Pronunciation:

meth-am-FET-a-meen

Brand Names:

• Desoxyn

Dosage Forms:

• Tablet

Warnings:

Methamphetamine has a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining methamphetamine for non-therapeutic use or distribution to others, and the drug should be prescribed or dispensed sparingly. Misuse of methamphetamine may cause sudden death and serious cardiovascular adverse events .

Classifications:

Therapeutic—

CNS Stimulant

Chemical—

Amphetamine (class)

Uses of This Medicine:

Methamphetamine is used to treat attention-deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

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

This medicine is available only with a doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of methamphetamine in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methamphetamine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving methamphetamine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Sibutramine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Acetazolamide
• Alfentanil
• Almotriptan
• Aluminum
• Amifampridine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anileridine
• Benzhydrocodone
• Benzthiazide
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Calcium Carbonate
• Carbamazepine
• Chlorothiazide
• Chlorpheniramine
• Cimetidine
• Cinacalcet
• Citalopram
• Clobazam
• Clomipramine
• Cobicistat
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dexlansoprazole
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Dihydroxyaluminum Aminoacetate
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Esomeprazole
• Ethylmorphine
• Fenfluramine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Gepirone
• Granisetron
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Imipramine
• Iobenguane I 131
• Ketobemidone
• Lansoprazole
• Lasmiditan
• Levomilnacipran
• Levorphanol
• Lithium
• Lofepramine
• Lorcaserin
• Magaldrate
• Magnesium Carbonate
• Melitracen
• Meperidine
• Metaxalone
• Methadone
• Milnacipran
• Mirabegron
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nicomorphine
• Nortriptyline
• Omeprazole
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Palonosetron
• Pantoprazole
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Piritramide
• Polythiazide
• Protriptyline
• Quinidine
• Quinine
• Rabeprazole
• Remifentanil
• Ritonavir
• Rizatriptan
• Rolapitant
• Sertraline
• Sodium Bicarbonate
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Terbinafine
• Tianeptine
• Tilidine
• Tramadol
• Trazodone
• Trichlormethiazide
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Xipamide
• Ziprasidone
• Zolmitriptan

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Agitation, severe or
• Arteriosclerosis (hardening of the arteries), severe or
• Drug abuse, history of or
• Glaucoma or
• Heart attack, recent or
• Heart failure or
• Hypertension (high blood pressure), severe or
• Hyperthyroidism (overactive thyroid) or
• Stroke, history of—Should not be used in patients with these conditions.

• Alcohol abuse, history of—Use with caution. Dependence may be more likely to develop.

• Bipolar disorder (manic-depressive illness), history of or
• Coronary artery disease or
• Depression, or a family history of or
• Heart or blood vessel disease (eg, cardiomyopathy) or
• Heart rhythm problem (eg, ventricular arrhythmia) or
• Hypertension (high blood pressure), mild or
• Psychosis (mental illness), history of or
• Raynaud's phenomenon (blood vessel disease) or
• Seizures, history of or
• Tachycardia (rapid heart rate) or
• Tourette syndrome, or family history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you take too much, the medicine may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Do not take this medicine late in the evening. It may prevent you from falling asleep.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For ADHD:
    • Adults and children 6 years of age and older—At first, 5 milligrams (mg) 1 or 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 25 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure the medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI), including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]), within the past 14 days.

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

This medicine may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, trouble breathing, or fainting while taking this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child see, hear, or feel things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence may be:

• A strong desire or need to continue taking the medicine.
• A need to increase the dose to receive the same effects.
• Withdrawal effects after stopping the medicine such as mental depression, nausea or vomiting, stomach cramps or pain, trembling, or unusual tiredness or weakness.

Symptoms of an overdose include: aggressive, confusion, fever, muscle pains, stiffness, cramps, or spasms, panic state, restlessness, seeing, hearing, or feeling things that are not there, shakiness in legs, arms, hands, feet, trembling or shaking of hands or feet, overactive reflexes, rapid breathing, or unusual tiredness or weakness. Call your doctor right away if you notice these symptoms.

This medicine may cause some people to feel a false sense of wellbeing or to become dizzy, lightheaded, or less alert than they are normally. It may also cause blurred vision or other vision problems. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.

This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Agitation

false beliefs that cannot be changed by facts

seeing, hearing, or feeling things that are not there

Incidence not known

Blurred vision

chest discomfort or pain

dark-colored urine

difficulty breathing

dizziness

faintness

false or unusual sense of wellbeing

fast, pounding, or irregular heartbeat or pulse

fever

headache

muscle cramps, spasms, pain, or stiffness

pounding in the ears

restlessness

shakiness in the legs, arms, hands, or feet

swelling of the feet or lower legs

trembling or shaking of the hands or feet

trouble sleeping

twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

uncontrolled vocal outbursts and tics

unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Aggressive

angry

confusion

dark urine

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast breathing

fast, slow, or irregular heartbeat

muscle cramps, spasms, pain, or stiffness

nausea

restlessness

seeing, hearing, or feeling things that are not there

seizures

stomach cramps

sweating

tremor

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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