Tusnel DM Pediatric 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 gwye FEN e sin, deks troe meth OR fan, & 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
Cough and Cold Preparation; Expectorant; Antitussive; Decongestant
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Pharmacologic Class
Expectorant; NMDA Receptor Antagonist (Dextromethorphan); Alpha-1 Adrenergic Agonist (Phenylephrine)
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Pregnancy Category
Category C (based on components)
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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 is used to help relieve cough, chest congestion, and stuffy nose caused by the common cold, flu, or other breathing illnesses. Guaifenesin helps thin and loosen mucus in the lungs, making it easier to cough up. Dextromethorphan helps to reduce the urge to cough. Phenylephrine helps to clear up stuffy nose by shrinking blood vessels in the nasal passages.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience an upset stomach, taking it with food may help. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

To ensure accurate dosing, measure liquid medications carefully using the device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring tool.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding bathrooms and areas where children and pets may access it. Keep all medications in a safe location and dispose of unused or expired medications properly. Do not flush medications 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 your pharmacist, who may be aware of 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 is close to the time for your next scheduled 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 this 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 loosen mucus.
  • Use a humidifier to moisten the air.
  • Avoid irritants like smoke or strong fumes.
  • Get adequate rest.
  • Do not exceed the recommended dose.
  • Do not use for more than 7 days unless directed by a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically recommended for adult use; refer to adult formulations. If used, follow pediatric dosing guidelines for adolescents/adults based on weight/age, typically 10-20 mL every 4 hours as needed.
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Pediatric Dosing

Neonatal: Not established (Contraindicated)
Infant: Not established (Contraindicated for children under 4 years)
Child: Children 4 to under 6 years: Consult a doctor. Children 6 to under 12 years: 5-10 mL every 4 hours, not to exceed 6 doses in 24 hours. (Dosage may vary by specific product concentration, always refer to product label).
Adolescent: Children 12 years and over: 10-20 mL every 4 hours, not to exceed 6 doses in 24 hours.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; no specific dose adjustment guidelines for OTC products.
Moderate: Use with caution; no specific dose adjustment guidelines for OTC products.
Severe: Use with caution; no specific dose adjustment guidelines for OTC products. Avoid if possible.
Dialysis: Not specific guidelines; consult physician.

Hepatic Impairment:

Mild: Use with caution; no specific dose adjustment guidelines for OTC products.
Moderate: Use with caution; no specific dose adjustment guidelines for OTC products.
Severe: Use with caution; no specific dose adjustment guidelines for OTC products. Avoid if possible.
Confidence: Medium

Pharmacology

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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. 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 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: Not available (Guaifenesin: well absorbed; Dextromethorphan: well absorbed; Phenylephrine: variable oral bioavailability due to first-pass metabolism)
Tmax: Guaifenesin: ~1 hour; Dextromethorphan: ~2-2.5 hours; Phenylephrine: ~0.5-2 hours
FoodEffect: Not significantly affected by food for efficacy, but may delay absorption slightly.

Distribution:

Vd: Not available (Guaifenesin: widely distributed; Dextromethorphan: widely distributed; Phenylephrine: widely distributed)
ProteinBinding: Guaifenesin: Not significant; Dextromethorphan: ~60-70%; Phenylephrine: Not significant
CnssPenetration: Guaifenesin: Limited; Dextromethorphan: Yes (central action); Phenylephrine: Limited

Elimination:

HalfLife: Guaifenesin: ~1 hour; Dextromethorphan: ~2-4 hours (parent drug), 10-20 hours (dextrorphan); Phenylephrine: ~2-3 hours
Clearance: Not available
ExcretionRoute: Renal (primarily urine)
Unchanged: Guaifenesin: <1%; Dextromethorphan: <1% (parent drug); Phenylephrine: Variable, up to 16% unchanged
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Pharmacodynamics

OnsetOfAction: Guaifenesin: ~30 minutes; Dextromethorphan: ~15-30 minutes; Phenylephrine: ~15-30 minutes
PeakEffect: Guaifenesin: ~1 hour; Dextromethorphan: ~2-2.5 hours; Phenylephrine: ~0.5-2 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 help immediately, as they may be signs of a severe and potentially life-threatening side effect:
- 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, although not everyone will experience them. Some people may have no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
- Dizziness
- Feeling nervous and excitable
- Trouble sleeping

Important Note
This list does not include all possible 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.
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Seek Immediate Medical Attention If You Experience:

  • Cough that lasts more than 7 days or comes back
  • Cough with fever, rash, or persistent headache
  • Nervousness, dizziness, or sleeplessness
  • Rapid heart rate or palpitations
  • Difficulty urinating
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
  • Worsening symptoms
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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 you experienced, including any symptoms that occurred.
Respiratory issues, including 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, such as 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 your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Additionally, inform them about any existing health problems. 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 dosage 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. Note that different brands of this medication may be approved for use in children of various ages, so it is important to consult with your doctor before administering this drug to a child. If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe dizziness or drowsiness
  • Nausea, vomiting, stomach pain
  • Rapid heart rate, high blood pressure
  • Hallucinations, confusion, agitation
  • Seizures
  • Difficulty breathing
  • Urinary retention

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 with phenylephrine and serotonin syndrome with dextromethorphan)
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Major Interactions

  • Other sympathomimetics (e.g., pseudoephedrine, ephedrine, amphetamines) - increased cardiovascular effects
  • Tricyclic Antidepressants (TCAs) - increased pressor effects of phenylephrine
  • Beta-blockers (non-selective) - may increase pressor effects of phenylephrine
  • Serotonergic drugs (e.g., SSRIs, SNRIs, triptans) - increased risk of serotonin syndrome with dextromethorphan
  • Alcohol and other CNS depressants - increased sedation with dextromethorphan
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Moderate Interactions

  • Digoxin - increased risk of arrhythmias with phenylephrine
  • Antihypertensive drugs - phenylephrine may reduce their effect
  • Linezolid - MAOI activity, risk of serotonin syndrome/hypertensive crisis
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Minor Interactions

  • Not specific for guaifenesin

Monitoring

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Routine Monitoring

Symptom improvement (cough, congestion, mucus)

Frequency: Daily, as needed

Target: Reduction in severity and frequency of symptoms

Action Threshold: Lack of improvement after 7 days, worsening symptoms, or development of new symptoms (e.g., fever, rash, persistent headache) warrants medical evaluation.

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

Frequency: Daily, as needed

Target: Absence or mild, tolerable side effects

Action Threshold: Severe or persistent side effects, or signs of allergic reaction, require discontinuation and medical attention.

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Symptom Monitoring

  • Cough frequency and intensity
  • Nasal congestion
  • Mucus production and consistency
  • Sore throat
  • Fever
  • Headache
  • Dizziness
  • Nervousness
  • Insomnia
  • Nausea
  • Vomiting
  • Rash
  • Difficulty breathing

Special Patient Groups

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Pregnancy

Generally not recommended during pregnancy unless clearly necessary and under medical supervision. All three components are Pregnancy Category C, meaning animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, or no animal studies have been conducted and there are no adequate and well-controlled studies in humans. Consult a healthcare provider.

Trimester-Specific Risks:

First Trimester: Avoid if possible, especially phenylephrine due to potential vasoconstrictive effects.
Second Trimester: Use with caution, only if benefits outweigh risks.
Third Trimester: Use with caution, especially phenylephrine near term due to potential effects on uterine blood flow.
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Lactation

Use with caution. Guaifenesin is generally considered compatible with breastfeeding. Dextromethorphan is generally considered compatible, but high doses or prolonged use should be avoided. Phenylephrine is excreted into breast milk and may cause irritability or sleep disturbances in the infant, and may reduce milk supply. Consult a healthcare provider.

Infant Risk: L3 (Moderate risk) - potential for infant irritability, sleep disturbances, or decreased milk supply with phenylephrine. Monitor infant for adverse effects.
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Pediatric Use

Not recommended for children under 4 years of age due to potential for serious adverse effects and lack of proven efficacy. For children 4-6 years, consult a doctor. For children 6 years and older, use strictly according to label directions and age/weight-based dosing. Accidental overdose is a significant risk in young children.

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Geriatric Use

Use with caution in elderly patients, especially those with pre-existing cardiovascular conditions (hypertension, heart disease), prostate enlargement (risk of urinary retention), or glaucoma, due to the phenylephrine component. Start with the lowest effective dose and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • This product is for symptomatic relief only and does not treat the underlying cause of cough or congestion.
  • Educate parents/caregivers on the importance of accurate dosing using the provided measuring device, not household spoons.
  • Advise against using multiple cough and cold products simultaneously to avoid accidental overdose of active ingredients.
  • Phenylephrine can cause nervousness, sleeplessness, and increased blood pressure; advise patients to monitor for these effects.
  • Dextromethorphan can cause drowsiness; caution patients about driving or operating machinery.
  • If cough persists for more than 7 days, or is accompanied by fever, rash, or persistent headache, medical evaluation is necessary to rule out a more serious condition.
  • Not effective for chronic cough associated with asthma, emphysema, or smoking.
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Alternative Therapies

  • Single-ingredient Guaifenesin (expectorant)
  • Single-ingredient Dextromethorphan (cough suppressant)
  • Single-ingredient Phenylephrine (decongestant)
  • Saline nasal sprays (for congestion)
  • Humidifiers
  • Honey (for cough in children >1 year)
  • Non-pharmacological measures for cold symptoms
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Cost & Coverage

Average Cost: Varies widely by retailer and specific product size/concentration per bottle
Generic Available: Yes
Insurance Coverage: Over-the-counter (OTC) - generally not covered by prescription insurance, but may be eligible for FSA/HSA.
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.