Zenzedi 10mg 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. Consistency is key, so take your medication at the same time every day.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. It's essential to store your medication in a secure location where children and pets cannot access it, and where others cannot easily get to it. Consider using a locked box or area to keep your medication safe. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, consult with your pharmacist, who may be aware of drug take-back programs in your area.
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 the missed one.
Lifestyle & Tips
- Take exactly as prescribed; do not take more or less than directed.
- Do not crush, chew, or break tablets; swallow whole if extended-release.
- Avoid alcohol consumption.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Store securely to prevent misuse or diversion.
- Maintain a healthy diet and regular sleep schedule.
- Report any new or worsening mental health symptoms immediately.
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Restlessness or shakiness
Uncontrolled body movements or sounds (e.g., humming, throat clearing, yelling, or making loud noises)
Changes in vision or eye pain, swelling, or redness
Erectile dysfunction or decreased sex interest
Seizures
Stomach pain
Muscle pain or weakness, dark urine, or difficulty urinating
Prolonged or frequent erections
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold sensations 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 heart rhythms or sudden death, notify your doctor. Seek immediate medical attention if you experience:
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. Call your doctor right away if you experience:
Agitation
Balance problems
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:
Dizziness or headache
Dry mouth
Difficulty sleeping
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Unpleasant taste in the mouth
Feeling nervous or excitable
* Hair loss
If you're concerned about any side effects or have questions, consult 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 (especially with exercise)
- Numbness, coolness, or pain in fingers or toes
- Unexplained wounds on fingers or toes
- New or worsening aggression, hostility, or irritability
- 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)
- Unexplained fever, muscle stiffness, or severe confusion (signs of serotonin syndrome)
- Blurred vision or other vision changes
Before Using This Medicine
It is essential to inform your doctor about the following:
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 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 (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past medical history, including:
+ Drug abuse
+ Stroke
Current medications, particularly:
+ 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 use. 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.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness and clear vision.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and you may need higher doses 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 lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Monitoring and Tests
You may need to undergo heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor. Regularly monitor your blood pressure and heart rate as directed by your doctor.
Interactions and Warnings
This medication may cause high blood pressure, so it is crucial to recognize the signs, such as severe headache, dizziness, fainting, or changes in vision. If you experience any of these symptoms, contact your doctor immediately. Before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products, consult your doctor.
Lab Tests and Seizure Risk
Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests. Additionally, this medication may increase the risk of seizures, particularly in individuals 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 altered thinking. If you or a family member have a history of mental health issues, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or mood changes like depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.
Pediatric Considerations
In some cases, this medication may affect growth in children and adolescents. They may require regular growth checks, 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.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- Hyperpyrexia
- Rhabdomyolysis
- 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 symptomatic and supportive measures, including 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) - risk of hypertensive crisis.
- Linezolid (MAOI activity)
- Methylene Blue (MAOI activity)
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.
- Antihypertensives - may antagonize hypotensive effects.
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine blood levels and prolong half-life.
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease amphetamine blood levels and shorten half-life.
- Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase absorption and exposure.
- Antipsychotics (e.g., haloperidol, chlorpromazine) - may antagonize stimulant effects.
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, ritonavir) - may increase amphetamine exposure.
- Adrenergic blockers (e.g., beta-blockers) - may potentiate pressor effects of amphetamines.
- Antacids containing magnesium or aluminum - may delay absorption.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: Amphetamines can cause dose-related increases in BP and HR.
Timing: Prior to initiation of therapy.
Rationale: Growth suppression has been reported in pediatric patients.
Timing: Prior to initiation of therapy (pediatric patients).
Rationale: To assess risk for new or worsening psychiatric symptoms.
Timing: Prior to initiation of therapy.
Rationale: To assess risk for serious cardiovascular events.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: At each visit or at least every 3-6 months.
Target: Within normal limits for age.
Action Threshold: Persistent elevation requiring intervention or discontinuation.
Frequency: Every 3-6 months (pediatric patients).
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss.
Frequency: At each visit.
Target: Stable mood and behavior.
Action Threshold: New or worsening psychiatric symptoms.
Frequency: At each visit.
Target: No signs of diversion or misuse.
Action Threshold: Signs of drug-seeking behavior or misuse.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Numbness, coolness, or pain in fingers/toes (Raynaud's phenomenon)
- Unexplained wounds on fingers/toes
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Amphetamines have been associated with adverse pregnancy outcomes including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.
Trimester-Specific Risks:
Lactation
L4 (Potentially Hazardous). 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), 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
Approved for ADHD in children 6 years and older, and narcolepsy in children 12 years and older. Growth suppression (weight and/or height) has been reported with long-term stimulant use; monitor growth regularly. Psychiatric adverse events (e.g., psychosis, mania) can occur.
Geriatric Use
Use with caution in elderly patients due to increased sensitivity to sympathomimetic effects (e.g., cardiovascular effects, anxiety, insomnia). Start with lower doses and titrate slowly. Monitor for cardiovascular and psychiatric adverse events.
Clinical Information
Clinical Pearls
- Dextroamphetamine is a Schedule II controlled substance due to its high potential for abuse and dependence. Prescribe and dispense sparingly.
- Individualize dosing based on patient response and tolerability. Start low and titrate slowly.
- Monitor blood pressure and heart rate regularly, especially at baseline and after dose adjustments.
- Educate patients and caregivers about the risk of growth suppression in children and the importance of monitoring height and weight.
- Counsel patients on the signs and symptoms of serotonin syndrome and the importance of avoiding concomitant use with MAOIs and other serotonergic drugs.
- Be aware of the potential for new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression) and advise patients to report these immediately.
- Avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., extreme fatigue, depression, sleep disturbances).
Alternative Therapies
- Methylphenidate (Ritalin, Concerta, Focalin)
- Atomoxetine (Strattera)
- Guanfacine (Intuniv)
- Clonidine (Kapvay)
- Modafinil (Provigil) - for narcolepsy
- Armodafinil (Nuvigil) - for narcolepsy