D-Amphetamine Salt Combo 12.5mg Tb
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
Not available
FDA Approved
Feb 1996
DEA Schedule
Schedule II
Overview
What is this medicine?
This medication is a stimulant that works in your brain to help improve focus, attention, and control over impulsive behavior. It's used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. It helps balance certain natural chemicals in your brain.
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 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 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.
- Avoid alcohol, as it can increase side effects.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Monitor your heart rate and blood pressure regularly as advised by your doctor.
- Report any new or worsening mental health symptoms (e.g., anxiety, agitation, hallucinations) immediately.
- Report any signs of heart problems (e.g., chest pain, shortness of breath, fainting) immediately.
- Maintain a healthy diet and monitor weight, especially in children, due to potential appetite suppression.
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:
Initial: 5 mg once or twice daily. Titrate in 5 mg increments weekly. Max: 40 mg/day.
Dose Range:
5 - 40 mg
Condition-Specific Dosing:
ADHD:
Initial 5 mg once or twice daily, titrate weekly by 5 mg to optimal response. Max 40 mg/day.
Narcolepsy:
Initial 10 mg daily, titrate weekly by 10 mg. Max 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, titrate weekly by 5 mg to optimal response. Max 30 mg/day.
Adolescent:
ADHD (13-17 years): Initial 10 mg once daily, titrate weekly by 10 mg to optimal response. Max 40 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
Consider lower starting dose and slower titration.
Moderate:
Consider lower starting dose and slower titration.
Severe:
Use with caution; consider lower doses and extended dosing intervals. Specific guidelines not well-established.
Dialysis:
Not well-studied; use with extreme caution. Amphetamines are not significantly removed by dialysis.
Hepatic Impairment:
Mild:
Adjustment not typically required.
Moderate:
Adjustment not typically required.
Severe:
Adjustment not typically required.
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:
Approximately 3 hours (for immediate-release)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
Approximately 3.5-4.5 L/kg
ProteinBinding:
Approximately 15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Amphetamine: 9-11 hours (pH-dependent)
Clearance:
Highly variable, pH-dependent
ExcretionRoute:
Renal (primarily)
Unchanged:
Approximately 30-50% (highly dependent on urine pH; increased in acidic urine, decreased in alkaline urine)
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. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you 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 or 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 or pelvic pain
Other severe side effects, including:
+ Erectile dysfunction
+ 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 Warnings
If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify 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 Possible Side Effects
While many people may not experience side effects or only have minor side effects, it's essential to be aware of the following:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in your mouth
Weight loss
If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor for guidance. 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 or 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 or pelvic pain
Other severe side effects, including:
+ Erectile dysfunction
+ 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 Warnings
If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify 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 Possible Side Effects
While many people may not experience side effects or only have minor side effects, it's essential to be aware of the following:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in your mouth
Weight loss
If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor for guidance. 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 spells
- New or worsening aggression or hostility
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- New or worsening tics (uncontrolled movements or sounds)
- Unexplained numbness, pain, or discoloration in fingers or toes
- Severe headache
- Blurred vision
- 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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past medical history, including:
+ Drug abuse
+ Stroke
Kidney disease
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
* Breast-feeding status: Do not breast-feed while taking this medication.
This list is not exhaustive. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past medical history, including:
+ Drug abuse
+ Stroke
Kidney disease
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
* Breast-feeding status: Do not breast-feed while taking this medication.
This list is not exhaustive. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may need higher doses to achieve the same effect. This is known as tolerance. If you notice that the medication is not working as well as it should, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of this medication may lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully. Report any adverse effects to your doctor.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions or concerns, discuss them with your doctor. This medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you will need to have regular blood work done as instructed 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 Health and Mood Changes
New or worsening behavior and mood changes, such as changes in 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. Contact your doctor immediately 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 severe and 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 problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Growth Effects 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, so 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 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.
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 performing tasks that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may need higher doses to achieve the same effect. This is known as tolerance. If you notice that the medication is not working as well as it should, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of this medication may lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully. Report any adverse effects to your doctor.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions or concerns, discuss them with your doctor. This medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you will need to have regular blood work done as instructed 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 Health and Mood Changes
New or worsening behavior and mood changes, such as changes in 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. Contact your doctor immediately 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 severe and 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 problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Growth Effects 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, so 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 and Breastfeeding
If you are pregnant or plan to become pregnant, consult your doctor to discuss the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- Hyperpyrexia
- Rhabdomyolysis
- Cardiac arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea
- Vomiting
- Diarrhea
- Abdominal cramps
- Convulsions
- Coma
- Death
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis)
- Linezolid (MAOI activity)
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Antihypertensives (may counteract effects)
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase amphetamine excretion, decrease efficacy
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - decrease amphetamine excretion, increase efficacy/toxicity
- Proton Pump Inhibitors (PPIs) and H2 blockers (may increase absorption and exposure)
- Alcohol (additive CNS effects, increased risk of cardiovascular events)
Moderate Interactions
- Antipsychotics (may antagonize stimulant effects)
- Antidepressants (TCAs, bupropion - may increase cardiovascular risk)
- Opioids (potential for additive CNS depression or paradoxical effects)
- Caffeine and other stimulants (additive stimulant effects, increased risk of adverse events)
- CYP2D6 inhibitors (e.g., quinidine, paroxetine, fluoxetine, ritonavir) - may increase amphetamine exposure
Minor Interactions
- Not specifically categorized as minor, but general caution with any CNS active agents.
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 and weight loss in all patients.
Timing: Prior to initiation.
Psychiatric History (including family history of suicide, bipolar disorder, psychosis)
Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new psychotic/manic symptoms.
Timing: Prior to initiation.
Cardiac History (including family history of sudden cardiac death or arrhythmias)
Rationale: Risk of serious cardiovascular events.
Timing: Prior to initiation.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or every 3-6 months.
Target: Within normal limits for age/patient.
Action Threshold: Sustained elevation (e.g., >95th percentile for age/sex/height or significant increase from baseline) warrants investigation and potential dose adjustment/discontinuation.
Weight and Height (pediatric)
Frequency: Every 3-6 months.
Target: Consistent growth trajectory.
Action Threshold: Significant deviation from expected growth curve warrants investigation and potential drug holiday or alternative therapy.
Psychiatric Status (mood, anxiety, psychotic symptoms, tics)
Frequency: At each visit.
Target: Stable, absence of new or worsening symptoms.
Action Threshold: Emergence of new psychotic symptoms, severe anxiety, agitation, or tics warrants immediate evaluation and potential discontinuation.
ADHD Symptom Control and Functional Improvement
Frequency: At each visit.
Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning.
Action Threshold: Lack of efficacy or intolerable side effects warrants dose adjustment or change in therapy.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hostility
- Psychotic symptoms (hallucinations, delusions)
- Manic symptoms (euphoria, grandiosity, decreased need for sleep)
- Severe anxiety
- Agitation
- Depression
- Tics or dyskinesias
- Unexplained weight loss
- Sleep disturbances
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal harm, 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 increased risk of congenital malformations not definitively established.
Second Trimester:
Potential for growth restriction and adverse pregnancy 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 human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, anorexia, reduced weight gain, cardiovascular effects), breastfeeding is not recommended during treatment.
Infant Risk:
Moderate to High (L3-L4) - potential for irritability, poor feeding, sleep disturbances, and cardiovascular effects in the infant.
Pediatric Use
Closely monitor growth (height and weight) and cardiovascular parameters. Assess for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics). Long-term safety and efficacy in children under 6 years have not been established for ADHD.
Geriatric Use
Use with caution due to increased sensitivity to sympathomimetic effects and higher prevalence of cardiovascular disease. Consider lower starting doses and slower titration. Monitor cardiovascular status closely.
Clinical Information
Clinical Pearls
- Amphetamine salts are highly effective but carry significant risks of abuse, dependence, and cardiovascular/psychiatric adverse events.
- Careful patient selection and thorough baseline assessment (cardiac, psychiatric history) are crucial.
- Regular monitoring of blood pressure, heart rate, and weight (especially in children) is essential.
- Educate patients and caregivers on potential side effects, signs of abuse, and the importance of adherence.
- Consider drug holidays or dose adjustments if growth suppression or significant side effects occur.
- Avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., severe fatigue, depression).
Alternative Therapies
- Methylphenidate (Ritalin, Concerta, Focalin, Daytrana)
- Lisdexamfetamine (Vyvanse)
- Dexmethylphenidate (Focalin)
- Non-stimulants: Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay), Viloxazine (Qelbree)
- Behavioral therapy, psychotherapy
Cost & Coverage
Average Cost:
$20 - $60 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (generic)
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, which provides crucial information for patients. 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 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.