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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Phenylephrine Hydrochloride
Brand Name
Childrens Sudafed Pe
Generic Name
Phenylephrine Hydrochloride
Active Ingredient
PhenylephrineCategory
Non-Standardized Chemical Allergen [EPC]
Salt Form
Hydrochloride
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 2.5 mg/5mL | SOLUTION | ORAL | 50580-784 |
Detailed information about Childrens Sudafed Pe
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Childrens Sudafed Pe, you must consult a qualified healthcare professional.
Phenylephrine is a potent alpha-1 adrenergic agonist used primarily as a nasal decongestant and vasopressor. It works by inducing vasoconstriction to reduce mucosal swelling or increase systemic blood pressure.
For oral nasal decongestion, the typical adult dose is 10 mg every 4 hours as needed. Patients should not exceed 60 mg in a 24-hour period. For nasal sprays, the standard application is 2 to 3 sprays in each nostril every 4 hours. Intravenous dosing for hypotension is highly individualized and managed by specialists in a hospital setting, often starting with a bolus of 50 mcg to 100 mcg.
For children aged 6 to 12 years, the typical oral dose is 5 mg every 4 hours, not to exceed 30 mg per day. Use in children under 4 years of age is generally not recommended for OTC cough and cold products. Parents should always consult a pediatrician before administering phenylephrine to children.
Caution is advised in patients with severe renal impairment (kidney disease), as the drug is primarily excreted through the urine. Lower doses or increased monitoring may be necessary.
Because phenylephrine undergoes significant first-pass metabolism in the liver, patients with hepatic impairment (liver disease) should use this medication with caution under medical supervision.
Elderly patients (65+) may be more sensitive to the effects of phenylephrine, particularly its impact on blood pressure and heart rate. Healthcare providers often recommend starting at the lower end of the dosing range.
Oral phenylephrine can be taken with or without food. If stomach upset occurs, taking it with a small meal may help. Nasal sprays should be used by blowing the nose first, then spraying while inhaling deeply. To prevent rhinitis medicamentosa (rebound congestion), nasal sprays should not be used for more than 3 consecutive days.
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not double the dose to catch up.
Signs of overdose include severe hypertension (high blood pressure), palpitations (racing heart), headache, vomiting, and tremors. In severe cases, it may lead to cardiac arrhythmias (irregular heartbeat). In the event of a suspected overdose, contact a poison control center or seek emergency medical care immediately.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Common side effects associated with phenylephrine include:
> Warning: Stop taking Phenylephrine and call your doctor immediately if you experience any of these:
Prolonged use of topical nasal phenylephrine (more than 3-5 days) can lead to rebound congestion, where the nasal passages become more congested than before once the medication wears off. Chronic use of systemic phenylephrine is not recommended as it may mask underlying conditions or lead to persistent elevations in blood pressure.
No FDA black box warnings currently exist for phenylephrine. However, healthcare providers emphasize that it should be used with extreme caution in patients with cardiovascular disease.
Report any unusual symptoms to your healthcare provider.
Phenylephrine is a potent vasoconstrictor. Patients with pre-existing cardiovascular conditions must consult a healthcare provider before use. It is also found in many multi-ingredient cold products; always check labels to avoid accidental double-dosing.
No FDA black box warnings for Phenylephrine.
For patients using phenylephrine chronically or in a clinical setting, healthcare providers may monitor:
Phenylephrine generally does not cause drowsiness; however, some patients may experience dizziness or tremors. Assess your reaction to the medication before driving or operating heavy machinery.
While there is no direct chemical interaction between phenylephrine and alcohol, alcohol can increase heart rate and blood pressure, potentially compounding the cardiovascular side effects of phenylephrine.
For oral use, phenylephrine can typically be stopped without a tapering schedule. For nasal sprays, stopping after prolonged use may require a gradual reduction or the use of saline sprays to manage rebound congestion.
> Important: Discuss all your medical conditions with your healthcare provider before starting Phenylephrine.
Phenylephrine is not known to significantly interfere with most common laboratory tests, though it may occasionally cause false-positive results in certain urine drug screenings for amphetamines, depending on the assay used.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Phenylephrine must NEVER be used in the following circumstances:
Healthcare providers will perform a careful risk-benefit analysis for patients with:
Patients who have had allergic reactions to other sympathomimetic amines (such as pseudoephedrine or epinephrine) may have an increased risk of cross-sensitivity to phenylephrine.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Phenylephrine.
Phenylephrine is classified as FDA Pregnancy Category C. This means that animal studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. It should only be used during pregnancy if the potential benefit justifies the potential risk. Some studies suggest that use in the first trimester may be associated with a slight increase in the risk of gastroschisis (a birth defect of the abdominal wall).
It is unknown if phenylephrine is excreted in human breast milk. Because many drugs are excreted in milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Phenylephrine is approved for use in children as young as 4 to 6 years old in specific OTC formulations, but dosing must be strictly followed. Growth effects have not been documented with short-term use for congestion. It is NOT approved for use in infants and toddlers due to the risk of serious side effects.
Geriatric patients are at a higher risk for adverse effects, including hypertension and urinary retention. Healthcare providers often recommend lower doses and frequent monitoring of blood pressure in this population.
In patients with significant kidney disease, the clearance of phenylephrine metabolites may be reduced. While specific GFR-based dosing is not standardized for OTC use, clinical caution is required.
Patients with cirrhosis or other liver impairments may have altered metabolism of phenylephrine. Dose adjustments are generally managed on a case-by-case basis by a physician.
> Important: Special populations require individualized medical assessment.
Phenylephrine is a powerful, direct-acting alpha-1 adrenergic receptor agonist. It has virtually no affinity for beta-adrenergic receptors at therapeutic doses. By binding to alpha-1 receptors on vascular smooth muscle, it activates the Gq-protein, which stimulates phospholipase C. This leads to an increase in intracellular calcium, resulting in smooth muscle contraction and systemic vasoconstriction.
Following oral administration, the onset of action for nasal decongestion typically occurs within 15 to 30 minutes and lasts for approximately 4 hours. When administered intravenously, the pressor effect is immediate and lasts for 5 to 20 minutes. Tolerance (tachyphylaxis) can develop with repeated use, particularly with topical nasal formulations.
| Parameter | Value |
|---|---|
| Bioavailability | ~38% (Oral) |
| Protein Binding | Low/Minimal |
| Half-life | 2 - 3 hours |
| Tmax | 0.75 - 2 hours (Oral) |
| Metabolism | MAO-mediated oxidative deamination |
| Excretion | Renal 80-90% |
Phenylephrine is a member of the sympathomimetic amine class. It is therapeutically categorized as a decongestant and a vasopressor. It is chemically related to epinephrine but lacks the beta-stimulating properties of the latter.
Common questions about Childrens Sudafed Pe
Phenylephrine is primarily used as a decongestant to provide temporary relief from nasal stuffiness caused by the common cold, allergies, or sinusitis. It works by shrinking the blood vessels in the nasal passages, which reduces swelling and congestion. In a hospital setting, healthcare providers use an injectable form of phenylephrine to treat dangerously low blood pressure (hypotension) during surgery or anesthesia. It is also found in some eye drops to dilate the pupils and in topical creams to treat hemorrhoids. Always consult your doctor to ensure it is the correct treatment for your specific symptoms.
The most frequently reported side effects of oral phenylephrine include nervousness, dizziness, and sleeplessness (insomnia). Some patients also experience a mild headache, restlessness, or a feeling of being 'jittery' shortly after taking the medication. These effects are generally mild and resolve as the drug is metabolized by the body. However, if you experience a rapid heartbeat, severe headache, or increased anxiety, you should stop taking the medication and contact your healthcare provider. Topical nasal use can also cause a temporary stinging or burning sensation in the nose.
It is generally advised to avoid or limit alcohol consumption while taking phenylephrine. While there is no known direct chemical interaction that makes the drug toxic, alcohol can increase your heart rate and affect your blood pressure. Since phenylephrine also increases blood pressure and heart rate, combining the two may put unnecessary strain on your cardiovascular system. Additionally, alcohol can worsen the dizziness or restlessness some people feel while taking decongestants. Always discuss your lifestyle habits with your doctor before starting a new medication.
Phenylephrine is classified as Pregnancy Category C, meaning its safety in pregnant women has not been fully established through controlled clinical trials. Some healthcare providers suggest avoiding oral phenylephrine, especially during the first trimester, due to potential risks to the developing fetus's blood flow. Nasal sprays may be preferred by some doctors because they result in less systemic absorption, but they should still be used only under medical guidance. If you are pregnant or planning to become pregnant, you must discuss the risks and benefits with your obstetrician. Alternatives like saline nasal sprays are often recommended as a first-line treatment for congestion during pregnancy.
When taken orally as a tablet or liquid, phenylephrine typically begins to work within 15 to 30 minutes. The peak effect for nasal decongestion is usually reached within one to two hours after ingestion. For those using the nasal spray formulation, the effects are much faster, often providing relief within seconds to minutes of application. The duration of action for oral forms is generally about 4 hours, which is why it is often dosed several times a day. If you do not feel relief after several doses, consult your healthcare provider to re-evaluate your symptoms.
Oral phenylephrine can generally be stopped abruptly without experiencing withdrawal symptoms, as it is typically used for short-term symptom relief. However, if you have been using phenylephrine nasal sprays for more than three consecutive days, you should be cautious. Stopping the nasal spray suddenly after prolonged use can cause 'rebound congestion,' where your nasal passages become even more swollen than they were initially. To avoid this, healthcare providers recommend using nasal sprays for no more than three days. If you find yourself dependent on the spray, your doctor can help you transition to other treatments.
If you miss a dose of phenylephrine, you should take it as soon as you remember, provided it is not almost time for your next scheduled dose. If it is close to the time for your next dose, skip the missed one and continue with your regular dosing schedule. Never take two doses at once to make up for a missed one, as this increases the risk of side effects like high blood pressure or heart palpitations. Since phenylephrine is often taken 'as needed' for symptoms, skipping a dose may simply mean your congestion returns temporarily. Consult your pharmacist if you are unsure about your dosing schedule.
There is no clinical evidence to suggest that short-term or long-term use of phenylephrine causes weight gain. Phenylephrine is a sympathomimetic amine, a class of drugs that generally tends to slightly increase metabolism rather than decrease it. Unlike some other medications like certain antidepressants or steroids, phenylephrine does not affect appetite or fat storage in a way that leads to weight changes. If you notice unexplained weight gain while taking any medication, it is important to discuss this with your healthcare provider to rule out other underlying health conditions. Always monitor your health holistically while on medication.
Phenylephrine can interact with several other drugs, some of which can be dangerous. It should never be taken with Monoamine Oxidase Inhibitors (MAOIs), as this can cause a life-threatening spike in blood pressure. It may also interact with blood pressure medications, antidepressants, and certain heart medicines like digoxin. Because phenylephrine is found in many 'multi-symptom' cold and flu products, taking it alongside other OTC medicines can lead to an accidental overdose. Always provide your healthcare provider with a full list of your current medications and supplements to ensure there are no harmful interactions.
Yes, phenylephrine is widely available as a generic medication and is often much less expensive than brand-name versions. You can find generic phenylephrine hydrochloride in various forms, including oral tablets, liquids, and nasal sprays. It is also a common active ingredient in many store-brand 'Cold and Sinus' or 'Allergy' relief products. Generic versions are required by the FDA to have the same quality, strength, and purity as the brand-name equivalents. When purchasing, check the 'Drug Facts' label on the packaging to confirm that phenylephrine is the active ingredient.
Other drugs with the same active ingredient (Phenylephrine)