Pseudoephedrine 60mg Tablets
It is used to treat nose stuffiness.
Drug Class
Nasal decongestant
Pharmacologic Class
Sympathomimetic amine; alpha-adrenergic agonist
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled (List I chemical, subject to Combat Methamphetamine Epidemic Act of 2005 restrictions)
Overview
What is this medicine?
Pseudoephedrine is a decongestant that helps relieve stuffy nose and sinus pressure caused by colds, allergies, or hay fever. It works by narrowing the blood vessels in your nasal passages, which reduces swelling and allows you to breathe more easily.
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, but if it causes stomach upset, take it with food. Swallow the medication whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, 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, check with your pharmacist for guidance on proper disposal. 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, but if it causes stomach upset, take it with food. Swallow the medication whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, 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, check with your pharmacist for guidance on proper disposal. 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 taking pseudoephedrine close to bedtime as it can cause insomnia.
- Limit or avoid caffeine intake while taking pseudoephedrine, as both can cause nervousness, irritability, and difficulty sleeping.
- Stay hydrated to help thin mucus.
- Do not exceed the recommended dose or duration of use.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
60 mg every 4-6 hours as needed
Dose Range:
60 - 240 mg
Condition-Specific Dosing:
maximumDailyDose:
240 mg in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (generally not recommended for children under 4 years)
Child:
4-5 years: Consult a physician; 6-11 years: 30 mg every 4-6 hours as needed (max 120 mg/24 hours)
Adolescent:
12 years and older: 60 mg every 4-6 hours as needed (max 240 mg/24 hours)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, monitor for adverse effects.
Moderate:
Consider dose reduction (e.g., 30 mg every 4-6 hours) or extended dosing interval (e.g., every 6-8 hours).
Severe:
Use with caution; consider significant dose reduction (e.g., 30 mg every 6-8 hours) or avoidance due to prolonged half-life.
Dialysis:
Pseudoephedrine is dialyzable; consider post-dialysis dosing or avoidance.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed (primarily renally eliminated).
Pharmacology
Mechanism of Action
Pseudoephedrine is a sympathomimetic amine that acts directly on alpha-adrenergic receptors in the nasal mucosa, causing vasoconstriction and reducing swelling. It also has indirect effects by releasing norepinephrine from neuronal storage sites.
Pharmacokinetics
Absorption:
Bioavailability:
High (approximately 90-100%)
Tmax:
0.5-2 hours (immediate release)
FoodEffect:
Minimal effect on absorption rate or extent.
Distribution:
Vd:
2.6-3.5 L/kg
ProteinBinding:
Low (approximately 13-20%)
CnssPenetration:
Limited (can cross blood-brain barrier, leading to CNS effects like insomnia, nervousness)
Elimination:
HalfLife:
5-9 hours (pH dependent; shorter in acidic urine, longer in alkaline urine)
Clearance:
Not readily available, primarily renal clearance.
ExcretionRoute:
Renal (urine)
Unchanged:
55-90% (depending on urine pH)
Pharmacodynamics
OnsetOfAction:
30 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-6 hours (immediate release)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Dizziness or fainting
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Shortness of breath
Shakiness
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 unusual symptoms that bother you or persist, contact your doctor for guidance:
Dizziness
Feeling nervous and excitable
* Trouble sleeping
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Dizziness or fainting
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Shortness of breath
Shakiness
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 unusual symptoms that bother you or persist, contact your doctor for guidance:
Dizziness
Feeling nervous and excitable
* Trouble sleeping
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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:
- Severe dizziness or lightheadedness
- Fast, pounding, or irregular heartbeat (palpitations)
- Severe headache
- Chest pain
- Difficulty breathing
- Hallucinations or unusual behavior
- Difficulty urinating (especially in men)
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. 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.
It is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. This will enable them to determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. 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.
It is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. This will enable them to determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your chance of experiencing serious adverse effects. Additionally, do not take this medication for a longer duration than specified by your doctor.
When taking this drug, it is recommended to limit your consumption of caffeine-containing products, such as tea, coffee, and cola, as well as chocolate. Combining these substances with this medication may cause nervousness, shakiness, and an increased heart rate.
Please note that different formulations of this medication may be suitable for children of various ages. Before administering this drug to a child, consult with their doctor to ensure the appropriate form and dosage are used.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor. This will enable you to make an informed decision regarding the use of this drug during this time.
To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your chance of experiencing serious adverse effects. Additionally, do not take this medication for a longer duration than specified by your doctor.
When taking this drug, it is recommended to limit your consumption of caffeine-containing products, such as tea, coffee, and cola, as well as chocolate. Combining these substances with this medication may cause nervousness, shakiness, and an increased heart rate.
Please note that different formulations of this medication may be suitable for children of various ages. Before administering this drug to a child, consult with their doctor to ensure the appropriate form and dosage are used.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor. This will enable you to make an informed decision regarding the use of this drug during this time.
Overdose Information
Overdose Symptoms:
- Severe nervousness, restlessness, or anxiety
- Insomnia
- Tremor
- Seizures
- Hallucinations
- High blood pressure (hypertensive crisis)
- Rapid or irregular heartbeat (tachycardia, arrhythmias)
- Nausea, vomiting
- Urinary retention
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US). Management is supportive and symptomatic, potentially including activated charcoal, benzodiazepines for CNS excitation, and alpha-blockers for severe hypertension.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis.
Major Interactions
- Beta-blockers (non-selective) - may reduce antihypertensive effect and increase risk of hypertension and bradycardia.
- Tricyclic Antidepressants (TCAs) - may potentiate pressor effects.
- Other sympathomimetics (e.g., decongestants, appetite suppressants, amphetamines) - increased risk of cardiovascular and CNS adverse effects.
- Ergot alkaloids (e.g., ergotamine, methysergide) - increased risk of vasoconstriction and hypertension.
Moderate Interactions
- Antihypertensives (e.g., ACE inhibitors, ARBs, diuretics) - may reduce antihypertensive effect.
- Cardiac glycosides (e.g., digoxin) - increased risk of arrhythmias.
- General anesthetics (e.g., halothane) - increased risk of arrhythmias.
- Linezolid - theoretical risk of hypertensive crisis (weak MAOI activity).
Minor Interactions
- Caffeine - additive CNS stimulant effects (nervousness, insomnia).
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: To identify pre-existing hypertension or cardiac conditions that may be exacerbated by pseudoephedrine.
Timing: Prior to initiation, especially in patients with cardiovascular risk factors.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Periodically, especially in patients with hypertension or cardiac conditions.
Target: Maintain within patient's normal or controlled range.
Action Threshold: Significant increase in BP or HR; discontinue if sustained or symptomatic.
Symptom monitoring for CNS effects
Frequency: Daily during use.
Target: Absence of excessive nervousness, insomnia, dizziness.
Action Threshold: Severe or persistent CNS effects; consider dose reduction or discontinuation.
Symptom Monitoring
- Nervousness
- Insomnia
- Dizziness
- Headache
- Palpitations
- Tremor
- Anxiety
- Restlessness
- Difficulty urinating (especially in men with prostatic hypertrophy)
Special Patient Groups
Pregnancy
Pseudoephedrine is generally considered Category C in pregnancy. While some studies suggest a possible association with gastroschisis (a rare birth defect) when used in the first trimester, the overall risk is considered low. Use should be avoided in the first trimester if possible, and used with caution in later trimesters, only if the potential benefit outweighs the risk.
Trimester-Specific Risks:
First Trimester:
Possible, but low, risk of gastroschisis. Avoid if possible.
Second Trimester:
Generally considered safer than first trimester, but use with caution.
Third Trimester:
Use with caution; theoretical risk of reduced uterine blood flow or maternal hypertension. Avoid near term due to potential for maternal/fetal tachycardia.
Lactation
Pseudoephedrine is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk Category L2). However, it can reduce milk supply, especially in the early postpartum period or with prolonged use. Monitor the infant for irritability or sleep disturbances.
Infant Risk:
Low risk of adverse effects in the infant. Potential for irritability or sleep disturbances. Risk of decreased milk supply.
Pediatric Use
Not recommended for children under 4 years of age due to lack of established efficacy and potential for serious adverse effects. Use with caution and appropriate dosing in children 4-11 years. Always use pediatric-specific formulations and dosing instructions.
Geriatric Use
Use with caution in elderly patients due to increased sensitivity to sympathomimetic effects (e.g., CNS stimulation, cardiovascular effects, urinary retention). Start with lower doses and monitor closely for adverse reactions, especially in those with pre-existing cardiovascular disease, hypertension, or prostatic hypertrophy.
Clinical Information
Clinical Pearls
- Pseudoephedrine is a highly effective decongestant but is often restricted due to its use in illicit methamphetamine production. Patients must typically purchase it from behind the pharmacy counter with ID.
- Advise patients to avoid taking pseudoephedrine within 4-6 hours of bedtime to prevent insomnia.
- Counsel patients on potential cardiovascular and CNS side effects, especially those with pre-existing conditions.
- Pseudoephedrine can cause urinary retention, particularly in men with benign prostatic hyperplasia (BPH).
- Differentiate from phenylephrine, which is less effective orally as a decongestant due to extensive first-pass metabolism.
Alternative Therapies
- Phenylephrine (oral or nasal spray)
- Oxymetazoline (nasal spray)
- Nasal saline sprays/rinses
- Intranasal corticosteroids (for allergic rhinitis)
- Oral antihistamines (for allergy symptoms)
- Steam inhalation
Cost & Coverage
Average Cost:
$5 - $20 per 30 tablets (generic 60mg)
Generic Available:
Yes
Insurance Coverage:
Often OTC, may be covered by some insurance plans with a prescription or as part of a health savings account (HSA)/flexible spending account (FSA).
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.