Sudogest 12 Hour 120mg ER Caplets
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 (regulated as a List I chemical precursor)
Overview
What is this medicine?
Sudogest 12 Hour is an extended-release caplet containing pseudoephedrine, which is a decongestant. It helps relieve stuffy nose and sinus pressure caused by colds, allergies, or hay fever by shrinking swollen blood vessels in the 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, 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, protected from light and moisture. Keep it in a dry place, away from the bathroom. Ensure all medications are stored safely and out of 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 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 normal 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, protected from light and moisture. Keep it in a dry place, away from the bathroom. Ensure all medications are stored safely and out of 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 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 normal 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.
- Do not crush, chew, or break the extended-release caplet; swallow it whole.
- Avoid taking close to bedtime (e.g., within 4-6 hours) as it can cause insomnia.
- Stay hydrated to help thin mucus.
- Avoid alcohol while taking this medication, as it may increase side effects like dizziness or drowsiness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
120 mg extended-release caplet orally every 12 hours
Dose Range:
120 - 240 mg
Condition-Specific Dosing:
maximumDailyDose:
240 mg (two 120 mg caplets) 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:
12 years and older: 120 mg extended-release caplet orally every 12 hours
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed
Severe:
CrCl < 30 mL/min: Consider dose reduction (e.g., 60 mg every 12 hours) or avoidance due to prolonged half-life and increased risk of adverse effects.
Dialysis:
Pseudoephedrine is dialyzable; however, specific dosing recommendations for dialysis patients are not well-established for ER formulations. Use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed
Severe:
No specific adjustment needed (pseudoephedrine is minimally metabolized by the liver)
Confidence:
High
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 congestion. It also has some beta-adrenergic activity.
Pharmacokinetics
Absorption:
Bioavailability:
Good oral absorption (approximately 80-90%)
Tmax:
Extended-release: 4-8 hours (for 120 mg ER)
FoodEffect:
Food may slightly delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
Approximately 2.6 L/kg
ProteinBinding:
Low (approximately 10-20%)
CnssPenetration:
Limited (less than ephedrine, but can cause CNS stimulation at higher doses)
Elimination:
HalfLife:
Approximately 4-8 hours (highly dependent on urine pH; acidic urine decreases half-life, alkaline urine increases it)
Clearance:
Approximately 7.5-10.5 mL/min/kg
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
55-90% (excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Extended-release: 30-60 minutes
PeakEffect:
Extended-release: 4-8 hours
DurationOfAction:
Extended-release: 12 hours
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
Severe stomach pain
Severe nausea or vomiting
Other Possible Side Effects
Most people taking this medication will not experience side effects, or they may be mild. However, if you notice any of the following side effects, or if they bother you or do not go away, contact your doctor:
Dizziness
Feeling nervous or excitable
* Trouble sleeping
Reporting Side Effects
This is not a comprehensive list of all possible 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
Fast or abnormal heartbeat
Shortness of breath
Shakiness
Severe stomach pain
Severe nausea or vomiting
Other Possible Side Effects
Most people taking this medication will not experience side effects, or they may be mild. However, if you notice any of the following side effects, or if they bother you or do not go away, contact your doctor:
Dizziness
Feeling nervous or excitable
* Trouble sleeping
Reporting Side Effects
This is not a comprehensive list of all possible 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
- Nervousness, restlessness, or difficulty sleeping that is severe or persistent
- Tremor
- Difficulty urinating (especially if you have an enlarged prostate)
- Chest pain
- Shortness of breath
- 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 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 medical history, including any health problems you have
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 medical history, including any health problems you have
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.
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 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 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 conversation will help you understand the implications for both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe nervousness, restlessness, or irritability
- 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 Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, potentially including activated charcoal, benzodiazepines for agitation/seizures, and alpha-blockers for severe hypertension.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of hypertensive crisis)
Major Interactions
- Other sympathomimetics (e.g., decongestants, appetite suppressants, amphetamines) - increased risk of cardiovascular and CNS effects
- Tricyclic Antidepressants (TCAs) - may potentiate pressor effects
- Beta-blockers (non-selective) - may increase risk of hypertension and bradycardia due to unopposed alpha-adrenergic stimulation
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - increased risk of vasoconstriction and hypertension
Moderate Interactions
- Antihypertensives (e.g., guanethidine, methyldopa, reserpine) - pseudoephedrine may reduce their hypotensive effects
- Cardiac glycosides (e.g., digoxin) - increased risk of arrhythmias
- Linezolid (has MAOI activity) - risk of hypertensive crisis
Minor Interactions
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - may increase pseudoephedrine excretion, reducing efficacy
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - may decrease pseudoephedrine excretion, increasing efficacy/toxicity
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline, especially in patients with pre-existing hypertension or cardiovascular disease, as pseudoephedrine can increase BP.
Timing: Prior to initiation
Heart Rate (HR)
Rationale: To establish baseline, as pseudoephedrine can cause tachycardia or palpitations.
Timing: Prior to initiation
Routine Monitoring
Symptom relief (nasal congestion, sinus pressure)
Frequency: Daily, as needed
Target: Improved breathing, reduced congestion
Action Threshold: Lack of efficacy after 7 days, or worsening symptoms, warrants medical evaluation.
Blood Pressure (BP)
Frequency: Periodically, especially in patients with hypertension or cardiovascular risk factors
Target: Within patient's target range
Action Threshold: Significant increase in BP (e.g., >20 mmHg systolic or >10 mmHg diastolic) warrants discontinuation and medical advice.
Heart Rate (HR)
Frequency: Periodically, if patient reports palpitations or tachycardia
Target: Within normal limits for patient
Action Threshold: Persistent tachycardia or new onset arrhythmias warrants discontinuation and medical advice.
Symptom Monitoring
- Nervousness
- Restlessness
- Insomnia
- Dizziness
- Headache
- Palpitations
- Tremor
- Difficulty urinating (especially in men with prostatic hypertrophy)
Special Patient Groups
Pregnancy
Pseudoephedrine is generally considered 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.
Trimester-Specific Risks:
First Trimester:
Potential, though conflicting, association with gastroschisis. Generally advised to avoid if possible.
Second Trimester:
Generally considered safer than in the first trimester, but still use with caution.
Third Trimester:
Use with caution; may cause maternal hypertension or fetal tachycardia. Avoid close to term due to potential for vasoconstriction.
Lactation
Pseudoephedrine is excreted into breast milk. While generally considered compatible with breastfeeding (L2), it can cause irritability, jitteriness, or sleep disturbances in the infant. It may also decrease milk supply, especially in the early postpartum period or with prolonged use.
Infant Risk:
Low to moderate (irritability, sleep disturbances, potential for decreased milk supply)
Pediatric Use
Extended-release pseudoephedrine 120mg is not recommended for children under 12 years of age due to potential for serious adverse effects and difficulty in accurate dosing. For younger children, liquid formulations or lower-dose immediate-release products may be used under medical supervision, but generally, decongestants are not recommended for children under 4-6 years.
Geriatric Use
Elderly patients may be more sensitive to the adverse effects of pseudoephedrine, particularly cardiovascular (hypertension, tachycardia) and central nervous system (insomnia, nervousness, dizziness) effects. Use with caution and consider lower doses or alternative therapies, especially in those with pre-existing cardiovascular disease, hypertension, or prostatic hypertrophy.
Clinical Information
Clinical Pearls
- Pseudoephedrine is sold 'behind the counter' in the US due to its use as a precursor in methamphetamine production. Patients must show ID and there are purchase limits.
- Advise patients not to take this medication if they have severe hypertension, severe coronary artery disease, or are taking MAOIs.
- Extended-release formulations are designed for 12-hour relief; emphasize not to crush or chew the caplets.
- Patients with prostatic hypertrophy may experience increased difficulty with urination.
- Monitor for signs of CNS stimulation (insomnia, nervousness) and cardiovascular effects (palpitations, increased blood pressure).
Alternative Therapies
- Oral phenylephrine (less effective as a decongestant than pseudoephedrine)
- Topical nasal decongestants (e.g., oxymetazoline, xylometazoline - use for no more than 3-5 days to avoid rebound congestion)
- Nasal saline sprays/rinses
- Intranasal corticosteroids (for allergic rhinitis)
- Oral antihistamines (for allergic rhinitis symptoms)
- Steam inhalation
Cost & Coverage
Average Cost:
$5 - $15 per 10-20 caplets
Generic Available:
Yes
Insurance Coverage:
Generally not covered by insurance as it is an over-the-counter (OTC) medication, unless prescribed by a physician and the plan specifically covers OTCs.
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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.