Siltussin DM Alcohol Free Syrup

Manufacturer SILARX Active Ingredient Guaifenesin and Dextromethorphan Liquid(gwye FEN e sin & deks troe meth OR fan) Pronunciation Guaifenesin (gwye FEN e sin); Dextromethorphan (deks troe meth OR fan)
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
Expectorant, Antitussive
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Pharmacologic Class
Expectorant (Guaifenesin); Antitussive, NMDA receptor antagonist, Sigma-1 receptor agonist (Dextromethorphan)
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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 is used to help relieve cough and chest congestion. Guaifenesin helps to thin and loosen mucus in your lungs, making it easier to cough up. Dextromethorphan helps to reduce the urge to cough.
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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. 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. If no device is included, ask your pharmacist for a suitable measuring tool to ensure you take the correct dose.

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 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 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 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 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 thin mucus and stay hydrated.
  • Avoid irritants like smoke, dust, and pollutants that can worsen cough.
  • Get adequate rest.
  • Do not exceed the recommended dose.
  • Do not use for chronic cough (e.g., asthma, emphysema) or cough with excessive phlegm unless directed by a doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Guaifenesin 200-400 mg and Dextromethorphan 10-20 mg every 4 hours as needed, or Dextromethorphan 30 mg every 6-8 hours as needed. Max Guaifenesin 2.4 g/day, Max Dextromethorphan 120 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended for children under 4 years)
Child: Children 6 to under 12 years: Guaifenesin 100-200 mg and Dextromethorphan 5-10 mg every 4 hours as needed. Max Guaifenesin 1.2 g/day, Max Dextromethorphan 60 mg/day. Not recommended for children under 6 years unless directed by a doctor.
Adolescent: Children 12 years and older: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically needed.
Moderate: Use with caution; monitor for adverse effects. No specific dose adjustment guidelines.
Severe: Use with caution; monitor for adverse effects. Accumulation of metabolites may occur. Consult physician.
Dialysis: Not well studied; use with caution. Dextromethorphan and its metabolites are renally excreted.

Hepatic Impairment:

Mild: No specific adjustment typically needed.
Moderate: Use with caution; monitor for adverse effects. Dextromethorphan is extensively metabolized by the liver.
Severe: Use with caution; monitor for adverse effects. Significant dose reduction may be necessary for Dextromethorphan. Consult physician.

Pharmacology

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Mechanism of Action

Guaifenesin acts as an expectorant by increasing the volume and decreasing the viscosity of secretions in the respiratory tract, thereby facilitating the removal of mucus. Dextromethorphan acts centrally on the cough center in the medulla oblongata to elevate the cough threshold, thereby suppressing cough.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (both well absorbed orally)
Tmax: Guaifenesin: ~1 hour; Dextromethorphan: ~2-2.5 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect extent of absorption.

Distribution:

Vd: Not available (both widely distributed)
ProteinBinding: Guaifenesin: Not significant; Dextromethorphan: Not significant
CnssPenetration: Dextromethorphan: Yes; Guaifenesin: Limited

Elimination:

HalfLife: Guaifenesin: ~1 hour; Dextromethorphan: ~2-4 hours (parent drug), Dextrorphan: ~10-26 hours
Clearance: Not available
ExcretionRoute: Renal (both)
Unchanged: Guaifenesin: Negligible; Dextromethorphan: Small amount
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Pharmacodynamics

OnsetOfAction: Guaifenesin: ~30 minutes; Dextromethorphan: ~15-30 minutes
PeakEffect: Guaifenesin: ~1 hour; Dextromethorphan: ~2-3 hours
DurationOfAction: Guaifenesin: ~4-6 hours; Dextromethorphan: ~4-8 hours
Confidence: Medium

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately
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 medical attention right away:

* 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. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns 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. Your doctor can provide medical advice about side effects and help you manage them.
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Seek Immediate Medical Attention If You Experience:

  • Cough that lasts more than 7 days (or 5 days for children), comes back, or occurs with fever, rash, or persistent headache.
  • Nervousness, dizziness, or sleeplessness.
  • Severe nausea or vomiting.
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
  • Signs of serotonin syndrome (e.g., agitation, confusion, rapid heart rate, sweating, muscle stiffness, twitching, tremors, severe nausea, vomiting, diarrhea).
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have to this drug, its components, or other substances, including foods and medications. 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 may interact with this drug.

It is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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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. Taking more than the recommended amount can increase your chance of experiencing serious adverse effects. Additionally, do not take this medication for a longer duration than specified by your doctor.

If you are following a low-sodium or sodium-free diet, consult with your doctor before taking this medication, as some products may contain sodium. Similarly, if you have phenylketonuria (PKU), discuss this with your doctor, as some formulations of this drug may contain phenylalanine.

Note that certain forms of this medication may not be suitable for children of all ages. If you have any questions or concerns, consult with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Dextromethorphan overdose: Nausea, vomiting, dizziness, drowsiness, blurred vision, nystagmus (involuntary eye movements), ataxia (loss of coordination), hallucinations, agitation, confusion, psychosis, respiratory depression, seizures, coma.
  • Guaifenesin overdose: Nausea, vomiting, stomach pain, dizziness, drowsiness.

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 Dextromethorphan due to risk of serotonin syndrome)
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid, St. John's Wort) (increased risk of serotonin syndrome with Dextromethorphan)
  • Other CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, opioids) (additive CNS depression with Dextromethorphan)
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Moderate Interactions

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, amiodarone, haloperidol, thioridazine) (may increase Dextromethorphan levels and adverse effects)
  • Alcohol (additive CNS depression, potential for increased Dextromethorphan effects)
  • Other cough and cold preparations (risk of accidental overdose if containing similar active ingredients)
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Minor Interactions

  • Not many significant minor interactions for these specific agents.

Monitoring

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Routine Monitoring

Symptom improvement (cough frequency/severity, mucus production)

Frequency: Daily

Target: Reduction in symptoms

Action Threshold: If symptoms worsen or persist for more than 7 days (or 5 days for children), or are accompanied by fever, rash, or persistent headache, discontinue and consult a healthcare professional.

Adverse effects (e.g., dizziness, drowsiness, nausea, vomiting)

Frequency: Daily

Target: Absence or mild, tolerable effects

Action Threshold: If severe or persistent, discontinue use.

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Symptom Monitoring

  • Cough frequency and severity
  • Sputum production and consistency
  • Presence of fever, rash, or persistent headache
  • Signs of allergic reaction (e.g., rash, itching, swelling)
  • Signs of CNS depression (e.g., drowsiness, dizziness, confusion)
  • Signs of serotonin syndrome (e.g., agitation, hallucinations, rapid heart beat, fever, overactive reflexes, nausea, vomiting, diarrhea)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Limited data; generally avoided if possible, especially in the first trimester.
Second Trimester: Considered relatively safer than first trimester, but still use with caution.
Third Trimester: Considered relatively safer than first trimester, but still use with caution.
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Lactation

L3 (Moderately Safe). Both guaifenesin and dextromethorphan are excreted into breast milk in small amounts. Use with caution and monitor the infant for drowsiness or irritability. Consult a healthcare professional.

Infant Risk: Low to moderate risk of drowsiness or irritability in the infant. Generally considered compatible with breastfeeding when used at recommended doses, but observe infant.
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Pediatric Use

Not recommended for children under 6 years of age. For children 6-12 years, use specific pediatric dosing. Risk of accidental overdose, especially with combination products. Always use a dosing device provided with the product.

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Geriatric Use

Use with caution in elderly patients due to increased sensitivity to CNS effects (dizziness, drowsiness) of dextromethorphan and potential for polypharmacy. Start with lower doses if necessary and monitor closely.

Clinical Information

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Clinical Pearls

  • Advise patients to stay well-hydrated to maximize the expectorant effect of guaifenesin.
  • Caution patients about potential drowsiness or dizziness, especially when driving or operating machinery.
  • Emphasize that this medication is for temporary relief of cough and congestion, not for chronic conditions.
  • Educate patients about the risk of serotonin syndrome when combining dextromethorphan with other serotonergic drugs, including certain antidepressants.
  • Remind patients to check labels of other OTC medications to avoid accidental overdose of similar ingredients.
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Alternative Therapies

  • Single-ingredient guaifenesin (expectorant)
  • Single-ingredient dextromethorphan (cough suppressant)
  • Other cough suppressants (e.g., benzonatate, codeine - prescription only)
  • Other expectorants (e.g., saline nasal spray, steam inhalation)
  • Humidifiers
  • Honey (for cough relief)
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Cost & Coverage

Average Cost: Varies widely per bottle
Generic Available: Yes
Insurance Coverage: Typically OTC, not covered by prescription plans unless specifically prescribed and covered by certain FSA/HSA plans.
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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 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.