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Amphetamine Sulfate (Evekeo Odt)

Trade Name : Evekeo ODT

Arbor Pharmaceuticals

TABLET, ORALLY DISINTEGRATING

Strength 5 mg/1

AMPHETAMINE SULFATE Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amphetamine Sulfate (Evekeo Odt) which is also known as Evekeo ODT and Manufactured by Arbor Pharmaceuticals. It is available in strength of 5 mg/1 per ml. Read more

Amphetamine Sulfate (Evekeo Odt) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • CNS stimulants, including EVEKEO 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 , .
  • WARNING: ABUSE AND DEPENDENCE
  • See full prescribing information for complete boxed warning.
  • CNS stimulants, including EVEKEO 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. (, )
  • EVEKEO ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age .
  • EVEKEO ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. ()
  • No data
  • Administer in the morning with or without food or liquid. ()
  • Starting dose is 5 mg once or twice daily. If necessary, administer an additional dose after 4 to 6 hours. ()
  • Titrate daily dosage in increments of 5 mg at weekly intervals. ()
  • Place the whole tablet on tongue and allow to disintegrate in saliva so that it can be swallowed. ()
  • Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine salt compositions and differing pharmacokinetic profiles. (n n
  • EVEKEO ODT (amphetamine sulfate) orally disintegrating tablets are supplied as follows:
  • Orally disintegrating tablets: 5 mg, 10 mg, 15 mg, and 20 mg. ()
  • EVEKEO ODT is contraindicated in patients:
  • Known hypersensitivity to amphetamine products or other ingredients in EVEKEO ODT. ()
  • Use of monoamine oxidase inhibitor (MAOI) or within 14 days of the last MAOI dose. ()
  • No data
  • Serious Cardiovascular Reactions
  • Blood Pressure and Heart Rate Increases
  • Psychiatric Adverse Reactions
  • Long-term Suppression of Growth
  • Seizuresn- .
  • Peripheral Vasculopathy, including Raynaud's Phenomenon
  • Serotonin Syndrome
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • Most common adverse reactions (incidence u22654% and at a rate at least twice placebo) in pediatric patients (6 -17 years of age) are: decreased appetite and insomnia. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Arbor Pharmaceuticals, LLC at 1-866-516-4950 or FDA at 1-800-FDA-1088 or n
  • Acidifying and Alkalinizing Agents
  • 2.5
  • 7.1
  • No data
  • Pregnancy: May cause fetal harm ()
  • Lactation: Breastfeeding not recommended ()
  • No data
  • 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.
  • D-amphetamine is not dialyzable.
  • EVEKEO ODT orally disintegrating tablets contain amphetamine sulfate, a CNS stimulant, as a 1 to 1 ratio of dextroamphetamine sulfate and levoamphetamine sulfate (d- and l-amphetamine sulfate). Amphetamine sulfate is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0-6.0. It is freely soluble in water and slightly soluble in alcohol.
  • Structural Formula:
  • Each EVEKEO ODT tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of racemic amphetamine sulfate. Each tablet also contains the following inactive ingredients: amino methacrylate copolymer, citric acid, crospovidone, ethylcellulose, dibutyl sebacate, magnesium stearate, malic acid, mannitol, microcrystalline cellulose, and sucralose.
  • No data
  • No data
  • The safety and effectiveness of EVEKEO ODT for the treatment of ADHD has been established based on an adequate and well-controlled study of immediate-release amphetamine sulfate (EVEKEO). Below is a description of this study and its results.
  • Study 1 (NCT01986062) was conducted with EVEKEO tablets in children ages 6 to 12 years who met DSM-IV-TR criteria for ADHD. Following 8 weeks of open-label dose optimization, patients were randomly assigned to continue their optimized dose of EVEKEO (10 to 40 mg/day in divided doses) or placebo for 1 week. After 1 week, patients crossed-over to receive the alternate treatment. At the end of each treatment week, efficacy assessments were conducted at 0.75, 2, 4, 6, 8, and 10 hours post-dose using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale. SKAMP is a 13-item teacher-rated scale that assesses manifestations of ADHD in a classroom setting. The SKAMP-Combined score was obtained by summing items 1 through 13. The primary efficacy outcome assessed by the SKAMP-Combined score at 2 hours postdose was statistically significantly better in EVEKEO treatment compared to placebo (Table 3). Key secondary efficacy endpoints were the time-to-onset and duration-of-effect of EVEKEO using SKAMP-Combined scores. SKAMP-Combined scores were statistically significantly better for patients in the EVEKEO treatment group compared to patients in the placebo treatment group beginning at 0.75 hours post-dose and at each assessment through 10 hours post-dose. (Figure 1).
  • Figure 1:tLS Mean SKAMP-Combined Scores by Treatment and Timepoint for Pediatric Patients (6 to 12 years) with ADHD after 1 Week of Double Blind Treatment (Study 1)
  • The values at pre-dose hour (zero) are observed means.
  • EVEKEO ODT is supplied as follows:
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Manufactured for: Arbor Pharmaceuticals, LLCAtlanta, GA 30328
  • EVK-PI-00
  • No data
  • NDC 24338-031-30Rx Only
  • EVEKEO ODTu2122 CII
  • amphetamine sulfate
  • ORALLY DISINTEGRATING TABLET
  • 5 mg tablets
  • Do not crush or chew tablets.
  • Dispenser: Please provide the accompanying Medication Guide to each patient.
  • Contains 30 Tablets
  • arborn PHARMACEUTICALS, LLC
  • NDC 24338-033-30Rx Only
  • EVEKEO ODTu2122 CII
  • amphetamine sulfate
  • ORALLY DISINTEGRATING TABLET
  • 10 mg tablets
  • Do not crush or chew tablets.
  • Dispenser: Please provide the accompanying Medication Guide to each patient.
  • Contains 30 Tablets
  • arborn PHARMACEUTICALS, LLC
  • NDC 24338-035-30Rx Only
  • EVEKEO ODTu2122 CII
  • amphetamine sulfate
  • ORALLY DISINTEGRATING TABLET
  • 15 mg tablets
  • Do not crush or chew tablets.
  • Dispenser: Please provide the accompanying Medication Guide to each patient.
  • Contains 30 Tablets
  • arborn PHARMACEUTICALS, LLC
  • NDC 24338-037-15Rx Only
  • EVEKEO ODTu2122 CII
  • amphetamine sulfate
  • ORALLY DISINTEGRATING TABLET
  • 20 mg tablets
  • Do not crush or chew tablets.
  • Dispenser: Please provide the accompanying Medication Guide to each patient.
  • Contains 15 Tablets
  • arborn PHARMACEUTICALS, LLC

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