Tusnel Pediatric Liquid

Manufacturer LLORENS PHARMACEUTICAL Active Ingredient Guaifenesin, Pseudoephedrine, and Dextromethorphan Liquid(gwye FEN e sin, soo doe e FED rin, & deks troe meth OR fan) Pronunciation Guaifenesin (gwye FEN e sin), Pseudoephedrine (soo doe e FED rin), Dextromethorphan (deks troe meth OR fan)
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
Cough and Cold Preparation
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Pharmacologic Class
Expectorant; Decongestant; Antitussive
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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 medication is a combination product used to relieve symptoms of the common cold, flu, or other respiratory illnesses. Guaifenesin helps thin and loosen mucus in the lungs, making it easier to cough up. Pseudoephedrine helps clear stuffy noses by reducing swelling in the nasal passages. Dextromethorphan helps reduce the urge to cough.
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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 maintain the effectiveness and safety of your medication:

Store it at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a safe and 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, who may be aware of 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 the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular dosing 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 (water, juice) to help thin mucus and stay hydrated.
  • Get adequate rest to aid recovery.
  • Avoid irritants like smoke or strong fumes.
  • Use a humidifier to help soothe irritated airways.

Dosing & Administration

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Adult Dosing

Standard Dose: Dosage varies by specific product concentration. Typically, for components: Guaifenesin 200-400 mg every 4 hours; Pseudoephedrine 30-60 mg every 4-6 hours; Dextromethorphan 10-20 mg every 4 hours. Max daily doses apply.

Condition-Specific Dosing:

maxDailyDose: Guaifenesin: 2400 mg; Pseudoephedrine: 240 mg; Dextromethorphan: 120 mg
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Pediatric Dosing

Neonatal: Not established (generally not recommended for children under 2-4 years)
Infant: Not established (generally not recommended for children under 2-4 years)
Child: Dosage varies by specific product concentration and age/weight. Common guidelines for children 6-11 years: Guaifenesin 100-200 mg every 4 hours (max 1200 mg/day); Pseudoephedrine 30 mg every 4-6 hours (max 120 mg/day); Dextromethorphan 5-10 mg every 4 hours (max 60 mg/day). For children 4-5 years, doses are typically half of the 6-11 year old dose. Always follow product-specific instructions.
Adolescent: Typically adult dosing for ages 12 years and older.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically required.
Moderate: Use with caution. Pseudoephedrine clearance may be reduced; consider extended dosing intervals or lower doses.
Severe: Use with caution; consider dose reduction or extended dosing intervals, especially for Pseudoephedrine and Dextromethorphan. Pseudoephedrine clearance is significantly reduced.
Dialysis: Pseudoephedrine is dialyzable to some extent. Dextromethorphan and Guaifenesin are not well studied in dialysis patients; use with caution and monitor for adverse effects.

Hepatic Impairment:

Mild: No specific adjustment typically required.
Moderate: Use with caution. Dextromethorphan is metabolized by CYP2D6; consider lower doses or extended intervals.
Severe: Use with caution; consider dose reduction or extended dosing intervals, especially for Dextromethorphan due to impaired metabolism.

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 trachea and bronchi, thereby facilitating the removal of mucus through ciliary action and coughing. Pseudoephedrine is a sympathomimetic amine that acts as a direct and indirect agonist on adrenergic receptors. It causes vasoconstriction in the nasal mucosa, leading to reduced swelling and congestion. Dextromethorphan is an antitussive agent that acts centrally on the cough center in the medulla to elevate the cough threshold. It is a sigma-1 receptor agonist and an NMDA receptor antagonist, and at higher doses, it can inhibit serotonin reuptake.
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Pharmacokinetics

Absorption:

Bioavailability: High for all components (well absorbed orally)
Tmax: Guaifenesin: ~1 hour; Pseudoephedrine: 1-2 hours; Dextromethorphan: 2-3 hours
FoodEffect: Minimal or no significant effect on absorption for all components.

Distribution:

Vd: Guaifenesin: Not well characterized; Pseudoephedrine: 2.6-3.5 L/kg; Dextromethorphan: Large (suggests extensive tissue distribution)
ProteinBinding: Guaifenesin: Not significant; Pseudoephedrine: Minimal (~10%); Dextromethorphan: Not significant
CnssPenetration: Yes (Dextromethorphan, Pseudoephedrine); Limited (Guaifenesin)

Elimination:

HalfLife: Guaifenesin: ~1 hour; Pseudoephedrine: 4-6 hours (pH dependent); Dextromethorphan: 2-4 hours (parent), 10-20 hours (dextrorphan)
Clearance: Not precisely quantified for combination, but rapid for Guaifenesin, moderate for Pseudoephedrine and Dextromethorphan.
ExcretionRoute: Renal (primarily urine)
Unchanged: Guaifenesin: <1%; Pseudoephedrine: 55-90% (pH dependent); Dextromethorphan: <1% (parent), significant portion as metabolites.
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Pharmacodynamics

OnsetOfAction: Guaifenesin: ~30 minutes; Pseudoephedrine: 15-30 minutes; Dextromethorphan: 15-30 minutes
PeakEffect: Guaifenesin: ~1 hour; Pseudoephedrine: 1-2 hours; Dextromethorphan: 2-3 hours
DurationOfAction: Guaifenesin: ~4 hours; Pseudoephedrine: 4-6 hours; Dextromethorphan: 4-6 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while 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

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 persist, contact your doctor for guidance:

Dizziness
Trouble sleeping
Feeling nervous and excitable

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to 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 do not improve within 5-7 days (children) or 7 days (adults).
  • Cough returns or occurs with fever, rash, or persistent headache.
  • Nervousness, dizziness, or sleeplessness.
  • Rapid heartbeat or palpitations.
  • Severe nausea, vomiting, or stomach pain.
  • Signs of an 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, 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 lead to very 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 lot 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 disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure 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 weigh the benefits and risks of taking this medication to both you and your baby, allowing for an informed decision about your treatment.
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Overdose Information

Overdose Symptoms:

  • Drowsiness, dizziness, confusion, hallucinations (especially with dextromethorphan)
  • Nausea, vomiting, stomach upset
  • Rapid heart rate, palpitations, high blood pressure (pseudoephedrine)
  • Nervousness, restlessness, tremors, seizures (pseudoephedrine)
  • Difficulty breathing
  • Serotonin syndrome symptoms (agitation, confusion, rapid heart rate, sweating, muscle rigidity, tremors, uncoordinated movements)

What to Do:

Seek immediate medical attention or call a poison control center (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 with pseudoephedrine and serotonin syndrome with dextromethorphan)
  • Other sympathomimetics (e.g., other decongestants, appetite suppressants, amphetamines) (additive pressor effects)
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, St. John's Wort) (increased risk of serotonin syndrome with dextromethorphan)
  • Beta-blockers (reduced antihypertensive effect of beta-blockers, increased risk of hypertension with pseudoephedrine)
  • Tricyclic Antidepressants (TCAs) (potentiate pressor effects of pseudoephedrine)
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, amiodarone, bupropion) (can significantly increase dextromethorphan levels, leading to increased adverse effects and serotonin syndrome risk)
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Moderate Interactions

  • Antihypertensive agents (pseudoephedrine may reduce the effect of antihypertensives)
  • Digitalis glycosides (pseudoephedrine may increase risk of ectopic pacemaker activity)
  • Alcohol and other CNS depressants (additive CNS depression with dextromethorphan)
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Minor Interactions

  • Urinary acidifiers (e.g., ammonium chloride) (may increase pseudoephedrine excretion)
  • Urinary alkalinizers (e.g., sodium bicarbonate) (may decrease pseudoephedrine excretion)

Monitoring

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Routine Monitoring

Symptom resolution (cough, congestion)

Frequency: Daily during treatment

Target: Improvement or resolution of symptoms

Action Threshold: Worsening symptoms, no improvement after 7 days (adults) or 5 days (children), or development of new symptoms (e.g., fever, rash, persistent headache)

Adverse effects (e.g., insomnia, nervousness, dizziness, nausea)

Frequency: Daily during treatment

Target: Absence or mild, tolerable effects

Action Threshold: Severe or persistent adverse effects

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Symptom Monitoring

  • Cough frequency and severity
  • Nasal congestion and discharge
  • Sore throat (if present)
  • Fever (if present)
  • Sleep patterns
  • Irritability or restlessness (especially in children)
  • Nausea or stomach upset

Special Patient Groups

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Pregnancy

Generally classified as Pregnancy 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; pseudoephedrine use in the first trimester has been inconsistently linked to minor birth defects in some studies, though overall risk is considered low.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Pseudoephedrine should be used with caution, especially near term, due to potential for vasoconstriction and effects on uterine blood flow. Dextromethorphan and guaifenesin are generally considered low risk.
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Lactation

Lactation Risk L3 (Moderate Concern). All three components are excreted into breast milk. Pseudoephedrine can decrease milk supply and may cause irritability in the infant. Dextromethorphan and guaifenesin are generally considered compatible with caution, but infant monitoring for drowsiness or irritability is advised. Consult a healthcare provider.

Infant Risk: Irritability, restlessness, or drowsiness in the infant; potential for decreased milk supply.
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Pediatric Use

Not recommended for children under 2 years of age due to potential for serious side effects. For children 2-11 years, use only products specifically formulated for their age group and follow dosing instructions carefully. Always use a measuring device provided with the product. Overdosing can be dangerous.

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Geriatric Use

Elderly patients may be more sensitive to the effects of pseudoephedrine (e.g., increased blood pressure, insomnia, urinary retention) and dextromethorphan (e.g., dizziness, sedation). Use with caution and consider lower starting doses.

Clinical Information

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Clinical Pearls

  • Educate patients that this product treats symptoms, not the underlying cause of the cold or flu.
  • Advise against using this product for chronic cough (e.g., asthma, emphysema) unless directed by a doctor.
  • Stress the importance of accurate dosing, especially in children, using the provided measuring device.
  • Warn patients about potential for drowsiness or dizziness, and to avoid driving or operating machinery until they know how the medication affects them.
  • Remind patients to check other OTC medications for similar active ingredients to avoid accidental overdose.
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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)
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Cost & Coverage

Average Cost: Price varies widely by retailer and specific product size/concentration per bottle
Generic Available: Yes
Insurance Coverage: Often not covered by prescription plans as it's an OTC product, 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 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 it's a good idea to check with your pharmacist. 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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.