Tusnel Pediatric Drops
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 / Sympathomimetic (Pseudoephedrine)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled (Pseudoephedrine has sales restrictions)
Overview
What is this medicine?
This medicine is a combination of two drugs: Guaifenesin, which helps thin and loosen mucus in your lungs, making it easier to cough up. Pseudoephedrine is a decongestant that helps shrink swollen blood vessels in your nose, relieving stuffiness. It's used to help relieve chest congestion and nasal stuffiness caused by the common cold, flu, or allergies.
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 essential to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. When taking the liquid form of this medication, measure your dose accurately using the measuring 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 the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of any unused or expired medication properly. Do not flush medication 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 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 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 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.
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 essential to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. When taking the liquid form of this medication, measure your dose accurately using the measuring 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 the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of any unused or expired medication properly. Do not flush medication 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 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 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 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.
Lifestyle & Tips
- Drink plenty of fluids (water, juice) to help thin mucus.
- Use a humidifier to moisten the air.
- Get adequate rest.
- Avoid irritants like smoke or allergens.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable for 'Pediatric Drops' formulation. Adult formulations typically 200-400 mg Guaifenesin / 30-60 mg Pseudoephedrine every 4-6 hours.
Pediatric Dosing
Neonatal:
Not established (Contraindicated for children under 2 years)
Infant:
Not established (Contraindicated for children under 2 years)
Child:
Specific dosing varies by product concentration. Typically for children 6 to under 12 years: 5 mL (e.g., 100 mg Guaifenesin / 15 mg Pseudoephedrine) every 4-6 hours, not to exceed 4 doses in 24 hours. For children 2 to under 6 years: Consult a physician; generally not recommended without medical advice. Dosing for this age group is typically half of the 6-12 year old dose (e.g., 2.5 mL).
Adolescent:
Typically treated as adult dosing, but specific pediatric formulations may have different concentrations. Follow product label for children 12 years and older.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required, but use with caution.
Moderate:
Use with caution; consider reduced dose or extended interval due to pseudoephedrine excretion.
Severe:
Contraindicated or significant dose reduction required due to pseudoephedrine accumulation. Consult physician.
Dialysis:
Not well studied; likely removed by dialysis. Avoid or use with extreme caution.
Hepatic Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
No specific adjustment required, but use with caution in severe liver disease due to potential for altered drug metabolism/elimination.
Pharmacology
Mechanism of Action
Guaifenesin acts as an expectorant by increasing the volume and decreasing the viscosity of respiratory tract secretions, making coughs more productive and helping to clear airways. Pseudoephedrine is a sympathomimetic amine that acts directly and indirectly on adrenergic receptors. It causes vasoconstriction in the nasal mucosa, reducing swelling and congestion.
Pharmacokinetics
Absorption:
Bioavailability:
Guaifenesin: Well absorbed orally, ~60-90%. Pseudoephedrine: Well absorbed orally, ~100%.
Tmax:
Guaifenesin: ~1 hour. Pseudoephedrine: ~0.5-2 hours.
FoodEffect:
Guaifenesin: Minimal effect. Pseudoephedrine: Minimal effect, may slightly delay absorption.
Distribution:
Vd:
Guaifenesin: Not extensively studied, but widely distributed. Pseudoephedrine: ~2.6-3.5 L/kg.
ProteinBinding:
Guaifenesin: ~10-20%. Pseudoephedrine: Minimal (~10-20%).
CnssPenetration:
Guaifenesin: Limited. Pseudoephedrine: Yes (can cause CNS stimulation).
Elimination:
HalfLife:
Guaifenesin: ~1 hour. Pseudoephedrine: ~4-6 hours (longer in alkaline urine).
Clearance:
Not readily available for combination, varies by individual.
ExcretionRoute:
Guaifenesin: Primarily renal (as metabolites). Pseudoephedrine: Primarily 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
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
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
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.
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
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
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.
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.
- Fast or pounding heartbeat.
- Difficulty urinating.
- Any signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, 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.
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 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 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.
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.
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 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 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.
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 this medication for a child, note that different brands may be suitable for different age groups. Therefore, it is crucial to consult with your doctor before administering this drug to a child.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. A discussion about the potential benefits and risks of this medication to both you and your baby is necessary to make an informed decision.
When considering this medication for a child, note that different brands may be suitable for different age groups. Therefore, it is crucial to consult with your doctor before administering this drug to a child.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. A discussion about the potential benefits and risks of this medication to both you and your baby is necessary to make an informed decision.
Overdose Information
Overdose Symptoms:
- Severe dizziness or lightheadedness
- Extreme nervousness, restlessness, or irritability
- Hallucinations
- Seizures
- Rapid or irregular heartbeat
- High blood pressure
- Difficulty breathing
- Nausea, vomiting
What to Do:
Seek immediate medical attention or call Poison Control (1-800-222-1222). Bring the medication bottle with you.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis.
Major Interactions
- Beta-blockers (non-selective) - risk of hypertension and bradycardia.
- Tricyclic Antidepressants (TCAs) - enhanced pressor effect of pseudoephedrine.
- Other sympathomimetics (e.g., decongestants, appetite suppressants, amphetamines) - additive cardiovascular effects.
- Ergot alkaloids (e.g., ergotamine, methysergide) - increased risk of vasoconstriction.
Moderate Interactions
- Antihypertensives (e.g., methyldopa, reserpine, guanethidine) - pseudoephedrine may reduce their effect.
- Digitalis glycosides - increased risk of ectopic pacemaker activity.
- Urinary alkalinizers (e.g., sodium bicarbonate, antacids) - may increase pseudoephedrine half-life and duration of action.
- Urinary acidifiers (e.g., ammonium chloride) - may decrease pseudoephedrine half-life.
Minor Interactions
- Not readily available for minor interactions specific to this combination.
Monitoring
Routine Monitoring
Symptom resolution (cough, congestion)
Frequency: Daily
Target: Improvement or resolution 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.
Symptom Monitoring
- Effectiveness in reducing cough and congestion
- Signs of adverse effects (e.g., nervousness, sleeplessness, dizziness, headache, increased heart rate, elevated blood pressure)
- Signs of allergic reaction (e.g., rash, itching, swelling)
- Changes in cough characteristics (e.g., productive vs. dry, color of mucus)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Pseudoephedrine use in the first trimester has been associated with a small increased risk of gastroschisis and other vascular disruptions, though data are conflicting. Guaifenesin is generally considered low risk.
Trimester-Specific Risks:
First Trimester:
Pseudoephedrine: Possible small increased risk of certain birth defects (e.g., gastroschisis, limb reduction defects). Guaifenesin: Generally considered low risk.
Second Trimester:
Pseudoephedrine: Generally considered safer than first trimester, but still use with caution. Guaifenesin: Low risk.
Third Trimester:
Pseudoephedrine: May cause maternal hypertension or fetal tachycardia; avoid close to term. Guaifenesin: Low risk.
Lactation
Pseudoephedrine is excreted into breast milk and may cause irritability or sleep disturbances in the infant, and may decrease milk supply. Guaifenesin is also excreted into breast milk, but in small amounts and is generally considered compatible with breastfeeding. Use with caution; monitor infant for adverse effects.
Infant Risk:
Pseudoephedrine: Irritability, sleep disturbances, potential for decreased milk supply. Guaifenesin: Low risk of adverse effects.
Pediatric Use
Not recommended for children under 2 years of age due to potential for serious side effects. For children 2-12 years, use only under the guidance of a healthcare professional and strictly follow age-appropriate dosing on the product label. Overdosing in young children can be fatal.
Geriatric Use
Use with caution in elderly patients due to increased sensitivity to pseudoephedrine's effects (e.g., CNS stimulation, cardiovascular effects, urinary retention). Start with lower doses and monitor closely, especially in those with pre-existing cardiovascular conditions, hypertension, or prostatic hypertrophy.
Clinical Information
Clinical Pearls
- Always use the provided measuring device (dropper or dosing cup) for pediatric formulations to ensure accurate dosing.
- Educate parents/caregivers on the importance of not exceeding recommended doses and avoiding other products containing pseudoephedrine or guaifenesin.
- Advise against use in children under 2 years of age unless specifically directed by a physician.
- Pseudoephedrine can be diverted for illicit methamphetamine production; be aware of sales restrictions.
- Hydration is key for guaifenesin's effectiveness in thinning mucus.
Alternative Therapies
- Single-ingredient Guaifenesin (e.g., Mucinex)
- Saline nasal sprays (for congestion)
- Humidifiers
- Honey (for cough in children >1 year)
- Rest and fluids
- Acetaminophen or ibuprofen (for fever/aches)
Cost & Coverage
Average Cost:
Varies widely by brand and retailer per bottle (e.g., 4 oz or 8 oz)
Generic Available:
Yes
Insurance Coverage:
Typically Over-The-Counter (OTC) and not covered by insurance unless prescribed by a physician and deemed medically necessary.
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 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 overdose, including the medication taken, the amount, and the time it occurred.