Sudogest 60mg 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 (List I Chemical - subject to sales restrictions)
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 shrinking blood vessels in the nasal passages, which helps to open them up and make breathing easier.
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 the best disposal method or explore 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 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 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 the best disposal method or explore 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 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
- Take with a full glass of water.
- Avoid taking close to bedtime (e.g., within 4-6 hours) as it can cause insomnia.
- Do not exceed the recommended dose.
- Monitor blood pressure if you have high blood pressure.
- Stay hydrated.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
60 mg every 4 to 6 hours as needed
Dose Range:
60 - 240 mg
Condition-Specific Dosing:
Maximum daily dose:
240 mg in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (generally not recommended for children under 2 years)
Child:
2-5 years: Not recommended without physician consultation; 6-11 years: 30 mg every 4-6 hours (max 120 mg/24 hours)
Adolescent:
12 years and older: 60 mg every 4-6 hours (max 240 mg/24 hours)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed
Moderate:
Consider dose reduction or extended dosing interval (e.g., 60 mg every 6-8 hours)
Severe:
Use with caution; consider significant dose reduction (e.g., 30 mg every 6-8 hours) or avoidance if CrCl < 10 mL/min
Dialysis:
Pseudoephedrine is dialyzable; administer after dialysis session if needed, or adjust dose based on residual renal function.
Hepatic Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed
Severe:
No specific adjustment needed
Pharmacology
Mechanism of Action
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 decreases blood flow, leading to decongestion. It also has some beta-adrenergic activity.
Pharmacokinetics
Absorption:
Bioavailability:
High (well absorbed orally)
Tmax:
0.5 - 2 hours (for immediate-release formulations)
FoodEffect:
Minimal effect on absorption rate or extent
Distribution:
Vd:
2.6 - 3.5 L/kg
ProteinBinding:
Low (approximately 10-20%)
CnssPenetration:
Limited (less than ephedrine, but can cause CNS stimulation at higher doses)
Elimination:
HalfLife:
4 - 6 hours (can be shorter in acidic urine, longer in alkaline urine)
Clearance:
Not readily available, primarily renal excretion
ExcretionRoute:
Renal (urine)
Unchanged:
55-90% (highly dependent on urinary pH)
Pharmacodynamics
OnsetOfAction:
15 - 30 minutes
PeakEffect:
1 - 2 hours
DurationOfAction:
4 - 6 hours
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, 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 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, 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
- Chest pain
- Palpitations or irregular heartbeat
- Severe dizziness or lightheadedness
- Difficulty breathing
- Hallucinations or unusual behavior
- Seizures
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 and its symptoms.
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.
All prescription and over-the-counter medications, natural products, and vitamins you are taking, as well as any health problems you have. This is not an exhaustive list, and it is crucial to discuss all potential interactions with your doctor and pharmacist to ensure safe use.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to verify that it is safe to do so in conjunction with this medication.
Any allergies you have, including allergies to this drug, its components, or other substances. 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, 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.
All prescription and over-the-counter medications, natural products, and vitamins you are taking, as well as any health problems you have. This is not an exhaustive list, and it is crucial to discuss all potential interactions with your doctor and pharmacist to ensure safe use.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to verify that it is safe to do so in conjunction with this medication.
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 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 conversation will help you understand the implications for both 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 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 conversation will help you understand the implications for both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe nervousness or restlessness
- Insomnia
- Dizziness
- Tremor
- Seizures
- Hallucinations
- High blood pressure (hypertensive crisis)
- Tachycardia or arrhythmias
- Palpitations
- Nausea
- Vomiting
- Dry mouth
- Urinary retention
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US).
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, tricyclic antidepressants) - increased risk of cardiovascular effects (hypertension, arrhythmias)
- Beta-blockers (non-selective) - may reduce antihypertensive effect of beta-blockers and increase risk of hypertension and bradycardia
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - increased risk of vasoconstriction and hypertension
Moderate Interactions
- Digoxin - increased risk of arrhythmias
- Antacids (e.g., sodium bicarbonate) - may increase pseudoephedrine half-life and duration of action by increasing urinary pH
- Urinary acidifiers (e.g., ammonium chloride) - may decrease pseudoephedrine half-life and duration of action by decreasing urinary pH
- Methyldopa - may reduce antihypertensive effect
- Linezolid - theoretical risk of hypertensive crisis (weak MAOI activity)
Minor Interactions
- Not many clinically significant minor interactions reported beyond those affecting urinary pH.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: Pseudoephedrine can increase blood pressure, especially in susceptible individuals (e.g., those with hypertension).
Timing: Before initiating therapy, especially in patients with pre-existing cardiovascular conditions.
Heart Rate (HR)
Rationale: Pseudoephedrine can cause tachycardia or palpitations.
Timing: Before initiating therapy, especially in patients with pre-existing cardiovascular conditions.
Routine Monitoring
Blood Pressure (BP)
Frequency: Periodically during therapy, especially if symptoms of hypertension develop or in patients with pre-existing hypertension.
Target: Maintain within patient's normal or target range.
Action Threshold: Significant increase above baseline or target range; consider dose reduction or discontinuation.
Heart Rate (HR)
Frequency: Periodically during therapy, especially if symptoms of palpitations or tachycardia develop.
Target: Maintain within patient's normal range.
Action Threshold: Persistent tachycardia or new onset of arrhythmias; consider dose reduction or discontinuation.
Symptom Monitoring
- Resolution of nasal congestion
- Insomnia
- Nervousness
- Dizziness
- Headache
- Palpitations
- Tremor
- Anxiety
- Restlessness
Special Patient Groups
Pregnancy
Pseudoephedrine is generally considered Category C. While some studies suggest a possible association with gastroschisis when used in the first trimester, data are conflicting and overall risk appears low. Use should be weighed against potential benefits, especially in the first trimester. Avoid prolonged or high-dose use.
Trimester-Specific Risks:
First Trimester:
Possible, but low, risk of gastroschisis (abdominal wall defect); conflicting data. Use with caution.
Second Trimester:
Generally considered safer than first trimester, but still use with caution and only if clearly needed.
Third Trimester:
Generally considered safer than first trimester, but use with caution. Avoid near term due to potential for maternal hypertension or fetal tachycardia.
Lactation
Pseudoephedrine is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding (L2). Monitor the infant for irritability, sleep disturbances, or decreased milk supply in the mother.
Infant Risk:
Low risk; monitor for irritability, sleep disturbances. May rarely decrease milk supply, especially with repeated doses.
Pediatric Use
Not recommended for children under 2 years of age due to lack of efficacy and potential for serious adverse effects. For children 2-11 years, use only under medical supervision and with age-appropriate dosing. Adolescents (12+) can follow adult dosing.
Geriatric Use
Use with caution in elderly patients due to increased susceptibility to adverse effects, particularly cardiovascular (hypertension, arrhythmias) and central nervous system (insomnia, nervousness, confusion). Start with lower doses and titrate carefully. Monitor blood pressure and heart rate closely.
Clinical Information
Clinical Pearls
- Pseudoephedrine is a highly effective decongestant but is subject to sales restrictions due to its use in illicit methamphetamine production.
- Advise patients to avoid taking pseudoephedrine close to bedtime to prevent insomnia.
- Counsel patients on potential cardiovascular side effects, especially those with pre-existing hypertension or heart conditions.
- Remind patients to check other cold/flu medications for pseudoephedrine or other sympathomimetics to avoid accidental overdose.
- For patients with controlled hypertension, short-term use of pseudoephedrine may be acceptable under medical supervision, but phenylephrine or saline nasal sprays might be preferred alternatives.
Alternative Therapies
- Phenylephrine (oral or nasal spray) - less effective orally due to poor bioavailability
- Oxymetazoline (nasal spray) - topical decongestant, risk of rebound congestion with prolonged use
- Saline nasal sprays/washes - non-pharmacological, safe for all ages
- Corticosteroid nasal sprays (e.g., fluticasone, mometasone) - for allergic rhinitis, slower onset
- Antihistamines (e.g., loratadine, cetirizine, fexofenadine) - for allergic rhinitis symptoms, some have mild anticholinergic drying effects
- Ipratropium bromide nasal spray - for rhinorrhea
Cost & Coverage
Average Cost:
$5 - $20 per 30 tablets (60mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.