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amphetamine
Overview
What is Dyanavel XR?
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.
Structural Formula:
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
:
What does Dyanavel XR look like?
What are the available doses of Dyanavel XR?
Extended-release oral suspension contains 2.5 mg amphetamine base per mL.
What should I talk to my health care provider before I take Dyanavel XR?
How should I use Dyanavel XR?
DYANAVEL XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see
]
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) [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 DYANAVEL XR use [see
and
].
What interacts with Dyanavel XR?
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What are the warnings of Dyanavel XR?
Sorry No Records found
What are the precautions of Dyanavel XR?
Sorry No Records found
What are the side effects of Dyanavel XR?
Sorry No records found
What should I look out for while using Dyanavel XR?
DYANAVEL XR is contraindicated:
What might happen if I take too much Dyanavel XR?
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 Dyanavel XR?
Dispense in a tight container with child-resistant closure.Store at 20° to 25°C (68° to 77°F); excursions permitted from 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].The pharmacist should insert the bottle adapter firmly into the neck of the bottle and provide the oral dosing dispenser to the patient when dispensing this product. DisposalComply 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.Dispense in a tight container with child-resistant closure.Store at 20° to 25°C (68° to 77°F); excursions permitted from 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].The pharmacist should insert the bottle adapter firmly into the neck of the bottle and provide the oral dosing dispenser to the patient when dispensing this product. DisposalComply 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.Dispense in a tight container with child-resistant closure.Store at 20° to 25°C (68° to 77°F); excursions permitted from 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].The pharmacist should insert the bottle adapter firmly into the neck of the bottle and provide the oral dosing dispenser to the patient when dispensing this product. DisposalComply 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.Dispense in a tight container with child-resistant closure.Store at 20° to 25°C (68° to 77°F); excursions permitted from 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].The pharmacist should insert the bottle adapter firmly into the neck of the bottle and provide the oral dosing dispenser to the patient when dispensing this product. DisposalComply 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.Dispense in a tight container with child-resistant closure.Store at 20° to 25°C (68° to 77°F); excursions permitted from 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].The pharmacist should insert the bottle adapter firmly into the neck of the bottle and provide the oral dosing dispenser to the patient when dispensing this product. DisposalComply 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.BACTROBAN cream is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2% mupirocin free acid) in an oil- and water-based emulsion.BACTROBAN cream, 2% is supplied in 15‑gram and 30‑gram tubes.NDC 0029-1527-22 (15-gram tube)NDC 0029-1527-25 (30-gram tube)Store at or below 25°C (77°F). Do not freeze.BACTROBAN cream is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2% mupirocin free acid) in an oil- and water-based emulsion.BACTROBAN cream, 2% is supplied in 15‑gram and 30‑gram tubes.NDC 0029-1527-22 (15-gram tube)NDC 0029-1527-25 (30-gram tube)Store at or below 25°C (77°F). Do not freeze.BACTROBAN cream is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2% mupirocin free acid) in an oil- and water-based emulsion.BACTROBAN cream, 2% is supplied in 15‑gram and 30‑gram tubes.NDC 0029-1527-22 (15-gram tube)NDC 0029-1527-25 (30-gram tube)Store at or below 25°C (77°F). Do not freeze.BACTROBAN cream is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2% mupirocin free acid) in an oil- and water-based emulsion.BACTROBAN cream, 2% is supplied in 15‑gram and 30‑gram tubes.NDC 0029-1527-22 (15-gram tube)NDC 0029-1527-25 (30-gram tube)Store at or below 25°C (77°F). Do not freeze.BACTROBAN cream is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2% mupirocin free acid) in an oil- and water-based emulsion.BACTROBAN cream, 2% is supplied in 15‑gram and 30‑gram tubes.NDC 0029-1527-22 (15-gram tube)NDC 0029-1527-25 (30-gram tube)Store at or below 25°C (77°F). Do not freeze.
Clinical Information
Chemical Structure
No Image foundClinical 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
DYANAVEL XR is contraindicated:Furosemide tablets may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.
Furosemide tablets should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with Furosemide tablets, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
There is a risk of ototoxic effects if cisplatin and Furosemide tablets are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if Furosemide tablets are not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
Furosemide tablets have a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.
Lithium generally should not be given with diuretics because they reduce lithium’s renal clearance and add a high risk of lithium toxicity.
Furosemide tablets combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of Furosemide tablets, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.
Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.
Furosemide tablets may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.
Simultaneous administration of sucralfate and Furosemide tablets may reduce the natriuretic and antihypertensive effects of Furosemide tablets. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Furosemide tablets is achieved. The intake of Furosemide tablets and sucralfate should be separated by at least two hours.
In isolated cases, intravenous administration of Furosemide tablets within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of Furosemide tablets concomitantly with chloral hydrate is, therefore, not recommended.
Phenytoin interferes directly with renal action of Furosemide tablets. There is evidence that treatment with phenytoin leads to decrease intestinal absorption of Furosemide tablets, and consequently to lower peak serum furosemide concentrations.
Methotrexate and other drugs that, like Furosemide tablets, undergo significant renal tubular secretion may reduce the effect of Furosemide tablets. Conversely, Furosemide tablets may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both Furosemide tablets and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of Furosemide tablets.
Furosemide tablets can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.
Concomitant use of cyclosporine and Furosemide tablets is associated with increased risk of gouty arthritis secondary to Furosemide tablets-induced hyperurecemia and cyclosporine impairment of renal urate excretion.
One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.
Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of Furosemide tablets (furesomide) in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and Furosemide tablets should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Furosemide tablets is achieved.
CNS stimulants, including DYANAVEL XR, 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:
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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