Poly-Vent DM 60-20-380mg Tablets
It is used to treat nose stuffiness.It is used to thin mucus so it can be taken from the body by coughing.It is used to relieve coughing.
Drug Class
Cold, Cough, and Allergy Preparation; Expectorant, Decongestant, Antitussive
Pharmacologic Class
Expectorant; Alpha-adrenergic Agonist; NMDA Receptor Antagonist (Antitussive)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Poly-Vent DM is a medication used to relieve symptoms of the common cold, flu, or allergies. It contains three active ingredients: Guaifenesin helps thin and loosen mucus in your lungs, making it easier to cough up. Pseudoephedrine helps clear up stuffy nose and sinus congestion. Dextromethorphan helps reduce coughing.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort. It's also important to 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. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it's almost time for your next dose, skip the missed dose and continue with 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 prescription and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort. It's also important to 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. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it's almost time for your next dose, skip the missed dose and continue with 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, clear broths) to help thin mucus and stay hydrated.
- Avoid alcohol while taking this medication, as it can increase drowsiness and other side effects.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
- Do not take with other medications containing pseudoephedrine, dextromethorphan, or guaifenesin to avoid accidental overdose.
- Do not use for persistent or chronic cough (e.g., from smoking, asthma, emphysema) or if cough is accompanied by excessive phlegm, unless directed by a doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 tablet (Guaifenesin 380mg, Pseudoephedrine 60mg, Dextromethorphan 20mg) orally every 4 to 6 hours as needed
Dose Range:
1 - 4 mg
Condition-Specific Dosing:
maximumDailyDose:
Do not exceed 4 tablets in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age due to pseudoephedrine and dextromethorphan content. For children 6-12 years, consult a physician.
Adolescent:
12 years and older: Same as adult dosing
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Use with caution; consider dose reduction or extended dosing interval. Pseudoephedrine and Dextromethorphan are renally excreted.
Severe:
Contraindicated or significant dose reduction/extended interval required. Consult physician. Pseudoephedrine and Dextromethorphan accumulate.
Dialysis:
Not well studied; generally avoid or use with extreme caution. Pseudoephedrine is dialyzable to some extent.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution; consider dose reduction for dextromethorphan due to hepatic metabolism.
Severe:
Use with caution; consider dose reduction or extended interval for dextromethorphan. Pseudoephedrine and guaifenesin are less affected by hepatic impairment.
Confidence:
Medium
Pharmacology
Mechanism of Action
Guaifenesin acts as an expectorant by increasing the volume and decreasing the viscosity of respiratory tract secretions, facilitating their removal by ciliary action and coughing. Pseudoephedrine is a sympathomimetic amine that acts directly and indirectly on adrenergic receptors, primarily alpha-adrenergic receptors in the respiratory mucosa, causing vasoconstriction and reducing nasal congestion. Dextromethorphan is a non-opioid antitussive that acts centrally on the cough center in the medulla to elevate the cough threshold.
Pharmacokinetics
Absorption:
Bioavailability:
Guaifenesin: Rapidly absorbed; Pseudoephedrine: Well absorbed (90-100%); Dextromethorphan: Rapidly absorbed
Tmax:
Guaifenesin: ~1 hour; Pseudoephedrine: 1-2 hours; Dextromethorphan: 2-2.5 hours
FoodEffect:
Minimal effect on absorption for all components.
Distribution:
Vd:
Guaifenesin: Not extensively distributed; Pseudoephedrine: ~2.5 L/kg; Dextromethorphan: Large Vd (5-6 L/kg)
ProteinBinding:
Guaifenesin: ~30%; Pseudoephedrine: Minimal (<10%); Dextromethorphan: ~60-70%
CnssPenetration:
Guaifenesin: Limited; Pseudoephedrine: Yes; Dextromethorphan: Yes
Elimination:
HalfLife:
Guaifenesin: ~1 hour; Pseudoephedrine: 9-16 hours (pH dependent); Dextromethorphan: 1.4-3.9 hours (extensive metabolizers), up to 45 hours (poor metabolizers)
Clearance:
Not available
ExcretionRoute:
Guaifenesin: Renal (metabolites); Pseudoephedrine: Renal (55-75% unchanged); Dextromethorphan: Renal (metabolites and unchanged drug)
Unchanged:
Guaifenesin: <1%; Pseudoephedrine: 55-75%; Dextromethorphan: <1% (extensive metabolizers)
Pharmacodynamics
OnsetOfAction:
Guaifenesin: ~30 minutes; Pseudoephedrine: 15-30 minutes; Dextromethorphan: 15-30 minutes
PeakEffect:
Guaifenesin: ~1 hour; Pseudoephedrine: 1-2 hours; Dextromethorphan: 2-2.5 hours
DurationOfAction:
Guaifenesin: ~4-6 hours; Pseudoephedrine: 4-6 hours; Dextromethorphan: 4-6 hours
Confidence:
Medium
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, or 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
- Trouble sleeping
- Feeling nervous and excitable
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, 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, or 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
- Trouble sleeping
- Feeling nervous and excitable
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, 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:
- Chest pain or palpitations
- Severe dizziness or lightheadedness
- Persistent headache
- Nervousness, restlessness, or difficulty sleeping that is severe
- Rash or itching
- Difficulty breathing
- Signs of serotonin syndrome (agitation, confusion, rapid heart rate, sweating, muscle stiffness, twitching, shivering, diarrhea)
- If symptoms do not improve within 7 days or are accompanied by fever, rash, or persistent headache, consult a doctor.
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. 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, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications may interact with this drug.
If you have a cough that produces a significant amount of mucus, a chronic cough caused by smoking or exposure to smoke, or lung conditions such as asthma or emphysema.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage 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. 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, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications may interact with this drug.
If you have a cough that produces a significant amount of mucus, a chronic cough caused by smoking or exposure to smoke, or lung conditions such as asthma or emphysema.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage 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 weigh the benefits and risks of taking this medication to both you and your baby, allowing for an informed decision about your treatment.
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 weigh the benefits and risks of taking this medication to both you and your baby, allowing for an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Severe dizziness or drowsiness
- Nervousness, restlessness, or tremors
- Seizures
- Hallucinations
- Rapid or irregular heartbeat
- High blood pressure
- Nausea, vomiting
- Difficulty breathing
- Coma
What to Do:
In case of overdose, seek immediate medical attention. Call 911 or your local poison control center (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 and serotonin syndrome.
Major Interactions
- Other sympathomimetics (e.g., decongestants, appetite suppressants, amphetamines) - additive cardiovascular effects.
- Beta-adrenergic blockers (non-selective) - may reduce pseudoephedrine's effect and increase risk of hypertension.
- Tricyclic Antidepressants (TCAs) - may potentiate pseudoephedrine's pressor effects.
- Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), Triptans, other serotonergic drugs - increased risk of serotonin syndrome with dextromethorphan.
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - may increase dextromethorphan levels and toxicity.
Moderate Interactions
- Antihypertensive agents (e.g., methyldopa, reserpine, guanethidine) - pseudoephedrine may reduce their hypotensive effects.
- CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics) - additive CNS depression with dextromethorphan.
- Digoxin - pseudoephedrine may increase risk of arrhythmias.
- Linezolid - potential for serotonin syndrome with dextromethorphan.
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.
Routine Monitoring
Symptom relief (cough, congestion)
Frequency: Daily, as needed
Target: Improved symptoms
Action Threshold: Lack of improvement after 7 days, or worsening symptoms, warrants medical evaluation.
Adverse effects (e.g., insomnia, nervousness, dizziness, elevated BP/HR)
Frequency: Daily, as needed
Target: Absence or mild, tolerable effects
Action Threshold: Severe or persistent adverse effects, or signs of serotonin syndrome, require immediate medical attention.
Symptom Monitoring
- Cough frequency and severity
- Nasal congestion
- Sputum production and character
- Blood pressure
- Heart rate
- Sleep patterns (insomnia)
- Nervousness/restlessness
- Dizziness
- Nausea/vomiting
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart beat, fever, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended unless clearly needed and the potential benefits outweigh the potential risks. All three components are Pregnancy Category C.
Trimester-Specific Risks:
First Trimester:
Pseudoephedrine use in the first trimester has been associated with a small increased risk of gastroschisis and other vascular disruption defects in some studies, though data are conflicting. Dextromethorphan and guaifenesin are generally considered low risk.
Second Trimester:
Generally considered safer than first trimester, but caution still advised.
Third Trimester:
Pseudoephedrine use near term may cause maternal hypertension or fetal tachycardia. Dextromethorphan and guaifenesin are generally considered low risk.
Lactation
Not recommended during breastfeeding due to the presence of pseudoephedrine, which can pass into breast milk and may cause irritability or sleep disturbances in the infant, and may decrease milk supply. Dextromethorphan and guaifenesin also pass into breast milk.
Infant Risk:
L3 (Moderate risk). Pseudoephedrine can cause irritability, sleep disturbances in infants, and may reduce milk supply. Dextromethorphan and its active metabolite dextrorphan are present in milk, but infant effects are generally not reported with usual doses. Guaifenesin is present in milk, but infant effects are not reported.
Pediatric Use
Not recommended for children under 12 years of age. For children 6-12 years, use only under the guidance of a healthcare professional due to potential risks of pseudoephedrine and dextromethorphan, including overdose and adverse effects. Always use pediatric-specific formulations and dosing if available and appropriate.
Geriatric Use
Use with caution in elderly patients, who may be more susceptible to the adverse effects of pseudoephedrine (e.g., hypertension, insomnia, nervousness) and dextromethorphan (e.g., dizziness, sedation). Start with lower doses and monitor closely for adverse effects, especially in those with pre-existing cardiovascular conditions, glaucoma, or prostatic hypertrophy.
Clinical Information
Clinical Pearls
- Advise patients to stay well-hydrated to maximize the expectorant effect of guaifenesin.
- Caution patients about the potential for CNS stimulation (nervousness, insomnia) from pseudoephedrine and CNS depression (drowsiness, dizziness) from dextromethorphan, which can be additive.
- Emphasize the importance of checking labels of other OTC cold/flu medications to avoid duplicating ingredients and accidental overdose.
- Patients with hypertension, heart disease, thyroid disease, diabetes, or prostatic enlargement should consult a physician before using this product due to pseudoephedrine content.
- Educate patients on the signs of serotonin syndrome, especially if they are taking other serotonergic medications.
Alternative Therapies
- Single-ingredient expectorants (e.g., guaifenesin)
- Single-ingredient decongestants (e.g., pseudoephedrine, phenylephrine)
- Single-ingredient antitussives (e.g., dextromethorphan, benzonatate)
- Non-pharmacological treatments (e.g., saline nasal sprays, humidifiers, honey for cough, rest, fluids)
Cost & Coverage
Average Cost:
Not available (varies widely) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often OTC, but prescription versions may be covered)
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 occurred.