Zenzedi 2.5mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. You can take this medication with or without food. To minimize the risk of 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
Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom. Keep your medication in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposal, consult your pharmacist, who may be aware of local drug take-back programs.
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.
Lifestyle & Tips
- Take exactly as prescribed by your doctor. Do not take more or less than directed.
- Do not crush, chew, or break the tablets if they are extended-release (Zenzedi is immediate-release, so this is less critical but generally good advice for stimulants).
- Avoid taking doses late in the day to prevent sleep problems.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Limit or avoid caffeine intake, as it can increase stimulant effects and side effects.
- Maintain a healthy diet and regular exercise, especially for children, to support overall health and manage potential appetite suppression.
- Regularly monitor blood pressure and heart rate as advised by your doctor.
- Report any new or worsening mental health symptoms (e.g., anxiety, agitation, hallucinations) immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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 medical attention immediately:
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 medical help immediately 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 you're concerned about any side effects or have questions, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain
- Shortness of breath
- Fainting spells
- Fast or pounding heartbeat
- Numbness, coolness, or pain in fingers or toes
- Unexplained wounds on fingers or toes
- New or worsening aggression or hostility
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- New manic symptoms (e.g., extreme energy, racing thoughts)
- Severe headache
- Blurred vision
- Unexplained weight loss (especially in children)
- Slowed growth (in children)
Before Using This Medicine
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 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 problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & 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 the medication 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. Instead, consult your doctor, who will provide guidance on how to safely taper off the medication.
Monitoring and Follow-up
Before starting this medication, you may need to undergo heart tests to ensure your safety. Your doctor will discuss the results with you and provide further instructions. 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. If you experience severe headache, dizziness, fainting, or changes in vision, seek medical attention immediately.
Interactions with Other Medications
Certain over-the-counter (OTC) products, such as 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 your 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 Behavior
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 hallucinations, changes in behavior, or 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 teenagers. Regular growth checks may be necessary to monitor any potential effects. Consult your doctor for more information.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor. This will help you make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- High fever
- Rhabdomyolysis
- Arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea
- Vomiting
- Diarrhea
- Abdominal cramps
- Convulsions
- Coma
- Death
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
- Linezolid (MAOI activity)
- Methylene blue (MAOI activity)
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome
- Antihypertensive agents - may reduce hypotensive effect
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase dextroamphetamine levels and prolong half-life
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease dextroamphetamine levels and shorten half-life
- Proton Pump Inhibitors (PPIs) / H2 blockers - may increase absorption and exposure
- Antipsychotics - may antagonize stimulant effects
Moderate Interactions
Minor Interactions
- Caffeine - additive stimulant effects
Monitoring
Baseline Monitoring
Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).
Timing: Prior to initiation and periodically during treatment.
Rationale: Risk of growth suppression.
Timing: Prior to initiation and periodically during treatment.
Rationale: Risk of exacerbating pre-existing psychiatric conditions (e.g., psychosis, bipolar disorder) or inducing new ones.
Timing: Prior to initiation.
Rationale: To screen for underlying cardiac abnormalities that could be exacerbated by stimulant use.
Timing: Prior to initiation, if indicated.
Routine Monitoring
Frequency: At least annually, or more frequently if clinically indicated.
Target: Within normal limits for age/patient.
Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.
Frequency: Every 3-6 months.
Target: Normal growth trajectory.
Action Threshold: Significant deviation from expected growth curve; consider drug holiday or alternative treatment.
Frequency: Regularly during follow-up visits.
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence or worsening of psychiatric symptoms; consider dose reduction or discontinuation.
Frequency: Regularly during follow-up visits.
Target: Improved attention, reduced hyperactivity/impulsivity, improved wakefulness.
Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative treatment.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Fainting
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Agitation
- Unexplained weight loss
- Growth deceleration (in children)
- Numbness, coolness, or pain in fingers/toes (Raynaud's phenomenon)
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit outweighs the potential risk to the fetus. Amphetamines may cause fetal harm, including premature birth and low birth weight. Neonates exposed to amphetamines in utero may experience withdrawal symptoms.
Trimester-Specific Risks:
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, weight loss, cardiovascular effects), breastfeeding is generally not recommended during treatment with dextroamphetamine.
Pediatric Use
Approved for ADHD and narcolepsy in children 6 years and older. Monitor growth (height and weight) carefully. Risk of growth suppression. Monitor for psychiatric adverse events.
Geriatric Use
Use with caution in elderly patients, generally starting at the lower end of the dosing range, due to increased sensitivity to adverse effects (especially cardiovascular and psychiatric). Consider age-related decreases in renal function.
Clinical Information
Clinical Pearls
- Administer the last dose of the day at least 6 hours before bedtime to minimize insomnia.
- Patients should be screened for cardiac disease prior to initiation, especially if they have a family history of sudden cardiac death or arrhythmias.
- Monitor for signs of abuse or diversion, as dextroamphetamine has a high potential for abuse.
- Consider drug holidays in pediatric patients to assess the need for continued therapy and to mitigate potential growth suppression.
- Inform patients about the potential for Raynaud's phenomenon (peripheral vasculopathy) and to seek medical attention if symptoms occur.
- Urine pH significantly affects dextroamphetamine excretion; acidic urine increases excretion, while alkaline urine decreases it, potentially leading to higher drug levels.
Alternative Therapies
- Methylphenidate (e.g., Ritalin, Concerta)
- Atomoxetine (Strattera)
- Guanfacine (Intuniv)
- Clonidine (Kapvay)
- Modafinil (Provigil - for narcolepsy)
- Armodafinil (Nuvigil - for narcolepsy)