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What is Dyanavel XR?
Dyanavel XR is used to treat narcolepsy (sleep disorder). It is also used to treat attention-deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.
Dyanavel XR is also used for weight reduction in obese patients.
Dyanavel XR works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. Dyanavel XR is used as part of a total treatment program that also includes social, educational, and psychological treatment.
Dyanavel XR is available only with a doctor's prescription.
Dyanavel XR indications
Dyanavel XR™ (Dyanavel XR sulfate tablets, USP) is indicated for:
- Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted.
- Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines should be weighed against possible risks inherent in use of the drug, such as those described below.
How should I use Dyanavel XR?
Use Dyanavel XR as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Dyanavel XR comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dyanavel XR refilled.
- Take Dyanavel XR by mouth with or without food.
- Take your doses of Dyanavel XR 4 to 6 hours apart unless your doctor tells you otherwise.
- Do not drink fruit juice at the same time that you take Dyanavel XR. Certain fruit juices (eg, grapefruit, apple, orange) may decrease Dyanavel XR's effectiveness.
- Take Dyanavel XR on a regular schedule to get the most benefit from it. Taking Dyanavel XR at the same time each day will help you remember to take it.
- If you miss a dose of Dyanavel XR, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Dyanavel XR.
Uses of Dyanavel XR in details
This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Dyanavel XR 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.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used to treat a certain sleeping disorder (narcolepsy). It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.
How to use Dyanavel XR
Read the Medication Guide provided by your pharmacist before you start taking Dyanavel XR 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 after noon may cause trouble sleeping (insomnia).
Keep the medication in the original package until you are ready to take a dose. Dry your hands before handling the medication. Peel back the foil layer of the blister pack to remove a tablet. Do not push the tablet through the foil because it may get damaged. Place the tablet on your tongue, allow it to dissolve, and swallow with your saliva. You do not need to take this medication with water or other liquid. Do not crush or chew the tablet.
The dosage is based on your medical condition and response to treatment. Your doctor may adjust your dose to find the dose that is best for you. 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 sometimes stop the medication for a short time to see if the medication is still needed.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (including severe tiredness, sleep problems, mental/mood changes such as depression) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
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.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your condition does not get better or if it gets worse.
Dyanavel XR description
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. By mimicking the structures of the catecholamine neurotransmitters, noradrenaline and dopamine, amphetamines modulate monoamine release, reuptake, and signalling within the brain. Although "Dyanavel XR" is used as a descriptor of its own structural class, Dyanavel XR properly refers to a racemic free base composed of equal parts of its two optical antipodes: levo-Dyanavel XR and dextro-Dyanavel XR. Used in the past for the treatment of depression, stress, and for concentration improvement, it is currently available as a prescription drug for the treatment of attention hyperactivity disorder (ADHD), narcolepsy, and as an adjunct in the treatment of exogenous obesity. Dyanavel XR is also available in a mixed salt/mixed enantiomer form (Adderall), where d-Dyanavel XR and l-Dyanavel XR are available in a ratio of 3:1. It is also available in a prodrug form as lisdexamfetamine.
Dyanavel XR dosage
Prior to treating patients with 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.
Dosing Considerations For All Patients
Dyanavel XR may be taken with or without food. Individualize the dosage according to the therapeutic needs and response of the patient.
Dyanavel XR should be taken as follows:
- The tablet should remain in the blister pack until the patient is ready to take it.
- The patient or caregiver should use dry hands to open the blister.
- Tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet. The tablet should not be pushed through the foil.
- As soon as the blister is opened, the tablet should be removed and placed on the patient’s tongue.
- The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing.
- The tablet will disintegrate in saliva so that it can be swallowed.
The recommended starting dosage is 6.3 mg once daily in the morning. Increase in increments of 3.1 mg or 6.3 mg at weekly intervals. The maximum recommended dose is 18.8 mg daily for patients 6 to 12 years, and 12.5 mg daily for patients 13 to 17 years.
The recommended dose is Dyanavel XR 12.5 mg daily.
Switching From Other Dyanavel XR Products
Patients taking ADDERALL XR may be switched to Dyanavel XR at the equivalent dose taken once daily. Refer to Table 1 for equivalent doses of Dyanavel XR and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, Dyanavel XR aspartate monohydrate, and Dyanavel XR sulfate extended-release capsules) is also referred to as mixed salts of a single-entity Dyanavel XR product extended-release capsules (MAS ER).
Table 1: Equivalent Doses of Dyanavel XR and ADDERALL XR (Mixed Salts of a Single-Entity Dyanavel XR Product) Extended-Release Capsules
|Dyanavel XR||3.1 mg||6.3 mg||9.4 mg||12.5 mg||15.7 mg||18.8 mg|
|Dyanavel XR extended-release orally disintegrating tablets|
|ADDERALL XR||5 mg||10 mg||15 mg||20 mg||25 mg||30 mg|
|Mixed salts of a single-entity Dyanavel XR product extended-release capsules (MAS ER)|
If switching from any other Dyanavel XR products, discontinue that treatment, and titrate with Dyanavel XR using the titration schedule.
Do not substitute for other Dyanavel XR products on a milligram-per-milligram basis because of different Dyanavel XR 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 Dyanavel XR. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Dyanavel XR dosage accordingly.
Dosage Forms And Strengths
Dyanavel XR 3.1 mg Dyanavel XR Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side)
Dyanavel XR 6.3 mg Dyanavel XR Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A2 on one side)
Dyanavel XR 9.4 mg Dyanavel XR Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A3 on one side)
Dyanavel XR 12.5 mg Dyanavel XR Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A4 on one side)
Dyanavel XR 15.7 mg Dyanavel XR Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A5 on one side)
Dyanavel XR 18.8 mg Dyanavel XR Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A6 on one side)
Storage And Handling
Dyanavel XR 3.1 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-005-30
Dyanavel XR 6.3 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A2 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-010-30
Dyanavel XR 9.4 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A3 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-015-30
Dyanavel XR 12.5 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A4 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-020-30
Dyanavel XR 15.7 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A5 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-025-30
Dyanavel XR 18.8 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A6 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-030-30
Store at 20°C to 25° C (68°F to 77° F). Excursions permitted to 15-30° C (59-86° F)
Store Dyanavel XR blister packages in the rigid, plastic travel case provided after removal from the carton. To obtain additional travel cases, patients and health care professionals can call Neos Therapeutics, Inc., at 1-XXX-XXX-XXXX.
Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Dyanavel XR 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 Dyanavel XR with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Dyanavel XR in the household trash.
Manufactured by: Neos Therapeutics, LP., Grand Prairie, TX 75050. Made in USA. Revised: Jan 2016
Dyanavel XR interactions
Drugs Having Clinically Important Interactions With Amphetamines
Table 5: Drugs having clinically important interactions with amphetamines.
|MAO Inhibitors (MAOI)|
|Clinical Impact||MAOI antidepressants slow Dyanavel XR metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.|
|Intervention||Do not administer Dyanavel XR during or within 14 days following the administration of MAOI.|
|Examples||selegiline, isocarboxazid, phenelzine, tranylcypromine|
|Clinical Impact||Increase blood levels and potentiate the action of Dyanavel XR.|
|Intervention||Co-administration of Dyanavel XR and gastrointestinal alkalinizing agents should be avoided.|
|Examples||Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate). |
Urinary alkalinizing agents (e.g., acetazolamide, some thiazides).
|Clinical Impact||Lower blood levels and efficacy of amphetamines.|
|Intervention||Increase dose based on clinical response.|
|Examples||Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid).|
|Clinical Impact||May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-Dyanavel XR in the brain; cardiovascular effects can be potentiated.|
|Intervention||Monitor frequently and adjust or use alternative therapy based on clinical response.|
|Proton Pump Inhibitors|
|Clinical Impact||Time to maximum concentration (Tmax) of Dyanavel XR is increased compared to when administered alone.|
|Intervention||Monitor patients for changes in clinical effect and adjust therapy based on clinical response.|
Drug/Laboratory Test Interactions
Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.
Drug Abuse And Dependence
Dyanavel XR contains Amphetamine, which is a Schedule II controlled substance in the U.S. Controlled Substance Act (CSA).
Dyanavel XR, is a CNS stimulant that contains Amphetamine which has a high potential for abuse. Abuse is characterized by impaired control of drug use, compulsive use despite harm, and craving.
Signs and symptoms of Dyanavel XR abuse may include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. Abusers of amphetamines may use other unapproved routes of administration which can result in overdose and death.
To reduce the abuse of Dyanavel XR, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and re-evaluate the need for Dyanavel XR use.
Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) may occur during the chronic therapy of CNS stimulants including Dyanavel XR.
Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants including Dyanavel XR. Withdrawal symptoms after abrupt cessation following prolonged high dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
Dyanavel XR side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Drug Dependence
- Hypersensitivity to Dyanavel XR, or other components of DYANAVEL XR
- Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors
- Serious Cardiovascular Reactions
- Blood Pressure and Heart Rate Increases
- Psychiatric Adverse Reactions
- Long-Term Suppression of Growth
- Peripheral Vasculopathy, including Raynaud's phenomenon
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Trials Experience With Other Dyanavel XR Products In Pediatric Patients And Adults With ADHD
Cardiovascular: Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic Dyanavel XR use.
Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea.
Eye Disorders: Vision blurred, mydriasis.
Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.
Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Endocrine: Impotence, changes in libido.
Clinical Trials Experience With DYANAVEL XR In Pediatric Patients With ADHD
There is limited experience with DYANAVEL XR in controlled trials. Based on this limited experience, the adverse reaction profile of DYANAVEL XR appears similar to other Dyanavel XR extended-release products. The most common ( ≥ 2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6–12 years) were: epistaxis, allergic rhinitis and upper abdominal pain.
Table 1: Common adverse reactions occurring in ≥ 2% of Subjects on DYANAVEL XR and greater than Placebo during the double blind phase.
|Preferred Term||DYANAVELXR |
|Respiratory, thoracic and mediastinal disorders|
|Abdominal pain upper||3.8%||2.1%|
The following adverse reactions have been identified during post approval use of other Dyanavel XR products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Endocrine: frequent or prolonged erections.
Musculoskeletal, Connective Tissue, and Bone Disorders: rhabdomyolysis.
Psychiatric Disorders: dermatillomania.
Dyanavel XR contraindications
Dyanavel XR is contraindicated in patients:
- With known hypersensitivity to Dyanavel XR, or other components of Dyanavel XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other Dyanavel XR products.
- Receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MOAI (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
Active ingredient matches for Dyanavel XR:
Amfetamine in United States.
|Unit description / dosage (Manufacturer)||Price, USD|
|Dyanavel XR suspension, extended release 2.5 mg/mL (Tris Pharma Inc (US))|
List of Dyanavel XR substitutes (brand and generic names):
|Anfetamina L.CH. (Chile)|
|Tablet; Oral; Amphetamine Sulfate 5 mg|
|Tablet; Oral; Amphetamine Sulfate 10 mg|
|Evekeo tablet 5 mg/1 (Arbor Pharmaceuticals, Inc. (US))|
|Evekeo tablet 10 mg/1 (Arbor Pharmaceuticals, Inc. (US))|
- DailyMed. "AMPHETAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "AMPHETAMINE". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "AMPHETAMINE". http://www.drugbank.ca/drugs/DB00182 (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Dyanavel XR are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Dyanavel XR. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
1 consumer reported usefulWas the Dyanavel XR drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Consumer reported price estimatesNo survey data has been collected yet
Consumer reported time for resultsNo survey data has been collected yet
1 consumer reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology