Tusnel DM Liquid

Manufacturer LLORENS PHARMACEUTICAL Active Ingredient Guaifenesin, Dextromethorphan, and Phenylephrine Liquid(gwye FEN e sin, deks troe meth OR fan, & fen il EF rin) Pronunciation Guaifenesin (gwye FEN e sin), Dextromethorphan (deks troe meth OR fan), Phenylephrine (fen il EF rin)
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.
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Drug Class
Antitussive, Expectorant, Decongestant
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Pharmacologic Class
Opioid derivative (Dextromethorphan), Guaiacol derivative (Guaifenesin), Alpha-1 adrenergic agonist (Phenylephrine)
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medicine helps relieve coughs by thinning mucus in your airways (guaifenesin) and by calming your cough reflex (dextromethorphan). It also helps clear up stuffy nose and sinus congestion by shrinking blood vessels in your nose (phenylephrine).
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most out of your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
When taking a liquid dose, measure it carefully using the measuring device that comes with your medication. If one is not provided, ask your pharmacist for a suitable device to measure your dose accurately.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure 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, 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 your medication on a regular schedule:

Take a missed dose as soon as you remember.
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 your medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Drink plenty of fluids to help thin mucus and make coughs more productive.
  • Avoid driving or operating machinery if you experience dizziness or drowsiness.
  • Do not exceed the recommended dose.
  • Avoid alcohol while taking this medication as it can increase drowsiness.

Dosing & Administration

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Adult Dosing

Standard Dose: Dosage varies by specific product concentration. Typically, Guaifenesin 200-400 mg, Dextromethorphan 10-20 mg, Phenylephrine 5-10 mg every 4 hours as needed.

Condition-Specific Dosing:

maximumDailyDose: Guaifenesin: 2400 mg/day; Dextromethorphan: 120 mg/day; Phenylephrine: 60 mg/day
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended for children under 2 years)
Child: Dosage varies by age/weight and product concentration. Typically, for ages 6-12 years, half of adult dose. Not recommended for children under 6 years without physician consultation.
Adolescent: Similar to adult dosing, follow product-specific instructions for ages 12 years and older.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically required, use with caution.
Moderate: Use with caution; monitor for increased side effects, especially with phenylephrine.
Severe: Use with caution; consider dose reduction or avoidance due to potential accumulation of metabolites, especially for dextromethorphan and phenylephrine.
Dialysis: Considerations: Not well studied for combination. Avoid or use with extreme caution.

Hepatic Impairment:

Mild: No specific adjustment typically required.
Moderate: Use with caution; consider dose reduction for dextromethorphan and phenylephrine due to impaired metabolism.
Severe: Use with caution; significant dose reduction or avoidance may be necessary for dextromethorphan and phenylephrine due to impaired metabolism and increased risk of adverse effects.

Pharmacology

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Mechanism of Action

Guaifenesin is an expectorant that works by increasing the volume and decreasing the viscosity of secretions in the respiratory tract, making coughs more productive. Dextromethorphan is an antitussive that acts centrally on the cough center in the medulla to elevate the cough threshold. Phenylephrine is a direct-acting sympathomimetic amine that primarily acts as an alpha-1 adrenergic agonist, causing vasoconstriction in the nasal mucosa, leading to reduced swelling and congestion.
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Pharmacokinetics

Absorption:

Bioavailability: Guaifenesin: Rapidly absorbed; Dextromethorphan: Rapidly absorbed; Phenylephrine: Variable oral bioavailability (approx. 38%) due to first-pass metabolism.
Tmax: Guaifenesin: ~1 hour; Dextromethorphan: ~2 hours; Phenylephrine: ~1-2 hours
FoodEffect: Generally not significantly affected by food, but may delay absorption slightly.

Distribution:

Vd: Guaifenesin: Not well-defined; Dextromethorphan: Large Vd; Phenylephrine: Not well-defined
ProteinBinding: Guaifenesin: Not significant; Dextromethorphan: ~60-70%; Phenylephrine: Not significant
CnssPenetration: Guaifenesin: Limited; Dextromethorphan: Yes (central action); Phenylephrine: Limited (due to polarity)

Elimination:

HalfLife: Guaifenesin: ~1 hour; Dextromethorphan: ~2-4 hours (parent drug), 10-20 hours (dextrorphan); Phenylephrine: ~2-3 hours
Clearance: Guaifenesin: Rapid; Dextromethorphan: Variable, dependent on CYP2D6 activity; Phenylephrine: Rapid
ExcretionRoute: Renal (primarily metabolites)
Unchanged: Guaifenesin: <1%; Dextromethorphan: <1% (parent drug); Phenylephrine: <16%
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Pharmacodynamics

OnsetOfAction: Guaifenesin: ~30 minutes; Dextromethorphan: ~15-30 minutes; Phenylephrine: ~15-30 minutes
PeakEffect: Guaifenesin: ~1 hour; Dextromethorphan: ~2 hours; Phenylephrine: ~1-2 hours
DurationOfAction: Guaifenesin: ~4-6 hours; Dextromethorphan: ~5-6 hours; Phenylephrine: ~4 hours
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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
Most medications can cause side effects, but many people either do not experience them or have only mild symptoms. If you encounter any of the following side effects, or if any other side effects bother you or do not go away, contact your doctor for advice:
- Dizziness
- Feeling nervous and excitable
- Trouble sleeping

Important Note: This list does not include all possible side effects. If you have concerns about side effects, consult your doctor. For medical advice regarding 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.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms worsen or last more than 7 days (or 5 days for children)
  • Cough returns or is accompanied by fever, rash, or persistent headache
  • Nervousness, dizziness, or sleeplessness
  • Significant increase in blood pressure or heart rate
  • Allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
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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 to this medication, its components, or other substances, including foods and drugs. Be sure to describe the allergic reaction you experienced.
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.
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 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.
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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.
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Overdose Information

Overdose Symptoms:

  • Drowsiness, dizziness, confusion
  • Nausea, vomiting, stomach pain
  • Rapid heart rate, palpitations, high blood pressure
  • Nervousness, restlessness, tremors
  • Hallucinations, agitation, seizures (especially with high doses of dextromethorphan)
  • Difficulty breathing

What to Do:

Seek immediate medical attention or call Poison Control (1-800-222-1222). Bring the product packaging with you.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOIs due to risk of hypertensive crisis and serotonin syndrome with phenylephrine and dextromethorphan respectively)
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Major Interactions

  • Other sympathomimetics (e.g., pseudoephedrine, ephedrine) - increased risk of cardiovascular effects
  • Beta-blockers (non-selective) - may increase pressor response of phenylephrine
  • Tricyclic antidepressants (TCAs) - may potentiate pressor effects of phenylephrine
  • Serotonergic drugs (e.g., SSRIs, SNRIs, triptans) - increased risk of serotonin syndrome with dextromethorphan
  • CNS depressants (e.g., alcohol, sedatives, hypnotics, opioids) - increased CNS depression with dextromethorphan
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Moderate Interactions

  • Digoxin - increased risk of arrhythmias with phenylephrine
  • Alpha-adrenergic blocking agents - may reduce decongestant effect of phenylephrine
  • Antihypertensive drugs - phenylephrine may reduce their effect
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Minor Interactions

  • None specifically noted for minor severity with this combination.

Monitoring

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Routine Monitoring

Symptom relief (cough, congestion)

Frequency: Daily, as needed

Target: Improved comfort, reduced symptoms

Action Threshold: If symptoms worsen or persist beyond 7 days, seek medical attention.

Blood pressure (especially in patients with hypertension)

Frequency: As needed, if concerns arise

Target: Within patient's normal range

Action Threshold: Significant increase in blood pressure, seek medical attention.

Heart rate

Frequency: As needed, if concerns arise

Target: Within patient's normal range

Action Threshold: Palpitations, significant increase in heart rate, seek medical attention.

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Symptom Monitoring

  • Effectiveness of cough suppression and decongestion
  • Presence of dizziness or drowsiness
  • Nervousness, restlessness, or insomnia
  • Headache
  • Nausea or vomiting
  • Increased blood pressure or heart rate

Special Patient Groups

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Pregnancy

Generally considered Category C. Use only if the potential benefit justifies the potential risk to the fetus. Consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Limited data, generally advised to avoid unnecessary medications.
Second Trimester: May be used cautiously if benefits outweigh risks.
Third Trimester: May be used cautiously, but phenylephrine should be used with caution due to potential vasoconstrictive effects on uterine blood flow.
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Lactation

Use with caution. All components are excreted into breast milk. Guaifenesin and phenylephrine are L3 (moderately safe), Dextromethorphan is L2 (safer). Monitor infant for drowsiness, irritability, or feeding difficulties.

Infant Risk: Low to moderate risk of drowsiness, irritability, or mild gastrointestinal upset in the infant. Phenylephrine may theoretically reduce milk supply.
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Pediatric Use

Not recommended for children under 6 years of age. For children 6-12 years, use only under the guidance of a healthcare professional and follow specific product dosing for children. Overdose risk is higher in young children.

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Geriatric Use

Use with caution. Elderly patients may be more sensitive to the adverse effects of phenylephrine (e.g., increased blood pressure, CNS stimulation) and dextromethorphan (e.g., drowsiness, dizziness). Start with lower doses and monitor closely.

Clinical Information

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Clinical Pearls

  • Advise patients to read the label carefully to avoid accidental overdose, especially with other cough/cold products.
  • Emphasize the importance of hydration to maximize guaifenesin's expectorant effect.
  • Counsel patients on potential CNS side effects (drowsiness, dizziness) and to avoid activities requiring mental alertness until effects are known.
  • Warn patients about the risk of serotonin syndrome if combining with other serotonergic agents, and the absolute contraindication with MAOIs.
  • Phenylephrine is less effective orally as a decongestant compared to pseudoephedrine due to extensive first-pass metabolism, but it is available OTC without restriction.
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Alternative Therapies

  • Single-ingredient Guaifenesin (for expectorant effect)
  • Single-ingredient Dextromethorphan (for cough suppression)
  • Single-ingredient Phenylephrine (for decongestion)
  • Saline nasal sprays (for congestion)
  • Humidifiers (for cough and congestion)
  • Honey (for cough relief)
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Cost & Coverage

Average Cost: Varies widely by brand and formulation (e.g., $5-$20) per bottle (e.g., 4 fl oz)
Generic Available: Yes
Insurance Coverage: Generally not covered by prescription insurance as it is an over-the-counter (OTC) medication, but may be eligible for FSA/HSA.
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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's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.