Zenzedi 15mg Tablets

Manufacturer ARBOR PHARMACEUTICALS Active Ingredient Dextroamphetamine Tablets(deks troe am FET a meen) Pronunciation deks-troe-AM-fet-uh-meen
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It is used to treat narcolepsy.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Sympathomimetic Amine; Norepinephrine-Dopamine Reuptake Inhibitor and Releaser
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Pregnancy Category
Category C
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FDA Approved
Jun 2013
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Zenzedi is a medication containing dextroamphetamine, a stimulant that works in the brain to help improve focus, attention, and control over impulses. It is primarily used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and narcolepsy.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. To minimize sleep disturbances, avoid taking it late in the day. Additionally, do not take this medication with fruit juice. Establish a routine by taking your medication at the same time every day.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. To ensure safety, keep your medication out of reach of children and pets, and store it in a secure location where others cannot access it. Consider using a locked box or area to store your medication. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on proper disposal or participate in a drug take-back program in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take exactly as prescribed; do not take more or less than directed.
  • Take in the morning or early afternoon to avoid sleep problems.
  • Avoid alcohol consumption while taking this medication.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not share this medication with others, as it has a high potential for abuse.
  • Maintain a healthy diet and regular exercise, especially for children, to support overall health and growth.

Dosing & Administration

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Adult Dosing

Standard Dose: 5 mg once or twice daily, titrated weekly
Dose Range: 5 - 40 mg

Condition-Specific Dosing:

ADHD: Initial 5 mg once or twice daily. May increase by 5 mg at weekly intervals until optimal response is obtained. Max 40 mg/day.
Narcolepsy: Initial 10 mg daily in divided doses. May increase by 10 mg at weekly intervals. Max 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial 2.5 mg once or twice daily. May increase by 2.5-5 mg at weekly intervals. Max 40 mg/day.
Adolescent: 13-17 years: Initial 5 mg once or twice daily. May increase by 5 mg at weekly intervals. Max 40 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; consider lower doses.
Moderate: Use with caution; consider lower doses.
Severe: Use with caution; consider lower doses. Monitor for adverse effects.
Dialysis: Not well studied; caution advised. Dextroamphetamine is not significantly removed by dialysis.

Hepatic Impairment:

Mild: Use with caution; consider lower doses.
Moderate: Use with caution; consider lower doses.
Severe: Use with caution; consider lower doses. Monitor for adverse effects.

Pharmacology

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Mechanism of Action

Dextroamphetamine is a sympathomimetic amine that stimulates the central nervous system. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
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Pharmacokinetics

Absorption:

Bioavailability: High (approximately 75-100%)
Tmax: 2-4 hours (immediate-release)
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 3-5 L/kg
ProteinBinding: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Adults: 10-12 hours; Children: 6-8 hours (pH-dependent)
Clearance: Highly variable, pH-dependent
ExcretionRoute: Renal (urine)
Unchanged: 30-50% (highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 2-4 hours
DurationOfAction: 4-6 hours (immediate-release)
Confidence: High

Safety & Warnings

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BLACK BOX WARNING

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND SHOULD BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF PATIENTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Restlessness
Shakiness
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in eyesight or eye pain, swelling, or redness
Erectile dysfunction
Decreased sex interest
Seizures
Stomach pain
Muscle pain or weakness, dark urine, or trouble passing urine
Frequent or prolonged erections
Changes in skin color, such as pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in hands or feet
Sores or wounds on fingers or toes

Heart Problems: Important Warning

If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out

Serotonin Syndrome: A Potentially Life-Threatening Condition

Taking this medication with certain other drugs can increase the risk of serotonin syndrome, a severe and potentially deadly condition. If you experience any of the following symptoms, contact your doctor right away:

Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache

Other Side Effects

Most people experience no side effects or only minor side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Dizziness or headache
Dry mouth
Trouble sleeping
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Bad taste in mouth
Feeling nervous and excitable
Hair loss

Reporting Side Effects

If you have questions about side effects or want to report a side effect, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting
  • New or worsening aggression, hostility, or agitation
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New or worsening tics (uncontrolled movements or sounds)
  • Unexplained numbness, pain, or discoloration in fingers or toes
  • Severe headache or blurred vision
  • Unusual changes in mood or behavior
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as they may cause very high blood pressure)
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.

Caution with Daily Activities

Until you know how this medication affects you, avoid driving and engaging in activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.

Tolerance and Dependence

If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. However, do not take more than the prescribed dose. Long-term or regular use of this medication can also lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this may cause withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.

Monitoring and Tests

Before starting this medication, you may need to undergo certain heart tests. If you have any questions or concerns, discuss them with your doctor. Additionally, this medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor. Be aware of the signs of high blood pressure, such as severe headache, dizziness, fainting, or changes in vision, and seek medical attention immediately if you experience any of these symptoms.

Interactions with Other Medications

Certain over-the-counter (OTC) products, including cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, may interact with this medication and increase blood pressure. Consult your doctor before taking any of these products.

Lab Tests and Seizure Risk

This medication may affect certain lab tests, so it is essential to inform all your healthcare providers and lab workers that you are taking this medication. Additionally, this medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.

Mental Health and Mood Changes

This medication may cause changes in behavior and mood, including hallucinations, anger, and depression. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek medical attention immediately if you experience any signs of mood changes, such as depression, suicidal thoughts, nervousness, or anxiety.

Growth and Development

In some cases, this medication may affect growth in children and teens. Regular growth checks may be necessary. Consult your doctor to discuss any concerns.

Pregnancy and Breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia
  • Rapid breathing
  • Confusion
  • Assaultiveness
  • Hallucinations
  • Panic states
  • Hyperpyrexia
  • Rhabdomyolysis
  • Tachycardia
  • Arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea, vomiting, diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma
  • Death

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes supportive care, gastric lavage, activated charcoal, and sedation for CNS overstimulation.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase plasma levels and prolong half-life of dextroamphetamine
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease plasma levels and shorten half-life of dextroamphetamine
  • Antihypertensives - may decrease the hypotensive effect of antihypertensives
  • Adrenergic blockers (e.g., guanethidine) - may inhibit the hypotensive effect of guanethidine
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Moderate Interactions

  • Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of dextroamphetamine
  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of dextroamphetamine
  • Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase absorption due to increased gastric pH
  • Alcohol - may increase risk of adverse cardiovascular events
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients.

Timing: Prior to initiation of therapy.

Psychiatric History (e.g., tics, psychosis, bipolar disorder)

Rationale: Stimulants can exacerbate or unmask psychiatric conditions.

Timing: Prior to initiation of therapy.

Cardiovascular Assessment (e.g., ECG if indicated by history/exam)

Rationale: To screen for underlying cardiac conditions that could be exacerbated by stimulants.

Timing: Prior to initiation of therapy, especially in patients with pre-existing cardiac conditions or family history.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or at least every 3-6 months.

Target: Within normal limits for age; monitor for significant increases.

Action Threshold: Sustained elevation above normal range, symptomatic changes; consider dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months in children and adolescents.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative therapy.

Psychiatric Symptoms (e.g., agitation, aggression, new-onset psychosis, mania, tics)

Frequency: At each visit.

Target: Absence of new or worsening symptoms.

Action Threshold: Emergence or worsening of symptoms; consider dose adjustment or discontinuation.

Abuse/Diversion Potential

Frequency: At each visit.

Target: No signs of abuse or diversion.

Action Threshold: Signs of abuse or diversion; implement appropriate management strategies.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Fainting
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • New or worsening tics
  • Unexplained weight loss
  • Sleep disturbances
  • Anxiety
  • Irritability

Special Patient Groups

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Pregnancy

Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Amphetamines may cause fetal harm.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out.
Second Trimester: Potential for premature birth and low birth weight.
Third Trimester: Risk of withdrawal symptoms (e.g., agitation, tremor, feeding difficulties) in the neonate if used late in pregnancy.
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Lactation

Dextroamphetamine is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 (Moderately safe) - Monitor infant for irritability, poor feeding, insomnia, and weight loss. Consider alternative if possible, or use lowest effective dose and monitor closely.
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Pediatric Use

Growth suppression (weight and/or height) has been reported with long-term stimulant use in children. Monitor growth parameters regularly. Psychiatric adverse events (e.g., psychosis, mania, aggression) can occur. Cardiovascular risks should be assessed.

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Geriatric Use

Clinical studies of Zenzedi did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Clinical Information

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Clinical Pearls

  • Zenzedi is an immediate-release formulation of dextroamphetamine, offering flexibility in dosing but requiring multiple daily doses.
  • Due to its Schedule II classification, strict prescribing and dispensing regulations apply.
  • Careful titration is essential to find the lowest effective dose and minimize adverse effects.
  • Patients should be screened for pre-existing cardiovascular conditions and psychiatric disorders before initiating therapy.
  • Educate patients and caregivers about the high abuse potential and the importance of secure storage.
  • Monitor for signs of growth suppression in pediatric patients and consider drug holidays if clinically appropriate.
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Alternative Therapies

  • Methylphenidate (Ritalin, Concerta, Focalin)
  • Atomoxetine (Strattera)
  • Guanfacine extended-release (Intuniv)
  • Clonidine extended-release (Kapvay)
  • Bupropion (Wellbutrin - off-label for ADHD)
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Cost & Coverage

Average Cost: $200 - $400 per 30 tablets (15mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand); Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.