Triprolidine 0.938mg Drops

Manufacturer CREEKWOOD Active Ingredient Triprolidine(trye PROE li deen) Pronunciation trye PROE li deen
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
C
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FDA Approved
Aug 1958
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Triprolidine is an antihistamine that helps relieve allergy symptoms like sneezing, runny nose, and itchy eyes or throat. It works by blocking a natural substance called histamine that your body makes during an allergic reaction. It can also help with cold symptoms like sneezing and runny nose. Be aware that this medication can 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, but if it causes stomach upset, take it with food. When taking the liquid form, measure the dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.

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 disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available 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 is 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 triprolidine, as this can increase drowsiness.
  • Stay hydrated to help with dry mouth, a common side effect.
  • If you experience blurred vision, avoid activities requiring clear vision.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 2.5 mg (approximately 2.67 mL of 0.938mg/mL solution) every 4 to 6 hours as needed
Dose Range: 2.5 - 10 mg

Condition-Specific Dosing:

maximum_daily_dose: 10 mg (approximately 10.67 mL) in 24 hours
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Pediatric Dosing

Neonatal: Not established; generally not recommended due to increased risk of adverse effects.
Infant: 6 months to < 2 years: 0.313 mg (approximately 0.33 mL) every 4 to 6 hours as needed, not to exceed 4 doses in 24 hours. Use with caution and only if clearly indicated.
Child: 2 to < 6 years: 0.625 mg (approximately 0.67 mL) every 4 to 6 hours as needed, not to exceed 4 doses in 24 hours. 6 to < 12 years: 1.25 mg (approximately 1.33 mL) every 4 to 6 hours as needed, not to exceed 4 doses in 24 hours.
Adolescent: 12 years and older: 2.5 mg (approximately 2.67 mL) every 4 to 6 hours as needed, not to exceed 4 doses in 24 hours.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor for increased sedation.
Moderate: Consider dose reduction (e.g., 50% of usual dose) or extended dosing interval (e.g., every 8-12 hours) due to potential for accumulation.
Severe: Significant dose reduction (e.g., 50-75% of usual dose) or extended dosing interval (e.g., every 12-24 hours) recommended. Avoid if possible.
Dialysis: Triprolidine is not significantly removed by dialysis. Follow severe renal impairment guidelines.

Hepatic Impairment:

Mild: No specific adjustment recommended, but monitor for increased sedation.
Moderate: Consider dose reduction (e.g., 50% of usual dose) or extended dosing interval (e.g., every 8-12 hours) due to impaired metabolism.
Severe: Significant dose reduction (e.g., 50-75% of usual dose) or extended dosing interval (e.g., every 12-24 hours) recommended. Avoid if possible.

Pharmacology

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Mechanism of Action

Triprolidine is a first-generation antihistamine that acts as a competitive antagonist of histamine at H1-receptors. It blocks the effects of histamine, thereby reducing symptoms such as sneezing, rhinorrhea, and itching associated with allergic reactions. It also possesses anticholinergic properties.
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Pharmacokinetics

Absorption:

Bioavailability: High (approximately 60-80%)
Tmax: 1 to 2 hours
FoodEffect: Minimal effect on absorption rate or extent.

Distribution:

Vd: Approximately 2.5-4 L/kg
ProteinBinding: Approximately 70-80%
CnssPenetration: Yes (readily crosses the blood-brain barrier, contributing to sedative effects)

Elimination:

HalfLife: 3 to 6 hours
Clearance: Approximately 0.5-1 L/kg/hr
ExcretionRoute: Primarily renal (as metabolites and unchanged drug)
Unchanged: Approximately 1% to 4% of the dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: 15 to 30 minutes
PeakEffect: 1 to 2 hours
DurationOfAction: 4 to 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 immediately or seek emergency 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
+ Difficulty 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Drowsiness
* Feeling nervous and excitable

Note: This is not an exhaustive list of 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:

  • Severe drowsiness or sedation that interferes with daily activities
  • Confusion or hallucinations (especially in children or elderly)
  • 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 is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.

To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination with your other medications and health conditions. Your doctor and pharmacist will work together to ensure that all your medications and health issues are compatible with this drug.
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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. Adhering to the recommended treatment duration is also crucial; do not take this drug for longer than specified by your doctor.

Until you are familiar with how this medication affects you, it is advisable to avoid operating a vehicle and engaging in other activities that require alertness. Additionally, refrain from consuming alcohol while taking this drug, as it may exacerbate its effects.

Before using marijuana, other cannabis products, or prescription and over-the-counter (OTC) medications that can cause drowsiness or impair your reactions, consult with your doctor to discuss potential interactions.

When administering this drug to children, exercise caution, as they may be at a higher risk of experiencing excitability.

If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to discuss the benefits and risks of this medication with your doctor to ensure the well-being of both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe drowsiness or deep sleep
  • CNS depression (e.g., decreased breathing, coma)
  • CNS excitation (especially in children, e.g., restlessness, irritability, hallucinations, seizures)
  • Anticholinergic effects (e.g., severe dry mouth, dilated pupils, flushed skin, fever, urinary retention, bowel obstruction)
  • Tachycardia
  • Hypotension or hypertension

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, including gastric lavage, activated charcoal, and close monitoring of vital signs.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation due to increased anticholinergic effects and potential for hypertensive crisis if combined with sympathomimetics)
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Major Interactions

  • CNS depressants (e.g., alcohol, opioids, benzodiazepines, sedatives, hypnotics, anxiolytics) - increased sedation and respiratory depression.
  • Other anticholinergic drugs (e.g., tricyclic antidepressants, atropine, some antipsychotics) - increased risk of anticholinergic side effects (dry mouth, urinary retention, blurred vision, constipation).
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Moderate Interactions

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - potential for increased triprolidine levels and enhanced effects.
  • Potassium chloride (oral) - increased risk of gastrointestinal lesions due to decreased GI motility.
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Minor Interactions

  • Not many specific minor interactions; generally additive effects with other sedating or anticholinergic agents.

Monitoring

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Baseline Monitoring

Assessment of allergy/cold symptoms

Rationale: To establish baseline severity and guide treatment.

Timing: Prior to initiation of therapy.

Review of concomitant medications

Rationale: To identify potential drug interactions, especially with CNS depressants or anticholinergics.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (symptom relief)

Frequency: Daily, as needed

Target: Reduction in sneezing, rhinorrhea, itching

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

Adverse effects (sedation, anticholinergic symptoms)

Frequency: Daily, as needed

Target: Minimal to no significant drowsiness, dry mouth, blurred vision, urinary retention, or constipation.

Action Threshold: Significant or bothersome side effects; consider dose reduction or discontinuation.

Mental status/Cognitive function (especially in elderly or children)

Frequency: As needed, particularly during initial therapy

Target: Alertness appropriate for age, no confusion or paradoxical excitation.

Action Threshold: Increased confusion, disorientation, or paradoxical agitation; discontinue or reduce dose.

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Nausea
  • Vomiting
  • Nervousness
  • Insomnia (paradoxical effect)
  • Thickening of bronchial secretions

Special Patient Groups

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Pregnancy

Triprolidine is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data are available, but animal studies have shown some adverse effects at high doses. Avoid use, especially in the third trimester, due to potential for neonatal effects.

Trimester-Specific Risks:

First Trimester: Limited human data; generally considered low risk for major malformations, but use only if clearly needed.
Second Trimester: Generally considered safer than first or third trimester, but still use with caution.
Third Trimester: Potential for neonatal effects such as irritability, tremors, or respiratory depression if used close to delivery. Avoid use in the third trimester.
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Lactation

Triprolidine is excreted into breast milk and can cause sedation or irritability in the infant, and may decrease milk supply due to its anticholinergic effects. Use with caution, monitor the infant for adverse effects, and consider alternative non-sedating antihistamines if possible. Classified as L3 (Moderately Safe) by some sources.

Infant Risk: Risk of sedation, irritability, or paradoxical excitation in the infant. Potential for decreased milk supply.
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Pediatric Use

Use with extreme caution, especially in infants and young children, due to increased susceptibility to CNS effects (sedation or paradoxical excitation, including seizures). Not recommended for infants under 6 months of age. Dosage must be carefully calculated based on age/weight. Overdose in children can be fatal.

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Geriatric Use

Elderly patients are more susceptible to the sedative and anticholinergic effects (e.g., confusion, dizziness, urinary retention, constipation) of triprolidine. Use lower doses and monitor closely. Triprolidine is generally listed on the Beers Criteria as a medication to avoid in older adults due to its anticholinergic properties and risk of falls.

Clinical Information

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Clinical Pearls

  • Triprolidine is a first-generation antihistamine known for its significant sedative and anticholinergic side effects.
  • It is often found in combination products with decongestants (e.g., pseudoephedrine) for cold and allergy symptom relief.
  • Due to its side effect profile, newer, non-sedating second-generation antihistamines are generally preferred for chronic allergy management.
  • Caution is advised in patients with conditions exacerbated by anticholinergic effects, such as glaucoma, prostatic hypertrophy, or bladder neck obstruction.
  • Paradoxical excitation (restlessness, insomnia, nervousness) can occur, especially in children and occasionally in adults.
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Alternative Therapies

  • Second-generation antihistamines (e.g., loratadine, cetirizine, fexofenadine, levocetirizine, desloratadine) for allergy symptoms with less sedation.
  • Other first-generation antihistamines (e.g., diphenhydramine, chlorpheniramine, brompheniramine) for similar indications but with varying side effect profiles.
  • Nasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis.
  • Cromolyn sodium nasal spray for allergy prevention.
  • Saline nasal sprays for symptomatic relief of congestion and runny nose.
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Cost & Coverage

Average Cost: Varies widely, typically low per 30 mL bottle (0.938mg/mL)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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. 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.