Sandoz Amphetamine XR

Brand Name

Sandoz Amphetamine XR

Common Name

mixed salts amphetamine extended release

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Amphetamine belongs to the family of medications known as stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD). It helps to increase attention and decrease hyperactivity and impulsiveness for children over 6 years of age, adolescents, and adults who have been diagnosed with ADHD.

Other measures (e.g., psychological, educational, and social therapies) are used along with mixed salts amphetamine as part of an overall treatment program for ADHD. An improvement in ADHD symptoms can be seen within one week of starting the medication.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The usual starting dose is 10 mg taken once daily in the morning. The dose is usually started low and increased gradually. The dose of this medication needs to be individualized according to the needs of the person taking the medication. Doses above 30 mg daily are not recommended.

This medication may be taken with or without food. Swallow this medication whole with water or other liquids. Do not crush or split the capsules. The capsule contains small pellets of medication specially designed to release their contents slowly inside the body. The capsule may be opened and the contents sprinkled over applesauce. The applesauce should be eaten immediately after sprinkling and not stored for later. Avoid chewing the applesauce – chewing could damage the pellets from the capsule. Eat all of the sprinkled applesauce to make sure you get the full dose.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule.  Taking a dose in the afternoon may cause difficulty sleeping, and should therefore be avoided. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

5mg
Each clear/blue capsule, imprinted "M. Amphet Salts" on one end and "5mg" on the other, contains 5 mg of mixed salts amphetamine. Nonmedicinal ingredients: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, starch, sugar spheres, talc, and triethyl citrate; gelatin capsules: edible inks, kosher gelatin, titanium dioxide, and FD&C Blue No. 2.

10 mg
Each blue/blue capsule imprinted "M. Amphet Salts" on one end and "10mg" on the other, contains 10 mg of mixed salts amphetamine. Nonmedicinal ingredients: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, starch, sugar spheres, talc, and triethyl citrate; gelatin capsules: edible inks, kosher gelatin, titanium dioxide, and FD&C Blue No. 2.

15 mg
Each blue/white capsule, imprinted "M. Amphet Salts" on one end and "15mg" on the other, contains 15 mg of mixed salts amphetamine. Nonmedicinal ingredients: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, starch, sugar spheres, talc, and triethyl citrate; gelatin capsules: edible inks, kosher gelatin, titanium dioxide, and FD&C Blue No. 2.

20 mg
Each orange/orange capsule, imprinted "M. Amphet Salts" on one end and "20mg" on the other, contains 20 mg of mixed salts amphetamine. Nonmedicinal ingredients: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, starch, sugar spheres, talc, and triethyl citrate; gelatin capsules: edible inks, kosher gelatin, titanium dioxide, red iron oxide, and yellow iron oxide.

25 mg
Each orange/white capsule, imprinted "M. Amphet Salts" on one end and "25mg" on the other, contains 25 mg of mixed salts amphetamine. Nonmedicinal ingredients: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, starch, sugar spheres, talc, and triethyl citrate; gelatin capsules: edible inks, kosher gelatin, titanium dioxide, red iron oxide, and yellow iron oxide.

30 mg
Each clear/orange capsule, imprinted "M. Amphet Salts" on one end and "30mg" on the other, contains 30 mg of mixed salts amphetamine. Nonmedicinal ingredients: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, starch, sugar spheres, talc, and triethyl citrate; gelatin capsules: edible inks, kosher gelatin, titanium dioxide, red iron oxide, and yellow iron oxide.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to mixed salts amphetamine extended release or any ingredients of the medication
• are allergic or sensitive to a group of medications known as sympathomimetics (e.g., pseudoephedrine, epinephrine, norepinephrine)
• are agitated
• are taking a monoamine oxidase (MAO) inhibitor medication (e.g., phenelzine, tranylcypromine) or have taken one in the last 14 days
• have a history of drug abuse
• have advanced hardening of the arteries
• have an overactive thyroid gland
• have glaucoma (increased pressure in the eye)
• have heart disease
• have moderate-to-severe high blood pressure

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• chills
• constipation
• decreased appetite
• decreased interest in sexual activity
• diarrhea
• dizziness
• drowsiness
• dry mouth
• fever
• grinding teeth
• headache
• heartburn
• irritability
• menstrual cramps
• mood changes
• nausea
• neck pain
• sensitivity to light
• stomach ache
• sweating
• thirst
• trouble falling asleep
• unpleasant taste in the mouth
• vomiting
• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• anxiety or nervousness
• behaviour changes (e.g., aggressiveness, agitation, anger, hostility)
• blurred vision or other vision changes
• fast heartbeat or heart palpitations
• hallucinations (hearing, seeing, or feeling things that are not actually there)
• increased blood pressure (e.g., headaches, dizziness, lightheadedness, ringing in the ears)
• mania (feeling unusually excited, over-active, or uninhibited)
• poor blood circulation (e.g., hands and feet becoming bluish, numb, unusually cold)
• psychotic symptoms (e.g., paranoid thoughts)
• shortness of breath
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of the heart muscle becoming enlarged (e.g., breathlessness, swelling in the legs)
• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
• tics (uncontrolled and repeated body movements)
• unexplained nosebleeds or bruising

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain
• convulsions (seizures)
• signs of decreased blood flow to the digestive tract (e.g., sudden severe abdominal pain, frequent, forceful bowel movements, urgency to have bowel movements, nausea, vomiting, diarrhea, blood in the stool)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• signs of a serious allergic reaction (e.g., difficulty breathing; hives; swelling of the face, lips, eyes, mouth, or throat)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)
• thoughts of suicide or harming yourself

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Behaviour or mood changes: People taking this medication have reported agitation, hallucinations, symptoms of depression, and thoughts of self-harm. If you experience these types of symptoms while taking mixed salts amphetamine, contact your doctor immediately.

Bipolar disorder: This medication may trigger a mixed or manic episode for people with bipolar disorder. If you have a history of bipolar disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Tell your doctor of any new or worsening mental problems while taking this medication.

Blood pressure: This medication can increase blood pressure and heart rate. Blood pressure should be monitored at appropriate intervals by your doctor. If you have high blood pressure, heart problems, or you have recently had a heart attack, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drug dependence: Use of mixed salts amphetamine can result in drug dependence, as well as abuse or misuse of this medication. Misuse of amphetamines can result in serious heart problems and sudden death.  

Epilepsy: There is some evidence that mixed salts amphetamine may increase the risk of seizures, particularly for people who have had seizures in the past. If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Exercise: Strenuous exercise may increase the risk of heart problems for people taking mixed salts amphetamine. People participating in strenuous exercise or activities should consult their doctor before taking mixed salts amphetamine extended release.

Heart problems: This medication can increase the risk of sudden death for people with heart problems. If you have heart problems, including an irregular heartbeat, or a family history of sudden death related to heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

This medication should generally not be used by people with known structural heart abnormalities, such as abnormal size, missing or poorly functioning heart valves, or problems with blood vessels connected to the heart.

Kidney function: Decreased kidney function may cause this medication to build up in the body. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Mental health: Stimulant medications such as mixed salts amphetamine extended release appear to make behaviour and thought disturbances worse for people who have psychotic conditions. They may also cause symptoms of psychosis and mania to develop for people who have not had these symptoms before. If you experience symptoms such as hallucinations, mania (feeling unusually over-excited or uninhibited), or delusional thinking, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

If you have a history of psychosis or other mental illness such as depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin syndrome: Severe reactions are possible when amphetamine is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. If you are taking antidepressants, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, or changes in mental state including delirium and agitation. Coma and death are possible. If you experience any of these symptoms, contact your doctor immediately.

Stopping the medication: People who abruptly stop taking this medication sometimes experience difficulty sleeping, extreme tiredness, and depression. Check with your doctor before stopping this medication.

Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication.  If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Suppression of growth: It is not known if mixed salts amphetamine extended-release causes growth suppression in children (i.e., less growth in height or weight than usual). However, this has been reported for children who use stimulants such as mixed salts amphetamine over long periods of time. Children who need long-term treatment should be carefully monitored for growth. Their doctor may also recommend a "drug holiday," where the medication is not given on weekends or during school holidays.

Tics: This medication may cause tics or worsening of motor or verbal tics. If you have Tourette's syndrome or develop tics while on this medication, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Vision problems: Difficulties with vision such as blurring of vision have been reported with stimulant use. If this problem persists, talk to your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are breast-feeding and taking mixed salts amphetamine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for and should not be used by children under 6 years of age.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Sandoz-Amphetamine-XR