Sudogest 12 Hour 120mg ER Tablets
It is used to treat nose stuffiness.
Drug Class
Nasal Decongestant
Pharmacologic Class
Alpha-adrenergic agonist; Sympathomimetic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
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 shrinking swollen blood vessels in the nasal passages, making it easier to breathe.
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 this 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 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 or participate in a local drug take-back program.
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, 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 this 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 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 or participate in a local drug take-back program.
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 have stimulant effects.
- Do not take more than the recommended dose or more frequently than every 12 hours.
- Do not use for more than 7 days unless directed by a doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
120 mg orally every 12 hours
Dose Range:
120 - 240 mg
Condition-Specific Dosing:
maximum_daily_dose:
240 mg (two 120 mg tablets) in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age for extended-release formulations.
Adolescent:
120 mg orally every 12 hours for ages 12 years and older.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but use with caution.
Moderate:
Use with caution; consider lower doses or extended intervals if adverse effects occur. Consult physician.
Severe:
Use with caution; consider lower doses or extended intervals (e.g., 120 mg every 24 hours). Consult physician.
Dialysis:
Pseudoephedrine is dialyzable. Administer after dialysis. Use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended, but use with caution.
Severe:
No specific adjustment recommended, but use with caution due to potential for increased sensitivity to sympathomimetic effects.
Pharmacology
Mechanism of Action
Pseudoephedrine is a sympathomimetic amine that acts directly and indirectly on adrenergic receptors. It primarily acts as an alpha-adrenergic agonist, causing vasoconstriction of the arterioles in the nasal mucosa, which reduces blood flow and decreases swelling of the nasal passages, leading to decongestion. It also has some beta-adrenergic activity.
Pharmacokinetics
Absorption:
Bioavailability:
Good (approximately 70-80%)
Tmax:
4-6 hours (for ER formulation)
FoodEffect:
Food may slightly delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
2.6-3.5 L/kg
ProteinBinding:
Low (approximately 13-20%)
CnssPenetration:
Limited (crosses blood-brain barrier, but less than ephedrine)
Elimination:
HalfLife:
9-16 hours (for ER formulation)
Clearance:
Not readily available for specific rate, primarily renal excretion.
ExcretionRoute:
Renal (urine)
Unchanged:
55-90% (excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
4-6 hours (for ER formulation)
DurationOfAction:
12 hours (for ER formulation)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 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
Severe stomach pain
Severe nausea or vomiting
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, contact your doctor for advice:
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, 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.
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 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
Severe stomach pain
Severe nausea or vomiting
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, contact your doctor for advice:
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, 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 headache
- Dizziness or lightheadedness
- Chest pain or tightness
- Fast or irregular heartbeat (palpitations)
- Significant increase in blood pressure
- Nervousness, anxiety, or restlessness that is severe or persistent
- Difficulty sleeping (insomnia)
- Hallucinations or unusual behavior
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 may 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 medical history, including any health problems you have or have had
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions or adverse effects.
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 may 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 medical history, including any health problems you have or have had
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions or adverse effects.
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 chances of experiencing adverse effects. Additionally, do not take this medication for a longer duration than specified by your doctor.
When using 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 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 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 chances of experiencing adverse effects. Additionally, do not take this medication for a longer duration than specified by your doctor.
When using 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 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 during this time.
Overdose Information
Overdose Symptoms:
- Severe nervousness, restlessness, or anxiety
- Insomnia
- Tremor
- Seizures
- Hallucinations
- High blood pressure (hypertensive crisis)
- Tachycardia (fast heart rate)
- Arrhythmias
- Palpitations
- Nausea, vomiting
- Urinary retention
What to Do:
Seek immediate medical attention or call Poison Control (1-800-222-1222). Treatment is supportive and symptomatic. May involve gastric lavage, activated charcoal, and management of cardiovascular and CNS effects.
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 (hypertension, tachycardia, arrhythmias).
- Tricyclic Antidepressants (TCAs) - may potentiate pressor effects of pseudoephedrine.
- Beta-blockers (non-selective, e.g., propranolol) - may increase risk of hypertension and bradycardia due to unopposed alpha-adrenergic activity.
- Digoxin - increased risk of arrhythmias.
Moderate Interactions
- Antihypertensives (e.g., guanethidine, methyldopa, reserpine, ACE inhibitors, ARBs, diuretics) - pseudoephedrine may reduce the antihypertensive effects.
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - increased risk of vasoconstriction.
- CNS depressants (e.g., alcohol, sedatives, hypnotics) - additive CNS depression (though pseudoephedrine is a stimulant, some formulations may contain sedating antihistamines, or individual sensitivity may occur).
Minor Interactions
- Caffeine - additive stimulant effects.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: Pseudoephedrine can increase blood pressure, especially in individuals with pre-existing hypertension.
Timing: Before initiating therapy, particularly in patients with cardiovascular conditions.
Heart Rate (HR)
Rationale: Pseudoephedrine can cause tachycardia or palpitations.
Timing: Before initiating therapy, particularly in patients with cardiovascular conditions.
Routine Monitoring
Symptom Relief (Nasal Congestion)
Frequency: Daily, as needed
Target: Improved breathing, reduced congestion
Action Threshold: If symptoms persist or worsen after 7 days, discontinue and consult a healthcare professional.
Blood Pressure (BP)
Frequency: Periodically, especially in patients with hypertension or cardiovascular disease.
Target: Maintain within patient's target range
Action Threshold: If significant increase in BP occurs, discontinue use and seek medical advice.
Heart Rate (HR)
Frequency: Periodically, especially in patients with cardiovascular disease.
Target: Maintain within patient's target range
Action Threshold: If significant tachycardia or palpitations occur, discontinue use and seek medical advice.
Symptom Monitoring
- Nervousness
- Dizziness
- Insomnia
- Headache
- Palpitations
- Tremor
- Anxiety
- Difficulty urinating (especially in men with prostatic enlargement)
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 of the abdominal wall) when used in the first trimester, though data are conflicting. Use should be avoided in the first trimester if possible, and used with caution and only if clearly needed in later trimesters, under medical supervision.
Trimester-Specific Risks:
First Trimester:
Possible association with gastroschisis; generally advised to avoid.
Second Trimester:
Use with caution if benefits outweigh risks; monitor for maternal hypertension.
Third Trimester:
Use with caution if benefits outweigh risks; monitor for maternal hypertension and potential effects on fetal heart rate.
Lactation
Pseudoephedrine is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk L2). However, it may decrease milk supply, especially in mothers with established lactation or those who are sensitive to its effects. Monitor 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 in the mother.
Pediatric Use
Extended-release pseudoephedrine is not recommended for children under 12 years of age due to potential for serious adverse effects and lack of established efficacy and safety in this age group for ER formulations. For younger children, liquid formulations with appropriate dosing are available, but generally, decongestants are not recommended for children under 2 years of age.
Geriatric Use
Use with caution in elderly patients due to increased sensitivity to sympathomimetic effects, particularly cardiovascular (hypertension, tachycardia) and central nervous system (insomnia, nervousness) adverse effects. Start with the lowest effective dose and monitor blood pressure and heart rate closely. Patients with pre-existing conditions like hypertension, glaucoma, or prostatic hypertrophy are at higher risk.
Clinical Information
Clinical Pearls
- Advise patients to avoid taking pseudoephedrine close to bedtime due to its stimulant effects and potential for insomnia.
- Counsel patients with pre-existing conditions such as hypertension, heart disease, hyperthyroidism, diabetes, or prostatic enlargement to consult their physician before using pseudoephedrine.
- Remind patients that pseudoephedrine is a stimulant and can cause nervousness, dizziness, or difficulty sleeping.
- Due to its potential for misuse in methamphetamine production, pseudoephedrine is often sold behind the pharmacy counter and subject to purchase limits (e.g., Combat Methamphetamine Epidemic Act of 2005).
Alternative Therapies
- Phenylephrine (oral decongestant, less effective than pseudoephedrine)
- Oxymetazoline (topical nasal decongestant spray, risk of rebound congestion with prolonged use)
- Saline nasal sprays or rinses (non-pharmacological, safe for all ages)
- Intranasal corticosteroids (e.g., fluticasone, mometasone - for allergic rhinitis, takes days to weeks for full effect)
- Antihistamines (for allergic rhinitis symptoms like sneezing, runny nose, itching)
Cost & Coverage
Average Cost:
$5 - $20 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often OTC, may not be covered by prescription plans unless prescribed)
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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.