D-Amphetamine Salt Combo 20mg 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 (CNS) Stimulant
Pharmacologic Class
Sympathomimetic Amine
Pregnancy 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.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. However, be sure to take your last dose of the day at least 4 hours before bedtime to minimize any potential disruptions to your sleep.
Before using any over-the-counter (OTC) products, consult with your doctor, especially if they may increase your blood pressure. These products include cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, and certain natural products or aids.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. If you're unsure about the best way to dispose of your medication, consult with your pharmacist, who may be aware of 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's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. However, be sure to take your last dose of the day at least 4 hours before bedtime to minimize any potential disruptions to your sleep.
Before using any over-the-counter (OTC) products, consult with your doctor, especially if they may increase your blood pressure. These products include cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, and certain natural products or aids.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. If you're unsure about the best way to dispose of your medication, consult with your pharmacist, who may be aware of 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'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, or more often than prescribed.
- Avoid taking doses late in the day to prevent sleep problems (insomnia).
- Avoid alcohol consumption while taking this medication.
- Store this medication in a secure place to prevent misuse or abuse.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Maintain a healthy diet and regular exercise, especially for children, to support overall health and growth.
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. May increase by 5 mg weekly. For Narcolepsy: Initial 10 mg daily. May increase by 10 mg weekly.
Dose Range:
5 - 60 mg
Condition-Specific Dosing:
ADHD:
Max 40 mg/day, typically divided doses.
Narcolepsy:
Max 60 mg/day, typically divided doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For ADHD (6-12 years): Initial 5 mg once or twice daily. May increase by 5 mg weekly. Max 30 mg/day.
Adolescent:
For ADHD (13-17 years): Initial 10 mg once daily. May increase by 10 mg weekly. Max 40 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment guidelines; monitor for adverse effects.
Moderate:
No specific dose adjustment guidelines; monitor for adverse effects.
Severe:
Consider lower doses or extended dosing intervals (CrCl < 30 mL/min).
Dialysis:
Not dialyzable; use with caution and monitor closely.
Hepatic Impairment:
Mild:
No specific dose adjustment guidelines; use with caution.
Moderate:
No specific dose adjustment guidelines; use with caution.
Severe:
No specific dose adjustment guidelines; use with caution and monitor closely.
Pharmacology
Mechanism of Action
Amphetamines are non-catecholamine sympathomimetic amines that exert their therapeutic effect by releasing norepinephrine and dopamine from presynaptic nerve terminals in the brain, particularly in the cortex and subcortical structures. They also inhibit the reuptake of these neurotransmitters, leading to increased extracellular levels.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (d-amphetamine) and 50% (l-amphetamine)
Tmax:
2-3 hours (immediate release)
FoodEffect:
Food can delay Tmax but does not significantly affect AUC. Acidifying agents (e.g., fruit juice) can decrease absorption, while alkalinizing agents can increase absorption.
Distribution:
Vd:
3-5 L/kg
ProteinBinding:
15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
d-amphetamine: 10-13 hours; l-amphetamine: 11-14 hours (highly dependent on urine pH)
Clearance:
Primarily renal excretion; clearance is pH-dependent.
ExcretionRoute:
Renal (urine)
Unchanged:
30-50% (highly dependent on urine pH; increased in acidic urine, decreased in alkaline urine)
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
2-3 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
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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Erectile dysfunction or changes in sex interest
Seizures
Uncontrolled body movements
Uncontrolled vocalizations (e.g., humming, throat clearing, yelling, or making loud noises)
Restlessness
Changes in vision
Prolonged or frequent erections
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold sensations in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Sudden death has occurred in people with pre-existing heart problems or defects; if you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor and seek medical help immediately if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Feeling nervous or excitable
Headache
Sleep disturbances
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Dizziness, fatigue, or weakness
Dry mouth
Unpleasant taste
* Weight loss
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Erectile dysfunction or changes in sex interest
Seizures
Uncontrolled body movements
Uncontrolled vocalizations (e.g., humming, throat clearing, yelling, or making loud noises)
Restlessness
Changes in vision
Prolonged or frequent erections
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold sensations in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Sudden death has occurred in people with pre-existing heart problems or defects; if you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor and seek medical help immediately if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Feeling nervous or excitable
Headache
Sleep disturbances
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Dizziness, fatigue, or weakness
Dry mouth
Unpleasant taste
* Weight loss
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (signs of heart problems)
- Numbness, pain, skin color change (pale, blue, or red), or unexplained wounds on fingers or toes (signs of circulation problems)
- New or worsening mental problems, such as seeing or hearing things that are not real (hallucinations), believing things that are not true (paranoia), or new mania (overly excited mood and activity)
- New or worsening aggressive behavior or hostility
- New or worsening tics (uncontrolled repetitive movements or sounds)
- Seizures
- Blurred vision
- Unexplained weight loss
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 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 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 first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.
When you first start taking this medication, be cautious when driving or performing tasks that require alertness and clear vision, as it may affect your ability to do so. Wait until you understand how this medication affects you before engaging in such activities.
Long-term or high-dose use of this medication can lead to tolerance, where the medication becomes less effective, and you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can lead to adverse effects.
Prolonged or regular use of this medication may cause dependence, and stopping it abruptly can lead to withdrawal symptoms. If you need to reduce the dose or stop taking this medication, consult your doctor, and follow their instructions carefully. Report any adverse effects to your doctor promptly.
Before starting this medication, you may need to undergo heart tests to ensure your safety. If you have any questions or concerns, discuss them with your doctor.
This medication may cause an increase in blood pressure. Monitor your blood pressure and heart rate as directed by your doctor. Additionally, follow your doctor's instructions for regular blood work to ensure your safety while taking this medication.
It is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests. Do not take antacids while using this medication, as they may interact with it.
Be aware that this medication may cause changes in behavior and mood, such as altered thinking, anger, and hallucinations. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
A rare but potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience symptoms such as agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary. Different brands of this medication may be suitable for different age groups, so consult your doctor before giving this medication to a child.
Before consuming alcohol while taking this medication, discuss the potential risks and benefits with your doctor. If you are pregnant or plan to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
When you first start taking this medication, be cautious when driving or performing tasks that require alertness and clear vision, as it may affect your ability to do so. Wait until you understand how this medication affects you before engaging in such activities.
Long-term or high-dose use of this medication can lead to tolerance, where the medication becomes less effective, and you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can lead to adverse effects.
Prolonged or regular use of this medication may cause dependence, and stopping it abruptly can lead to withdrawal symptoms. If you need to reduce the dose or stop taking this medication, consult your doctor, and follow their instructions carefully. Report any adverse effects to your doctor promptly.
Before starting this medication, you may need to undergo heart tests to ensure your safety. If you have any questions or concerns, discuss them with your doctor.
This medication may cause an increase in blood pressure. Monitor your blood pressure and heart rate as directed by your doctor. Additionally, follow your doctor's instructions for regular blood work to ensure your safety while taking this medication.
It is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests. Do not take antacids while using this medication, as they may interact with it.
Be aware that this medication may cause changes in behavior and mood, such as altered thinking, anger, and hallucinations. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
A rare but potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience symptoms such as agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary. Different brands of this medication may be suitable for different age groups, so consult your doctor before giving this medication to a child.
Before consuming alcohol while taking this medication, discuss the potential risks and benefits with your doctor. If you are pregnant or plan to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia (overactive reflexes)
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- Hyperpyrexia (very high fever)
- Rhabdomyolysis (muscle breakdown)
- Arrhythmias (irregular heartbeat)
- Hypertension (high blood pressure) or hypotension (low blood pressure)
- Circulatory collapse
- Nausea, vomiting, diarrhea, abdominal cramps
- Convulsions (seizures)
- Coma
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the U.S.). Treatment is supportive and may include gastric lavage, activated charcoal, sedation (e.g., benzodiazepines), external cooling for hyperthermia, and management of cardiovascular symptoms.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use) - risk of hypertensive crisis, serotonin syndrome.
- Linezolid
- Methylene blue (intravenous)
Major Interactions
- Acidifying agents (e.g., ascorbic acid, ammonium chloride, fruit juices) - decrease amphetamine absorption and increase excretion.
- Alkalinizing agents (e.g., sodium bicarbonate, antacids, acetazolamide) - increase amphetamine absorption and decrease excretion.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
- Antihypertensives - amphetamines may counteract their effects.
- Vasopressors - potentiate vasopressor effects.
- Halogenated anesthetics - increased risk of arrhythmias.
Moderate Interactions
- CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure and risk of adverse effects.
- Phenytoin, Phenobarbital - may alter metabolism of these drugs.
- Antipsychotics (e.g., chlorpromazine, haloperidol) - may antagonize stimulant effects.
Minor Interactions
- Not typically categorized as minor for amphetamines; focus on major and contraindicated interactions due to safety profile.
Monitoring
Baseline Monitoring
Blood pressure and heart rate
Rationale: To assess baseline cardiovascular status and identify pre-existing conditions that may contraindicate use or require close monitoring.
Timing: Prior to initiation of therapy.
Height and weight (especially in pediatric patients)
Rationale: To establish baseline growth parameters and monitor for potential growth suppression.
Timing: Prior to initiation of therapy.
Psychiatric history (e.g., bipolar disorder, psychosis, tics, anxiety)
Rationale: To identify risk factors for psychiatric adverse events or exacerbation of underlying conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood pressure and heart rate
Frequency: At each visit, or at least every 3-6 months.
Target: Within normal limits for age and individual baseline.
Action Threshold: Sustained elevation (e.g., >10-20 mmHg increase in BP, >10-20 bpm increase in HR) or symptoms of cardiovascular distress.
Height and weight (pediatric patients)
Frequency: Every 3-6 months.
Target: Normal growth curve progression.
Action Threshold: Significant deviation from expected growth curve or unexplained weight loss.
Mental status and behavioral changes
Frequency: At each visit.
Target: Stable mood, improved ADHD symptoms, absence of new or worsening psychiatric symptoms.
Action Threshold: Emergence of new psychotic symptoms (e.g., hallucinations, paranoia), manic symptoms, severe anxiety, aggression, or tics.
ADHD symptom control and functional improvement
Frequency: At each visit.
Target: Improved attention, reduced impulsivity/hyperactivity, improved academic/social functioning.
Action Threshold: Lack of efficacy or worsening of symptoms.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Fainting (syncope)
- Numbness, pain, skin color change, or unexplained wounds on fingers or toes (Raynaud's phenomenon)
- New or worsening mental problems (e.g., hallucinations, paranoia, mania, aggression)
- New or worsening tics
- Seizures
- Blurred vision
- Unexplained weight loss
Special Patient Groups
Pregnancy
Generally not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus. Amphetamines cross the placenta.
Trimester-Specific Risks:
First Trimester:
Limited data on congenital malformations; some studies suggest a possible increased risk of cardiac defects.
Second Trimester:
Increased risk of premature birth and low birth weight.
Third Trimester:
Increased risk of premature birth, low birth weight, and neonatal withdrawal syndrome (e.g., agitation, feeding difficulties, tremor, hypertonia, drowsiness) if used near term.
Lactation
Not recommended. Amphetamines are excreted into breast milk and can cause serious adverse reactions in a breastfed infant.
Infant Risk:
Moderate to High. Potential for irritability, poor feeding, sleep disturbances, weight loss, and cardiovascular effects in the infant.
Pediatric Use
Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, tics). Use with caution in children under 6 years as safety and efficacy are not established.
Geriatric Use
Use with caution due to increased sensitivity to sympathomimetic effects and higher risk of cardiovascular adverse events. Start with lower doses and titrate slowly. Monitor cardiovascular status closely.
Clinical Information
Clinical Pearls
- Amphetamines have a high potential for abuse and dependence. Prescribe and dispense with caution.
- Regularly monitor blood pressure and heart rate, especially at baseline and during dose titration.
- Monitor growth parameters (height and weight) in pediatric patients due to potential for growth suppression.
- Assess for pre-existing cardiac conditions or family history of sudden cardiac death before initiating therapy.
- Can unmask or exacerbate underlying psychiatric conditions, including psychosis, bipolar disorder, and tics. Discontinue if new psychiatric symptoms emerge.
- Avoid abrupt discontinuation 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.
- Educate patients and caregivers on proper storage to prevent diversion and accidental ingestion.
Alternative Therapies
- Atomoxetine (Strattera) - non-stimulant
- Guanfacine extended-release (Intuniv) - non-stimulant
- Clonidine extended-release (Kapvay) - non-stimulant
- Bupropion (Wellbutrin) - antidepressant with some stimulant properties
Cost & Coverage
Average Cost:
$30 - $100+ per 30 tablets (generic 20mg IR)
Generic Available:
Yes
Insurance Coverage:
Generic formulations are typically covered as Tier 1 or Tier 2. Brand-name Adderall may be Tier 3 or 4, or require prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 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, we encourage you 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.