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Adzenys XR-ODT

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Overview

What is Adzenys XR-ODT?

ADZENYS XR-ODT (amphetamine extended-release orally disintegrating tablet) contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant.

The labeled strengths reflect the amount of amphetamine base in ADZENYS XR-ODT whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products.

Structural Formula:

ADZENYS XR-ODT is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing.

ADZENYS XR-ODT also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol.



What does Adzenys XR-ODT look like?



What are the available doses of Adzenys XR-ODT?

Extended-release orally disintegrating tablets: 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg ()

What should I talk to my health care provider before I take Adzenys XR-ODT?

How should I use Adzenys XR-ODT?

ADZENYS XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see ].

Prior to treating patients with ADZENYS XR-ODT, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see ].

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 ADZENYS XR-ODT use [see and ].


What interacts with Adzenys XR-ODT?

Sorry No Records found


What are the warnings of Adzenys XR-ODT?

Sorry No Records found


What are the precautions of Adzenys XR-ODT?

Sorry No Records found


What are the side effects of Adzenys XR-ODT?

Sorry No records found


What should I look out for while using Adzenys XR-ODT?

ADZENYS XR-ODT is contraindicated:

CNS stimulants, including ADZENYS XR-ODT, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy [see , , and , ].


What might happen if I take too much Adzenys XR-ODT?

Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice for treatment of overdosage. Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.

Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Other reactions include arrhythmias, hypertension or hypotension, circulatory collapse, nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.


How should I store and handle Adzenys XR-ODT?

StorageStore at 20°C to 25º C (68°F to 77º F). Excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature]Store ADZENYS XR-ODT 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 1-888-236-6816.StorageStore at 20°C to 25º C (68°F to 77º F). Excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature]Store ADZENYS XR-ODT 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 1-888-236-6816.StorageStore at 20°C to 25º C (68°F to 77º F). Excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature]Store ADZENYS XR-ODT 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 1-888-236-6816.Product: 71335-0382NDC: 71335-0382-2 60 TABLET in a BOTTLENDC: 71335-0382-3 90 TABLET in a BOTTLENDC: 71335-0382-1 30 TABLET in a BOTTLEProduct: 71335-0382NDC: 71335-0382-2 60 TABLET in a BOTTLENDC: 71335-0382-3 90 TABLET in a BOTTLENDC: 71335-0382-1 30 TABLET in a BOTTLEProduct: 71335-0382NDC: 71335-0382-2 60 TABLET in a BOTTLENDC: 71335-0382-3 90 TABLET in a BOTTLENDC: 71335-0382-1 30 TABLET in a BOTTLEProduct: 71335-0382NDC: 71335-0382-2 60 TABLET in a BOTTLENDC: 71335-0382-3 90 TABLET in a BOTTLENDC: 71335-0382-1 30 TABLET in a BOTTLE


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Non-Clinical Toxicology
ADZENYS XR-ODT is contraindicated:

CNS stimulants, including ADZENYS XR-ODT, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy [see , , and , ].

Clinically Significant Drug Interactions:

Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.

CNS stimulants, including ADZENYS XR-ODT, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see , ].

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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