D-Amphetamine Salt Combo 30mg 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
C
FDA Approved
Jan 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 affecting certain natural chemicals in the brain that are involved in impulse control and hyperactivity.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your last dose of the day at least 4 hours before bedtime to minimize 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
+ 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.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
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 ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your last dose of the day at least 4 hours before bedtime to minimize 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
+ 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.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
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 by your doctor; do not take more or less than directed.
- Do not crush, chew, or break the tablets if they are extended-release (this specific product is immediate-release, so crushing/chewing is generally acceptable if needed for administration, but not for abuse).
- Avoid abrupt discontinuation, as this can lead to withdrawal symptoms.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Avoid alcohol consumption while on this medication.
- Store in a safe place to prevent misuse or diversion.
- Monitor for changes in mood, behavior, or new physical symptoms and report them to your doctor.
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:
For ADHD: Initial 5 mg once or twice daily; titrate weekly by 5 mg. Usual effective dose 20 mg/day in divided doses. Max 60 mg/day. For Narcolepsy: Initial 10 mg/day; titrate weekly by 10 mg. Usual effective dose 20-30 mg/day in divided doses. Max 60 mg/day.
Dose Range:
5 - 60 mg
Condition-Specific Dosing:
ADHD:
Initial 5 mg once or twice daily, titrate weekly by 5 mg to optimal response. Max 60 mg/day.
Narcolepsy:
Initial 10 mg/day, titrate weekly by 10 mg to optimal response. Max 60 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
ADHD (3-5 years): Initial 2.5 mg daily, titrate weekly by 2.5 mg. Max 40 mg/day. ADHD (6-12 years): Initial 5 mg once or twice daily, titrate weekly by 5 mg. Max 60 mg/day. Narcolepsy (6-12 years): Initial 5 mg daily, titrate weekly by 5 mg. Max 60 mg/day.
Adolescent:
ADHD (13-17 years): Initial 5-10 mg daily, titrate weekly by 5-10 mg. Max 60 mg/day. Narcolepsy (13-17 years): Initial 10 mg daily, titrate weekly by 10 mg. Max 60 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for adverse effects.
Moderate:
Consider lower doses (e.g., 75% of usual dose) and monitor closely.
Severe:
Consider significantly lower doses (e.g., 50% of usual dose) or avoid. Monitor closely.
Dialysis:
Not dialyzable. Use with extreme caution; consider avoiding.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Use with caution; consider lower doses.
Severe:
Use with caution; consider lower doses and monitor for increased adverse effects.
Pharmacology
Mechanism of Action
Dextroamphetamine and amphetamine are non-catecholamine sympathomimetic amines that exert their therapeutic effect by increasing the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, and by blocking the reuptake of these monoamines into the presynaptic neuron. This leads to increased concentrations of norepinephrine and dopamine in the synaptic cleft.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (oral)
Tmax:
2-4 hours (immediate-release)
FoodEffect:
Food may delay Tmax but does not significantly affect AUC.
Distribution:
Vd:
3-5 L/kg
ProteinBinding:
15-26%
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Levoamphetamine: 11-14 hours (highly dependent on urine pH)
Clearance:
Highly variable, dependent on urine pH.
ExcretionRoute:
Renal (urine)
Unchanged:
30-50% (dependent on urine pH; increased in acidic urine, decreased in alkaline urine)
Pharmacodynamics
OnsetOfAction:
30-60 minutes (immediate-release)
PeakEffect:
2-4 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. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
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 when passing urine
+ 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 feeling in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or trouble passing urine
Important Heart-Related Information
If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Other Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have minor ones. 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
Throwing up
Decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in your mouth
* Weight loss
Reporting Side Effects
If you have questions about side effects or want to report any 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 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
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 when passing urine
+ 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 feeling in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or trouble passing urine
Important Heart-Related Information
If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Other Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have minor ones. 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
Throwing up
Decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in your mouth
* Weight loss
Reporting Side Effects
If you have questions about side effects or want to report any 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
- Fainting
- Palpitations or irregular heartbeat
- Severe headache
- Blurred vision or other vision changes
- Numbness, coolness, or pain in fingers or toes
- Unexplained wounds on fingers or toes
- New or worsening anxiety, agitation, or aggression
- Hallucinations (seeing or hearing things that are not real)
- Delusions (false beliefs)
- Manic symptoms (e.g., extreme energy, racing thoughts, unusual behavior)
- Uncontrolled muscle movements or tics
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
+ 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 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
+ 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 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
Important Warnings and Precautions
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not exceed the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Monitoring and Tests
Your doctor may require you to undergo heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor. Regularly check your blood pressure and heart rate as directed by your doctor. You will also need to have blood work done as scheduled by your doctor.
Interactions and Lab Tests
This medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication. Do not take antacids while using this drug.
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 or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Immediately report any hallucinations, changes in behavior, or mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Serotonin Syndrome
A 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 agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and adolescents. They may require regular growth checks. Different brands of this medication may be suitable for different age groups. Consult your doctor before giving this medication to a child.
Alcohol Use
Discuss alcohol consumption with your doctor before using this medication.
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.
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not exceed the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Monitoring and Tests
Your doctor may require you to undergo heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor. Regularly check your blood pressure and heart rate as directed by your doctor. You will also need to have blood work done as scheduled by your doctor.
Interactions and Lab Tests
This medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication. Do not take antacids while using this drug.
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 or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Immediately report any hallucinations, changes in behavior, or mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Serotonin Syndrome
A 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 agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and adolescents. They may require regular growth checks. Different brands of this medication may be suitable for different age groups. Consult your doctor before giving this medication to a child.
Alcohol Use
Discuss alcohol consumption with your doctor before using this medication.
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 (very high fever)
- Rhabdomyolysis (muscle breakdown)
- Arrhythmias (irregular heartbeats)
- Hypertension (high blood pressure) or hypotension (low blood pressure)
- Circulatory collapse
- Nausea
- Vomiting
- Diarrhea
- Abdominal cramps
- Convulsions (seizures)
- Coma
What to Do:
In case of suspected overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Antihypertensive agents - may reduce hypotensive effect
- Tricyclic Antidepressants (TCAs) - may increase amphetamine levels and potentiate cardiovascular effects
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine blood levels and prolong half-life
Moderate Interactions
- Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease amphetamine blood levels and shorten half-life
- Proton Pump Inhibitors (PPIs) - may increase absorption and exposure
- Antihistamines - may counteract sedative effects
- Phenothiazines - may inhibit amphetamine 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 of therapy.
Height and Weight (Pediatric)
Rationale: Risk of growth suppression.
Timing: Prior to initiation of therapy.
Psychiatric History and Symptoms
Rationale: Risk of new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression).
Timing: Prior to initiation of therapy.
Cardiac History and ECG (if indicated)
Rationale: To identify pre-existing cardiac conditions that may contraindicate use.
Timing: Prior to initiation, especially if family history of sudden cardiac death or known cardiac abnormalities.
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 and clinical status.
Action Threshold: Sustained elevation above normal range; consider dose reduction or discontinuation.
Height and Weight (Pediatric)
Frequency: Every 3-6 months.
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration; consider drug holiday or alternative therapy.
Psychiatric Symptoms
Frequency: At each visit.
Target: Absence of new or worsening psychosis, mania, aggression, or severe anxiety.
Action Threshold: Emergence or worsening of symptoms; consider dose adjustment or discontinuation.
Abuse Potential
Frequency: At each visit.
Target: Adherence to prescribed regimen, no signs of diversion or misuse.
Action Threshold: Signs of misuse, diversion, or dependence; consider referral for substance use disorder treatment.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Fainting
- Palpitations
- Severe headache
- Blurred vision
- Numbness, coolness, or pain in fingers/toes
- Unexplained wounds on fingers/toes
- New or worsening anxiety
- Agitation
- Hallucinations
- Delusions
- Mania
- Aggression
- Tics or dyskinesias
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Amphetamines may cause adverse pregnancy outcomes, including premature birth and low birth weight. Neonates exposed to amphetamines during the third trimester are at risk for withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations cannot be ruled out.
Second Trimester:
Potential for growth restriction and other adverse outcomes.
Third Trimester:
Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypotonia).
Lactation
Amphetamines are 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), breastfeeding is generally not recommended during treatment.
Infant Risk:
Moderate to High
Pediatric Use
Careful monitoring of growth (height and weight) is essential due to the risk of growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression) and cardiovascular effects. Long-term safety and efficacy in children under 3 years for ADHD and under 6 years for narcolepsy have not been established.
Geriatric Use
Use with caution, generally starting at lower doses, due to increased sensitivity to stimulant effects and potential for comorbid cardiovascular conditions. Monitor closely for cardiovascular and psychiatric adverse events.
Clinical Information
Clinical Pearls
- D-Amphetamine Salt Combo (mixed amphetamine salts) is a Schedule II controlled substance with a high potential for abuse and dependence. Prescribe and dispense with caution.
- Dosing is highly individualized; titrate slowly to achieve optimal therapeutic effect with minimal side effects.
- Monitor blood pressure and heart rate regularly due to cardiovascular risks. Consider an ECG at baseline for patients with pre-existing cardiac conditions or family history of sudden cardiac death.
- In children, monitor height and weight regularly due to the risk of growth suppression.
- Educate patients and caregivers about the signs of psychiatric adverse events (e.g., new or worsening psychosis, mania, aggression) and the importance of reporting them immediately.
- Avoid abrupt discontinuation, especially after prolonged high-dose therapy, to prevent withdrawal symptoms (e.g., extreme fatigue, depression, sleep disturbances).
- Urine pH significantly affects amphetamine excretion; acidic urine increases excretion, while alkaline urine decreases it. This can impact drug levels and duration of action.
Alternative Therapies
- Atomoxetine (Strattera)
- Guanfacine extended-release (Intuniv)
- Clonidine extended-release (Kapvay)
- Bupropion (Wellbutrin - off-label for ADHD)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$100+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1-3 (generics typically Tier 1 or 2, brand may be Tier 3 or higher)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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 important information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.