D-Amphetamine Salt Combo 10mg Tab
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.
Drug Class
Central Nervous System (CNS) Stimulant
Pharmacologic Class
Sympathomimetic Amine
Pregnancy Category
Category C
FDA Approved
Feb 1996
DEA Schedule
Schedule II
Overview
What is this medicine?
This medication is a stimulant used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and narcolepsy. It works by increasing certain natural substances in the brain that help with focus and attention, and reduce impulsivity and hyperactivity.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to 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. However, be sure to take your last dose of the day at least 4 hours before bedtime to minimize any potential disruptions to your sleep.
Before using any over-the-counter (OTC) products, consult with your doctor, especially if they may increase your blood pressure. These products include cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, and certain natural products or aids.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. If you have unused or expired medication, 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, as there may be drug take-back programs available 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.
To get the most benefit from your medication, it's essential to 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. However, be sure to take your last dose of the day at least 4 hours before bedtime to minimize any potential disruptions to your sleep.
Before using any over-the-counter (OTC) products, consult with your doctor, especially if they may increase your blood pressure. These products include cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, and certain natural products or aids.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. If you have unused or expired medication, 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, as there may be drug take-back programs available 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.
- Take in the morning to avoid sleep problems. If taking multiple doses, ensure the last dose is not too late in the day.
- Avoid abrupt discontinuation, especially after prolonged use, as withdrawal symptoms may occur.
- Store securely to prevent misuse or diversion.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Avoid alcohol while taking this medication.
- Maintain a healthy diet and regular sleep schedule.
Available Forms & Alternatives
Available Strengths:
- D-Amphetamine Salt Combo 5mg Tabs
- D-Amphetamine Salt Combo 10mg Tab
- D-Amphetamine Salt Combo 20mg Tabs
- D-Amphetamine Salt Combo 30mg Tabs
- D-Amphetamine Salt Combo 15mg Tabs
- D-Amphetamine Salt Combo 7.5mg Tabs
- D-Amphetamine Salt Combo 12.5mg Tb
- D-Amphetamine ER 30mg Salt Combo CP
- D-Amphetamine ER 20mg Salt Combo CP
- D-Amphetamine ER 10mg Salt Combo CP
- D-Amphetamine ER 5mg Salt Combo CP
- D-Amphetamine ER 25mg Salt Combo CP
- D-Amphetamine ER 15mg Salt Combo CP
- D-Amphetamine Salt Combo 10mg Tab
- D-Amphetamine ER 12.5mg Slt Cmb 3b
- D-Amphetamine ER 37.5mg Slt Cmb 3b
- D-Amphetamine ER 50mg Slt Cmb 3b CP
- D-Amphetamine ER 25mg Slt Cmb 3b CP
Dosing & Administration
Adult Dosing
Standard Dose:
ADHD: Initial 5 mg orally once or twice daily; titrate by 5 mg weekly. Narcolepsy: Initial 10 mg orally daily; titrate by 10 mg weekly.
Dose Range:
5 - 60 mg
Condition-Specific Dosing:
ADHD:
Initial 5 mg orally once or twice daily; may increase by 5 mg at weekly intervals until optimal response. Max 40 mg/day (rarely up to 60 mg/day).
Narcolepsy:
Initial 10 mg orally daily; may increase by 10 mg at weekly intervals. Max 60 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
ADHD (6-12 years): Initial 5 mg orally once or twice daily; may increase by 5 mg at weekly intervals. Max 40 mg/day. Narcolepsy (6-12 years): Initial 5 mg orally daily; may increase by 5 mg at weekly intervals. Max 60 mg/day.
Adolescent:
ADHD (13-17 years): Initial 10 mg orally once daily; may increase by 10 mg at weekly intervals. Max 40 mg/day. Narcolepsy (13-17 years): Initial 10 mg orally daily; may increase by 10 mg at weekly intervals. Max 60 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment provided, but monitor for adverse effects.
Moderate:
Consider lower initial doses and slower titration. Monitor for adverse effects.
Severe:
Consider lower initial doses and slower titration. Monitor for adverse effects. Use with caution.
Dialysis:
Not well studied. Amphetamines are not significantly removed by hemodialysis. Use with extreme caution, consider contraindication due to potential for accumulation and increased toxicity.
Hepatic Impairment:
Mild:
No specific dose adjustment provided, but monitor for adverse effects.
Moderate:
No specific dose adjustment provided, but monitor for adverse effects.
Severe:
No specific dose adjustment provided, but monitor for adverse effects. Use with caution.
Pharmacology
Mechanism of Action
Dextroamphetamine and amphetamine are non-catecholamine sympathomimetic amines that exert their therapeutic effects by increasing the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, and by blocking their reuptake. This leads to increased concentrations of these neurotransmitters in the synaptic cleft, enhancing neurotransmission in areas of the brain associated with attention and impulse control.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (oral)
Tmax:
Immediate-release (IR): 2-4 hours; Extended-release (XR): 7 hours
FoodEffect:
Food does not significantly affect the extent of absorption, but may delay Tmax for IR formulations. For XR, high-fat meals may delay absorption.
Distribution:
Vd:
Approximately 3-5 L/kg
ProteinBinding:
15-20%
CnssPenetration:
Yes, readily crosses the blood-brain barrier
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Amphetamine: 9-11 hours (IR); 10-13 hours (XR)
Clearance:
Highly dependent on urinary pH. Acidic urine increases clearance.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-50% (dependent on urinary pH; higher in acidic urine)
Pharmacodynamics
OnsetOfAction:
Immediate-release: 30-60 minutes
PeakEffect:
Immediate-release: 2-4 hours
DurationOfAction:
Immediate-release: 4-6 hours; Extended-release: 10-12 hours
Safety & Warnings
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.
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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in vision
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower abdominal pain
+ Pelvic pain
Erectile dysfunction (difficulty getting or maintaining an erection)
Decreased sex drive
Seizures
Uncontrolled body movements
Uncontrolled vocalizations (e.g., humming, throat clearing, yelling, or making loud noises)
Restlessness
Changes in vision
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
Muscle pain or weakness, dark urine, or difficulty urinating
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek immediate medical attention if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:
Feeling nervous or excitable
Headache
Difficulty sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in the mouth
* Weight loss
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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.
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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in vision
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower abdominal pain
+ Pelvic pain
Erectile dysfunction (difficulty getting or maintaining an erection)
Decreased sex drive
Seizures
Uncontrolled body movements
Uncontrolled vocalizations (e.g., humming, throat clearing, yelling, or making loud noises)
Restlessness
Changes in vision
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
Muscle pain or weakness, dark urine, or difficulty urinating
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek immediate medical attention if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:
Feeling nervous or excitable
Headache
Difficulty sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in the mouth
* Weight loss
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 (seek immediate medical attention)
- New or worsening aggression, hostility, or irritability
- New psychotic symptoms (e.g., hearing voices, believing things that are not true)
- New manic symptoms (e.g., extreme energy, racing thoughts)
- Unexplained numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained weight loss or lack of growth (in children)
- Blurred vision or other vision changes
- Severe headache
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial 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 you experienced, including the 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)
Existing health problems, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Kidney disease
Current medications, particularly:
+ Acetazolamide
+ Sodium bicarbonate
Use of certain drugs for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: this may increase the risk of very high blood pressure)
Concurrent use of:
+ Linezolid
+ Methylene blue
* Breast-feeding status: do not breast-feed while taking this medication
This list is not exhaustive. It is essential 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 dosage of any medication without consulting your doctor.
It is crucial 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 you experienced, including the 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)
Existing health problems, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Kidney disease
Current medications, particularly:
+ Acetazolamide
+ Sodium bicarbonate
Use of certain drugs for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: this may increase the risk of very high blood pressure)
Concurrent use of:
+ Linezolid
+ Methylene blue
* Breast-feeding status: do not breast-feed while taking this medication
This list is not exhaustive. It is essential 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 dosage 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.
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
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. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can lead to adverse effects.
Long-term or regular use of this medication can lead to dependence, and stopping it suddenly may cause withdrawal symptoms. If you need to reduce the dose or stop taking the medication, consult your doctor first. They will provide guidance on how to safely taper off the medication.
Before starting this medication, you may need to undergo heart tests to ensure it is safe for you to take. If you have any 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. Additionally, you will need to have regular blood tests to check for any potential side effects. Inform your doctor about any adverse effects you experience.
It is also important to note that this medication may affect the results of certain lab tests. Be sure to inform all your healthcare providers and lab personnel that you are taking this medication.
Do not take antacids while taking this medication, as they may interact with it.
In some cases, this medication can cause changes in behavior and mood, such as hallucinations, anger, or 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. If you experience any of the following symptoms, contact your doctor immediately: hallucinations, changes in behavior, depression, thoughts of suicide, nervousness, mood swings, abnormal thinking, anxiety, or loss of interest in life.
This medication may increase the risk of seizures in some individuals, particularly those who have a history of seizures. Discuss your risk with your doctor to determine if you are more likely to experience seizures while taking this medication.
There is a rare but potentially life-threatening condition called serotonin syndrome that can occur if you take this medication with certain other drugs. If you experience any of the following symptoms, contact your doctor immediately: agitation, changes in balance, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary to monitor any potential effects. Different brands of this medication may be approved for use in different age groups, so consult your doctor before giving it to a child.
Before consuming alcohol while taking this medication, discuss the potential risks with your doctor.
If you are pregnant or plan to become pregnant, inform your doctor. They will help you weigh the benefits and risks of taking this medication during pregnancy.
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
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. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can lead to adverse effects.
Long-term or regular use of this medication can lead to dependence, and stopping it suddenly may cause withdrawal symptoms. If you need to reduce the dose or stop taking the medication, consult your doctor first. They will provide guidance on how to safely taper off the medication.
Before starting this medication, you may need to undergo heart tests to ensure it is safe for you to take. If you have any 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. Additionally, you will need to have regular blood tests to check for any potential side effects. Inform your doctor about any adverse effects you experience.
It is also important to note that this medication may affect the results of certain lab tests. Be sure to inform all your healthcare providers and lab personnel that you are taking this medication.
Do not take antacids while taking this medication, as they may interact with it.
In some cases, this medication can cause changes in behavior and mood, such as hallucinations, anger, or 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. If you experience any of the following symptoms, contact your doctor immediately: hallucinations, changes in behavior, depression, thoughts of suicide, nervousness, mood swings, abnormal thinking, anxiety, or loss of interest in life.
This medication may increase the risk of seizures in some individuals, particularly those who have a history of seizures. Discuss your risk with your doctor to determine if you are more likely to experience seizures while taking this medication.
There is a rare but potentially life-threatening condition called serotonin syndrome that can occur if you take this medication with certain other drugs. If you experience any of the following symptoms, contact your doctor immediately: agitation, changes in balance, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary to monitor any potential effects. Different brands of this medication may be approved for use in different age groups, so consult your doctor before giving it to a child.
Before consuming alcohol while taking this medication, discuss the potential risks with your doctor.
If you are pregnant or plan to become pregnant, inform your doctor. They will help you weigh 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. Seek immediate medical attention. Treatment is generally supportive and symptomatic, including gastric lavage, activated charcoal, and management of hyperthermia, seizures, and cardiovascular effects.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis (do not use within 14 days of MAOI)
Major Interactions
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease amphetamine levels
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase amphetamine levels
- Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of amphetamines
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans) - increased risk of serotonin syndrome
- Antihypertensives - amphetamines may counteract their effects
- Halogenated anesthetics - increased risk of arrhythmias
Moderate Interactions
- Proton Pump Inhibitors (PPIs) and H2-receptor blockers - may increase amphetamine absorption/levels (especially for XR formulations)
- Antipsychotics - may antagonize stimulant effects
- Lithium - may antagonize stimulant effects
- Phenytoin, phenobarbital - may alter amphetamine metabolism
- Opioids - potential for additive CNS depression or paradoxical effects
Minor Interactions
- Caffeine and other stimulants - additive stimulant effects
- Alcohol - may alter absorption or increase adverse effects
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Amphetamines can cause dose-related increases in BP and HR; screen for pre-existing cardiovascular conditions.
Timing: Prior to initiation
Height and Weight
Rationale: Monitor for growth suppression in pediatric patients.
Timing: Prior to initiation
Psychiatric History
Rationale: Screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated.
Timing: Prior to initiation
ECG (Electrocardiogram)
Rationale: Consider for patients with pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.
Timing: Prior to initiation (if indicated)
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit (e.g., every 3-6 months or more frequently during titration)
Target: Within normal limits for age; monitor for significant increases
Action Threshold: Sustained elevation above normal range, or symptomatic changes; consider dose reduction or discontinuation
Height and Weight
Frequency: Every 3-6 months (pediatric patients)
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative treatment
Psychiatric Status
Frequency: At each visit
Target: Stable mood, absence of new or worsening psychotic/manic symptoms
Action Threshold: Emergence of psychotic symptoms, mania, aggression, or severe anxiety; consider discontinuation
Efficacy (ADHD/Narcolepsy symptoms)
Frequency: At each visit, especially during titration
Target: Improved attention, reduced hyperactivity/impulsivity, reduced excessive daytime sleepiness
Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative treatment
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New onset or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Depression
- Tics or dyskinesias
- Peripheral vasculopathy (e.g., Raynaud's phenomenon)
- Unexplained weight loss
- Growth deceleration (in children)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Amphetamines may cause fetal harm, including premature birth and low birth weight. Neonatal withdrawal symptoms (agitation, feeding difficulties) have been reported.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations, though data are limited and inconsistent.
Second Trimester:
Risk of growth restriction and premature birth.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, tremor, feeding difficulties, respiratory distress) if used near term.
Lactation
L3 (Moderate risk). Amphetamines are excreted into breast milk. Potential for adverse effects in the infant (e.g., irritability, poor feeding, sleep disturbances, weight loss). Weigh the developmental and health benefits of breastfeeding against the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.
Infant Risk:
Irritability, poor feeding, sleep disturbances, weight loss, and potential long-term neurodevelopmental effects. Monitor infant closely.
Pediatric Use
Use in children under 6 years of age is not recommended due to insufficient data on safety and efficacy. Monitor growth (height and weight) carefully, as growth suppression has been reported. Psychiatric adverse events (e.g., psychosis, mania) can occur.
Geriatric Use
Use with caution in elderly patients, generally starting with lower doses and titrating slowly, due to increased sensitivity to stimulant effects and higher prevalence of cardiovascular disease. Monitor for cardiovascular and psychiatric adverse events.
Clinical Information
Clinical Pearls
- Amphetamines have a high potential for abuse and dependence; assess patients for risk factors prior to prescribing and monitor for signs of abuse and dependence during treatment.
- Cardiovascular monitoring (BP, HR) is crucial, especially in patients with pre-existing cardiac conditions. Avoid use in patients with symptomatic cardiovascular disease or moderate to severe hypertension.
- Psychiatric adverse events, including new or worsening psychosis or mania, can occur. Screen for bipolar disorder before initiating treatment.
- Growth suppression can occur in pediatric patients; monitor height and weight regularly.
- Avoid co-administration with MAOIs due to the risk of hypertensive crisis.
- Urinary pH significantly affects amphetamine excretion; avoid concurrent use of urinary acidifiers or alkalinizers unless carefully managed.
- Patients should be advised to take the medication in the morning to avoid insomnia.
Alternative Therapies
- Atomoxetine (Strattera) - non-stimulant
- Guanfacine extended-release (Intuniv) - non-stimulant
- Clonidine extended-release (Kapvay) - non-stimulant
- Bupropion (Wellbutrin) - off-label for ADHD
- Cognitive Behavioral Therapy (CBT)
- Behavioral therapy
- Lifestyle modifications (diet, exercise, sleep hygiene)
Cost & Coverage
Average Cost:
$30 - $150 per 30 tablets (generic 10mg IR)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic); Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is vital to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is vital to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.