Ed A-Hist DM 10mg-4mg-10mg Tablets

Manufacturer WOMEN'S CHOICE PHARMACEUTICALS Active Ingredient Chlorpheniramine, Phenylephrine, and Dextromethorphan Tablets(klor fen IR a meen, fen il EF rin, & deks troe meth OR fan) Pronunciation KLOR fen IR a meen, fen il EF rin, & deks troe meth OR fan
It is used to treat nose stuffiness.It is used to ease allergy signs.It is used to relieve coughing.
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Drug Class
Cold, Cough, and Allergy Relief
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Pharmacologic Class
Antihistamine (First Generation), Alpha-Adrenergic Agonist, Antitussive
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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 medication is a combination product used to relieve symptoms of the common cold, allergies, and flu. It contains an antihistamine (chlorpheniramine) to help with sneezing, runny nose, and watery eyes; a decongestant (phenylephrine) to help clear stuffy nose; and a cough suppressant (dextromethorphan) to help reduce coughing.
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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

Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Ensure all medications are stored safely and out of 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. If you're unsure about the best disposal method, consult your pharmacist. 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 extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than advised.
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Lifestyle & Tips

  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it may cause drowsiness or dizziness.
  • Avoid alcohol and other CNS depressants while taking this medication, as they can increase drowsiness.
  • Drink plenty of fluids to help loosen mucus and soothe a sore throat.
  • Do not exceed the recommended dose, as this can lead to serious side effects.
  • If symptoms do not improve within 7 days or are accompanied by fever, rash, or persistent headache, consult a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 tablet every 4-6 hours as needed
Dose Range: 1 - 6 mg

Condition-Specific Dosing:

maximumDailyDose: Do not exceed 6 tablets in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not recommended for children under 6 years of age. For children 6 to under 12 years, consult a doctor; typical dose is 1/2 tablet every 4-6 hours, not to exceed 3 tablets in 24 hours.
Adolescent: 1 tablet every 4-6 hours as needed, not to exceed 6 tablets in 24 hours (for ages 12 years and older)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; consider dose reduction
Moderate: Use with caution; consider dose reduction
Severe: Avoid or use with extreme caution; significant dose reduction likely needed
Dialysis: Not well-studied; avoid or use with extreme caution

Hepatic Impairment:

Mild: Use with caution; consider dose reduction
Moderate: Use with caution; consider dose reduction
Severe: Avoid or use with extreme caution; significant dose reduction likely needed

Pharmacology

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Mechanism of Action

Chlorpheniramine is a first-generation antihistamine that competitively antagonizes H1 receptors, thereby preventing histamine-mediated effects such as sneezing, rhinorrhea, and itching. Phenylephrine is a direct-acting sympathomimetic amine that acts predominantly on alpha-adrenergic receptors, causing vasoconstriction in the nasal mucosa, leading to decongestion. Dextromethorphan is a non-opioid antitussive that acts centrally on the cough center in the medulla to elevate the cough threshold. It is also an NMDA receptor antagonist and sigma-1 receptor agonist.
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Pharmacokinetics

Absorption:

Bioavailability: Chlorpheniramine: ~25-50%; Phenylephrine: ~38% (due to first-pass metabolism); Dextromethorphan: High (rapid)
Tmax: Chlorpheniramine: 2-6 hours; Phenylephrine: 0.75-2 hours; Dextromethorphan: 2-2.5 hours
FoodEffect: Food may delay absorption but generally does not significantly affect extent of absorption.

Distribution:

Vd: Chlorpheniramine: 3.2 L/kg; Phenylephrine: Not well-defined; Dextromethorphan: High (lipophilic)
ProteinBinding: Chlorpheniramine: 69-72%; Phenylephrine: Not well-defined; Dextromethorphan: ~60-70%
CnssPenetration: Chlorpheniramine: Yes (causes sedation); Phenylephrine: Limited; Dextromethorphan: Yes

Elimination:

HalfLife: Chlorpheniramine: 12-43 hours; Phenylephrine: 2-3 hours; Dextromethorphan: 3-4 hours (parent), 10-20 hours (dextrorphan)
Clearance: Not precisely quantified for combination
ExcretionRoute: Renal (primarily)
Unchanged: Chlorpheniramine: ~34%; Phenylephrine: Minimal; Dextromethorphan: Minimal (parent), significant dextrorphan
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Pharmacodynamics

OnsetOfAction: Chlorpheniramine: 15-60 minutes; Phenylephrine: 15-30 minutes; Dextromethorphan: 15-60 minutes
PeakEffect: Chlorpheniramine: 3-6 hours; Phenylephrine: 1-2 hours; Dextromethorphan: 1-2 hours
DurationOfAction: Chlorpheniramine: 4-6 hours; Phenylephrine: 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Chest pain or pressure
Rapid heartbeat
Shakiness

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 do not go away, contact your doctor:

Dizziness
Drowsiness
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 drowsiness
  • Nervousness, restlessness, or trouble sleeping
  • Fast or pounding heartbeat
  • High blood pressure
  • Difficulty urinating
  • Blurred vision
  • Hallucinations or confusion
  • Signs of serotonin syndrome (agitation, sweating, muscle stiffness, shivering, diarrhea, rapid heart rate)
  • Allergic reaction (rash, itching, swelling, severe dizziness, trouble 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 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, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of 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 your medications, including:

Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins

Additionally, inform them about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change 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. Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.

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 likelihood of experiencing adverse effects. Additionally, do not take this medication for a longer duration than prescribed by your doctor.

While taking this drug, it is recommended that you avoid consuming alcohol. Before using marijuana, other forms of cannabis, or any prescription or over-the-counter medications that may cause drowsiness, consult with your doctor to discuss potential interactions.

When administering this medication to a child, exercise caution, as children may be at a higher risk of experiencing excitability. It is crucial to note that different brands of this medication may be suitable for children of various ages. Therefore, consult with your doctor before giving this drug to a child. Furthermore, do not use this medication as a means to induce sleep in a child; instead, discuss alternative solutions with your doctor.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is necessary to have a discussion about the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe drowsiness or dizziness
  • Nausea, vomiting
  • Excitement, restlessness, or irritability
  • Hallucinations
  • Seizures
  • Rapid or irregular heartbeat
  • High blood pressure
  • Dilated pupils
  • Difficulty breathing
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US).

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOIs due to risk of hypertensive crisis with phenylephrine and serotonin syndrome with dextromethorphan)
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Major Interactions

  • Other sympathomimetics (e.g., pseudoephedrine, ephedrine, stimulants) - increased cardiovascular effects
  • Tricyclic antidepressants (TCAs) - potentiated pressor effects of phenylephrine
  • Beta-blockers (non-selective) - increased risk of hypertension and bradycardia with phenylephrine
  • CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, opioids) - increased sedation and respiratory depression with chlorpheniramine and dextromethorphan
  • Anticholinergic drugs (e.g., atropine, some antipsychotics, TCAs) - increased anticholinergic side effects with chlorpheniramine
  • Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, linezolid, St. John's Wort) - increased risk of serotonin syndrome with dextromethorphan
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased dextromethorphan and chlorpheniramine levels, potentially leading to toxicity
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Moderate Interactions

  • Digoxin - potential for increased cardiac effects with phenylephrine
  • Antihypertensives - phenylephrine may reduce the effect of antihypertensive medications
  • Metoclopramide - may affect absorption of other drugs
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Minor Interactions

  • Food (see pharmacokinetics)

Monitoring

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Routine Monitoring

Symptom relief (cough, congestion, sneezing)

Frequency: Daily, as needed

Target: Reduction in symptoms

Action Threshold: Lack of improvement or worsening of symptoms after several days of use

Blood Pressure (for patients with hypertension)

Frequency: Periodically, if concerns arise

Target: Within patient's normal range

Action Threshold: Significant increase in blood pressure

Heart Rate (for patients with cardiac conditions)

Frequency: Periodically, if concerns arise

Target: Within patient's normal range

Action Threshold: Significant increase in heart rate or palpitations

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Symptom Monitoring

  • Drowsiness or sedation
  • Dizziness
  • Nervousness or restlessness
  • Insomnia
  • Dry mouth, nose, or throat
  • Blurred vision
  • Urinary difficulty
  • Constipation
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, overactive reflexes, nausea, vomiting, diarrhea, incoordination)
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Special Patient Groups

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Pregnancy

Generally not recommended during pregnancy due to the presence of phenylephrine (Category C) and dextromethorphan (Category C), and chlorpheniramine (Category B/C). Consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Potential risks with phenylephrine (vasoconstriction, reduced uterine blood flow).
Second Trimester: Use with caution, generally avoided unless benefits outweigh risks.
Third Trimester: Avoid, especially near term, due to potential for adverse effects on the fetus (e.g., respiratory depression with dextromethorphan, anticholinergic effects with chlorpheniramine).
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Lactation

Use is generally not recommended. All three components are excreted into breast milk. Chlorpheniramine can cause drowsiness in the infant and may decrease milk supply. Phenylephrine can cause irritability and may decrease milk supply. Dextromethorphan can cause drowsiness in the infant. Consult a healthcare provider.

Infant Risk: L3 (Moderate Risk) - Potential for infant drowsiness, irritability, and decreased milk supply.
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Pediatric Use

Not recommended for children under 6 years of age due to potential for serious side effects, including overdose. For children 6-12 years, use only under the guidance of a healthcare professional and with specific pediatric formulations/dosing. Adolescents (12 years and older) can generally follow adult dosing.

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Geriatric Use

Use with caution in elderly patients (65 years and older) due to increased susceptibility to anticholinergic effects (e.g., confusion, urinary retention, constipation, dry mouth) from chlorpheniramine and cardiovascular effects (e.g., increased blood pressure, heart rate) from phenylephrine. Start with lower doses and monitor closely.

Clinical Information

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Clinical Pearls

  • This combination product is designed for multi-symptom relief of cold, cough, and allergy symptoms. Ensure the patient's symptoms align with the active ingredients to avoid unnecessary drug exposure.
  • Counsel patients on the potential for drowsiness and to avoid activities requiring mental alertness until they know how the medication affects them.
  • Emphasize the critical interaction with MAOIs; patients must be explicitly warned about this.
  • Advise patients with underlying conditions such as high blood pressure, heart disease, thyroid disease, diabetes, glaucoma, or prostate enlargement to consult a doctor before use.
  • Over-the-counter cough and cold products should not be used in children under 6 years of age.
  • Be aware of the risk of serotonin syndrome, especially if patients are taking other serotonergic medications.
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Alternative Therapies

  • Single-ingredient antihistamines (e.g., loratadine, cetirizine for non-drowsy allergy relief)
  • Single-ingredient decongestants (e.g., pseudoephedrine, oxymetazoline nasal spray)
  • Single-ingredient antitussives (e.g., guaifenesin, benzonatate)
  • Non-pharmacological remedies (e.g., saline nasal sprays, humidifiers, honey for cough, rest, fluids)
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets
Generic Available: Yes
Insurance Coverage: Over-the-counter (OTC) - 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 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 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.