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What is the most important information I should know about Amphetamine extended-release oral suspension?
Amphetamine extended-release oral suspension can cause serious side effects, including:
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Abuse and dependence. Amphetamine extended-release oral suspension, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Amphetamine extended-release oral suspension.
- Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
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Heart-related problems, including:
- sudden death, stroke and heart attacks in adults
- sudden death in children and adolescents who have heart problems or heart defects
- increased blood pressure and heart rate
Your healthcare provider should check you or your child carefully for heart problems before starting Amphetamine extended-release oral suspension.
Tell your healthcare provider if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your healthcare provider should check your or your child's blood pressure and heart rate regularly during treatment with Amphetamine extended-release oral suspension.
Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Amphetamine extended-release oral suspension.
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Mental (psychiatric) problems, including:
- new or worse behavior and thought problems
- new or worse bipolar illness
- new psychotic symptoms (such as hearing voices, seeing or believing things that are not real), or new manic symptoms
Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with Amphetamine extended-release oral suspension, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
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What is Amphetamine extended-release oral suspension?
Amphetamine extended-release oral suspension is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Amphetamine extended-release oral suspension may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
It is not known if Amphetamine extended-release oral suspension is safe and effective in children under 6 years of age.
Amphetamine extended-release oral suspension is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Amphetamine extended-release oral suspension in a safe place to protect it from theft. Never give your Amphetamine extended-release oral suspension to anyone else, because it may cause death or harm them. Selling or giving away Amphetamine extended-release oral suspension may harm others and is against the law.
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Do not take Amphetamine extended-release oral suspension if you or your child are:
- allergic to amphetamine or any of the ingredients in Amphetamine extended-release oral suspension. See the end of this Medication Guide for a complete list of ingredients in Amphetamine extended-release oral suspension.
- taking or have taken within the past 14 days, a medicine used to treat depression called monoamine oxidase inhibitor (MAOI).
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Before taking Amphetamine extended-release oral suspension, tell your or your child's healthcare provider about all medical conditions, including if you or your child:
- have heart problems, heart defects, or high blood pressure
- have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide
- have circulation problems in fingers and toes
Tell your doctor:
- if you or your child have kidney problems. Your doctor may lower the dose.
- if you or your child are pregnant or plan to become pregnant. It is not known if Amphetamine extended-release oral suspension will harm your unborn baby. Tell your healthcare provider if you or your child become pregnant during treatment with Amphetamine extended-release oral suspension.
- There is a pregnancy registry for females who are exposed to Amphetamine extended-release oral suspension during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Amphetamine extended-release oral suspension and their baby. If you or your child becomes pregnant during treatment with Amphetamine extended-release oral suspension, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.
- are breastfeeding or plan to breastfeed. Amphetamine extended-release oral suspension passes into breast milk. You or your child should not breastfeed during treatment with Amphetamine extended-release oral suspension.
Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Amphetamine extended-release oral suspension and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment with Amphetamine extended-release oral suspension.
Your healthcare provider will decide whether Amphetamine extended-release oral suspension can be taken with other medicines.
Especially tell your healthcare provider if you or your child takes medicine used to treat depression, including MAOIs.
Do not start any new medicine during treatment while taking Amphetamine extended-release oral suspension without talking to your healthcare provider first. |
How should I take Amphetamine extended-release oral suspension?
- Take Amphetamine extended-release oral suspension exactly as prescribed by your healthcare provider.
- Your healthcare provider may change the dose if needed.
- Take Amphetamine extended-release oral suspension 1 time each day in the morning.
- Amphetamine extended-release oral suspension can be taken with or without food. Do not add Amphetamine extended-release oral suspension to food or mix with other liquids before taking.
- Shake the bottle of Amphetamine extended-release oral suspension well before each dose.
- Use the oral dosing syringe or measuring device provided by your pharmacist to measure the prescribed dose of Amphetamine extended-release oral suspension.
- Wash the oral dosing syringe or measuring device after each use.
- Replace the child-resistant bottle cap after each use.
- Your healthcare provider may sometimes stop Amphetamine extended-release oral suspension treatment for a while to check ADHD symptoms.
If you or your child take(s) too much Amphetamine extended-release oral suspension, call your
healthcare provider or poison control center or go to the nearest hospital emergency room right away.
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What should I avoid during treatment with Amphetamine extended-release oral suspension?
You should avoid drinking alcohol during treatment with Amphetamine extended-release oral suspension.
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What are possible side effects of Amphetamine extended-release oral suspension?
Amphetamine extended-release oral suspension can cause serious side effects, including:
- See
"What is the most important information I should know about Amphetamine extended-release oral suspension?"
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Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Amphetamine extended-release oral suspension . Your healthcare provider may stop treatment with Amphetamine extended-release oral suspension if they are not growing or gaining weight as expected.
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Circulation problems in fingers and toes (peripheral vasculopathy including Raynaud's phenomenon). Signs and symptoms may include:
- fingers or toes may feel numb, cool, painful
- fingers or toes may change from pale, to blue, to red
Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
Call your healthcare provider right away if you or your child have any unexplained wounds appearing on fingers or toes during treatment with Amphetamine extended-release oral suspension .
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Serotonin Syndrome. This problem may happen when Amphetamine extended-release oral suspension is 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 or other changes in mental status
- problems controlling your movements or muscle twitching
- fast heartbeat
- high or low blood pressure
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- sweating or fever
- muscle stiffness or tightness
- nausea vomiting or diarrhea
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| The most common side effects of Amphetamine extended-release oral suspension in children 6 to 12 years of age include: |
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- decreased appetite
- problems sleeping
- stomach pain
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- extreme mood change
- vomiting
- nervousness
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| The most common side effects of Amphetamine extended-release oral suspension in children 13 to 17 years of age include: |
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- decreased appetite
- problems sleeping
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| The most common side effects of Amphetamine extended-release oral suspension in adults include: |
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- dry mouth
- decreased appetite
- problems sleeping
- headache
- weight loss
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- nausea
- anxiety
- restlessness
- dizziness
- fast heartbeat
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- diarrhea
- weakness
- urinary tract infection
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| These are not all the possible side effects of Amphetamine extended-release oral suspension. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store Amphetamine extended-release oral suspension?
- Store Amphetamine extended-release oral suspension at room temperature between 68°F to 77°F (20°C to 25°C).
- Store Amphetamine extended-release oral suspension in a safe place, like a locked cabinet.
- Dispose of remaining, unused, or expired Amphetamine extended-release oral suspension by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Amphetamine extended-release oral suspension 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 discard Amphetamine extended-release oral suspension in the household trash.
Keep Amphetamine extended-release oral suspension and all medicines out of the reach of children. |
General information about the safe and effective use of Amphetamine extended-release oral suspension
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Amphetamine extended-release oral suspension for a condition for which it has not been prescribed. Do not give Amphetamine extended-release oral suspension to other people, even if they have the same condition. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about Amphetamine extended-release oral suspension that was written for healthcare professionals.
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What are the ingredients in Amphetamine extended-release oral suspension?
Active ingredients:
amphetamine
Inactive ingredients: purified water, sorbitol, propylene glycol, xanthan gum, natural orange flavor, methacrylic acid and methyl methacrylate copolymer, sodium polystyrene sulfonate, vegetable oil, triethyl citrate, methylparaben, citric acid, sucralose, propylparaben, orange color (FD&C Yellow No. 6), and polyethylene glycol
Distributed by:
Prasco Laboratories, Mason OH 45040 USA
For more information about Amphetamine extended-release oral suspension contact Neos Therapeutics, Inc. at 1-888-236-6816
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