Amdex

Amdex 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

Amdex 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.

Amdex 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.

Amdex 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. Amdex is used as part of a total treatment program that also includes social, educational, and psychological treatment.

Amdex 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 Amdex.

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, Amdex 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

Amdex (Amdex 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

See also:
What is the most important information I should know about Amdex?

Do not use Amdex 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 Amdex before the MAO inhibitor has cleared from your body.

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

Amdex 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.

Use Amdex sustained-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Amdex sustained-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Amdex sustained-release capsules refilled.
• Take Amdex sustained-release capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow Amdex sustained-release capsules whole. Do not break, crush, or chew before swallowing.
• Do not drink fruit juice at the same time that you take Amdex sustained-release capsules. Certain fruit juices (eg, grapefruit, apple, orange) may decrease Amdex sustained-release capsules's effectiveness.
• Take Amdex sustained-release capsules on a regular schedule to get the most benefit from it. Taking Amdex sustained-release capsules at the same time each day will help you remember to take it.
• If you miss a dose of Amdex 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 Amdex sustained-release capsules.

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.

See also:
What other drugs will affect Amdex?

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.

See also:
What are the possible side effects of Amdex?

Applies to Amdex: oral capsule extended release, oral solution, oral tablet

As well as its needed effects, Amdex (the active ingredient contained in Amdex) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Amdex, check with your doctor immediately:

Rare

• Agitation
• delusions
• seeing, hearing, or feeling things that are not there

• 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 Amdex, 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 Amdex 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

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