D-Amphetamine Salt Combo 7.5mg 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.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your last dose of the day at least 4 hours before bedtime to minimize 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
+ Certain natural products or aids
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, away from bathrooms.
Store all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your pharmacist for guidance on the best disposal methods, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your last dose of the day at least 4 hours before bedtime to minimize 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
+ Certain natural products or aids
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, away from bathrooms.
Store all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your pharmacist for guidance on the best disposal methods, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed by your doctor. Do not take more or less, or more often than prescribed.
- Do not stop taking this medication suddenly without talking to your doctor, as withdrawal symptoms can occur.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Avoid alcohol while taking this medication.
- Monitor your heart rate and blood pressure regularly as advised by your doctor.
- Maintain a healthy diet and ensure adequate sleep, as this medication can affect appetite and sleep patterns.
- Store in a safe place to prevent misuse or abuse.
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 in divided doses.
Dose Range:
5 - 60 mg
Condition-Specific Dosing:
ADHD:
Initial 5 mg once or twice daily; titrate weekly in 5 mg increments to optimal response. Max 40 mg/day.
Narcolepsy:
Initial 10 mg daily in divided doses; titrate weekly in 10 mg increments. Max 60 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
ADHD (3-5 years): Initial 2.5 mg daily; titrate weekly in 2.5 mg increments. Max 40 mg/day. ADHD (6-12 years): Initial 5 mg once or twice daily; titrate weekly in 5 mg increments. Max 40 mg/day.
Adolescent:
ADHD (13-17 years): Initial 10 mg daily; titrate weekly in 10 mg increments. Max 40 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
Consider lower initial doses and slower titration.
Moderate:
Consider lower initial doses and slower titration; monitor for adverse effects.
Severe:
Use with caution; consider significant dose reduction or avoidance. Not recommended for ESRD.
Dialysis:
Not recommended; significant portion excreted unchanged.
Hepatic Impairment:
Mild:
No specific guidelines; monitor for increased effects.
Moderate:
No specific guidelines; monitor for increased effects.
Severe:
No specific guidelines; monitor for increased effects. Use with caution.
Pharmacology
Mechanism of Action
Amphetamine and dextroamphetamine 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:
High (approximately 75% for dextroamphetamine, 73% for amphetamine)
Tmax:
2-4 hours (immediate release)
FoodEffect:
Food can delay Tmax but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
3-5 L/kg
ProteinBinding:
Low (15-26%)
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Amphetamine: 9-11 hours (highly dependent on urine pH)
Clearance:
Highly dependent on urine pH; increased in acidic urine, decreased in alkaline urine.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-50% excreted unchanged in urine; up to 70% in acidic urine.
Pharmacodynamics
OnsetOfAction:
30-60 minutes (immediate release)
PeakEffect:
2-4 hours
DurationOfAction:
4-6 hours (immediate release)
Confidence:
High
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 pass urine
+ Fever
+ Lower stomach pain or pelvic pain
Other severe side effects, including:
+ Difficulty getting or maintaining an erection
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
+ Restlessness
+ Changes in eyesight
+ Prolonged or frequent erections
+ Changes in skin color, such as pale, blue, gray, purple, or red discoloration
+ Numbness, pain, tingling, or cold feeling in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or trouble passing urine
Important Heart-Related Warnings
If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Other Possible Side Effects
Most people do not experience severe side effects, and many have only minor or no side effects at all. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in your mouth
Weight loss
Reporting Side Effects
If you have questions about side effects or want to report any side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention 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 pass urine
+ Fever
+ Lower stomach pain or pelvic pain
Other severe side effects, including:
+ Difficulty getting or maintaining an erection
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
+ Restlessness
+ Changes in eyesight
+ Prolonged or frequent erections
+ Changes in skin color, such as pale, blue, gray, purple, or red discoloration
+ Numbness, pain, tingling, or cold feeling in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or trouble passing urine
Important Heart-Related Warnings
If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Other Possible Side Effects
Most people do not experience severe side effects, and many have only minor or no side effects at all. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in your mouth
Weight loss
Reporting Side Effects
If you have questions about side effects or want to report any side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain
- Shortness of breath
- Fainting spells
- Severe headache
- Numbness, coolness, or pain in fingers or toes
- Unexplained wounds on fingers or toes
- New or worsening aggression or hostility
- New or worsening agitation or restlessness
- Seeing or hearing things that are not real (hallucinations)
- Unusual thoughts or paranoia
- New or worsening tics (uncontrolled movements or sounds)
- Blurred vision or other vision changes
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial 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. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Existing health problems, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, such as:
+ Drug abuse
+ Stroke
Kidney disease
Current medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline), as they may cause 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 essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems 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 crucial 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. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Existing health problems, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, such as:
+ Drug abuse
+ Stroke
Kidney disease
Current medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline), as they may cause 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 essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems 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 Precautions
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and you may need higher doses to achieve the same effect. If you experience a decrease in the drug'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 result in 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. Your doctor may also order blood tests to monitor your condition.
Potential Side Effects
This medication may cause high blood pressure. Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.
Interactions with Other Medications
Do not take antacids with this medication.
Mental Health 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 disorders, such as depression or bipolar illness, 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 drugs. Seek immediate medical attention if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and 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 Use
Discuss alcohol consumption with your doctor before using this medication.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, consult your doctor to discuss the benefits and risks of using this medication during pregnancy.
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and you may need higher doses to achieve the same effect. If you experience a decrease in the drug'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 result in 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. Your doctor may also order blood tests to monitor your condition.
Potential Side Effects
This medication may cause high blood pressure. Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.
Interactions with Other Medications
Do not take antacids with this medication.
Mental Health 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 disorders, such as depression or bipolar illness, 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 drugs. Seek immediate medical attention if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and 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 Use
Discuss alcohol consumption with your doctor before using this medication.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, consult your doctor to discuss the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia (overactive reflexes)
- Rapid breathing
- Confusion
- Hallucinations
- Panic states
- Hyperpyrexia (very high fever)
- Rhabdomyolysis (muscle breakdown)
- Arrhythmias (irregular heartbeat)
- Hypertension (high blood pressure) or Hypotension (low blood pressure)
- Circulatory collapse
- Convulsions (seizures)
- Coma
What to Do:
In case of suspected overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
- Serotonergic 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 blood levels and prolong half-life
- Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease amphetamine blood levels and shorten half-life
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects of amphetamines
- Antihypertensives - amphetamines may antagonize the hypotensive effects
- Halogenated Anesthetics - increased risk of arrhythmias
Moderate Interactions
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines
- Lithium - may inhibit the stimulant effects of amphetamines
- Opioids - additive CNS depression (if used for sedation)
- Alcohol - may increase CNS adverse effects
- CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure
Minor Interactions
- Antihistamines - may cause additive sedation (if sedating antihistamines)
- Proton Pump Inhibitors (PPIs) / H2 Blockers - may slightly increase amphetamine absorption due to gastric pH changes
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).
Timing: Prior to initiation and periodically during treatment.
Height and Weight
Rationale: Risk of growth suppression in pediatric patients.
Timing: Prior to initiation and periodically during treatment (especially in children).
Psychiatric History and Status
Rationale: Risk of new or worsening psychiatric symptoms (psychosis, mania, aggression).
Timing: Prior to initiation and periodically during treatment.
ECG (Electrocardiogram)
Rationale: Consider for patients with pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.
Timing: Prior to initiation (if indicated).
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Every 3-6 months or at each visit, more frequently if clinically indicated.
Target: Within normal limits for age and clinical status.
Action Threshold: Persistent elevation (e.g., >95th percentile for age/sex/height or significant increase from baseline); consider dose reduction or discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric patients); annually (adults).
Target: Normal growth trajectory (pediatric); stable weight (adult).
Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative treatment.
Psychiatric Status (e.g., mood, anxiety, agitation, tics, psychosis)
Frequency: At each visit.
Target: Stable or improved psychiatric symptoms.
Action Threshold: Emergence of new or worsening psychiatric symptoms (e.g., hallucinations, paranoia, mania, severe agitation, tics); consider dose adjustment or discontinuation.
Peripheral Vasculopathy (e.g., Raynaud's phenomenon)
Frequency: Periodically, especially if symptoms reported.
Target: Absence of digital changes.
Action Threshold: New onset or worsening of digital changes (e.g., numbness, coolness, pain, skin color changes); consider discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Fainting
- Severe headache
- Numbness, coolness, or pain in fingers or toes
- Unexplained wounds on fingers or toes
- New or worsening aggression
- New or worsening agitation
- Hallucinations
- Paranoia
- Mania
- New or worsening tics
- Blurred vision
Special Patient Groups
Pregnancy
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Amphetamines may cause premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Limited data; some studies suggest a possible association with congenital malformations, but evidence is inconclusive.
Second Trimester:
Not well studied; potential for fetal growth restriction.
Third Trimester:
Risk of withdrawal symptoms in the neonate (e.g., agitation, tremor, feeding difficulties, respiratory distress) if exposed near term.
Lactation
Amphetamines are excreted into breast milk. Avoid breastfeeding or use with extreme caution. Monitor breastfed infants for signs of adverse effects such as irritability, sleep disturbances, poor feeding, or poor weight gain.
Infant Risk:
L3 (Moderately Safe) to L4 (Possibly Hazardous) - depends on dose and infant age. Potential for irritability, insomnia, poor feeding, and growth suppression in the infant.
Pediatric Use
Careful monitoring of growth (height and weight) is essential due to the risk of growth suppression. Monitor for cardiovascular effects (BP, HR) and psychiatric symptoms (e.g., new or worsening aggression, psychosis, mania, tics). Not recommended for children under 3 years of age for ADHD or under 6 years for narcolepsy.
Geriatric Use
Use with caution in elderly patients, generally starting at lower doses and titrating slowly, due to increased sensitivity to sympathomimetic effects and a higher prevalence of cardiovascular disease. Monitor closely for cardiovascular and psychiatric adverse events.
Clinical Information
Clinical Pearls
- Amphetamines have a high potential for abuse and dependence; assess patients for risk of abuse prior to prescribing and monitor for signs of abuse and dependence during treatment.
- Monitor growth in pediatric patients; consider drug holidays if growth suppression is observed.
- Perform a thorough cardiovascular assessment prior to initiation and monitor blood pressure and heart rate regularly.
- Assess for pre-existing psychiatric conditions and monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics).
- Avoid abrupt discontinuation, especially after prolonged high-dose therapy, to prevent withdrawal symptoms.
- Inform patients about the risk of peripheral vasculopathy, including Raynaud's phenomenon, and advise them to report any new numbness, coolness, or pain in fingers or toes.
Alternative Therapies
- Atomoxetine (Strattera)
- Guanfacine extended-release (Intuniv)
- Clonidine extended-release (Kapvay)
- Bupropion (Wellbutrin - off-label for ADHD)
Cost & Coverage
Average Cost:
$20 - $100+ per 30 tablets (generic 7.5mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for 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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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 detailed information, including the substance taken, the amount, and the time it occurred.