were addicted to alcohol, prescription drugs, or street drugs.

Who Shouldn't Take Adderall?

Adderall should not be used if you or your child:

  • Have heart disease or hardened arteries
  • have moderate to severe high blood pressure
  • Have hyperthyroidism
  • have an eye problem called glaucoma
  • are very anxious, tense, or excited
  • have a history of substance abuse
  • are taking or have used an antidepressant called a monoamine oxidase inhibitor or MAOI in the past 14 days.
  • are sensitive, allergic, or react to other stimulants

Adderall is not recommended for use in children under 3 years of age.

Adderall may not be right for you or your child. Before starting Adderall, tell your doctor or your child's about any health problems (or a family history of), including:

  • Heart problems, heart defects, high blood pressure
  • mental problems such as psychosis, mania, bipolar illness, or depression
  • Tics or Tourette syndrome
  • Liver or kidney problems
  • Thyroid problems
  • Seizures or have had an abnormal brain wave test (EEG)
  • Circulatory problems in fingers or toes

Tell your doctor if you or your child are pregnant, planning to become pregnant, or are breastfeeding.

Can Adderall be taken with other medicines?

Tell your doctor about any medicines you or your child are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements. Adderall and some medicines can interact with each other and cause serious side effects. Sometimes the doses of other medicines need to be adjusted while you are taking Adderall.

Your doctor will decide whether Adderall can be taken with other medicines.

In particular, tell your doctor if you or your child are taking:

  • Antidepressant medications including MAOIs
  • Blood pressure medication
  • Confiscation drugs
  • blood thinning drugs
  • Cold or allergy medicines that contain decongestants
  • Gastric acid medication

Know the medications you or your child are taking. Have a list of your medicines ready to show your doctor and pharmacist.

Do not start new medicines while taking Adderall without first talking to your doctor.

How should Adderall be taken?

  • Take Adderall exactly as directed. Your doctor may adjust the dose until it is right for you or your child.
  • Adderall tablets are usually taken two to three times a day. The first dose is usually taken when you first wake up in the morning. One or two more doses can be taken 4 to 6 hours apart during the day.
  • Adderall can be taken with or without food.
  • From time to time, your doctor may stop your Adderall treatment for a while to check for ADHD symptoms.
  • Your doctor may do regular blood, heart, and pressure tests while you are taking Adderall. Children should have their height and weight checked frequently while taking Adderall. Treatment with Adderall can be stopped if these tests reveal a problem.
  • If you or your child take too much Adderall or overdose, call your doctor, poison control center, or seek emergency treatment right away.

What are possible side effects of Adderall?

See 'What is the Most Important Information I Should Know About Adderall?' Information on reported heart and mental problems.

Other serious side effects are:

  • Slowing growth (height and weight) in children
  • Seizures, mainly in patients with a history of seizures
  • Visual disturbances or blurred vision
  • Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome can occur when medicines like Adderall are taken with certain other medicines. Symptoms of serotonin syndrome can include:
    • Restlessness, hallucinations, coma, or other changes in mental status
    • Problems controlling your movements or muscle twitching
    • fast heartbeat
    • high or low blood pressure
    • Sweating or fever
    • Nausea or vomiting
    • diarrhea
    • Muscle stiffness or tension

Common side effects are:

  • stomach pain
  • decreased appetite
  • nervousness

Adderall can affect your or your child's ability to drive or engage in other dangerous activities.

Talk to your doctor if you or your child experiences any side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1800-FDA-1088.

How should I store Adderall?

  • Store Adderall in a safe place at room temperature, 20-25 ° C.
  • Keep Adderall and all medicines out of the reach of children.

General information about Adderall

Medicines are sometimes prescribed for purposes other than those listed in a medication guide. Do not use Adderall for a condition for which it was not prescribed. Do not give Adderall to anyone else, even if they have the same condition. It can harm them and is against the law. This medication guide summarizes the most important information about Adderall. For more information, speak to your doctor. You can ask your doctor or pharmacist for information about Adderall that is written for healthcare professionals. For more information on Adderall, contact Teva Pharmaceuticals at 1-888-838-2872.

What are the ingredients in Adderall?

Active ingredient: Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, USP, amphetamine sulfate, USP

Inactive ingredients: Lactitol, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate and other ingredients.

This medication guide has been approved by the United States Food and Drug Administration.