Alahist PE 2-7.5mg Tablets

Manufacturer POLY PHARMACEUTICALS Active Ingredient Dexbrompheniramine and Phenylephrine Pronunciation AL-uh-hist P.E.
It is used to treat nose stuffiness.It is used to ease allergy signs.
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Drug Class
Antihistamine/Decongestant Combination
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Pharmacologic Class
H1-receptor Antagonist (1st Generation); Alpha-1 Adrenergic Agonist
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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?

Alahist PE is a medication that helps relieve cold and allergy symptoms like sneezing, runny nose, watery eyes, and nasal congestion. It contains an antihistamine to dry up secretions and a decongestant to clear stuffy noses.
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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. If it causes stomach upset, taking it with food may help.

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. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal. You may also have access to drug take-back programs in your area.

Missing a Dose

If you take this medication regularly and miss a dose, take it 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

  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness or dizziness.
  • Avoid alcohol and other sedating medications while taking Alahist PE, as this can increase drowsiness.
  • Drink plenty of fluids to help thin mucus and prevent dry mouth.
  • Do not exceed the recommended dose, as this can increase the risk of serious side effects, especially related to the heart and blood pressure.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 1 tablet (2 mg dexbrompheniramine / 7.5 mg phenylephrine) orally every 4 to 6 hours as needed
Dose Range: 1 - 6 mg

Condition-Specific Dosing:

maximumDailyDose: 6 tablets (12 mg dexbrompheniramine / 45 mg phenylephrine) in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (Phenylephrine generally not recommended under 4 years)
Child: Not established (Phenylephrine generally not recommended under 4 years); for children 6-12 years, lower strength formulations or physician consultation recommended. For this specific strength, generally not recommended under 12 years.
Adolescent: 1 tablet (2 mg dexbrompheniramine / 7.5 mg phenylephrine) orally every 4 to 6 hours as needed (for ages 12 years and older)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor for increased side effects.
Moderate: Use with caution; consider dose reduction or extended dosing interval.
Severe: Avoid use if possible; if necessary, significant dose reduction and close monitoring required.
Dialysis: Considerations: Not well studied; avoid use due to potential for accumulation of active drug or metabolites.

Hepatic Impairment:

Mild: Use with caution; monitor for increased side effects.
Moderate: Use with caution; consider dose reduction or extended dosing interval.
Severe: Avoid use if possible; if necessary, significant dose reduction and close monitoring required.

Pharmacology

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Mechanism of Action

Dexbrompheniramine is a first-generation antihistamine that competitively antagonizes H1-receptors, thereby preventing histamine from binding and reducing allergic symptoms like sneezing, rhinorrhea, and watery eyes. It also possesses anticholinergic properties, contributing to its drying effects. Phenylephrine is a direct-acting sympathomimetic amine that primarily acts as an alpha-1 adrenergic agonist, causing vasoconstriction in the nasal mucosa, which reduces swelling and congestion.
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Pharmacokinetics

Absorption:

Bioavailability: Dexbrompheniramine: Approximately 40-60%; Phenylephrine: Low oral bioavailability (approx. 38%) due to extensive first-pass metabolism.
Tmax: Dexbrompheniramine: 2-5 hours; Phenylephrine: 0.5-2 hours
FoodEffect: Food may slightly delay absorption but generally does not significantly affect extent of absorption.

Distribution:

Vd: Dexbrompheniramine: 2.5-3.5 L/kg; Phenylephrine: Not well established, but widely distributed.
ProteinBinding: Dexbrompheniramine: 70-80%; Phenylephrine: Not extensively protein bound.
CnssPenetration: Dexbrompheniramine: Yes (readily crosses blood-brain barrier, causing sedation); Phenylephrine: Limited (does not readily cross blood-brain barrier).

Elimination:

HalfLife: Dexbrompheniramine: 10-25 hours; Phenylephrine: 2-3 hours
Clearance: Not precisely quantified for combination, but primarily renal for dexbrompheniramine and hepatic/renal for phenylephrine.
ExcretionRoute: Dexbrompheniramine: Urine (unchanged drug and metabolites); Phenylephrine: Urine (metabolites and some unchanged drug).
Unchanged: Dexbrompheniramine: Approximately 30-40%; Phenylephrine: Less than 16% (oral).
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Pharmacodynamics

OnsetOfAction: Dexbrompheniramine: 15-60 minutes; Phenylephrine: 15-30 minutes
PeakEffect: Dexbrompheniramine: 2-6 hours; Phenylephrine: 1-2 hours
DurationOfAction: Dexbrompheniramine: 4-8 hours; Phenylephrine: 4-6 hours
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediately:

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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:

Feeling dizzy or sleepy
Feeling nervous and excitable
Trouble sleeping

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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:

  • Severe dizziness or lightheadedness
  • Significant increase in heart rate or palpitations
  • Chest pain
  • Difficulty urinating or inability to urinate
  • Severe nervousness, anxiety, or restlessness
  • Hallucinations or confusion
  • Blurred vision that is severe or persistent
  • Any signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
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 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 are experiencing. This will enable them to assess potential interactions and ensure it is safe for you to take this medication. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than the prescribed amount may increase your risk of experiencing severe side effects. Additionally, do not take this medication for a longer duration than recommended by your doctor.

Until you are aware of how this medication affects you, it is crucial to avoid operating a vehicle, performing tasks, or engaging in activities that require alertness. It is also recommended to refrain from consuming alcohol while taking this medication. Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness or slow your reactions, consult with your doctor.

If the patient is a child, exercise caution when administering this medication, as children may be at a higher risk of experiencing excitability. If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor, as it is necessary to discuss the potential benefits and risks to both you and the baby.
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Overdose Information

Overdose Symptoms:

  • Dexbrompheniramine: Severe drowsiness, profound sedation, coma, seizures, hallucinations, ataxia, anticholinergic effects (dilated pupils, flushed skin, dry mouth, fever, urinary retention), cardiovascular collapse.
  • Phenylephrine: Severe hypertension, headache, vomiting, reflex bradycardia, palpitations, arrhythmias, cerebral hemorrhage, seizures, anxiety, restlessness, tremor, insomnia.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, potentially involving activated charcoal, gastric lavage, and management of cardiovascular or CNS effects.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis and prolonged anticholinergic effects.
  • Severe hypertension
  • Severe coronary artery disease
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Major Interactions

  • Other sympathomimetics (e.g., pseudoephedrine, ephedrine, amphetamines) - increased risk of cardiovascular effects (hypertension, arrhythmias).
  • Tricyclic Antidepressants (TCAs) - may potentiate pressor effects of phenylephrine.
  • Beta-blockers (non-selective) - may increase pressor response to phenylephrine and risk of hypertension.
  • CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, opioids) - increased risk of profound sedation and respiratory depression.
  • Anticholinergics (e.g., atropine, tricyclic antidepressants, some antipsychotics) - increased risk of anticholinergic side effects (dry mouth, urinary retention, blurred vision, constipation).
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Moderate Interactions

  • Digoxin - increased risk of arrhythmias.
  • Ergot alkaloids - increased risk of vasoconstriction.
  • Certain antihypertensives (e.g., methyldopa, reserpine) - reduced antihypertensive effect.
  • Oral anticoagulants - antihistamines may theoretically interfere with metabolism, but clinical significance is low.
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Minor Interactions

  • Antacids (aluminum or magnesium containing) - may increase absorption of phenylephrine.
  • Kaolin - may decrease absorption of dexbrompheniramine.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Phenylephrine can cause increases in BP and HR, especially in susceptible individuals.

Timing: Prior to initiation, especially in patients with pre-existing cardiovascular conditions.

Medical History (especially cardiovascular, thyroid, prostate, glaucoma)

Rationale: To identify contraindications or conditions requiring caution.

Timing: Prior to initiation.

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Routine Monitoring

Symptom Relief (nasal congestion, sneezing, rhinorrhea)

Frequency: Daily, as needed

Target: Reduction in symptoms

Action Threshold: Lack of efficacy after appropriate trial, consider alternative therapy.

Adverse Effects (e.g., drowsiness, dizziness, dry mouth, blurred vision, nervousness, insomnia, palpitations, urinary difficulty)

Frequency: Daily, as needed

Target: Absence or mild, tolerable side effects

Action Threshold: Severe or persistent side effects, consider dose reduction or discontinuation.

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Periodically, especially in patients with hypertension or cardiovascular risk factors.

Target: Within patient's normal range or controlled limits.

Action Threshold: Significant or sustained elevation, consider discontinuation or alternative.

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Symptom Monitoring

  • Drowsiness or sedation
  • Dizziness or lightheadedness
  • Dry mouth, nose, or throat
  • Blurred vision
  • Nervousness or restlessness
  • Insomnia or difficulty sleeping
  • Palpitations or rapid heartbeat
  • Increased blood pressure
  • Difficulty urinating (especially in men with prostatic hypertrophy)
  • Headache
  • Nausea or vomiting

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Both dexbrompheniramine and phenylephrine are Category C. Antihistamines and decongestants are generally avoided in the first trimester if possible. Phenylephrine use in late pregnancy may theoretically reduce uterine blood flow.

Trimester-Specific Risks:

First Trimester: Avoid if possible; potential for increased risk of birth defects with some antihistamines (though not strongly established for dexbrompheniramine). Phenylephrine use in early pregnancy is generally discouraged.
Second Trimester: Use with caution; generally considered safer than first trimester, but still weigh risks vs. benefits.
Third Trimester: Use with caution; phenylephrine may cause vasoconstriction and potentially reduce uterine blood flow. Antihistamines may cause irritability in neonates if used close to delivery.
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Lactation

L3 (Moderate risk). Both dexbrompheniramine and phenylephrine are excreted into breast milk. Antihistamines can cause drowsiness, irritability, or anticholinergic effects in the infant and may decrease milk supply. Phenylephrine can also cause irritability or cardiovascular effects in the infant and may reduce milk supply. Use with caution; monitor infant for adverse effects. Non-sedating antihistamines and non-systemic decongestants are preferred.

Infant Risk: Moderate risk of drowsiness, irritability, anticholinergic effects, or cardiovascular effects in the infant. Potential for decreased milk supply.
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Pediatric Use

Not recommended for children under 12 years of age for this specific strength due to the phenylephrine component. Decongestants are generally not recommended for children under 4 years due to risk of serious side effects. Always consult a pediatrician for appropriate dosing and product selection for children.

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Geriatric Use

Use with caution. Elderly patients are more susceptible to the anticholinergic effects (e.g., urinary retention, constipation, confusion, dry mouth) and sympathomimetic effects (e.g., hypertension, tachycardia, insomnia, nervousness) of this combination. Start with lower doses and monitor closely for adverse effects. Avoid in patients with glaucoma, prostatic hypertrophy, or severe cardiovascular disease.

Clinical Information

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Clinical Pearls

  • This product combines a sedating antihistamine with a decongestant, so warn patients about potential drowsiness and advise against driving or operating machinery.
  • Counsel patients to avoid alcohol and other CNS depressants while taking this medication.
  • Advise patients with pre-existing conditions like hypertension, heart disease, thyroid disease, glaucoma, or prostate enlargement to consult their physician before use due to the phenylephrine component.
  • Emphasize the importance of not exceeding the recommended dose to minimize the risk of serious cardiovascular and CNS side effects.
  • This combination is for symptomatic relief of cold and allergy symptoms; it does not treat the underlying cause of infection.
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Alternative Therapies

  • Single-ingredient antihistamines (e.g., loratadine, fexofenadine, cetirizine for non-sedating; diphenhydramine for sedating)
  • Single-ingredient decongestants (e.g., pseudoephedrine, oxymetazoline nasal spray)
  • Nasal saline rinses
  • Nasal corticosteroids (for allergic rhinitis)
  • Cromolyn sodium nasal spray
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Cost & Coverage

Average Cost: $15 - $40 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 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 medication taken, the amount, and the time it occurred.