Poly-Vent IR 60-380mg Tablets
It is used to treat nose stuffiness.It is used to thin mucus so it can be taken from the body by coughing.
Drug Class
Expectorant; Nasal Decongestant
Pharmacologic Class
Expectorant (Guaifenesin); Alpha-adrenergic agonist (Pseudoephedrine)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled (Pseudoephedrine is a List I chemical, regulated for sale)
Overview
What is this medicine?
This medication is used to relieve chest congestion (from thick mucus) and nasal stuffiness caused by the common cold, flu, or allergies. Guaifenesin helps thin and loosen mucus in your lungs, making it easier to cough up. Pseudoephedrine helps shrink swollen blood vessels in your nose, reducing stuffiness.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food. If it causes stomach upset, taking it with food may help. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, ask your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication regularly, take a missed dose 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, do not take it more frequently than directed by your doctor.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food. If it causes stomach upset, taking it with food may help. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, ask your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication regularly, take a missed dose 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, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Drink plenty of fluids (water, juice) to help thin mucus and make it easier to cough up.
- Avoid alcohol, as it can increase drowsiness and other side effects.
- Avoid driving or operating machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
- Do not take more than the recommended dose or for longer than 7 days without consulting a doctor.
- Store medication at room temperature, away from moisture and heat.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 tablet (Guaifenesin 380mg / Pseudoephedrine 60mg) orally every 4 to 6 hours as needed
Dose Range:
1 - 4 mg
Condition-Specific Dosing:
maximumDailyDose:
Do not exceed 4 tablets (240mg Pseudoephedrine, 1520mg Guaifenesin) in 24 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (Not recommended for children under 4 years)
Child:
4 to < 12 years: Consult a physician. Dosing typically lower and based on weight/age for individual components. Not generally recommended for self-medication.
Adolescent:
âĨ 12 years: 1 tablet (Guaifenesin 380mg / Pseudoephedrine 60mg) orally every 4 to 6 hours as needed. Do not exceed 4 tablets in 24 hours.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically needed.
Moderate:
Use with caution. Pseudoephedrine excretion may be reduced.
Severe:
Use with caution or avoid. Significant reduction in pseudoephedrine clearance. Consider dose reduction or extended dosing interval.
Dialysis:
Pseudoephedrine is dialyzable. Guaifenesin is not significantly dialyzed. Use with caution; monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment typically needed.
Moderate:
No specific adjustment typically needed, but use with caution in severe liver disease due to potential altered metabolism.
Severe:
Use with caution. Monitor for increased side effects, especially from pseudoephedrine.
Pharmacology
Mechanism of Action
Guaifenesin acts as an expectorant by increasing the volume and decreasing the viscosity of respiratory tract secretions, thereby facilitating their removal by ciliary action and coughing. Pseudoephedrine is a sympathomimetic amine that acts directly and indirectly on adrenergic receptors. It causes vasoconstriction of nasal arterioles, leading to reduced blood flow and decreased swelling of nasal mucous membranes, thereby reducing nasal congestion.
Pharmacokinetics
Absorption:
Bioavailability:
Guaifenesin: Well absorbed orally. Pseudoephedrine: Well absorbed orally (approx. 90%).
Tmax:
Guaifenesin: ~1 hour. Pseudoephedrine: ~0.5-2 hours.
FoodEffect:
Food may slightly delay absorption but does not significantly affect the extent of absorption for either component.
Distribution:
Vd:
Guaifenesin: Not extensively studied, but widely distributed. Pseudoephedrine: ~2.6-3.5 L/kg.
ProteinBinding:
Guaifenesin: Low (~10%). Pseudoephedrine: Low (~10-20%).
CnssPenetration:
Guaifenesin: Limited. Pseudoephedrine: Yes (crosses blood-brain barrier, leading to CNS effects like stimulation).
Elimination:
HalfLife:
Guaifenesin: ~1 hour. Pseudoephedrine: ~4-6 hours (longer in alkaline urine).
Clearance:
Guaifenesin: Rapid. Pseudoephedrine: Primarily renal.
ExcretionRoute:
Guaifenesin: Renal (as metabolites). Pseudoephedrine: Renal (55-90% unchanged, remainder as norpseudoephedrine).
Unchanged:
Guaifenesin: <1%. Pseudoephedrine: 55-90%.
Pharmacodynamics
OnsetOfAction:
Guaifenesin: ~30 minutes. Pseudoephedrine: ~15-30 minutes.
PeakEffect:
Guaifenesin: ~1 hour. Pseudoephedrine: ~1-2 hours.
DurationOfAction:
Guaifenesin: ~4-6 hours. Pseudoephedrine: ~4-6 hours.
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 medical attention immediately:
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
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
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. Your doctor can provide medical advice on managing side effects.
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 attention immediately:
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
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
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. Your doctor can provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- If symptoms do not improve within 7 days or worsen.
- If cough is accompanied by fever, rash, or persistent headache.
- If you experience nervousness, dizziness, or sleeplessness.
- If you develop a rapid heartbeat or palpitations.
- If you have difficulty urinating.
- Signs of an allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing).
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.
Respiratory issues, such as a cough that produces a significant amount of mucus, a chronic cough caused by smoking or exposure to smoke, or lung conditions like asthma or emphysema.
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 severely 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 you experienced, including any symptoms that occurred.
Respiratory issues, such as a cough that produces a significant amount of mucus, a chronic cough caused by smoking or exposure to smoke, or lung conditions like asthma or emphysema.
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 severely 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. Adhering to the recommended treatment duration is also crucial; do not take this drug for longer than the period specified by your doctor.
When considering administration to children, note that different brands of this medication may be approved for use in various age groups. Therefore, it is crucial to consult with your doctor before giving this drug to a child to ensure the appropriate brand and dosage are used.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss your situation with your doctor. This conversation will help you understand the benefits and risks associated with taking this medication during these periods, allowing you to make an informed decision regarding your health and the health of your baby.
When considering administration to children, note that different brands of this medication may be approved for use in various age groups. Therefore, it is crucial to consult with your doctor before giving this drug to a child to ensure the appropriate brand and dosage are used.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss your situation with your doctor. This conversation will help you understand the benefits and risks associated with taking this medication during these periods, allowing you to make an informed decision regarding your health and the health of your baby.
Overdose Information
Overdose Symptoms:
- Severe nervousness, restlessness, or anxiety
- Insomnia
- Dizziness or lightheadedness
- Tremors or seizures
- Hallucinations
- Rapid or irregular heartbeat (tachycardia, arrhythmias)
- High blood pressure (hypertensive crisis)
- Nausea, vomiting
- Difficulty breathing
- Urinary retention
What to Do:
Seek immediate medical attention or call Poison Control (1-800-222-1222). Management is supportive, including gastric lavage, activated charcoal, and symptomatic treatment for cardiovascular and CNS effects.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, selegiline, tranylcypromine, linezolid, methylene blue) - concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis.
Major Interactions
- Other sympathomimetics (e.g., decongestants, appetite suppressants, amphetamines) - increased risk of cardiovascular and CNS adverse effects.
- Beta-blockers (non-selective) - may reduce antihypertensive effect and increase risk of hypertension and bradycardia.
- Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, imipramine) - may potentiate pressor effects of pseudoephedrine.
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - increased risk of vasoconstriction and hypertension.
Moderate Interactions
- Antihypertensives (e.g., methyldopa, reserpine, guanethidine) - pseudoephedrine may reduce their antihypertensive effects.
- Cardiac glycosides (e.g., digoxin) - increased risk of arrhythmias.
- Thyroid hormones - increased risk of cardiovascular effects.
- Caffeine and other CNS stimulants - increased risk of nervousness, irritability, insomnia.
Minor Interactions
- Antacids - may increase pseudoephedrine absorption.
- Kaolin - may decrease pseudoephedrine absorption.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Pseudoephedrine can increase BP and HR, especially in patients with pre-existing cardiovascular conditions.
Timing: Prior to initiation, especially in patients with hypertension or cardiac disease.
Medical History (Hypertension, Heart Disease, Diabetes, Thyroid Disease, Glaucoma, Prostate Enlargement)
Rationale: Pseudoephedrine is contraindicated or requires caution in these conditions.
Timing: Prior to initiation.
Routine Monitoring
Symptom Improvement (Nasal congestion, cough, mucus consistency)
Frequency: Daily
Target: Reduction in symptoms
Action Threshold: If symptoms worsen or persist beyond 7 days, discontinue and seek medical advice.
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Periodically, especially in patients with pre-existing cardiovascular conditions or those reporting palpitations/dizziness.
Target: Within patient's normal range
Action Threshold: Significant increase in BP/HR, or new onset of palpitations/arrhythmias, discontinue and seek medical advice.
CNS side effects (Insomnia, nervousness, dizziness)
Frequency: Daily
Target: Absence or mild, tolerable
Action Threshold: Severe or persistent CNS effects, discontinue and seek medical advice.
Symptom Monitoring
- Nasal congestion
- Cough frequency and productivity
- Sputum thickness and color
- Insomnia
- Nervousness or restlessness
- Dizziness
- Headache
- Palpitations or rapid heart rate
- Increased blood pressure
- Tremor
- Difficulty urinating (especially in men with prostate enlargement)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Pseudoephedrine has been associated with a small increased risk of gastroschisis in some studies, particularly in the first trimester. Guaifenesin is generally considered low risk but data are limited.
Trimester-Specific Risks:
First Trimester:
Pseudoephedrine: Potential small risk of gastroschisis. Guaifenesin: Limited data, generally avoided unless clearly needed.
Second Trimester:
Generally considered safer than first trimester for pseudoephedrine, but still use with caution.
Third Trimester:
Pseudoephedrine: Avoid close to term due to potential for maternal hypertension and fetal tachycardia. Guaifenesin: Generally considered low risk.
Lactation
L3 (Moderately Safe). Both guaifenesin and pseudoephedrine are excreted into breast milk. Pseudoephedrine can reduce milk supply, especially in early lactation. Monitor infant for irritability, sleep disturbances, or other adverse effects.
Infant Risk:
Low to moderate. Pseudoephedrine can cause irritability, sleep disturbances, and potentially reduce milk supply. Guaifenesin is generally considered safe for the infant, but data are limited.
Pediatric Use
Not recommended for children under 4 years of age due to potential for serious side effects and lack of proven efficacy. For children 4-12 years, use only under medical supervision and with age-appropriate dosing. Adolescents âĨ12 years can follow adult dosing. Always use pediatric formulations or consult a healthcare professional for appropriate dosing.
Geriatric Use
Use with caution. Elderly patients may be more sensitive to the cardiovascular and CNS effects of pseudoephedrine (e.g., hypertension, tachycardia, insomnia, nervousness, urinary retention). Start with the lowest effective dose and monitor closely for adverse effects. Consider pre-existing conditions like hypertension, glaucoma, or prostate enlargement.
Clinical Information
Clinical Pearls
- Advise patients to stay well-hydrated to maximize the expectorant effect of guaifenesin.
- Caution patients about potential CNS stimulation (insomnia, nervousness) from pseudoephedrine, especially if taken close to bedtime.
- Remind patients that pseudoephedrine is often kept behind the pharmacy counter due to regulations on its sale (Combat Methamphetamine Epidemic Act of 2005).
- Educate patients to check other cold/flu medications for similar active ingredients to avoid accidental overdose.
- This combination is for symptomatic relief and does not treat the underlying cause of the cold or flu.
Alternative Therapies
- Single-ingredient Guaifenesin (e.g., Mucinex)
- Single-ingredient Pseudoephedrine (e.g., Sudafed)
- Nasal saline sprays (for congestion)
- Humidifiers (for congestion and cough)
- Cough suppressants (e.g., dextromethorphan, codeine - if cough is non-productive and bothersome)
- Antihistamines (for allergy-related symptoms)
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often available over-the-counter (OTC) without prescription. If prescribed, typically Tier 1 or 2 on most insurance formularies.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 details about the medication taken, the amount, and the time it happened.