D-Amphetamine Salt Combo 15mg Tabs
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 Stimulant
Pharmacologic Class
Amphetamine; Sympathomimetic
Pregnancy Category
Category C
FDA Approved
Sep 2001
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 affecting certain natural chemicals in the brain to help improve focus, attention, and reduce impulsivity or excessive daytime sleepiness.
How to Use This Medicine
Taking Your Medication Correctly
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. However, 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. Examples of such products include cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like 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.
When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about 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 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 the missed one.
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. However, 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. Examples of such products include cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like 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.
When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about 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 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 the missed one.
Lifestyle & Tips
- Take exactly as prescribed; do not take more or less than directed.
- Do not crush, chew, or break extended-release tablets/capsules (if applicable).
- 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 consumption.
- Store securely to prevent misuse or theft.
- Regularly monitor blood pressure and heart rate as advised by your doctor.
- Maintain a healthy diet and monitor growth in children.
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:
Varies by indication and individual response
Dose Range:
5 - 60 mg
Condition-Specific Dosing:
ADHD:
Initial: 5 mg once or twice daily; may increase by 5 mg weekly to a maximum of 40 mg/day (divided doses).
Narcolepsy:
Initial: 10 mg daily; may increase by 10 mg weekly to a maximum of 60 mg/day (divided doses).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
ADHD (6-12 years): Initial 5 mg once or twice daily; may increase by 5 mg weekly to a maximum of 30 mg/day (divided doses).
Adolescent:
ADHD (13-17 years): Initial 10 mg once daily; may increase by 10 mg weekly to a maximum of 40 mg/day (divided doses).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for adverse effects.
Moderate:
Consider lower initial doses and slower titration. Monitor for adverse effects.
Severe:
Use with caution; consider lower initial doses and slower titration. Monitor for adverse effects.
Dialysis:
Not well studied; use with extreme caution. Amphetamines are not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Amphetamine and dextroamphetamine are non-catecholamine sympathomimetic amines that exert their CNS stimulant effects by increasing the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain. They also block the reuptake of these monoamines, leading to increased concentrations in the synaptic cleft. Dextroamphetamine is a more potent CNS stimulant than amphetamine.
Pharmacokinetics
Absorption:
Bioavailability:
High (approximately 75% for amphetamine, 70% for dextroamphetamine)
Tmax:
Approximately 3 hours (for immediate-release formulations)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
Approximately 3-5 L/kg
ProteinBinding:
Approximately 15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Amphetamine: 9-11 hours; Dextroamphetamine: 10-13 hours (highly dependent on urinary pH)
Clearance:
Highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-50% (dependent on urinary pH)
Pharmacodynamics
OnsetOfAction:
30-60 minutes (immediate-release)
PeakEffect:
1-3 hours (immediate-release)
DurationOfAction:
4-6 hours (immediate-release)
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 AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF PATIENTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
Side Effects
Serious 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 experience 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
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
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 stomach pain
+ Pelvic pain
Other serious side effects, including:
+ Difficulty getting or maintaining an erection
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
+ Restlessness
+ Changes in eyesight
+ Prolonged or frequent erections
+ Changes in skin color, such as pale, blue, gray, purple, or red discoloration
+ Numbness, pain, tingling, or cold sensation in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or difficulty urinating
If you have a history of heart problems or heart defects, 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
Other Side Effects
Most people do not experience serious side effects, and many have only minor side effects or none at all. 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:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in the mouth
* Weight loss
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, 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.
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 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
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
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 stomach pain
+ Pelvic pain
Other serious side effects, including:
+ Difficulty getting or maintaining an erection
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
+ Restlessness
+ Changes in eyesight
+ Prolonged or frequent erections
+ Changes in skin color, such as pale, blue, gray, purple, or red discoloration
+ Numbness, pain, tingling, or cold sensation in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or difficulty urinating
If you have a history of heart problems or heart defects, 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
Other Side Effects
Most people do not experience serious side effects, and many have only minor side effects or none at all. 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:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in the mouth
* Weight loss
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, 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 or hostility
- New or worsening psychotic symptoms (e.g., hearing voices, paranoia)
- New or worsening manic symptoms (e.g., extreme energy, racing thoughts)
- Unexplained numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained weight loss or growth deceleration in children
- Severe headache, blurred vision, or seizures
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
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
+ A history of drug abuse
+ A history of stroke
Kidney disease, as this may affect how your body processes the medication
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure
+ Linezolid or methylene blue
If you are breast-feeding, as you should not breast-feed while taking this medication
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor.
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
+ A history of drug abuse
+ A history of stroke
Kidney disease, as this may affect how your body processes the medication
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure
+ Linezolid or methylene blue
If you are breast-feeding, as you should not breast-feed while taking this medication
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. 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.
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This is crucial to prevent accidents and ensure your safety.
Long-term or high-dose use of this medication can lead to tolerance, where the drug 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, as this can lead to adverse effects.
Prolonged or regular use of this medication may cause dependence, and suddenly stopping it can result in withdrawal symptoms. If you need to reduce the dose or stop taking this medication, consult your doctor, and follow their instructions carefully. Report any adverse effects to your doctor promptly.
Before starting this medication, you may need to undergo heart tests to ensure your safety. If you have any questions or concerns, discuss them with your doctor.
This medication may cause an increase in blood pressure. Monitor your blood pressure and heart rate as directed by your doctor. Additionally, have regular blood tests as advised by your doctor to ensure your safety.
It is essential to note that this medication may affect the results of certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Do not take antacids while using this medication, as they may interact with it.
There is a risk of new or worsening behavioral and mood changes, such as altered thinking, anger, and hallucinations, associated with this medication. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor to determine if you are more susceptible to seizures while taking this medication.
A rare but potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience symptoms such as agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary. Different brands of this medication may be suitable for different age groups, so consult your doctor before giving this medication to a child.
Before consuming alcohol, discuss the potential risks with your doctor. If you are pregnant or plan to become pregnant, consult your doctor to weigh the benefits and risks of using this medication during pregnancy.
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This is crucial to prevent accidents and ensure your safety.
Long-term or high-dose use of this medication can lead to tolerance, where the drug 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, as this can lead to adverse effects.
Prolonged or regular use of this medication may cause dependence, and suddenly stopping it can result in withdrawal symptoms. If you need to reduce the dose or stop taking this medication, consult your doctor, and follow their instructions carefully. Report any adverse effects to your doctor promptly.
Before starting this medication, you may need to undergo heart tests to ensure your safety. If you have any questions or concerns, discuss them with your doctor.
This medication may cause an increase in blood pressure. Monitor your blood pressure and heart rate as directed by your doctor. Additionally, have regular blood tests as advised by your doctor to ensure your safety.
It is essential to note that this medication may affect the results of certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Do not take antacids while using this medication, as they may interact with it.
There is a risk of new or worsening behavioral and mood changes, such as altered thinking, anger, and hallucinations, associated with this medication. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor to determine if you are more susceptible to seizures while taking this medication.
A rare but potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience symptoms such as agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary. Different brands of this medication may be suitable for different age groups, so consult your doctor before giving this medication to a child.
Before consuming alcohol, discuss the potential risks with your doctor. If you are pregnant or plan to become pregnant, consult your doctor to weigh 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
- Cardiac arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea, abdominal cramps
- Convulsions
- Coma
What to Do:
Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Management includes supportive care, gastric lavage, activated charcoal, and potentially benzodiazepines for agitation/seizures, and alpha-blockers for severe hypertension.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
- Linezolid
- Methylene blue
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome
- Antihypertensives - may reduce hypotensive effects
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase amphetamine levels
- Urinary acidifiers (e.g., ascorbic acid, ammonium chloride) - decrease amphetamine levels
- Proton pump inhibitors (PPIs) and H2 blockers - may increase amphetamine absorption
- Antipsychotics (e.g., haloperidol, chlorpromazine) - may antagonize stimulant effects
- Alcohol - may increase risk of adverse cardiovascular events
Moderate Interactions
- Tricyclic antidepressants (TCAs) - increased cardiovascular risk
- Antacids containing magnesium or aluminum - may increase absorption
- Opioids - potential for additive CNS effects
- Caffeine - additive stimulant effects
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).
Timing: Prior to initiation.
Height and Weight
Rationale: Risk of growth suppression in pediatric patients.
Timing: Prior to initiation (pediatric).
Psychiatric History (e.g., bipolar disorder, psychosis, tics)
Rationale: Risk of exacerbating or unmasking psychiatric conditions.
Timing: Prior to initiation.
ECG (Electrocardiogram)
Rationale: Consider for patients with pre-existing cardiac conditions or family history of sudden cardiac death.
Timing: Prior to initiation (if indicated).
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or at least every 3-6 months.
Target: Within normal limits for age/individual.
Action Threshold: Sustained elevation requiring intervention or discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric).
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss.
Psychiatric Status (e.g., mood, anxiety, tics, psychotic symptoms)
Frequency: At each visit.
Target: Stable, without new or worsening symptoms.
Action Threshold: Emergence of new psychotic symptoms, mania, severe anxiety, or tics.
Efficacy (ADHD/Narcolepsy symptoms)
Frequency: At each visit.
Target: Improved symptom control.
Action Threshold: Lack of efficacy or worsening symptoms.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression/hostility
- New or worsening psychotic symptoms (hallucinations, delusions)
- Manic symptoms
- Severe anxiety or agitation
- Motor or verbal tics
- Unexplained weight loss
- Peripheral vasculopathy (e.g., Raynaud's phenomenon)
Special Patient Groups
Pregnancy
Generally not recommended during pregnancy due to potential risks to the fetus, including premature birth, low birth weight, and withdrawal symptoms in the neonate. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations cannot be ruled out.
Second Trimester:
Potential for growth restriction and premature birth.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence) if used near term.
Lactation
Amphetamines are excreted into breast milk and can cause serious adverse reactions in a breastfed infant (e.g., agitation, insomnia, poor feeding, weight loss). Breastfeeding is generally not recommended while taking this medication.
Infant Risk:
High (L4 - Possibly hazardous)
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully. Risk of growth suppression. Monitor for emergence or worsening of psychiatric symptoms or tics.
Geriatric Use
Use with caution in elderly patients due to increased sensitivity to sympathomimetic effects and potential for underlying cardiovascular conditions. Consider lower initial doses and slower titration. Monitor for cardiovascular and psychiatric adverse effects.
Clinical Information
Clinical Pearls
- Amphetamine salt combo is a mixture of four amphetamine salts: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate.
- The 15mg strength refers to the total amphetamine base equivalent.
- Immediate-release formulations are typically dosed 1-3 times daily, while extended-release formulations are once daily.
- Patients should be advised to avoid abrupt discontinuation, especially after prolonged high-dose therapy, to prevent withdrawal symptoms (e.g., severe fatigue, depression).
- Educate patients and caregivers about the high abuse potential and the importance of secure storage.
- Regularly assess for signs of cardiovascular issues (BP, HR, symptoms) and psychiatric changes.
- Consider drug holidays in pediatric patients to assess continued need and mitigate growth suppression, though this practice is controversial and should be discussed with a specialist.
Alternative Therapies
- Methylphenidate (e.g., Ritalin, Concerta, Focalin)
- Dexmethylphenidate (Focalin)
- Atomoxetine (Strattera)
- Guanfacine extended-release (Intuniv)
- Clonidine extended-release (Kapvay)
- Bupropion (Wellbutrin) - off-label for ADHD
Cost & Coverage
Average Cost:
$30 - $100+ per 30 tablets (15mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
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 your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information about its use. It is important to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
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, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information about its use. It is important to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
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, and the time it occurred.