Dextroamphetamine 10mg Tablets

Dextroamphetamine is a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The exact mechanism of action in ADHD and narcolepsy is not fully understood but is believed to involve the activation of brainstem arousal systems and the cerebral cortex.

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 notice 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
Restlessness
Shakiness
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in eyesight or eye pain, swelling, or redness
Erectile dysfunction
Decreased sex interest
Seizures
Stomach pain
Muscle pain or weakness, dark urine, or trouble passing urine
Frequent or prolonged erections
Changes in skin color, such as pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in hands or feet
Sores or wounds on fingers or toes

Important Heart-Related Warnings

If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek 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

Serotonin Syndrome: A Potentially Life-Threatening Condition

Taking this medication with certain other drugs can increase the risk of serotonin syndrome, a severe and potentially deadly condition. If you experience any of the following symptoms, contact your doctor right away:

Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache

Other Possible Side Effects

While many people may not experience side effects or only have minor ones, it's essential to be aware of the following potential side effects:

Dizziness or headache
Dry mouth
Trouble sleeping
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Bad taste in mouth
Feeling nervous and excitable
Hair loss

If you're concerned about any side effects or have questions, 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.

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 you experienced, including the symptoms that occurred.
If you or a family member has 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
If you have been diagnosed with any of the following health conditions:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have a history of:
+ Drug abuse
+ Stroke
If you are currently taking or have recently taken certain medications, including:
+ Acetazolamide or sodium bicarbonate
+ Antidepressant 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 breastfeeding, as you should not breastfeed 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.

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

Caution When Performing Daily Activities

Until you know how this medication affects you, avoid driving and engaging in other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.

Tolerance and Dependence

If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means that the medication may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. However, do not take more than the prescribed dose. Additionally, long-term or regular use of this medication can lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this may cause withdrawal symptoms. Instead, consult your doctor, who will provide guidance on how to safely taper off the medication.

Monitoring Your Health

Before starting this medication, you may need to undergo certain heart tests. If you have any questions or concerns, be sure to discuss them with your doctor. Additionally, this medication may cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor. If you experience severe headache, dizziness, fainting, or changes in vision, seek medical attention immediately.

Interactions with Other Medications

Certain over-the-counter (OTC) products, such as cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, may interact with this medication and increase your blood pressure. Before taking any of these products, consult your doctor.

Lab Tests and Seizure Risk

This medication may affect certain lab tests, so it is essential to inform all of your healthcare providers and lab workers that you are taking this medication. Additionally, this medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. If you have a history of seizures or are concerned about your risk, discuss this with your doctor.

Mental Health and Mood Changes

In some cases, this medication may cause changes in behavior and mood, including hallucinations, anger, and depression. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience any unusual changes in your mood or behavior, such as hallucinations, changes in thinking, or thoughts of suicide, seek medical attention immediately.

Growth and Development in Children and Teens

This medication may affect growth in children and teens. If you are a parent or caregiver, be sure to discuss this with your doctor, who may recommend regular growth checks.

Pregnancy and Breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor, who will discuss the benefits and risks of taking this medication during pregnancy.

• Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
• Linezolid (reversible MAOI activity)
• Methylene blue (reversible MAOI activity)

• Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
• Antihypertensives - may reduce hypotensive effect
• Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase dextroamphetamine levels and prolong half-life
• Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease dextroamphetamine levels and shorten half-life
• Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
• Propoxyphene - risk of seizures and psychosis
• Alcohol - may increase CNS adverse effects

• Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of dextroamphetamine
• Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase dextroamphetamine absorption/levels
• Antacids containing magnesium or aluminum - may increase dextroamphetamine absorption
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may increase dextroamphetamine levels
• Adrenergic blockers (e.g., beta-blockers) - may exacerbate hypertension

• Not available

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hallucinations
• Delusions
• Mania
• Severe anxiety
• Unexplained weight loss
• Insomnia
• Tics or dyskinesias
• Peripheral vasculopathy (e.g., Raynaud's phenomenon)

Category C. Dextroamphetamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal growth restriction and premature birth. Withdrawal symptoms (e.g., agitation, irritability, lethargy, poor feeding) have been reported in neonates born to mothers who used amphetamines chronically during pregnancy.

Dextroamphetamine is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, insomnia, weight loss, cardiovascular effects), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The American Academy of Pediatrics considers amphetamines to be a drug for which the effect on the nursing infant is unknown but may be of concern.

Safety and efficacy have been established in pediatric patients 6 years and older for ADHD and narcolepsy. Long-term effects on growth and weight should be monitored. Psychiatric adverse events (e.g., psychosis, mania) and cardiovascular events can occur. Use with caution in children with pre-existing cardiac conditions or family history of sudden cardiac death.

Clinical studies of dextroamphetamine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may be more sensitive to the cardiovascular and CNS stimulant effects.

• Amphetamines have a high potential for abuse and dependence; careful patient selection and monitoring are crucial.
• Monitor cardiovascular parameters (BP, HR) regularly due to risk of hypertension and tachycardia.
• Monitor growth and weight in pediatric patients due to risk of growth suppression.
• Assess for new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression) and tics.
• Avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., severe fatigue, depression).
• Educate patients on proper storage to prevent diversion and accidental ingestion.
• Urinary pH significantly affects elimination; avoid concurrent use with urinary alkalinizers (e.g., sodium bicarbonate) which can increase amphetamine levels and toxicity.

• Methylphenidate (Ritalin, Concerta, Focalin)
• Atomoxetine (Strattera)
• Guanfacine (Intuniv)
• Clonidine (Kapvay)
• Bupropion (Wellbutrin - off-label for ADHD)
• Modafinil/Armodafinil (for narcolepsy)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred, as this information will be crucial in determining the best course of action.