Amphetamine (Dyanavel Xr)

Trade Name : Dyanavel XR

Tris Pharma Inc

SUSPENSION, EXTENDED RELEASE

Strength 2.5 mg/mL

AMPHETAMINE 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 (Dyanavel Xr) which is also known as Dyanavel XR and Manufactured by Tris Pharma Inc. It is available in strength of 2.5 mg/mL per ml. Read more

Amphetamine (Dyanavel Xr) 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

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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
  • WARNING: ABUSE AND DEPENDENCE
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  • Indications and Usage ()u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 02/2019
  • Dosage and Administration ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a002/2019
  • Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 02/2019
  • DYANAVEL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older n
  • DYANAVEL XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older ()
  • No data
  • Extended-release oral suspension contains 2.5 mg amphetamine base equivalents per mL.
  • Extended-release oral suspension containing 2.5u00a0mg amphetamine base per mL ()
  • DYANAVEL XR is contraindicated:
  • No data
  • Serious Cardiovascular Reactions:n- 5.2
  • Blood Pressure and Heart Rate Increases:n- 5.3
  • Psychiatric Adverse Reactions:n- 5.4
  • Long-Term Suppression of Growth:n- 5.5
  • Peripheral Vasculopathy, including Raynaudu2019s phenomenon: n- 5.6
  • Serotonin Syndrome:n- Array
  • Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, tachycardia ()
  • No data
  • Acidifying and Alkalinizing Agents:
  • No data
  • Pregnancy:n- 8.1
  • Lactation:n- 8.2
  • 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.
  • DYANAVEL XR (amphetamine) extended release oral suspension, a CNS stimulant, is an extended-release liquid formulation containing a 3.2 to1 ratio of to 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.u00a0u00a0The 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:
  • No data
  • No data
  • The efficacy of DYANAVEL XR was evaluated in a laboratory classroom study conducted in 108 pediatric patients (aged 6 to 12 years) with ADHD. The study began with an open-label dose optimization period (5 weeks) with an initial DYANAVEL XR dose of 2.5 or 5 mg once daily in the morning. The dose could be titrated weekly in increments of 2.5 to 10 mg until an optimal dose or the maximum dose of 20 mg/day was reached. Subjects then entered a 1-week randomized, double-blind treatment with the individually optimized dose of DYANAVEL XR or placebo. At the end of the week, school teachers and raters evaluated the attention and behavior of the subjects in a laboratory classroom 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. Each item is rated on a 7-point impairment scale.
  • The primary efficacy endpoint was change from pre-dose in the SKAMP-Combined score at 4 hours post-dosing. The key secondary efficacy parameters were onset and duration of clinical effect. The change scores from pre-dose SKAMP-Combined scores at post-dose time points (1, 2, 4, 6, 8, 10, 12 and 13 hours) were used to evaluate the key secondary efficacy. Results from the double-blind, placebo-controlled week of the study are summarized in Table 3 and Figure 2.
  • SKAMP-Combined change scores from pre-dose demonstrated a statistically significant improvement at all time points (1, 2, 4, 6, 8, 10, 12, 13 hours) post-dosing with DYANAVEL XR compared to placebo.
  • Table 3: Primary efficacy result.
  • Figure 2. Change from pre-dose in SKAMP-Combined Score after treatment with DYANAVEL XR or Placebo.
  • Arrayn- Array
  • No data
  • Advise the patient to read the FDA-approved patient labeling ( and ).
  • Controlled Substance Status/Potential for Abuse, Misuse, and Dependence
  • Advise patients that DYANAVEL XR is a federally controlled substance because it can be abused or lead to dependence. Advise patients to store DYANAVEL XR in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired DYANAVEL XR by a medicine take-back program if available [see n n n n ].
  • Dosage and Administration Instructions
  • Provide the following instructions on administration to the patient:
  • Serious Cardiovascular Risks
  • Advise patients of serious cardiovascular risk (including sudden death, myocardial infarction, stroke, and hypertension) with DYANAVEL XR. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see ].
  • Blood Pressure and Heart Rate Increases
  • Instruct patients that DYANAVEL XR can cause elevations of their blood pressure and pulse rate [see ].
  • Psychiatric Risks
  • Advise patients that DYANAVEL XR, at recommended doses, may cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [see ].
  • Long-Term Suppression of Growth
  • Advise patients that DYANAVEL XR may cause slowing of growth and weight loss [see ].
  • Circulation Problems in Fingers and Toes [Peripheral vasculopathy, including Raynaudu2019s phenomenon]
  • Instruct patients beginning treatment with DYANAVEL XR about the risk of peripheral vasculopathy, including Raynaud's phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.
  • Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
  • Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking DYANAVEL XR.
  • Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see ].
  • Serotonin Syndrome
  • Caution patients about the risk of serotonin syndrome with concomitant use ofu00a0 DYANAVEL XR and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. Johnu2019s Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see n n and ]. Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.
  • Concomitant Medications
  • Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see ].
  • Pregnancy Registry
  • Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with DYANAVEL XR. Advise patients of the potential fetal effects from the use of DYANAVEL XR during pregnancy [see ].
  • Pregnancy
  • Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with DYANAVELXR. Advise patients of the potential fetal effects from the use of DYANAVELXR during pregnancy n
  • Lactation
  • Advise women not to breastfeed if they are taking DYANAVEL XR [see ].
  • Alcohol
  • Advise patients to avoid alcohol while taking DYANAVEL XR. Consumption of alcohol while taking DYANAVEL XR may result in a more rapid release of the dose of amphetamine [see ].
  • Manufactured by: n Monmouth Junction, NJ 08852
  • LB8417u00a002/2019
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Revised: 02/2019u00a0u00a0
  • DYANAVEL XR (du012b-an-uh-vel) (amphetamine) extended-release oral suspension, CII
  • Read this Instructions for Use before taking DYANAVEL XR and each time you get a refill. There may be new information. This leaflet does not take the place of talking with the healthcare provider about your or your childu2019s medical condition or treatment.
  • NDC 27808-102-01n- Array
  • Dyanaveln n- u00a0n- XR CIIn- Array
  • 2.5 mg/mLu00a0u00a0u00a0
  • Shake Well Before Usen
  • 464 mLu00a0u00a0u00a0 n- Rx only

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