Pseudoephedrine 30mg Tablets
It is used to treat nose stuffiness.
Drug Class
Decongestant
Pharmacologic Class
Sympathomimetic (alpha- and beta-adrenergic agonist)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pseudoephedrine is a medicine used to relieve stuffy nose and sinus pressure caused by colds, allergies, or hay fever. It works by narrowing the blood vessels in your nose, which helps to reduce swelling and open up your nasal passages.
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, take it with food to help minimize this side effect. It's essential to swallow the medication whole and 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. Ensure that all medications are kept 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or look into local drug take-back programs.
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 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. 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, take it with food to help minimize this side effect. It's essential to swallow the medication whole and 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. Ensure that all medications are kept 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or look into local drug take-back programs.
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 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. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Take with a full glass of water.
- Avoid taking close to bedtime to prevent insomnia.
- Stay hydrated.
- Avoid excessive caffeine intake while taking this medication.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
30 mg to 60 mg every 4 to 6 hours as needed
Dose Range:
30 - 60 mg
Condition-Specific Dosing:
maximumDailyDose:
240 mg in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (generally not recommended for children under 2 years)
Child:
2 to 5 years: 15 mg every 4 to 6 hours (max 60 mg/24 hours); 6 to 12 years: 30 mg every 4 to 6 hours (max 120 mg/24 hours)
Adolescent:
12 years and older: 30 mg to 60 mg every 4 to 6 hours (max 240 mg/24 hours)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment generally needed, monitor for adverse effects.
Moderate:
Consider dose reduction (e.g., 30 mg every 6-8 hours) or extended dosing interval.
Severe:
Use with caution; consider significant dose reduction (e.g., 30 mg every 12 hours) or avoidance. Monitor closely.
Dialysis:
Pseudoephedrine is dialyzable. Consider post-dialysis dosing or extended intervals.
Hepatic Impairment:
Mild:
No specific adjustment generally needed.
Moderate:
No specific adjustment generally needed.
Severe:
No specific adjustment generally needed, but monitor for increased sensitivity to adverse effects.
Pharmacology
Mechanism of Action
Pseudoephedrine is a sympathomimetic amine that acts directly on alpha-adrenergic receptors in the nasal mucosa to cause vasoconstriction, which reduces swelling and congestion. It also has indirect effects by releasing norepinephrine from neuronal storage sites.
Pharmacokinetics
Absorption:
Bioavailability:
High (approximately 80-90%)
Tmax:
0.5 to 2 hours (for immediate-release tablets)
FoodEffect:
Food may slightly delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
2.6 to 3.5 L/kg
ProteinBinding:
Low (approximately 10-20%)
CnssPenetration:
Limited (due to its polar nature, but can cause CNS stimulation at higher doses)
Elimination:
HalfLife:
4 to 6 hours (can be longer in alkaline urine)
Clearance:
Not readily available, primarily renal excretion
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
55% to 75% (highly dependent on urinary pH)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
1 to 2 hours
DurationOfAction:
4 to 6 hours
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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. While 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 do not go away, contact your doctor:
Dizziness
Feeling nervous and 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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. While 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 do not go away, contact your doctor:
Dizziness
Feeling nervous and 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 headache
- Dizziness or lightheadedness
- Chest pain or tightness
- Fast or irregular heartbeat (palpitations)
- Difficulty breathing
- Severe nervousness, anxiety, or restlessness
- Hallucinations
- Difficulty urinating
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. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, such as 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 may 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. This will help ensure that it is safe 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 confirm that it is safe to do so.
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, such as 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 may 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. This will help ensure that it is safe 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 confirm that it is safe to do so.
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 accelerated heartbeat.
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 your doctor to ensure the appropriate formulation 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 and its potential impact on you and your baby.
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 accelerated heartbeat.
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 your doctor to ensure the appropriate formulation 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 and its potential impact on you and your baby.
Overdose Information
Overdose Symptoms:
- Severe nervousness, restlessness, or anxiety
- Insomnia
- Tremor
- Seizures
- Hallucinations
- High blood pressure (hypertensive crisis)
- Tachycardia or arrhythmias
- Palpitations
- Nausea, vomiting
- Urinary retention
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)
Major Interactions
- Other sympathomimetics (e.g., decongestants, appetite suppressants, amphetamines) - increased cardiovascular effects
- Beta-blockers (non-selective) - increased risk of hypertension and bradycardia
- Tricyclic Antidepressants (TCAs) - enhanced pressor effects
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - increased risk of vasoconstriction
Moderate Interactions
- Digoxin - increased risk of arrhythmias
- Antihypertensives (e.g., guanethidine, methyldopa, reserpine) - reduced antihypertensive effect
- Linezolid - potential for hypertensive crisis
Minor Interactions
- Caffeine - additive CNS stimulation
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: Pseudoephedrine can increase blood pressure, especially in patients with pre-existing hypertension.
Timing: Before initiation, particularly in patients with cardiovascular risk factors.
Heart Rate (HR)
Rationale: Pseudoephedrine can cause tachycardia or palpitations.
Timing: Before initiation, particularly in patients with cardiovascular risk factors.
Routine Monitoring
Symptom relief (nasal congestion)
Frequency: Daily, as needed
Target: Improved breathing, reduced congestion
Action Threshold: Lack of improvement or worsening symptoms may indicate need for alternative therapy or medical evaluation.
Blood Pressure (BP)
Frequency: Periodically, especially in patients with hypertension or cardiovascular disease
Target: Within patient's normal or target range
Action Threshold: Significant increase (e.g., >20 mmHg systolic or >10 mmHg diastolic) or development of hypertensive symptoms.
Heart Rate (HR)
Frequency: Periodically, especially in patients with cardiovascular disease
Target: Within patient's normal range
Action Threshold: Persistent tachycardia, palpitations, or arrhythmias.
Symptom Monitoring
- Nasal congestion relief
- Headache
- Dizziness
- Nervousness
- Insomnia
- Palpitations
- Tremor
- Chest pain
- Difficulty urinating (especially in men with prostatic hypertrophy)
Special Patient Groups
Pregnancy
Pseudoephedrine is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Some studies suggest a possible association with gastroschisis when used in the first trimester, though data are conflicting. Generally, it is best to avoid decongestants in the first trimester.
Trimester-Specific Risks:
First Trimester:
Possible association with gastroschisis (abdominal wall defect), though data are inconsistent. Generally, avoid if possible.
Second Trimester:
Generally considered safer than in the first trimester, but use with caution and only if clearly needed.
Third Trimester:
Use with caution, especially near term, due to potential for maternal hypertension and fetal tachycardia. May reduce uterine blood flow.
Lactation
Pseudoephedrine is excreted into breast milk. While generally considered compatible with breastfeeding (L2), infants should be monitored for irritability, sleep disturbances, or decreased milk supply in the mother.
Infant Risk:
Low to moderate. Potential for irritability, sleep disturbances (insomnia), or mild CNS stimulation in the infant. May decrease milk supply, especially in mothers with established lactation.
Pediatric Use
Not recommended for children under 2 years of age due to potential for serious adverse effects. Use age-appropriate dosing for older children. Overdose can be particularly dangerous in this population.
Geriatric Use
Elderly patients may be more sensitive to the effects of pseudoephedrine, particularly cardiovascular (hypertension, tachycardia) and central nervous system (insomnia, nervousness) effects. Use with caution and consider lower starting doses.
Clinical Information
Clinical Pearls
- Pseudoephedrine is a precursor chemical for methamphetamine production, leading to restrictions on its sale (e.g., behind-the-counter sales, purchase limits).
- Patients with hypertension, heart disease, thyroid disease, diabetes, or prostatic hypertrophy should use pseudoephedrine with caution and under medical supervision.
- Advise patients to avoid taking pseudoephedrine close to bedtime due to its stimulant effects which can cause insomnia.
- Extended-release formulations are available for longer duration of action, but the 30mg tablet is typically immediate-release.
- Educate patients on the difference between pseudoephedrine and phenylephrine, as phenylephrine is often less effective as an oral decongestant.
Alternative Therapies
- Topical nasal decongestants (e.g., oxymetazoline, phenylephrine nasal spray - for short-term use only to avoid rebound congestion)
- Oral phenylephrine (less effective than pseudoephedrine)
- Saline nasal sprays/washes
- Antihistamines (for allergy-related congestion, e.g., loratadine, cetirizine, fexofenadine)
- Intranasal corticosteroids (for allergic rhinitis, e.g., fluticasone, budesonide)
Cost & Coverage
Average Cost:
$5 - $20 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 substance taken, the amount, and the time it occurred.