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DYANAVEL XR (amphetamine) extended release oral suspension, a CNS stimulant, is an extended-release liquid formulation containing a 3.2 to1 ratio of d- to l-amphetamine.
Each 1 mL of DYANAVEL XR contains 2.5 mg of amphetamine which is the same as the amount of amphetamine (base equivalent) found in a 4 mg strength amphetamine mixed salts product.
DYANAVEL XR (amphetamine) Structural Formula Illustration
DYANAVEL XR utilizes an ion exchange resin where the drug is bound to the resin (sodium polystyrene sulfonate) through an ionic binding reaction. DYANAVEL XR contains immediate release and extended-release components. The extended-release component is coated with an aqueous, pH-independent polymer. After drug release the ion-exchange resin is excreted in the feces.
Inactive Ingredients: anhydrous citric acid, bubblegum flavor, glycerin, methylparaben, modified food starch, polysorbate 80, povidone, polyvinyl acetate, propylparaben, sodium lauryl sulfate, sodium polystyrene sulfonate, sucralose, triacetin and xanthan gum.
This medication is used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brain. Amphetamine belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.
How to use Dyanavel XR
Read the Medication Guide provided by your pharmacist before you start taking amphetamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Taking this medication late in the day may cause trouble sleeping (insomnia).
Shake the bottle well before each use. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
Do not drink alcoholic beverages while taking this medication. Drinking alcohol may release all of the drug at once, increasing the risk of side effects.
The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
During treatment, your doctor may occasionally recommend stopping the medication for a short time to see whether there are any changes in your behavior and whether the medication is still needed.
Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
If you suddenly stop using this medication, you may have withdrawal symptoms (such as severe tiredness, sleep problems, mental/mood changes like depression). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if you do not get better or if you get worse.
DOSAGE AND ADMINISTRATION
Important Information Prior To Initiating Treatment
Prior to treating children, adolescents, and adults with CNS stimulants, including DYANAVEL XR, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam)
Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for DYANAVEL XR use
General Dosing Information
DYANAVEL XR should be orally administered once daily in the morning with or without food. The dose should be individualized according to the needs and responses of the patient. Before administering the dose, shake the bottle of DYANAVEL XR.
In children 6 years of age and older, start with 2.5 mg or 5 mg once daily in the morning. The dose may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days up to a maximum dose of 20 mg per day.
Pharmacological treatment of ADHD may be needed for extended periods. Healthcare providers should periodically re-evaluate the long-term use of DYANAVEL XR, and adjust dosage as needed.
Switching From Other Amphetamine Products
If switching from other amphetamine products, discontinue that treatment, and titrate with DYANAVEL XR using the above titration schedule.
Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine base compositions and differing pharmacokinetic profiles.
Dosage Modifications Due To Drug Interactions
Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust DYANAVEL XR dosage accordingly.
Avoid drinking alcohol while you are taking this medicine.
Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine. These can make your body absorb less of the medicine.
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
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 amphetamine, and may increase side effects.
Many drugs can affect amphetamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS
Dyanavel XR carries a boxed warning regarding the high potential for abuse of and dependence on central nervous system (CNS) stimulants, including Dyanavel XR. The warning also states that risk of abuse should be assessed prior to prescribing Dyanavel XR and that patients using the medication should be monitored for signs of abuse and dependency during treatment.
Dyanavel XR is contraindicated in patients with a known hypersensitivity to amphetamine products or any other components of the product, and in patients using or within 14 days of the last dose of a monoamine oxidase inhibitor. Treatment with Dyanavel XR also should be avoided in patients with structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease. CNS stimulants increase blood pressure and heart rate; therefore, patients should be monitored accordingly.
Use of CNS stimulants may cause psychotic or manic symptoms in patients with no history of either or exacerbation of symptoms in patients with preexisting psychosis. Patients should be evaluated for bipolar disorder prior to beginning treatment with stimulants. Because CNS stimulant use has been associated with growth suppression, height and weight should be monitored in pediatric patients during therapy. Peripheral vasculopathy, including Raynaud’s phenomenon, has been associated with CNS stimulant use.
Substances that alter urinary pH can alter serum levels of amphetamines. Acidifying agents can decrease amphetamine levels, whereas alkalinizing agents can increase amphetamine levels. Use of Dyanavel XR during pregnancy may cause fetal harm. It also should not be used during breast-feeding.
The most common adverse reactions are dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia.1
Loss of appetite, weight loss, dry mouth, stomach upset/pain, nausea/vomiting, dizziness, headache, diarrhea, fever, nervousness, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if you have any serious side effects, such as: signs of blood flow problems in the fingers or toes (such as coldness, numbness, pain, or skin color changes), unusual wounds on the fingers or toes, pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, abnormal thoughts, thoughts of suicide), uncontrolled movements (such as twitching, shaking), continuous chewing movements/teeth grinding, outbursts of words/sounds that are hard to control, vision changes (such as blurred vision), change in sexual ability/desire, frequent/prolonged erections (in males).
Get medical help right away if you have any very serious side effects, such as: fainting, seizures, severe headache, fast/pounding/irregular heartbeat, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take . Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
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