D-Amphetamine Salt Combo 5mg 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
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 affecting certain natural chemicals in the brain to help improve focus, attention, and control over behavior, or to help stay awake.
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 medication, do not flush it down the toilet or pour it down the drain unless specifically 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 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 medication, do not flush it down the toilet or pour it down the drain unless specifically 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 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 tablets; swallow whole.
- Avoid taking doses late in the day to prevent insomnia.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Avoid alcohol consumption.
- Store securely to prevent misuse or diversion.
- Regularly monitor blood pressure and heart rate as advised by your doctor.
- Maintain a healthy diet and monitor growth (for 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:
ADHD: Initial 5 mg once or twice daily. Narcolepsy: Initial 10 mg daily.
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 (rarely up to 60 mg/day). Doses usually given in 2-3 divided doses.
Narcolepsy:
Initial 10 mg daily in divided doses; may increase by 10 mg weekly to a maximum of 60 mg/day. Doses usually given in 2-3 divided doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
ADHD (3-5 years): Initial 2.5 mg daily; may increase by 2.5 mg weekly. ADHD (6-12 years): Initial 5 mg once or twice daily; may increase by 5 mg weekly. Narcolepsy (6-12 years): Initial 5 mg daily; may increase by 5 mg weekly.
Adolescent:
ADHD (13-17 years): Initial 10 mg daily; may increase by 10 mg weekly. Narcolepsy (13-17 years): Initial 10 mg daily; may increase by 10 mg weekly.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor for adverse effects.
Moderate:
Consider lower doses and monitor for adverse effects. Specific guidelines not well-defined.
Severe:
Use with caution; consider lower doses and extended dosing intervals. Specific guidelines not well-defined.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Amphetamines 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, particularly in the prefrontal cortex. They also block the reuptake of these monoamines, leading to increased concentrations in the synaptic cleft. The exact mechanism in ADHD and narcolepsy is not fully understood but is thought to involve stimulation of the CNS.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (oral)
Tmax:
Approximately 3 hours (for immediate-release formulations)
FoodEffect:
Food does not significantly affect the extent of absorption, but may delay Tmax.
Distribution:
Vd:
Approximately 3.5-4.5 L/kg
ProteinBinding:
Approximately 15-26%
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Amphetamine: 9-11 hours (pH-dependent)
Clearance:
Highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-50% (highly dependent on urinary pH)
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
1-3 hours
DurationOfAction:
4-6 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
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
Erectile dysfunction
Decreased sex interest
Seizures
Uncontrolled body movements
Uncontrolled vocalizations, such as humming, throat clearing, yelling, or making loud noises
Restlessness
Changes in eyesight
Prolonged or frequent erections
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Important Heart-Related Information
If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, including:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Other Possible Side Effects
While many people may not experience side effects or only have mild side effects, it's essential to be aware of the following potential side effects. If you experience any of these symptoms or if they persist or bother you, contact your doctor:
Feeling nervous or excitable
Headache
Trouble sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in mouth
Weight loss
Reporting 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
Erectile dysfunction
Decreased sex interest
Seizures
Uncontrolled body movements
Uncontrolled vocalizations, such as humming, throat clearing, yelling, or making loud noises
Restlessness
Changes in eyesight
Prolonged or frequent erections
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Important Heart-Related Information
If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, including:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Other Possible Side Effects
While many people may not experience side effects or only have mild side effects, it's essential to be aware of the following potential side effects. If you experience any of these symptoms or if they persist or bother you, contact your doctor:
Feeling nervous or excitable
Headache
Trouble sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in mouth
Weight loss
Reporting 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, 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)
- Severe headache
- Blurred vision
- Uncontrolled 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 you experienced, including the symptoms that occurred.
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 taken in 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 first.
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 you experienced, including the symptoms that occurred.
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 taken in 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 first.
Precautions & Cautions
Important Warnings and Precautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities 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 can lead to tolerance, where the medication may not work as well, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Monitoring and Tests
You may need to undergo heart tests before starting this medication. If you have 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 with Other Medications and Lab Tests
This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this medication. Do not take antacids with this medication.
Mental and Mood Changes
New or worsening behavior and mood changes, such as altered thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Immediately contact your doctor if you experience hallucinations, changes in behavior, or signs of mood changes, including 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 in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. 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 teens. They may require regular growth checks. Different brands of this medication may be approved for use in different age groups. Consult your doctor before giving this medication to a child.
Alcohol Consumption
Discuss alcohol consumption with your doctor before drinking while taking this medication.
Pregnancy
If you are pregnant or plan to become pregnant, consult your doctor to discuss the benefits and risks of using this medication during pregnancy.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities 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 can lead to tolerance, where the medication may not work as well, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Monitoring and Tests
You may need to undergo heart tests before starting this medication. If you have 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 with Other Medications and Lab Tests
This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this medication. Do not take antacids with this medication.
Mental and Mood Changes
New or worsening behavior and mood changes, such as altered thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Immediately contact your doctor if you experience hallucinations, changes in behavior, or signs of mood changes, including 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 in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. 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 teens. They may require regular growth checks. Different brands of this medication may be approved for use in different age groups. Consult your doctor before giving this medication to a child.
Alcohol Consumption
Discuss alcohol consumption with your doctor before drinking while taking this medication.
Pregnancy
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
- High fever
- Rhabdomyolysis
- Arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea
- Abdominal cramps
- Convulsions
- Coma
- Death
What to Do:
Call 911 or Poison Control (1-800-222-1222) immediately. Seek emergency medical attention. Management typically involves supportive care, gastric lavage, activated charcoal, and symptomatic treatment for agitation, hyperthermia, and cardiovascular effects.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
- Serotonin Syndrome-associated drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
Major Interactions
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - increase amphetamine levels and prolong half-life
- Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease amphetamine levels and shorten half-life
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects of amphetamines
- Antihypertensives - amphetamines may reduce the effectiveness of antihypertensives
- Halogenated Anesthetics - risk of arrhythmias
- Phenothiazines - may inhibit amphetamine effects
Moderate Interactions
- Antacids (e.g., magnesium hydroxide, aluminum hydroxide) - may increase absorption
- Proton Pump Inhibitors (PPIs) / H2 Blockers - may increase absorption
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may increase amphetamine exposure
- Adrenergic blockers (e.g., beta-blockers) - may potentiate pressor effects
- Antipsychotics - may antagonize 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
Rationale: Assess for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) that may be exacerbated.
Timing: Prior to initiation.
Cardiac History (ECG if indicated)
Rationale: Assess for structural cardiac abnormalities or other serious heart problems.
Timing: Prior to initiation, especially if family history of sudden cardiac death or known cardiac issues.
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.
Action Threshold: Persistent elevation requiring intervention or dose adjustment.
Height and Weight
Frequency: Every 3-6 months (pediatric).
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss.
Psychiatric Status
Frequency: At each visit.
Target: Stable mood, absence of psychotic symptoms, aggression, or suicidal ideation.
Action Threshold: Emergence or worsening of psychiatric symptoms.
Abuse Potential
Frequency: At each visit.
Target: No signs of drug-seeking behavior or misuse.
Action Threshold: Evidence of misuse, abuse, or diversion.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- New or worsening psychotic symptoms (e.g., hallucinations, delusions)
- Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
- Anxiety
- Insomnia
- Anorexia/weight loss
- Tics or dyskinesias
- Peripheral vasculopathy (e.g., Raynaud's phenomenon)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal harm, including premature delivery and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremor, hypertonia, feeding difficulty) 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 and persistent pulmonary hypertension of the newborn.
Lactation
L4 (Potentially Hazardous). Amphetamines are excreted into breast milk and can cause serious adverse reactions in a breastfed infant (e.g., irritability, poor feeding, insomnia, weight loss, cardiovascular effects). Breastfeeding is generally not recommended.
Infant Risk:
High risk of adverse effects; monitor for irritability, poor feeding, insomnia, weight loss, and cardiovascular effects.
Pediatric Use
Use in children under 3 years for ADHD is not recommended. Growth suppression (weight and height) has been reported; monitor growth regularly. Psychiatric adverse events (e.g., psychosis, mania, aggression) can occur. Cardiovascular monitoring is essential.
Geriatric Use
Use with caution due to increased sensitivity to sympathomimetic effects, particularly cardiovascular effects. Start with lower doses and titrate slowly. Monitor for hypertension, tachycardia, and psychiatric symptoms.
Clinical Information
Clinical Pearls
- Amphetamine salt combo is a mixture of four amphetamine salts, providing both immediate and sustained release characteristics (even in IR formulations due to different salt forms).
- Dosing is highly individualized; start low and titrate slowly based on patient response and tolerability.
- Educate patients and caregivers about the high abuse potential and the importance of secure storage.
- Monitor for cardiovascular changes (BP, HR) and psychiatric symptoms (e.g., aggression, psychosis, mania) at every visit.
- For pediatric patients, regular monitoring of height and weight is crucial due to the risk of growth suppression.
- Avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., extreme fatigue, depression).
- Urinary pH significantly affects elimination; acidifying agents decrease half-life, while alkalinizing agents increase it.
Alternative Therapies
- Methylphenidate (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 (5mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, 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. 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, don't hesitate to discuss them 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 quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. 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, don't hesitate to discuss them 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 quantity, and the time it occurred.