Aprodine 2.5mg-60mg Tablets
It is used to treat nose stuffiness.It is used to ease allergy signs.
Drug Class
Antihistamine and Decongestant Combination
Pharmacologic Class
H1-receptor antagonist (first-generation) & Alpha-adrenergic agonist
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aprodine is a combination medicine containing an antihistamine (triprolidine) and a decongestant (pseudoephedrine). It helps relieve symptoms like sneezing, runny nose, itchy eyes, and nasal congestion caused by allergies or the common cold.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also have access to drug take-back programs in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also have access to drug take-back programs in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness or dizziness.
- Avoid alcohol consumption while taking this medication, as it can increase drowsiness.
- Stay hydrated to help with dry mouth, a common side effect.
- Take the last dose several hours before bedtime if you experience insomnia or nervousness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 tablet (2.5 mg triprolidine / 60 mg pseudoephedrine) every 4 to 6 hours
Dose Range:
1 - 4 mg
Condition-Specific Dosing:
maximumDailyDose:
Do not exceed 4 tablets in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age for this strength
Adolescent:
1 tablet (2.5 mg triprolidine / 60 mg pseudoephedrine) every 4 to 6 hours (for ages 12 years and older), do not exceed 4 tablets in 24 hours
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required, but monitor for increased side effects.
Moderate:
Consider dose reduction (e.g., half dose) or extended dosing interval (e.g., every 6-8 hours) due to pseudoephedrine excretion.
Severe:
Use with caution; significant dose reduction or avoidance may be necessary. Consult product labeling.
Dialysis:
Pseudoephedrine is dialyzable. Avoid use or use with extreme caution and significant dose reduction. Consult nephrologist.
Hepatic Impairment:
Mild:
No specific adjustment typically required.
Moderate:
Use with caution; triprolidine is metabolized by the liver. Consider dose reduction or extended dosing interval.
Severe:
Use with caution; significant dose reduction or avoidance may be necessary. Consult product labeling.
Pharmacology
Mechanism of Action
Triprolidine is a first-generation antihistamine that competitively antagonizes H1-receptors, thereby preventing the effects of histamine (e.g., vasodilation, increased capillary permeability, pruritus, bronchoconstriction). It also possesses anticholinergic properties, contributing to its drying effects. Pseudoephedrine is a sympathomimetic amine that acts directly and indirectly on adrenergic receptors. It primarily acts on alpha-adrenergic receptors in the respiratory mucosa, causing vasoconstriction, which reduces swelling and congestion.
Pharmacokinetics
Absorption:
Bioavailability:
High (both components)
Tmax:
Triprolidine: 1-2 hours; Pseudoephedrine: 1-2 hours
FoodEffect:
Minimal effect on absorption, but may delay Tmax slightly.
Distribution:
Vd:
Triprolidine: ~2.5 L/kg; Pseudoephedrine: ~2.6 L/kg
ProteinBinding:
Triprolidine: ~80%; Pseudoephedrine: Minimal
CnssPenetration:
Yes (Triprolidine readily crosses BBB, Pseudoephedrine crosses to a lesser extent)
Elimination:
HalfLife:
Triprolidine: 3-5 hours; Pseudoephedrine: 4-8 hours (pH-dependent, shorter in acidic urine)
Clearance:
Not readily available for combination, varies by individual.
ExcretionRoute:
Triprolidine: Primarily renal (as metabolites); Pseudoephedrine: Primarily renal (largely unchanged)
Unchanged:
Triprolidine: <1%; Pseudoephedrine: 50-90%
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Many people have no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Feeling dizzy or sleepy
- Feeling nervous and excitable
- Trouble sleeping
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Many people have no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Feeling dizzy or sleepy
- Feeling nervous and excitable
- Trouble sleeping
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or lightheadedness
- Fast, pounding, or irregular heartbeat (palpitations)
- Severe nervousness, restlessness, or tremors
- Hallucinations or unusual thoughts/behavior
- Difficulty urinating
- Severe dry mouth or blurred vision
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Additionally, inform them about any health problems you have. This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Additionally, inform them about any health problems you have. This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than the prescribed amount can increase your risk of experiencing severe side effects. Additionally, do not take this medication for a longer duration than recommended by your doctor.
Until you are aware of how this medication affects you, it is crucial to avoid driving and engaging in other activities that require alertness. It is also recommended to abstain from consuming alcohol while taking this drug. Before using marijuana, other forms of cannabis, or any prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor to discuss potential interactions.
When administering this medication to a child, exercise caution, as children may have a higher risk of experiencing excitability. However, this medication may not be suitable for children of all ages, so it is vital to consult with your doctor before giving it to a child to determine the appropriate course of action.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the benefits and risks of taking this medication with you, considering both your health and the health of the baby.
Until you are aware of how this medication affects you, it is crucial to avoid driving and engaging in other activities that require alertness. It is also recommended to abstain from consuming alcohol while taking this drug. Before using marijuana, other forms of cannabis, or any prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor to discuss potential interactions.
When administering this medication to a child, exercise caution, as children may have a higher risk of experiencing excitability. However, this medication may not be suitable for children of all ages, so it is vital to consult with your doctor before giving it to a child to determine the appropriate course of action.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the benefits and risks of taking this medication with you, considering both your health and the health of the baby.
Overdose Information
Overdose Symptoms:
- Severe drowsiness or sedation (triprolidine)
- Excitement, restlessness, nervousness, tremors, convulsions (pseudoephedrine)
- Hallucinations
- Rapid or irregular heartbeat
- High blood pressure
- Dilated pupils
- Dry mouth, flushed skin
- Urinary retention
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, potentially including gastric lavage, activated charcoal, and management of cardiovascular or CNS effects.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of hypertensive crisis)
- Other sympathomimetics (e.g., other decongestants, appetite suppressants, amphetamines) - additive effects
Major Interactions
- Antihypertensives (e.g., beta-blockers, methyldopa, reserpine, guanethidine) - pseudoephedrine may reduce their effect
- Tricyclic Antidepressants (TCAs) - may enhance cardiovascular effects of pseudoephedrine
- CNS Depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, opioids) - additive CNS depression with triprolidine
- Digoxin - increased risk of arrhythmias with pseudoephedrine
Moderate Interactions
- Anticholinergics (e.g., atropine, some antipsychotics) - additive anticholinergic effects with triprolidine (e.g., dry mouth, urinary retention)
- Urinary acidifiers (e.g., ammonium chloride) - may increase pseudoephedrine excretion, reducing its effect
- Urinary alkalinizers (e.g., sodium bicarbonate) - may decrease pseudoephedrine excretion, increasing its effect
Minor Interactions
- Certain laboratory tests (e.g., allergy skin tests - triprolidine may suppress positive reactions)
Monitoring
Baseline Monitoring
Blood Pressure and Heart Rate
Rationale: Pseudoephedrine can increase blood pressure and heart rate, especially in susceptible individuals.
Timing: Prior to initiation, particularly in patients with hypertension or cardiovascular disease.
Medical History (Hypertension, Cardiovascular Disease, Diabetes, Thyroid Disorders, Glaucoma, Prostatic Hypertrophy)
Rationale: Pseudoephedrine is contraindicated or requires caution in these conditions.
Timing: Prior to initiation.
Routine Monitoring
Symptom Relief (Nasal Congestion, Sneezing, Runny Nose)
Frequency: Daily, as needed
Target: Adequate symptom control
Action Threshold: Lack of efficacy or worsening symptoms may indicate need for alternative therapy or medical evaluation.
Adverse Effects (Drowsiness, Dizziness, Insomnia, Nervousness, Dry Mouth, Palpitations)
Frequency: Daily, as needed
Target: Absence or mild, tolerable side effects
Action Threshold: Severe or persistent side effects warrant dose reduction or discontinuation.
Blood Pressure and Heart Rate
Frequency: Periodically, especially in patients with pre-existing cardiovascular conditions or if symptoms of hypertension/tachycardia develop.
Target: Within patient's normal range or controlled limits.
Action Threshold: Significant increase (e.g., >20 mmHg systolic or >10 mmHg diastolic) or sustained tachycardia warrants discontinuation and medical evaluation.
Symptom Monitoring
- Drowsiness
- Dizziness
- Insomnia
- Nervousness
- Restlessness
- Dry mouth
- Blurred vision
- Urinary retention
- Palpitations
- Increased blood pressure
- Headache
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Pseudoephedrine use in the first trimester has been associated with a small increased risk of gastroschisis and other vascular disruption defects, though data are conflicting. Triprolidine data are limited.
Trimester-Specific Risks:
First Trimester:
Pseudoephedrine: Possible small increased risk of gastroschisis and other vascular disruption defects. Triprolidine: Limited data, but generally avoided if alternatives exist.
Second Trimester:
Generally considered safer than first trimester, but use with caution and only if clearly needed.
Third Trimester:
Pseudoephedrine: May cause maternal hypertension or fetal tachycardia. Triprolidine: May cause CNS depression in neonate if used close to delivery.
Lactation
Both triprolidine and pseudoephedrine are excreted into breast milk. Use is generally discouraged due to potential for infant irritability, drowsiness, and decreased milk supply (pseudoephedrine).
Infant Risk:
Triprolidine: Drowsiness, irritability, anticholinergic effects in infant. Pseudoephedrine: Irritability, insomnia, tachycardia in infant; potential for decreased milk supply in mother.
Pediatric Use
Not recommended for children under 12 years of age for this strength due to potential for serious adverse effects, especially CNS stimulation or depression. Lower strength formulations may be available for younger children, but generally, antihistamine/decongestant combinations are not recommended for children under 6 years.
Geriatric Use
Elderly patients are more susceptible to the anticholinergic effects of triprolidine (e.g., dry mouth, urinary retention, constipation, blurred vision) and the cardiovascular/CNS stimulant effects of pseudoephedrine (e.g., hypertension, tachycardia, insomnia, nervousness). Use with caution, starting with lower doses and monitoring closely.
Clinical Information
Clinical Pearls
- Advise patients to avoid taking this medication close to bedtime due to the stimulant effects of pseudoephedrine.
- Educate patients about the potential for drowsiness and to avoid activities requiring mental alertness until effects are known.
- Warn patients about the risk of hypertensive crisis if taken with MAOIs or within 14 days of stopping MAOIs.
- Recommend adequate hydration to help manage dry mouth.
- Patients with underlying cardiovascular conditions, hypertension, or diabetes should use this product with extreme caution and under medical supervision.
Alternative Therapies
- Single-ingredient oral decongestants (e.g., pseudoephedrine, phenylephrine)
- Single-ingredient oral antihistamines (e.g., triprolidine, loratadine, cetirizine, fexofenadine)
- Intranasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis
- Saline nasal sprays for congestion
- Cromolyn sodium nasal spray for allergy prevention
Cost & Coverage
Average Cost:
Varies, typically $10-$30 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.