Zenzedi 15mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Generic 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 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.
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
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 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.
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 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.
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
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
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
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
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).
Timing: Prior to initiation of therapy.
Rationale: Risk of growth suppression in pediatric patients.
Timing: Prior to initiation of therapy.
Rationale: Stimulants can exacerbate or unmask psychiatric conditions.
Timing: Prior to initiation of therapy.
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.
Routine Monitoring
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.
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.
Frequency: At each visit.
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence or worsening of symptoms; consider dose adjustment or discontinuation.
Frequency: At each visit.
Target: No signs of abuse or diversion.
Action Threshold: Signs of abuse or diversion; implement appropriate management strategies.
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
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:
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.
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.
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
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.
Alternative Therapies
- Methylphenidate (Ritalin, Concerta, Focalin)
- Atomoxetine (Strattera)
- Guanfacine extended-release (Intuniv)
- Clonidine extended-release (Kapvay)
- Bupropion (Wellbutrin - off-label for ADHD)