Pseudoephedrine 120mg ER Tablets
It is used to treat nose stuffiness.
Drug Class
Decongestant
Pharmacologic Class
Alpha-adrenergic agonist; Sympathomimetic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled (though sales are restricted due to methamphetamine synthesis)
Overview
What is this medicine?
Pseudoephedrine is a medicine used to relieve stuffy nose (nasal congestion) caused by colds, allergies, or hay fever. It works by shrinking blood vessels in the nasal passages, which helps you 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. If it causes stomach upset, taking it with food may help. Swallow the medication whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets. When you no longer need this medication or it 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. Check with your pharmacist for guidance on the best way to dispose of unused or expired medications, and ask about potential 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, follow your doctor's instructions and do not take it more frequently than recommended.
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. Swallow the medication whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets. When you no longer need this medication or it 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. Check with your pharmacist for guidance on the best way to dispose of unused or expired medications, and ask about potential 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, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Stay hydrated by drinking plenty of fluids.
- Avoid excessive caffeine intake, as pseudoephedrine can also be stimulating.
- Do not take more than the recommended dose or more frequently than directed.
- Do not use for more than 7 days unless directed by a doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
120 mg orally every 12 hours
Dose Range:
120 - 240 mg
Condition-Specific Dosing:
maximumDailyDose:
240 mg/day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years for 120mg ER formulation
Adolescent:
120 mg orally every 12 hours (for ages 12 years and older)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed
Moderate:
Consider dose reduction or extended dosing interval (e.g., 120 mg every 24 hours)
Severe:
Avoid use or significantly reduce dose (e.g., 60 mg every 12 hours or 120 mg every 24 hours) due to prolonged half-life
Dialysis:
Pseudoephedrine is dialyzable; consider post-dialysis dosing or avoid use
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 as a direct and indirect agonist on alpha-adrenergic receptors in the respiratory mucosa. It causes vasoconstriction, which reduces swelling of nasal mucous membranes, decreases tissue hyperemia, edema, and nasal congestion, and opens obstructed Eustachian ostia.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80-90%
Tmax:
3-6 hours (for ER formulation)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
2.6-3.5 L/kg
ProteinBinding:
Approximately 13-20%
CnssPenetration:
Limited (less than ephedrine, but can cause CNS stimulation at higher doses)
Elimination:
HalfLife:
4-9 hours (can be prolonged in renal impairment)
Clearance:
Not available
ExcretionRoute:
Primarily renal (43-96% excreted unchanged)
Unchanged:
43-96%
Pharmacodynamics
OnsetOfAction:
30 minutes to 1 hour
PeakEffect:
3-6 hours (for ER formulation)
DurationOfAction:
12 hours (for ER formulation)
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
Rapid or irregular heartbeat
Shortness of breath
Shakiness
Severe stomach pain
Severe nausea or vomiting
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
Dizziness
Feeling nervous or excitable
* Trouble sleeping
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
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
Rapid or irregular heartbeat
Shortness of breath
Shakiness
Severe stomach pain
Severe nausea or vomiting
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
Dizziness
Feeling nervous or excitable
* Trouble sleeping
Reporting Side Effects
This list is not exhaustive, and you may experience other 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:
- Severe dizziness or lightheadedness
- Fast, pounding, or irregular heartbeat (palpitations)
- Severe headache
- Chest pain
- Difficulty breathing
- Hallucinations or unusual behavior
- Significant increase in blood pressure
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 and its symptoms.
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 prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your health problems, including any medical conditions or concerns
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 and its symptoms.
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 prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your health problems, including any medical conditions or concerns
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 prescribed may increase your risk of experiencing severe side effects. Additionally, do not take this medication for a longer duration than recommended by your doctor.
To minimize potential interactions, limit your consumption of caffeine-containing products, such as tea, coffee, and cola, as well as chocolate, as combining these with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you are considering giving this medication to a child, it is crucial to consult with your doctor first, as different formulations of this drug may be suitable for different age groups.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
To minimize potential interactions, limit your consumption of caffeine-containing products, such as tea, coffee, and cola, as well as chocolate, as combining these with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you are considering giving this medication to a child, it is crucial to consult with your doctor first, as different formulations of this drug may be suitable for different age groups.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe nervousness, restlessness, or anxiety
- Tremor
- Insomnia
- Hallucinations
- Seizures
- Rapid or irregular heartbeat
- High blood pressure (hypertensive crisis)
- Nausea, vomiting
- Urinary retention
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222). Treatment is supportive and symptomatic, potentially involving activated charcoal, benzodiazepines for agitation/seizures, and antihypertensives 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
- Other sympathomimetics (e.g., phenylephrine, ephedrine, amphetamines) - increased risk of cardiovascular effects
- Beta-blockers (non-selective) - may reduce antihypertensive effect and increase risk of hypertension and bradycardia
- Tricyclic Antidepressants (TCAs) - may potentiate pressor effects
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - increased risk of vasoconstriction and hypertension
Moderate Interactions
- Antihypertensives (e.g., guanethidine, methyldopa, reserpine) - pseudoephedrine may reduce their antihypertensive effects
- Cardiac glycosides (e.g., digoxin) - increased risk of arrhythmias
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - may decrease pseudoephedrine excretion, increasing its effects
- Urinary acidifiers (e.g., ammonium chloride) - may increase pseudoephedrine excretion, decreasing its effects
Minor Interactions
- Caffeine - additive CNS stimulant effects
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: Pseudoephedrine can cause vasoconstriction and elevate blood pressure, especially in susceptible individuals.
Timing: Prior to initiation, especially in patients with pre-existing hypertension.
Heart Rate
Rationale: Sympathomimetic effects can increase heart rate and cause palpitations.
Timing: Prior to initiation, especially in patients with pre-existing cardiac conditions.
Routine Monitoring
Blood Pressure
Frequency: As needed, especially if symptoms of hypertension develop or in patients with pre-existing hypertension.
Target: Maintain within patient's normal range or as clinically appropriate.
Action Threshold: Significant elevation (e.g., >140/90 mmHg or significant increase from baseline) warrants discontinuation or dose adjustment.
Heart Rate
Frequency: As needed, especially if symptoms of palpitations or tachycardia develop.
Target: Maintain within patient's normal range.
Action Threshold: Persistent tachycardia (>100 bpm at rest) or new onset arrhythmias warrants discontinuation.
Symptom Relief (Nasal Congestion)
Frequency: Daily, or as needed.
Target: Improved breathing, reduced nasal stuffiness.
Action Threshold: Lack of efficacy after appropriate trial period (e.g., 7 days) suggests need for alternative therapy.
Symptom Monitoring
- Nervousness
- Dizziness
- Insomnia
- Headache
- Palpitations
- Tremor
- Anxiety
- Restlessness
- Chest pain
- Shortness of breath
- Hallucinations (rare, especially at high doses)
Special Patient Groups
Pregnancy
Pseudoephedrine is classified as Pregnancy Category C. While generally considered low risk for major malformations, some studies suggest a possible association with gastroschisis (a birth defect) if used in the first trimester. Use should be avoided in the first trimester if possible, and used with caution in later trimesters only if the potential benefit outweighs the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Possible association with gastroschisis; generally avoid if alternatives are available.
Second Trimester:
Generally considered safer than first trimester, but use with caution.
Third Trimester:
Use with caution; may cause maternal hypertension or fetal tachycardia. Avoid close to term due to potential for premature labor or fetal distress.
Lactation
Pseudoephedrine is excreted into breast milk in small amounts. While generally considered compatible with breastfeeding by some sources (L3), it can reduce milk supply, especially in mothers with established lactation. Monitor infant for irritability, sleep disturbances, or excessive crying.
Infant Risk:
Low risk of adverse effects in the infant, but potential for irritability or sleep disturbances. Risk of decreased milk supply.
Pediatric Use
The 120mg extended-release formulation is not recommended for children under 12 years of age. For younger children, lower dose immediate-release formulations or alternative decongestants may be used under medical supervision. Over-the-counter cough and cold products are generally not recommended for children under 4 years old.
Geriatric Use
Elderly patients may be more susceptible to the adverse effects of pseudoephedrine, particularly cardiovascular (hypertension, tachycardia) and central nervous system (insomnia, nervousness, confusion) effects. Start with the lowest effective dose and monitor closely for adverse reactions. Use with caution in patients with pre-existing cardiovascular disease, hypertension, or prostatic hypertrophy.
Clinical Information
Clinical Pearls
- Pseudoephedrine is a highly effective oral decongestant, but its sales are restricted due to its use in illicit methamphetamine production.
- Counsel patients on potential CNS stimulation (insomnia, nervousness) and cardiovascular effects (palpitations, increased blood pressure).
- Advise patients to avoid taking doses close to bedtime due to potential for insomnia.
- Patients with hypertension, heart disease, thyroid disease, diabetes, or prostatic enlargement should consult a doctor before use.
- Extended-release formulations should be swallowed whole; do not crush, chew, or break.
- Limit use to 7 days unless directed by a healthcare professional to avoid rebound congestion (rhinitis medicamentosa) and potential for masking serious underlying conditions.
Alternative Therapies
- Phenylephrine (oral decongestant, less effective than pseudoephedrine)
- Oxymetazoline (topical nasal decongestant spray)
- Xylometazoline (topical nasal decongestant spray)
- Saline nasal sprays/washes
- Intranasal corticosteroids (for allergic rhinitis)
- Antihistamines (for allergic rhinitis symptoms)
- Ipratropium bromide nasal spray (for rhinorrhea)
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often covered as a Tier 1 or Tier 2 generic, but may require prescription due to sales restrictions.
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.