Chlorpheniramine 4mg Tablets

Manufacturer MARLEX PHARMACEUTICALS Active Ingredient Chlorpheniramine Tablets(klor fen IR a meen) Pronunciation klor fen IR a meen
It is used to ease allergy signs.
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Drug Class
Antihistamine
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Pharmacologic Class
First-generation H1-receptor antagonist
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Pregnancy Category
Category B
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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?

Chlorpheniramine is an antihistamine used to relieve symptoms of allergies, such as sneezing, runny nose, watery eyes, and itching. It can also help with common cold symptoms like sneezing and runny nose. It may cause drowsiness.
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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. Instead, consult your pharmacist for guidance on proper disposal. Many communities have drug take-back programs, which your pharmacist can help you find.

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 once or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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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 chlorpheniramine, as this can increase drowsiness.
  • Drink plenty of fluids to help with dry mouth, a common side effect.
  • If you experience blurred vision or difficulty urinating, contact your healthcare provider.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 4 mg every 4 to 6 hours as needed
Dose Range: 4 - 24 mg

Condition-Specific Dosing:

maximumDailyDose: 24 mg per 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (not recommended for children under 2 years)
Child: 2 to under 6 years: 1 mg every 4 to 6 hours (maximum 6 mg per 24 hours); 6 to under 12 years: 2 mg every 4 to 6 hours (maximum 12 mg per 24 hours)
Adolescent: 12 years and older: 4 mg every 4 to 6 hours (maximum 24 mg per 24 hours)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended
Moderate: Consider dose reduction (e.g., 50% of usual dose) due to prolonged half-life
Severe: Consider dose reduction (e.g., 50% of usual dose) due to prolonged half-life
Dialysis: Not significantly removed by dialysis; adjust dose based on clinical response and adverse effects

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: Consider dose reduction (e.g., 50% of usual dose) due to impaired metabolism
Severe: Consider dose reduction (e.g., 50% of usual dose) due to impaired metabolism
Confidence: Medium

Pharmacology

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Mechanism of Action

Chlorpheniramine is a first-generation alkylamine antihistamine that competitively antagonizes H1-receptors, thereby preventing the effects of histamine on capillaries, bronchi, and gastrointestinal smooth muscles. It also possesses anticholinergic and sedative properties due to its ability to cross the blood-brain barrier.
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Pharmacokinetics

Absorption:

Bioavailability: 25-60% (variable due to first-pass metabolism)
Tmax: 2-6 hours
FoodEffect: Minimal effect on absorption rate or extent

Distribution:

Vd: 3.2 L/kg
ProteinBinding: 69-72%
CnssPenetration: Yes

Elimination:

HalfLife: 12-43 hours (highly variable)
Clearance: Not available
ExcretionRoute: Renal (urine)
Unchanged: Approximately 34%
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Pharmacodynamics

OnsetOfAction: 15-60 minutes
PeakEffect: 2-6 hours
DurationOfAction: 4-6 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

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 guidance:

Feeling sleepy
* Feeling nervous and excitable

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to 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 drowsiness or sedation
  • Confusion or hallucinations
  • Difficulty urinating or inability to urinate
  • Rapid or irregular heartbeat
  • Seizures
  • Severe dizziness or fainting
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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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken safely with all 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.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your chances of experiencing adverse effects. Additionally, do not take this medication for a longer duration than specified by your doctor.

Until you are aware of how this medication affects you, it is recommended that you avoid operating a vehicle or engaging in activities that require alertness. It is also advisable to refrain from consuming alcohol while taking this drug.

Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.

If you are considering giving this medication to a child, it is crucial to discuss the suitability of different brands with your doctor, as they may be intended for use in specific age groups. When administering this medication to a child, exercise caution, as children may have a higher risk of experiencing excitability. Furthermore, do not use this medication as a means to induce sleep in a child; instead, consult with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is necessary to discuss 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 deep sleep
  • Excitement, nervousness, or restlessness (especially in children)
  • Hallucinations
  • Seizures
  • Dilated pupils
  • Flushed skin
  • Dry mouth and skin
  • Fever
  • Loss of coordination
  • Coma

What to Do:

In case of overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Emergency treatment may include activated charcoal, gastric lavage, and supportive care.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) within 14 days (may prolong and intensify anticholinergic and CNS depressant effects)
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Major Interactions

  • Alcohol (increased CNS depression)
  • Other CNS depressants (e.g., opioids, benzodiazepines, sedatives, hypnotics, anxiolytics, tricyclic antidepressants - increased CNS depression)
  • Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants, some antipsychotics - increased anticholinergic effects like dry mouth, urinary retention, blurred vision)
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Moderate Interactions

  • Potassium chloride (oral) (increased risk of GI lesions due to anticholinergic effects slowing GI motility)
  • Topical anesthetics (e.g., pramoxine - additive CNS depression if systemic absorption occurs)
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Minor Interactions

  • Not available

Monitoring

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Routine Monitoring

Symptom relief (e.g., allergy symptoms)

Frequency: As needed

Target: Reduction in symptoms

Action Threshold: Lack of efficacy or worsening symptoms

Adverse effects (e.g., drowsiness, dry mouth, blurred vision, urinary retention)

Frequency: As needed, especially during initial use

Target: Absence or tolerability of side effects

Action Threshold: Intolerable side effects, especially severe sedation or anticholinergic effects

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Nervousness (paradoxical excitation, especially in children)
  • Confusion (especially in elderly)

Special Patient Groups

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Pregnancy

Chlorpheniramine is generally considered acceptable for use during pregnancy, particularly in the second and third trimesters. It is classified as Pregnancy Category B. However, use in the first trimester should be with caution and only if clearly needed, as with any medication.

Trimester-Specific Risks:

First Trimester: Limited data, generally considered low risk but use with caution.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Chlorpheniramine is excreted into breast milk. It is rated L3 (moderately safe) by Hale's Lactation Risk Category. It may cause drowsiness or irritability in the infant and may decrease milk supply due to its anticholinergic effects. Use with caution, especially in newborns or premature infants. Consider a non-sedating antihistamine if possible.

Infant Risk: Moderate risk of infant drowsiness, irritability, or decreased milk supply.
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Pediatric Use

Not recommended for children under 2 years of age due to potential for serious side effects, including respiratory depression and paradoxical excitation. Use with caution in children 2-12 years, adhering strictly to recommended doses, as they may experience paradoxical excitation (e.g., restlessness, nervousness, insomnia) rather than sedation.

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Geriatric Use

Elderly patients are more susceptible to the sedative and anticholinergic effects of chlorpheniramine (e.g., confusion, dizziness, dry mouth, urinary retention, constipation). Start with lower doses and monitor closely for adverse effects. Avoid use in elderly patients with conditions exacerbated by anticholinergic effects (e.g., glaucoma, prostatic hypertrophy).

Clinical Information

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Clinical Pearls

  • Chlorpheniramine is a first-generation antihistamine known for its sedative and anticholinergic properties.
  • It is widely available over-the-counter (OTC) and often found in combination cold and allergy products.
  • Due to its sedative effects, it is often preferred for nighttime use or when sedation is not a concern.
  • Patients should be advised about potential impairment of driving or operating machinery.
  • Caution is advised in patients with glaucoma, prostatic hypertrophy, or bladder neck obstruction due to anticholinergic effects.
  • Paradoxical excitation (restlessness, nervousness) can occur, especially in young children.
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Alternative Therapies

  • Second-generation antihistamines (e.g., Loratadine, Cetirizine, Fexofenadine, Desloratadine, Levocetirizine) for less sedation and anticholinergic effects.
  • Nasal corticosteroids (e.g., Fluticasone, Mometasone) for allergic rhinitis.
  • Cromolyn sodium nasal spray (mast cell stabilizer).
  • Decongestants (e.g., Pseudoephedrine, Phenylephrine) for nasal congestion (often used in combination).
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Cost & Coverage

Average Cost: $5 - $20 per 100 tablets (generic)
Generic Available: Yes
Insurance Coverage: Over-the-counter (OTC) - generally not covered by prescription plans unless specifically prescribed and covered by certain FSA/HSA programs or specific insurance plans.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.