Supress DM Pediatric Drops 30ml

Manufacturer KRAMER-NOVIS Active Ingredient Guaifenesin and Dextromethorphan Liquid(gwye FEN e sin & deks troe meth OR fan) Pronunciation gwye FEN e sin & 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
Guaifenesin: Expectorant; Dextromethorphan: Non-opioid antitussive (NMDA receptor antagonist)
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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 a combination of two ingredients: Guaifenesin and Dextromethorphan. Guaifenesin helps to thin and loosen mucus in your chest, making it easier to cough up. Dextromethorphan helps to calm your cough. It's used to relieve chest congestion and cough caused by the common cold, flu, or other breathing illnesses.
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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 have access to 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 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 loosen mucus and stay hydrated.
  • Use a humidifier to moisten the air, which can help soothe a cough and thin mucus.
  • Avoid irritants like smoke, dust, and strong fumes.
  • Get adequate rest to help your body recover.

Dosing & Administration

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Adult Dosing

Standard Dose: Not the primary formulation for adults. For general adult use of similar combination products: Guaifenesin 200-400 mg every 4 hours; Dextromethorphan 10-20 mg every 4 hours or 30 mg every 6-8 hours, not to exceed 120 mg/day.
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Pediatric Dosing

Neonatal: Not established and generally not recommended for infants under 6 months.
Infant: Generally not recommended for children under 2 years of age for cough/cold symptoms due to lack of efficacy and potential for serious side effects. If used under medical supervision for specific conditions (e.g., cystic fibrosis), dosing must be individualized by a physician. Follow specific product instructions for 'drops' formulation, which may vary.
Child: For children 2 to under 6 years: Use with extreme caution and only under medical advice. Dosing is typically weight-based or age-based, e.g., Dextromethorphan 2.5-5 mg every 4 hours or 7.5 mg every 6-8 hours; Guaifenesin 50-100 mg every 4 hours. For children 6 to under 12 years: Dextromethorphan 5-10 mg every 4 hours or 15 mg every 6-8 hours; Guaifenesin 100-200 mg every 4 hours. Always follow specific product label instructions for 'drops' concentration and dosage.
Adolescent: For children 12 years and older: Dextromethorphan 10-20 mg every 4 hours or 30 mg every 6-8 hours; Guaifenesin 200-400 mg every 4 hours. Not to exceed 6 doses in 24 hours. Follow specific product label instructions.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment typically required, but use with caution.
Moderate: No specific dose adjustment typically required, but use with caution.
Severe: Use with caution. Accumulation of metabolites may occur. Consult a healthcare professional.
Dialysis: Considerations: Not well-studied. Use with caution and under medical supervision.

Hepatic Impairment:

Mild: No specific dose adjustment typically required, but use with caution.
Moderate: Use with caution. Dextromethorphan metabolism may be impaired, increasing risk of adverse effects. Consider lower doses.
Severe: Use with caution. Dextromethorphan metabolism may be significantly impaired, increasing risk of adverse effects. Consider lower doses or avoidance. Consult a healthcare professional.

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 and helping to clear airways. Dextromethorphan is a non-opioid antitussive that acts centrally on the cough center in the medulla oblongata to elevate the cough threshold, thereby suppressing the cough reflex. It is an NMDA receptor antagonist and a sigma-1 receptor agonist.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified for combination, but both are well-absorbed orally.
Tmax: Guaifenesin: ~1 hour; Dextromethorphan: ~2-2.5 hours.
FoodEffect: Food may slightly delay absorption but does not significantly affect bioavailability.

Distribution:

Vd: Guaifenesin: Not well-established; Dextromethorphan: Large volume of distribution (Vd ~5-6 L/kg).
ProteinBinding: Guaifenesin: Not extensively protein bound; Dextromethorphan: ~60-70%.
CnssPenetration: Dextromethorphan: Yes (acts centrally); Guaifenesin: Limited.

Elimination:

HalfLife: Guaifenesin: ~1 hour; Dextromethorphan: ~1.4-3.9 hours (parent drug), Dextrorphan: ~10 hours.
Clearance: Not precisely quantified for combination.
ExcretionRoute: Primarily renal (urine).
Unchanged: Guaifenesin: Very little unchanged drug excreted; Dextromethorphan: Small amount unchanged, primarily metabolites.
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Pharmacodynamics

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

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention 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 help 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, or 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 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, discuss them with 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 is available to provide medical advice about side effects.
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Seek Immediate Medical Attention If You Experience:

  • Cough that lasts more than 7 days or comes back.
  • Cough accompanied by fever, rash, persistent headache, or sore throat.
  • Worsening symptoms.
  • Difficulty breathing or shortness of breath.
  • 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, shivering, severe diarrhea).
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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.
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 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

Do not start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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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, adhere strictly to the dosage instructions provided by your doctor. Do not exceed the recommended dose, as this may increase your chance of experiencing severe side effects.

Additionally, do not take this medication for a longer duration than prescribed by your doctor.

If you are following a low-sodium or sodium-free diet, consult with your doctor before taking this medication, as some formulations may contain sodium.

Individuals with phenylketonuria (PKU) should also discuss this medication with their doctor, as certain products may contain phenylalanine.

Please note that some 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, it is crucial to 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:

  • Nausea
  • Vomiting
  • Dizziness
  • Drowsiness
  • Blurred vision
  • Rapid heartbeat
  • Agitation
  • Confusion
  • Hallucinations
  • Slurred speech
  • Unsteadiness
  • Difficulty breathing
  • Seizures
  • Coma

What to Do:

If you suspect an overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Be prepared to provide information about the medication taken and the amount.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, selegiline, tranylcypromine, linezolid, methylene blue) - concurrent use or within 14 days of stopping MAOIs due to risk of serotonin syndrome with Dextromethorphan.
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, tramadol, St. John's Wort) - increased risk of serotonin syndrome with Dextromethorphan.
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, amiodarone, bupropion) - may increase Dextromethorphan levels and risk of adverse effects.
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Moderate Interactions

  • Alcohol and other CNS depressants - increased CNS depression.
  • Other cough/cold products - risk of additive effects or overdose if containing similar ingredients.
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Minor Interactions

  • None commonly cited for significant clinical impact.

Monitoring

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Routine Monitoring

Cough frequency and severity

Frequency: Daily

Target: Reduction in cough

Action Threshold: No improvement after 7 days, worsening symptoms, or new symptoms (fever, rash, headache)

Sputum production and character

Frequency: Daily

Target: Thinner, easier to clear mucus

Action Threshold: No change or worsening of mucus consistency/color

Signs of adverse effects (e.g., nausea, dizziness, drowsiness)

Frequency: Daily

Target: Absence of significant side effects

Action Threshold: Presence of bothersome or severe side effects

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Symptom Monitoring

  • Cough relief
  • Mucus thinning/expectoration
  • Nausea
  • Vomiting
  • Dizziness
  • Drowsiness
  • Rash
  • Allergic reactions
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination)

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. Avoid if possible, especially during organogenesis.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Limited data. Dextromethorphan has theoretical risk of neonatal withdrawal if used chronically, though not well-documented for typical OTC use.
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Lactation

L3 (Moderately Safe). Both Guaifenesin and Dextromethorphan are excreted into breast milk in small amounts. Monitor infant for drowsiness or irritability. Use with caution, especially in preterm or neonates. Consult a healthcare professional.

Infant Risk: Low to moderate risk of drowsiness or irritability in the infant. Risk is generally low with occasional, short-term use.
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Pediatric Use

Not recommended for children under 2 years of age for cough/cold symptoms due to potential for serious side effects and lack of proven efficacy. For children 2-6 years, use only under the guidance of a healthcare professional. Always follow specific product instructions and dosage for pediatric formulations. Accidental overdose in young children is a significant concern; use dosing devices provided with the product.

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Geriatric Use

Use with caution in elderly patients due to potential for increased sensitivity to adverse effects (e.g., dizziness, drowsiness) and potential for drug interactions, especially if taking other CNS depressants or serotonergic medications. Start with lower doses if necessary and monitor closely.

Clinical Information

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Clinical Pearls

  • This product is for symptomatic relief only and does not treat the underlying cause of the cough or congestion.
  • Emphasize the importance of accurate dosing, especially for pediatric patients, using the provided measuring device.
  • Advise parents/caregivers that cough/cold products are generally not recommended for children under 2 years of age.
  • Counsel patients on the importance of hydration to maximize the expectorant effect of guaifenesin.
  • Warn about the risk of serotonin syndrome when combining dextromethorphan with MAOIs or other serotonergic drugs.
  • If cough persists for more than 7 days, worsens, or is accompanied by high fever, rash, or persistent headache, medical evaluation is necessary.
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Alternative Therapies

  • Single-ingredient Guaifenesin (for chest congestion)
  • Single-ingredient Dextromethorphan (for cough suppression)
  • Non-pharmacological measures: humidifiers, saline nasal sprays, honey (for children >1 year), warm liquids, rest.
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Cost & Coverage

Average Cost: Typically inexpensive (e.g., $5-$15) per 30ml bottle
Generic Available: Yes
Insurance Coverage: Over-the-counter (OTC), generally not covered by insurance unless prescribed or part of a flexible spending account (FSA)/health savings account (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 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 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.