Supress-PE Pediatric Drops 30ml

Manufacturer KRAMER-NOVIS Active Ingredient Guaifenesin and Phenylephrine Drops(gwye FEN e sin & fen il EF rin) Pronunciation gwye FEN e sin & 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.
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Drug Class
Expectorant, Nasal Decongestant
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Pharmacologic Class
Guaiacolate derivative, Alpha-1 Adrenergic Agonist
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Pregnancy Category
Category C (Phenylephrine and Guaifenesin are both 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 contains two active ingredients: Guaifenesin and Phenylephrine. Guaifenesin helps to thin and loosen mucus in the chest and throat, making it easier to cough up. Phenylephrine is a decongestant that helps to shrink swollen blood vessels in the nose, relieving stuffiness. It's used to help relieve coughs and nasal congestion due to colds or allergies in children.
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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. You can take this medication with or without food, but if it causes stomach upset, take it with food. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

To ensure accurate dosing, use the dropper that comes with the medication to measure your dose.

Storing and Disposing of Your Medication

Store this 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. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

Missing a Dose

If you take this medication regularly, take a 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 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

  • Ensure adequate hydration (drinking plenty of fluids) to help thin mucus.
  • Use a humidifier in the child's room to help moisten airways.
  • Elevate the child's head during sleep to help with drainage.
  • Avoid exposure to irritants like smoke or strong fumes.

Dosing & Administration

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Adult Dosing

Standard Dose: Not indicated for adult use (Pediatric Drops formulation). For adult formulations: Guaifenesin 200-400 mg every 4 hours (max 2.4 g/day); Phenylephrine 10 mg every 4 hours (max 60 mg/day).
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Pediatric Dosing

Neonatal: Not established (Contraindicated)
Infant: Not established (Generally contraindicated for children under 2 years for phenylephrine; consult product label for specific age/weight guidance, often not recommended under 4 or 6 years for decongestants).
Child: Dosing is highly dependent on product concentration and child's age/weight. Typical guidance for children 6-12 years (if product is indicated): Guaifenesin 100-200 mg every 4 hours; Phenylephrine 5 mg every 4 hours. For drops, this would be converted to mL based on concentration. ALWAYS refer to the specific product label for Supress-PE Pediatric Drops for accurate dosing by age/weight.
Adolescent: Dosing similar to adult recommendations for individual components, but for this specific pediatric drop formulation, it may not be appropriate. Adolescents (12+ years) may use adult OTC formulations.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically required for short-term use.
Moderate: Use with caution. Phenylephrine excretion may be prolonged. Guaifenesin may accumulate.
Severe: Use with caution. Reduced dose or extended interval may be necessary. Avoid if possible.
Dialysis: Not well studied. Avoid use or use with extreme caution and close monitoring.

Hepatic Impairment:

Mild: No specific adjustment typically required.
Moderate: Use with caution. Phenylephrine metabolism may be impaired.
Severe: Use with caution. Reduced dose or extended interval may be necessary. Avoid if possible.

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, thereby facilitating their removal by ciliary action and coughing. Phenylephrine is a direct-acting sympathomimetic amine that acts predominantly on alpha-1 adrenergic receptors in the arterioles of the nasal mucosa, causing vasoconstriction and reducing nasal congestion.
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Pharmacokinetics

Absorption:

Bioavailability: Guaifenesin: Well absorbed orally, ~60-90%. Phenylephrine: Variable oral bioavailability (low due to first-pass metabolism), ~38%.
Tmax: Guaifenesin: ~1 hour. Phenylephrine: ~0.5-2 hours.
FoodEffect: Guaifenesin: Minimal effect. Phenylephrine: Food may slightly delay absorption but not significantly alter extent.

Distribution:

Vd: Guaifenesin: Not extensively studied, but widely distributed. Phenylephrine: Not extensively studied.
ProteinBinding: Guaifenesin: Not extensively protein bound. Phenylephrine: Not extensively protein bound.
CnssPenetration: Guaifenesin: Limited. Phenylephrine: Limited (due to polarity and first-pass metabolism), but can cause CNS stimulation at higher doses.

Elimination:

HalfLife: Guaifenesin: ~1 hour. Phenylephrine: ~2-3 hours.
Clearance: Guaifenesin: Rapid. Phenylephrine: Rapid.
ExcretionRoute: Guaifenesin: Primarily renal (as metabolites). Phenylephrine: Primarily renal (as metabolites and unchanged drug).
Unchanged: Guaifenesin: <1% unchanged. Phenylephrine: ~2.6% unchanged.
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Pharmacodynamics

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

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
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 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, difficulty 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 or drowsiness
- Feeling nervous and excitable
- Difficulty sleeping

Reporting Side Effects
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:

  • Worsening symptoms or symptoms lasting more than 7 days (or 5 days for cough in children)
  • High fever (especially in infants/young children)
  • Rash or persistent headache
  • Nervousness, dizziness, or sleeplessness
  • Fast or pounding heartbeat
  • Difficulty breathing
  • Any signs of an allergic reaction (e.g., swelling of face/tongue, severe rash, difficulty 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 you experienced, including any symptoms that occurred.
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 increase the risk of very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
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.

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 adjust 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. Until you understand how this drug affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, refrain from consuming alcohol while taking this medication.

Before using marijuana, other cannabis products, or prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor. Adhere strictly to the dosage instructions provided by your doctor, as exceeding the recommended dose may increase the risk of severe side effects. Do not take this medication for a longer duration than prescribed by your doctor.

Be aware that different brands of this medication may be suitable for children of varying ages. 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 breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Guaifenesin: Nausea, vomiting, stomach upset, dizziness.
  • Phenylephrine: Severe nervousness, restlessness, insomnia, dizziness, headache, tremors, seizures, hallucinations, high blood pressure, rapid or irregular heartbeat, pallor, cold extremities.

What to Do:

If overdose is suspected, 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 MAOIs with phenylephrine can lead to hypertensive crisis.
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Major Interactions

  • Tricyclic Antidepressants (TCAs): May potentiate the pressor effects of phenylephrine.
  • Beta-blockers (non-selective): May increase the pressor effects of phenylephrine and lead to hypertension and bradycardia.
  • Other Sympathomimetics (e.g., other decongestants, appetite suppressants, amphetamines): Increased risk of cardiovascular effects (hypertension, tachycardia).
  • Ergot alkaloids (e.g., ergotamine, methysergide): Increased risk of vasoconstriction and hypertension.
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Moderate Interactions

  • Alpha-adrenergic blockers (e.g., prazosin): May reduce the effect of phenylephrine.
  • Cardiac glycosides (e.g., digoxin): Increased risk of arrhythmias with phenylephrine.
  • Linezolid: Potential for hypertensive crisis (MAOI-like activity).
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Minor Interactions

  • Antihypertensives: Phenylephrine may reduce the effectiveness of antihypertensive medications.

Monitoring

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Symptom Monitoring

  • Effectiveness of cough and congestion relief
  • Signs of adverse effects: restlessness, nervousness, insomnia, dizziness, headache, nausea, vomiting, increased heart rate, elevated blood pressure (especially in children with underlying conditions)
  • Signs of allergic reaction (rash, itching, swelling)
  • Changes in cough characteristics (e.g., worsening, new onset of fever, rash, persistent headache)

Special Patient Groups

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Pregnancy

Generally not recommended during pregnancy, especially in the first trimester, due to limited data and potential risks with phenylephrine. Category C. Consult a healthcare provider.

Trimester-Specific Risks:

First Trimester: Phenylephrine: Potential for vascular disruption; generally avoided. Guaifenesin: Limited data, generally avoided unless clearly necessary.
Second Trimester: Use with caution, only if clearly needed and benefits outweigh risks.
Third Trimester: Use with caution, especially near term, due to potential for maternal hypertension and fetal effects with phenylephrine.
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Lactation

Use with caution. Both guaifenesin and phenylephrine are excreted into breast milk. Phenylephrine may cause irritability or sleep disturbances in the infant and may reduce milk supply. Guaifenesin is generally considered compatible with breastfeeding but data are limited. L3 risk.

Infant Risk: Low to moderate risk of irritability, sleep disturbances, or mild cardiovascular effects in the infant from phenylephrine. Guaifenesin generally low risk.
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Pediatric Use

This product is specifically for pediatric use. However, nasal decongestants like phenylephrine are generally NOT recommended for children under 2 years of age due to lack of proven efficacy and potential for serious adverse effects (e.g., seizures, rapid heart rate, death). Some guidelines extend this to under 4 or 6 years. ALWAYS follow the specific age and weight-based dosing instructions on the product label and consult a pediatrician before administering to very young children. Accidental overdose is a significant risk in this population.

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Geriatric Use

Not indicated for geriatric use (pediatric formulation). For adult formulations, use with caution in elderly patients due to increased susceptibility to adverse effects of phenylephrine (e.g., hypertension, CNS stimulation, urinary retention), especially in those with pre-existing cardiovascular disease, hypertension, or benign prostatic hyperplasia.

Clinical Information

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Clinical Pearls

  • Always verify the specific product concentration and follow the manufacturer's dosing instructions precisely, especially for pediatric formulations, using an accurate measuring device.
  • Decongestants like phenylephrine are generally not recommended for children under 2 years of age due to safety concerns and lack of efficacy. Some guidelines extend this to under 4 or 6 years.
  • Educate parents on the importance of not exceeding the recommended dose and avoiding concomitant use with other cold/cough medications containing similar ingredients.
  • Advise parents to seek medical attention if symptoms worsen, new symptoms appear, or if the child experiences significant side effects.
  • Hydration is key for guaifenesin's effectiveness in thinning mucus.
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Alternative Therapies

  • Single-ingredient Guaifenesin (e.g., Mucinex)
  • Single-ingredient Phenylephrine (nasal sprays or oral tablets)
  • Saline nasal sprays/drops (for congestion)
  • Humidifiers
  • Honey (for cough in children >1 year)
  • Non-pharmacological measures for cold symptoms (rest, fluids)
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Cost & Coverage

Average Cost: Typically $5 - $15 per 30ml bottle
Generic Available: Yes
Insurance Coverage: OTC (Over-the-Counter) - 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 details. 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 information about the medication taken, the amount, and the time it happened.