Zenzedi 20mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. 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 take this medication with fruit juice. To establish a routine, take your medication at the same time every day.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from direct light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. It's essential to keep your medication out of reach of children and pets, and to prevent unauthorized access. Consider storing it in a locked box or secure area. 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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, or more often than prescribed.
- Do not crush, chew, or break the tablets. Swallow them whole.
- 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.
- Avoid alcohol while taking this medication.
- Store in a safe place to prevent misuse or theft.
- Regularly monitor blood pressure and heart rate as advised by your doctor.
- For children, monitor height and weight regularly.
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 notice 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
Difficulty 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 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
Heart Problems: Important Warning
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, including:
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 Side Effects
While many people may not experience side effects or only have minor ones, it's essential to be aware of the following possible side effects:
Dizziness or headache
Dry mouth
Difficulty 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, or fainting (seek immediate medical attention)
- New or worsening aggression, hostility, or irritability
- New or worsening thoughts of harming yourself or others
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- New tics or worsening of existing tics
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained fever, muscle stiffness, or confusion (signs of serotonin syndrome)
Before Using This Medicine
It is crucial to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you or a family member has a history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
If you have been diagnosed with:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have a history of:
+ Drug abuse
+ Stroke
If you are currently taking or have recently taken certain medications, including:
+ Acetazolamide or sodium bicarbonate
+ Antidepressants or Parkinson's disease medications (such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may increase the risk of 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 essential to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.
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 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 or 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. 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. 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 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 changes in 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. 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 Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Discuss any concerns 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 taking this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Aggressiveness
- Hallucinations
- Panic states
- High fever
- Rhabdomyolysis
- Arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea, abdominal cramps
- Convulsions
- Coma
What to Do:
Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
- Linezolid
- Methylene blue
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Antihypertensives (may counteract effects)
- Halogenated anesthetics (risk of arrhythmias)
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine levels
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease amphetamine levels
- Proton pump inhibitors (PPIs) and H2 blockers (may increase absorption of some extended-release formulations, less relevant for IR)
Moderate Interactions
- Antipsychotics (may antagonize stimulant effects)
- Antidepressants (TCAs, bupropion - may increase risk of cardiovascular effects or seizures)
- Antacids containing magnesium or aluminum (may increase absorption)
- Phenytoin (may alter phenytoin levels)
- Ethosuximide (may alter ethosuximide levels)
- Phenobarbital (may alter phenobarbital levels)
- Opioids (potential for additive CNS effects, respiratory depression)
Minor Interactions
- Caffeine (additive stimulant effects)
- Alcohol (may exacerbate adverse effects)
Monitoring
Baseline Monitoring
Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).
Timing: Prior to initiation.
Rationale: Risk of growth suppression in pediatric patients.
Timing: Prior to initiation (pediatric).
Rationale: Risk of new or worsening psychiatric symptoms (psychosis, mania, aggression).
Timing: Prior to initiation.
Rationale: To rule out underlying cardiac conditions that could be exacerbated by stimulants.
Timing: Prior to initiation (if indicated).
Routine Monitoring
Frequency: Regularly (e.g., at each visit or every 3-6 months)
Target: Within normal limits for age/individual
Action Threshold: Sustained elevation outside normal range; symptomatic changes.
Frequency: Every 3-6 months (pediatric)
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration or weight loss.
Frequency: Regularly (e.g., at each visit)
Target: Stable, improved ADHD symptoms, no new or worsening psychiatric symptoms
Action Threshold: Emergence of psychotic symptoms, manic episodes, severe anxiety, aggression, suicidal ideation.
Frequency: Regularly (e.g., at each visit)
Target: No signs of misuse or diversion
Action Threshold: Signs of drug-seeking behavior, escalating doses, loss of control.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Depression
- Suicidal ideation
- Unexplained weight loss
- Tics or dyskinesias
- Peripheral vasculopathy (e.g., Raynaud's phenomenon)
Special Patient Groups
Pregnancy
Generally not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus. Amphetamines have been associated with adverse pregnancy outcomes.
Trimester-Specific Risks:
Lactation
Dextroamphetamine is excreted into breast milk. Use is generally not recommended due to potential for serious adverse effects in the infant (e.g., irritability, poor feeding, sleep disturbances, weight loss, cardiovascular effects).
Pediatric Use
Approved for children 6 years and older for ADHD. Monitor growth (height and weight) carefully, as stimulants can cause growth suppression. Monitor for psychiatric adverse events.
Geriatric Use
Use with caution in elderly patients due to increased sensitivity to stimulant effects and higher prevalence of cardiovascular disease. Start with lower doses and titrate slowly. Monitor cardiovascular status closely.
Clinical Information
Clinical Pearls
- Dextroamphetamine is a potent CNS stimulant with a high abuse potential; careful prescribing and monitoring are essential.
- Individualize dosing based on patient response and tolerability, starting low and titrating slowly.
- Educate patients and caregivers on the importance of proper storage and disposal to prevent diversion.
- Monitor for cardiovascular changes (BP, HR) and psychiatric symptoms (psychosis, mania, aggression) at each visit.
- For pediatric patients, regular growth monitoring (height and weight) is crucial.
- Avoid abrupt discontinuation, especially after prolonged high-dose therapy, to prevent withdrawal symptoms (e.g., severe fatigue, depression).
- Urinary pH significantly impacts dextroamphetamine excretion; advise patients to avoid large amounts of vitamin C or acidic juices, and discuss antacid use.
Alternative Therapies
- Methylphenidate (Ritalin, Concerta, Focalin)
- Atomoxetine (Strattera)
- Guanfacine (Intuniv)
- Clonidine (Kapvay)
- Bupropion (Wellbutrin - off-label for ADHD)