Methamphetamine

Methamphetamine should not be used to treat excessive tiredness.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Usual Adult Dose for Obesity:

5 mg orally 30 minutes before each meal

Duration of Therapy: Should not exceed a few weeks

Use: Short-term adjunct in a weight reduction regimen based on caloric restriction; for patients in whom obesity is refractory to alternative therapy (e.g., repeated diets, group programs, other drugs).

Usual Pediatric Dose for Attention Deficit Disorder:

Age 6 Years and Older:
-Initial dose: 5 mg orally once or twice a day
-Maintenance dose: Daily dosage may be raised in increments of 5 mg at weekly intervals until an optimum clinical response is achieved; the usual effective dose is 20 to 25 mg per day.

Comments:
-The total daily dose may be given in 2 divided doses.
-Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Use: As part of a total treatment program for Attention Deficit Hyperactivity Disorder (ADHD), a behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

Usual Pediatric Dose for Obesity:

Age 12 Years and Older:
5 mg orally 30 minutes before each meal

Duration of Therapy: Should not exceed a few weeks

Use: Short-term adjunct in a weight reduction regimen based on caloric restriction; for patients in whom obesity is refractory to alternative therapy (e.g., repeated diets, group programs, other drugs).

In the U.S.

• Desoxyn

Available Dosage Forms:

• Tablet, Extended Release
• Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine (class)

For all uses of methamphetamine:

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how methamphetamine affects you.
• If you have been taking this medicine for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if methamphetamine stops working well. Do not take more than ordered.
• This medicine may be habit-forming with long-term use.
• If you have been taking this medicine for many weeks, talk with your doctor before stopping. You may want to slowly stop methamphetamine.
• You may have some heart tests before starting this medicine. Talk with your doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• This medicine may cause high blood pressure.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take methamphetamine.
• Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with this medicine. Tell your doctor if you or a family member have any mental or mood problems like low mood (depression) or bipolar illness, or if a family member has killed themselves. Call your doctor right away if you have hallucinations; change in the way you act; or signs of mood changes like low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take methamphetamine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

For obesity:

• Do not give to a child younger than 12 years of age.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time methamphetamine is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take methamphetamine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to methamphetamine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Methamphetamine HYDROCHLORIDE TABLETS, USP CII
(metham-fetă-mēn hīdrŏ-klōrīd)

5 mg

Read the Medication Guide that comes with Methamphetamine hydrochloride tablets before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your or your child's doctor about your or your child's treatment with Methamphetamine hydrochloride tablets.

What are Methamphetamine hydrochloride tablets?

Methamphetamine hydrochloride tablets are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder; (ADHD).

Methamphetamine hydrochloride tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Methamphetamine hydrochloride tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Methamphetamine hydrochloride tablets are also used short-term, along with a low calorie diet, for weight loss in obese patients who have not been able to lose weight on other therapies.

Methamphetamine hydrochloride tablets are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methamphetamine hydrochloride tablets in a safe place to prevent misuse and abuse. Selling or giving away Methamphetamine hydrochloride tablets may harm others, and is against the law.

Tell your or your child's doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Methamphetamine hydrochloride tablets?

Methamphetamine hydrochloride tablets should not be taken if you or your child:

• have heart disease or hardening of the arteries
• have moderate to severe high blood pressure
• have hyperthyroidism
• have an eye problem called glaucoma
• are agitated
• have a history of drug abuse
• are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
• are sensitive to, allergic to, or had a reaction to other stimulant medicines

Methamphetamine hydrochloride tablets are not recommended for use in children less than 6 years old in the treatment of ADHD.

Methamphetamine hydrochloride tablets may not be right for you or your child. Before starting Methamphetamine hydrochloride tablets tell your or your child's doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• tics or Tourette's syndrome
• thyroid problems
• diabetes
• seizures or have had an abnormal brain wave test (EEG)
• circulation problems in fingers and toes

Tell your or your child's doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can Methamphetamine hydrochloride tablets be taken with other medicines?

Tell your or your child's doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.

Methamphetamine hydrochloride tablets and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Methamphetamine hydrochloride tablets.

Your or your child's doctor will decide whether Methamphetamine hydrochloride tablets can be taken with other medicines.

Especially tell your or your child's doctor if you or your child takes:

• anti-depression medicines including MAOIs
• anti-psychotic medicines
• blood pressure medicines
• insulin
• seizure medicines

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Methamphetamine hydrochloride tablets without talking to your or your child's doctor first.

How should Methamphetamine hydrochloride tablets be taken?

• Take Methamphetamine hydrochloride tablets exactly as prescribed. Your or your child's doctor may adjust the dose until it is right for you or your child.
• Methamphetamine hydrochloride tablets are usually taken 1 or 2 times each day.
• From time to time, your or your child's doctor may stop Methamphetamine hydrochloride tablets treatment for a while to check ADHD symptoms.
• Your or your child's doctor may do regular checks of the blood, heart, and blood pressure while taking Methamphetamine hydrochloride tablets. Children should have their height and weight checked often while taking Methamphetamine hydrochloride tablets. Methamphetamine hydrochloride tablets treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much Methamphetamine hydrochloride tablets or overdoses, call your or your child's doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Methamphetamine hydrochloride tablets?

See "What is the most important information I should know about Methamphetamine hydrochloride tablets?" for information on reported heart and mental problems.

Other serious side effects include:

• slowing of growth (height and weight) in children
• seizures, mainly in patients with a history of seizures
• eyesight changes or blurred vision

Common side effects include:

Methamphetamine hydrochloride tablets may affect your or your child's ability to drive or do other dangerous activities.

Talk to your or your child's doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects.

Ask your or your child's doctor or pharmacist for more information.

Call your or your child's doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Mayne Pharma at 1-844-825-8500.

How should I store Methamphetamine hydrochloride tablets?

• Store Methamphetamine hydrochloride tablets in a safe place. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.
• Keep Methamphetamine hydrochloride tablets and all medicines out of the reach of children.

General information about Methamphetamine hydrochloride tablets:

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methamphetamine hydrochloride tablets for a condition for which it was not prescribed. Do not give Methamphetamine hydrochloride tablets to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Methamphetamine hydrochloride tablets. If you would like more information, talk with your or your child's doctor. You can ask your or your child's doctor or pharmacist for information about Methamphetamine hydrochloride tablets that was written for healthcare professionals.

For more information about Methamphetamine hydrochloride tablets, contact Mayne Pharma at 1-844-825-8500.

What are the ingredients in Methamphetamine hydrochloride tablets?

Active Ingredient: Methamphetamine hydrochloride, USP

Inactive Ingredients: Corn starch, lactose monohydrate, stearic acid and talc

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Mayne Pharma
Greenville, NC 27834

61169

05/2017

• Anorexiant
• Central Nervous System Stimulant
• Sympathomimetic

A sympathomimetic amine related to ephedrine and amphetamine with CNS stimulant activity; causes release of catecholamines (primarily dopamine and other catecholamines) from their storage sites in the presynaptic nerve terminals. Inhibits reuptake and metabolism of catecholamines through inhibition of monoamine transporters and oxidase.

Absorption

Rapid from GI tract

Metabolism

Predominately hepatic via aromatic hydroxylation, N-dealkylation and deamination; forms ≥7 metabolites

Excretion

Urine primarily (dependent on urine pH; alkaline urine increases the half-life); ~62% of dose eliminated within first 24 hours as ~33% unchanged drug with remainder as metabolites

Half-Life Elimination

4 to 5 hours

Refer to adult dosing; use with caution, starting at the lower end of the dosing range.

ADHD: Children ≥6 years and Adolescents: Oral: Initial: 5 mg once or twice daily; may increase in 5 mg increments at weekly intervals until optimum response is achieved; usual maintenance dose: 20 to 25 mg daily in 1 or 2 divided doses. Note: Interrupt therapy occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Exogenous obesity: Children ≥12 years and Adolescents: Oral: Refer to adult dosing.

Amphetamines may elevate plasma corticosteroid levels; may interfere with urinary steroid determinations.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry mouth, insomnia, constipation, diarrhea, bad taste, lack of appetite, nausea, or weight loss. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), angina, shortness of breath, severe dizziness, passing out, tachycardia, arrhythmia, tremors, agitation, severe anxiety, severe headache, sexual dysfunction, decreased libido, priapism, seizures, discoloration of hands or feet, burning or numbness of hands or feet, wounds on fingers or toes, dark urine, urinary retention, change in amount of urine passed, muscle pain, muscle weakness, mood changes, hallucinations, behavioral changes, or signs of depression (suicidal ideation, anxiety, emotional instability, illogical thinking) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Take the missed dose as soon as you remember, but not late in the day. Skip the missed dose if it is almost evening. Do not take extra medicine to make up the missed dose.

Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs methamphetamine, and may increase side effects.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• medication to treat depression or mental illness;

• insulin;

• blood pressure medicine; or

• seizure medicine.

This list is not complete. Other drugs may interact with methamphetamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Administration Advice:
-Regardless of indication, this drug should be administered at the lowest effective dose and dosage should be individually adjusted.
-Late evening dosage should be avoided because of the resulting insomnia.
-Patients should be advised not to increase dosage, except on advice of their healthcare provider.
-This drug can be taken with or without food.

Storage Requirements:
-This drug should be stored below 30 degrees Celsius (86 Fahrenheit) and protected from light.

General:
-This drug should not be used to combat fatigue or to replace rest in normal persons.
-Overdosage: Management is largely symptomatic and includes gastric evacuation, activated charcoal administration, and sedation; IV phentolamine has been suggested for acute severe hypertension, and chlorpromazine has been used to decrease CNS stimulation and sympathomimetic effects.

Monitoring:
-Cardiovascular: Blood pressure and heart rate; changes in fingers and toes
-General: Signs of abuse and dependence
-Musculoskeletal: Growth suppression
-Psychiatric: Aggressive behavior/hostility, psychotic and manic symptoms

Patient Advice:
-Avoid driving and other potentially dangerous activities such as operating machinery until you know how this drug affects you.