Zenzedi 5mg 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 Releasing Agent (NDRA) and Reuptake Inhibitor (NDRI)
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Pregnancy Category
Category C
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FDA Approved
Mar 2015
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Zenzedi is a stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and narcolepsy. It works by affecting certain natural chemicals in the brain to help improve focus, attention, and reduce impulsivity or excessive sleepiness.
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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 consume this medication with fruit juice. Establish a routine by taking your medication at the same time every day.

Storing and Disposing of Your Medication

Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. To ensure safety, store your medication in a secure location where children and others cannot access it. Consider using a locked box or area to protect your medication. Keep all medications out of reach of pets. 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. Consult your pharmacist for guidance on proper disposal methods, and inquire about potential drug take-back programs 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 the medication exactly as prescribed, usually in the morning to avoid sleep problems.
  • Avoid taking doses late in the day.
  • Do not crush, chew, or split the tablets unless instructed by your doctor.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Limit or avoid caffeine intake, as it can increase stimulant side effects.
  • Maintain a healthy diet and regular exercise, especially for children, as appetite suppression and growth effects can occur.
  • Store in a safe place to prevent misuse or abuse.

Dosing & Administration

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Adult Dosing

Standard Dose: ADHD: Initial 5 mg once or twice daily. Narcolepsy: Initial 10 mg daily in divided doses.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

ADHD: Titrate by 5 mg weekly to a maximum of 40 mg/day, given in 1-3 divided doses.
Narcolepsy: Titrate by 10 mg weekly to a maximum of 60 mg/day, given in divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (3-5 years): Initial 2.5 mg daily, titrate by 2.5 mg weekly. ADHD (6 years and older): Initial 5 mg once or twice daily, titrate by 5 mg weekly. Max 40 mg/day.
Adolescent: ADHD: Initial 5 mg once or twice daily, titrate by 5 mg weekly. Max 40 mg/day. Narcolepsy (12 years and older): Initial 10 mg daily in divided doses, titrate by 10 mg weekly. Max 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor for adverse effects.
Moderate: Consider lower doses and monitor closely.
Severe: Use with caution; consider significant dose reduction or avoidance due to primary renal excretion. Specific guidelines not well-defined.
Dialysis: Not available; amphetamines are not significantly dialyzable.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, monitor for adverse effects.
Severe: No specific adjustment recommended, monitor for adverse effects (hepatic metabolism is minor route).

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: Approximately 75-100%
Tmax: 1-3 hours (immediate-release)
FoodEffect: Food can 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 (pH dependent); Children: 6-8 hours
Clearance: Highly variable, pH dependent
ExcretionRoute: Renal (primarily unchanged drug)
Unchanged: Approximately 30-50% (higher in acidic urine)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 1-3 hours
DurationOfAction: 4-6 hours

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. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

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
Difficulty 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 difficulty 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 sensation in hands or feet
Sores or wounds on fingers or toes

Important Heart-Related Warnings

If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, such as:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

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
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Other Possible Side Effects

While many people may not experience side effects or only have mild ones, it's essential to be aware of the following potential side effects:

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

If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain
  • Shortness of breath
  • Fainting spells
  • New or worsening tics (uncontrolled movements or sounds)
  • Hallucinations (seeing or hearing things that aren't there)
  • Paranoia or suspiciousness
  • Aggressive behavior
  • Unexplained numbness, pain, or discoloration in fingers or toes
  • Severe headache
  • Blurred vision
  • Unusual sweating or fever
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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:

Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and severity.
A history of certain health conditions in you or your family, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past medical history of:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never 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.

Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.

Cardiovascular Monitoring
You may need to undergo heart tests before starting this medication. If you have questions or concerns, discuss them with your doctor. 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 contact your doctor 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 increase blood pressure. Consult your doctor before using these products.

Lab Tests and Seizure Risk
This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel 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 of seizures with your doctor.

Mental Health and Mood Changes
This medication may cause changes in behavior and mood, including hallucinations, anger, and altered thinking. 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. Contact your doctor immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.

Pediatric Growth and Development
This medication may affect growth in children and adolescents. Regular growth checks may be necessary, so discuss this with your doctor.

Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, consult your doctor to discuss the benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia
  • Rapid breathing
  • Confusion
  • Assaultiveness
  • Hallucinations
  • Panic states
  • Hyperpyrexia (very high fever)
  • Rhabdomyolysis
  • Arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma

What to Do:

In case of suspected overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
  • Halogenated Anesthetics (risk of sudden death)
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Major Interactions

  • Urinary Alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase amphetamine blood levels and prolong half-life
  • Tricyclic Antidepressants (TCAs) - potentiate cardiovascular effects of amphetamines
  • Serotonergic Drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome
  • Antihypertensives - amphetamines may antagonize the hypotensive effects
  • Proton Pump Inhibitors (PPIs) / H2 Blockers - may increase absorption of amphetamines
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Moderate Interactions

  • Urinary Acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease amphetamine blood levels and shorten half-life
  • Phenothiazines (e.g., chlorpromazine) - may antagonize the stimulant effects of amphetamines
  • Antipsychotics (e.g., haloperidol) - may antagonize the stimulant effects of amphetamines
  • CYP2D6 Inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure
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Minor Interactions

  • Not typically listed for minor interactions with significant clinical relevance.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Amphetamines can cause increases in BP and HR; screen for pre-existing cardiovascular conditions.

Timing: Prior to initiation

Weight and Height (pediatric patients)

Rationale: Monitor for growth suppression.

Timing: Prior to initiation

Psychiatric History (including family history of tics, Tourette's syndrome, bipolar disorder, psychosis)

Rationale: Amphetamines can exacerbate or unmask psychiatric symptoms.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: Consider for patients with pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.

Timing: Prior to initiation (if indicated)

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit (e.g., every 3-6 months or as clinically indicated)

Target: Within normal limits for age/individual

Action Threshold: Persistent elevation outside normal range; consider dose reduction, discontinuation, or referral to cardiology.

Weight and Height (pediatric patients)

Frequency: Every 3-6 months

Target: Consistent growth trajectory

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

Psychiatric Status (e.g., mood, anxiety, agitation, tics, psychotic symptoms)

Frequency: At each visit

Target: Stable, improved, or absence of new/worsening symptoms

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

Efficacy (ADHD symptoms, narcolepsy symptoms)

Frequency: At each visit

Target: Improved focus, reduced hyperactivity/impulsivity, reduced excessive daytime sleepiness

Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • Severe headache
  • New or worsening tics
  • Agitation
  • Hallucinations
  • Paranoia
  • Aggression
  • Unexplained weight loss
  • Sleep disturbances

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines may cause premature delivery and low birth weight. Neonates exposed to amphetamines in utero may experience withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations, though data are conflicting.
Second Trimester: Risk of premature birth and low birth weight.
Third Trimester: Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, drowsiness) if used close to delivery.
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Lactation

Dextroamphetamine is excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, weight loss), 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: L4 (Potentially Hazardous) - Monitor infant for irritability, poor feeding, sleep disturbances, and weight loss. Avoid if possible, or use lowest effective dose and monitor closely.
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Pediatric Use

Growth suppression (weight and height) has been reported with long-term use of stimulants in children. Monitor growth regularly. Psychiatric adverse events (e.g., psychosis, mania, aggression) can occur. Not recommended for children under 3 years of age for ADHD or under 6 years for narcolepsy.

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Geriatric Use

Use with caution in elderly patients due to increased sensitivity to sympathomimetic effects and potential for comorbidities (e.g., cardiovascular disease). Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Administer the last dose of the day at least 4-6 hours before bedtime to minimize insomnia.
  • Monitor for signs of abuse or diversion, especially in patients with a history of substance use disorder.
  • Consider drug holidays (e.g., weekends or school breaks) for pediatric patients to assess ongoing need and potentially mitigate growth suppression, under physician guidance.
  • Educate patients and caregivers on the importance of adherence and proper storage due to its Schedule II classification.
  • Be aware of the potential for cardiovascular and psychiatric adverse effects, and counsel patients on symptoms to report immediately.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta)
  • Lisdexamfetamine (Vyvanse)
  • Atomoxetine (Strattera)
  • Guanfacine (Intuniv)
  • Clonidine (Kapvay)
  • Modafinil (Provigil) - for narcolepsy
  • Armodafinil (Nuvigil) - for narcolepsy
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Cost & Coverage

Average Cost: $150 - $300 per 30 tablets (5mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand name; generic often Tier 1 or 2)
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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 your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them with 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it occurred.