Medication Guide

Methamphetamine Hydrochloride Tablets USP, CII

(meth″ am fet′ a meen hye″ droe klor′ ide)

Rx only

What is the most important information I should know about methamphetamine hydrochloride tablets? Methamphetamine hydrochloride tablets may cause serious side effects, including: • Abuse, misuse, and addiction. Methamphetamine hydrochloride tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methamphetamine hydrochloride tablets, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of methamphetamine hydrochloride tablets or when it is used in ways that are not approved, such as snorting or injection. o Your healthcare provider should check your child’s risk for abuse, misuse, and addiction before starting treatment with methamphetamine hydrochloride tablets and will monitor your child during treatment. o Methamphetamine hydrochloride tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give methamphetamine hydrochloride tablets to anyone else. See “What are methamphetamine hydrochloride tablets?” for more information. o Keep methamphetamine hydrochloride tablets in a safe place and properly dispose of any unused medicine. See “How should I store methamphetamine hydrochloride tablets?” for more information. o Tell your healthcare provider if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs. • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your child’s healthcare provider should check your child carefully for heart problems before starting treatment with methamphetamine hydrochloride tablets. Tell your child’s healthcare provider if your child has any heart problems, heart disease, or heart defects. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with methamphetamine hydrochloride tablets. • Increased blood pressure and heart rate. Your child’s healthcare provider should check your child’s blood pressure and heart rate regularly during treatment with methamphetamine hydrochloride tablets. • Mental (psychiatric) problems, including: o new or worse behavior and thought problems o new or worse bipolar illness o new psychotic symptoms (such as hearing voices or seeing or believing things that are not real) or new manic symptoms Tell your child’s healthcare provider about any mental problems your child has, or about a family history of suicide, bipolar illness, or depression. Call your child’s healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with methamphetamine hydrochloride tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What are methamphetamine hydrochloride tablets?

Methamphetamine hydrochloride tablets are a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years to 17 years of age. Methamphetamine hydrochloride tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if methamphetamine hydrochloride tablets are safe and effective in children under 6 years of age.

Methamphetamine hydrochloride tablets are a federally controlled substance (CII) because it contains methamphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep methamphetamine hydrochloride tablets in a safe place to protect it from theft. Never give your methamphetamine hydrochloride tablets to anyone else because it may cause death or harm them. Selling or giving away methamphetamine hydrochloride tablets may harm others and is against the law.

Do not take methamphetamine hydrochloride tablets if your child is:

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allergic to amphetamine or any of the ingredients in methamphetamine hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in methamphetamine hydrochloride tablets.

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taking, or has stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Before taking methamphetamine hydrochloride tablets, tell your child’s healthcare provider about all your child’s medical conditions, including if your child:

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has heart problems, heart disease, heart defects, or high blood pressure

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has mental problems including psychosis, mania, bipolar illness or depression, or a family history of suicide bipolar illness, or depression

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has circulation problems in fingers and toes

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has kidney problems

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have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome

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is pregnant or plans to become pregnant. Methamphetamine hydrochloride tablets may harm the unborn baby.

o

Pregnancy Exposure Registry: There is a pregnancy registry for women who are exposed to methamphetamine hydrochloride tablets during pregnancy. The purpose of the registry is to collect information about the health of women exposed to methamphetamine hydrochloride tablets and their baby. If your child becomes pregnant during treatment with methamphetamine hydrochloride tablets, talk to your child’s healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/ pregnancyregistry/othermedications/

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is breastfeeding or plans to breastfeed. Methamphetamine hydrochloride tablets pass into breast milk. Your child should not breastfeed during treatment with methamphetamine hydrochloride tablets. Talk to your child’s healthcare provider about the best way to feed the baby during treatment with methamphetamine hydrochloride tablets.

Tell your child’s healthcare provider about all of the medicines that your child takes including prescription and over-the-counter 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 changed during treatment with methamphetamine hydrochloride tablets. Your child’s healthcare provider will decide whether methamphetamine hydrochloride tablets can be taken with other medicines.

Especially tell your child’s healthcare provider if your child takes:

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medicines used to treat migraine headaches known as triptans

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tricyclic antidepressants

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fentanyl

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lithium

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tramadol

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tryptophan

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buspirone

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St. John’s Wort

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medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)

Ask your child’s healthcare provider if you are not sure if your child takes any of these medicines. Know the medicines your child takes. Keep a list of your child’s medicines with you to show your child’s healthcare provider and pharmacist. Do not start any new medicine during treatment with methamphetamine hydrochloride tablets without talking to your child’s healthcare provider first.

How should methamphetamine hydrochloride tablets be taken?

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Take methamphetamine hydrochloride tablets exactly as prescribed.

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Your child’s healthcare provider may change the dose or have your child stop taking methamphetamine hydrochloride tablets if needed.

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Methamphetamine hydrochloride tablets are usually taken 1 or 2 times each day. Avoid taking methamphetamine hydrochloride tablets late in the evening because it may cause sleep problems.

If your child takes too many methamphetamine hydrochloride tablets, call your child’s healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are possible side effects of methamphetamine hydrochloride tablets?

Methamphetamine hydrochloride tablets may cause serious side effects, including:

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See “What is the most important information I should know about methamphetamine hydrochloride tablets?”

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Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with methamphetamine hydrochloride tablets. Methamphetamine hydrochloride tablets treatment may be stopped if your child is not growing or gaining weight.

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Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:

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fingers or toes may feel numb, cool, painful

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fingers or toes may change color from pale, to blue, to red

Tell your child’s healthcare provider if your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes or if your child has any signs of unexplained wounds appearing on fingers or toes during treatment with methamphetamine hydrochloride tablets.

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Serotonin syndrome. This problem may happen when methamphetamine hydrochloride tablets are taken with certain other medicines and may be life-threatening. Call your healthcare provider or go to the nearest hospital emergency room if you have any of the following symptoms of serotonin syndrome:

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agitation, hallucinations, coma

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changes in blood pressure

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high body temperature

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dizziness

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sweating or fever

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muscle stiffness or tightness

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fast heartbeat

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flushing

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seizures

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nausea, vomiting, diarrhea

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loss of coordination

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confusion

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New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with methamphetamine hydrochloride tablets.

The most common side effects with methamphetamine hydrochloride tablets include:

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fast heartbeat or heart beating harder than normal

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dizziness

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trouble sleeping

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shaking

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headache

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diarrhea

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dry mouth

These are not all the possible side effects of methamphetamine hydrochloride tablets.

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

How should I store methamphetamine hydrochloride tablets?

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Store methamphetamine hydrochloride tablets at room temperature between 68°F to 77°F
(20°C to 25°C). [See USP Controlled Room Temperature.]

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Store methamphetamine hydrochloride tablets in a safe place like a locked cabinet.
Protect from light.

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Dispose of remaining, unused, or expired methamphetamine hydrochloride tablets by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site.
If no take-back program or DEA authorized collector is available, mix methamphetamine hydrochloride tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away methamphetamine hydrochloride tablets in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Keep methamphetamine hydrochloride tablets and all medicines out of the reach of children.

General information about the safe and effective use of 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 symptoms that your child has. It may harm them and it is against the law.

You can ask your child’s pharmacist or healthcare provider for information about methamphetamine hydrochloride tablets that is written for healthcare professionals.

What are the ingredients in methamphetamine hydrochloride tablets?

Active Ingredient: methamphetamine hydrochloride, USP

Inactive Ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, and purified water.

For more information about methamphetamine hydrochloride tablets, go to www.hikma.com or call Hikma Pharmaceuticals USA Inc. at 1-800-962-8364.

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

Distributed by: Hikma

Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07992

C50000760/03

Revised October 2023