Triprolidine 0.625mg/ml Liq 50ml

Manufacturer BRANDYWINE PHARMACEUTICALS 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
H1-receptor antagonist, First-generation
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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?

Triprolidine is an antihistamine that helps relieve symptoms of allergies, such as sneezing, runny nose, and watery eyes. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It can also 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. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable device to ensure accurate measurement.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, avoiding bathrooms. 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'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 CNS depressants while taking this medication, as they can increase drowsiness.
  • Drink plenty of fluids to help with dry mouth, a common side effect.
  • If you experience blurred vision, avoid activities requiring clear vision.
  • Do not exceed the recommended dose, as this can increase the risk of side effects.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 2.5 mg (4 ml) every 4 to 6 hours as needed
Dose Range: 2.5 - 10 mg

Condition-Specific Dosing:

maximumDailyDose: 10 mg (16 ml) in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended under 2 years)
Child: 2 to under 6 years: 0.625 mg (1 ml) every 4 to 6 hours as needed (Max 2.5 mg/day); 6 to under 12 years: 1.25 mg (2 ml) every 4 to 6 hours as needed (Max 5 mg/day)
Adolescent: 12 years and older: 2.5 mg (4 ml) every 4 to 6 hours as needed (Max 10 mg/day)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; consider dose reduction
Moderate: Use with caution; consider dose reduction
Severe: Use with caution; consider significant dose reduction or avoidance due to increased risk of adverse effects
Dialysis: Not well studied; likely not dialyzable due to protein binding and volume of distribution. Avoid or use with extreme caution.

Hepatic Impairment:

Mild: Use with caution; consider dose reduction
Moderate: Use with caution; consider dose reduction
Severe: Use with caution; consider significant dose reduction or avoidance due to impaired metabolism and increased risk of adverse effects
Confidence: Medium

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: High (well absorbed orally)
Tmax: Approximately 1-2 hours
FoodEffect: Minimal or no significant effect on absorption

Distribution:

Vd: Not extensively reported, but widely distributed throughout the body
ProteinBinding: Not extensively reported, but likely moderate
CnssPenetration: Yes (readily crosses the blood-brain barrier, leading to central nervous system effects like sedation)

Elimination:

HalfLife: Approximately 3-6 hours
Clearance: Not precisely quantified, primarily renal
ExcretionRoute: Primarily renal (urine)
Unchanged: A small percentage (less than 1%) is excreted unchanged in urine
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Pharmacodynamics

OnsetOfAction: Approximately 15-30 minutes
PeakEffect: Approximately 1-2 hours
DurationOfAction: Approximately 4-6 hours
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical help immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or 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 if you experience any of the following side effects or if they persist or bother you:
- Feeling sleepy
- Feeling nervous and excitable

Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for advice. 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 dizziness
  • Difficulty urinating
  • Severe dry mouth or nose
  • Blurred vision
  • Fast or irregular heartbeat
  • Nervousness, restlessness, or excitability (especially in children)
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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.
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 or exacerbate underlying health issues.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose 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 can increase your chance of experiencing serious adverse effects. Additionally, do not take this medication for a longer duration than specified by your doctor.

Until you understand how this medication affects you, avoid operating a vehicle, performing tasks that require alertness, or engaging in activities that demand your full attention. It is also recommended to refrain from consuming alcohol while taking this drug.

Before using marijuana, other forms of cannabis, or any prescription or over-the-counter (OTC) medications that may cause drowsiness or slow your reactions, consult with your doctor to discuss potential interactions.

When administering this medication to a child, exercise caution, as children may have a higher risk of experiencing excitability.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe drowsiness or sedation
  • Dizziness
  • Ataxia (loss of coordination)
  • Blurred vision
  • Dry mouth and skin
  • Flushing
  • Fever
  • Dilated pupils
  • Urinary retention
  • Tachycardia (rapid heart rate)
  • Hypertension (high blood pressure)
  • Nausea, vomiting
  • In severe cases: hallucinations, seizures, coma, respiratory depression, cardiovascular collapse

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 maintaining vital signs. Do not induce vomiting.

Drug Interactions

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Major Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Can prolong and intensify the anticholinergic and CNS depressant effects of triprolidine. Avoid concomitant use or use with extreme caution.
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Moderate Interactions

  • CNS Depressants (e.g., alcohol, opioids, benzodiazepines, sedatives, hypnotics, anxiolytics, other antihistamines): Additive CNS depression (increased sedation, dizziness, impaired coordination).
  • Anticholinergic Drugs (e.g., tricyclic antidepressants, atropine, some antipsychotics): Additive anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation).

Monitoring

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Baseline Monitoring

Patient history (allergies, existing medical conditions, current medications)

Rationale: To identify contraindications, potential drug interactions, and conditions that may be exacerbated by triprolidine (e.g., glaucoma, prostatic hypertrophy, asthma).

Timing: Prior to initiation of therapy

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Routine Monitoring

Symptom relief (e.g., sneezing, runny nose, watery eyes)

Frequency: As needed, during therapy

Target: Reduction or resolution of target symptoms

Action Threshold: Lack of efficacy may indicate need for alternative therapy or re-evaluation of diagnosis.

CNS effects (e.g., sedation, dizziness, impaired coordination)

Frequency: During therapy, especially with initial doses or dose adjustments

Target: Minimal or tolerable sedation

Action Threshold: Excessive sedation or impairment warrants dose reduction or discontinuation, and patient counseling on avoiding hazardous activities.

Anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation)

Frequency: During therapy

Target: Minimal or tolerable side effects

Action Threshold: Severe or bothersome anticholinergic effects may require dose adjustment or discontinuation.

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Symptom Monitoring

  • Sedation
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Nervousness (paradoxical excitation, especially in children)
  • Insomnia

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.

Trimester-Specific Risks:

First Trimester: Limited data; potential for increased risk of congenital malformations not definitively established but caution advised.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Use with caution, especially near term, due to potential for CNS depression or anticholinergic effects in the neonate.
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Lactation

Triprolidine is excreted into breast milk. Due to the potential for sedation in the infant and possible reduction in milk supply (due to anticholinergic effects), it is generally not recommended for use by nursing mothers. If used, monitor the infant for drowsiness or irritability.

Infant Risk: Moderate risk (L3) - potential for sedation, irritability, or paradoxical excitation in the infant; theoretical risk of decreased milk supply.
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Pediatric Use

Use with caution, especially in children under 2 years of age, due to increased susceptibility to adverse effects, including respiratory depression and paradoxical excitation (nervousness, restlessness, insomnia). Dosage must be carefully calculated based on age and weight. Not recommended for infants under 6 months.

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Geriatric Use

Elderly patients are more susceptible to the sedative and anticholinergic effects (e.g., dry mouth, urinary retention, constipation, confusion, dizziness) of triprolidine. Use with caution, starting with the lowest effective dose and monitoring closely for adverse effects. Avoid in elderly patients with conditions exacerbated by anticholinergic effects (e.g., glaucoma, prostatic hypertrophy).

Clinical Information

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Clinical Pearls

  • Triprolidine is a first-generation antihistamine known for its significant sedative and anticholinergic properties.
  • It is often found in combination products with decongestants (e.g., pseudoephedrine).
  • Patients should be warned about impaired ability to perform tasks requiring mental alertness (e.g., driving, operating machinery).
  • Advise patients to avoid concurrent use of alcohol and other CNS depressants.
  • Monitor for anticholinergic side effects, especially in elderly patients.
  • Paradoxical excitation can occur, particularly in young children.
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Alternative Therapies

  • Second-generation antihistamines (e.g., loratadine, cetirizine, fexofenadine) for less sedation
  • Other first-generation antihistamines (e.g., diphenhydramine, chlorpheniramine)
  • Nasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis
  • Cromolyn sodium nasal spray
  • Decongestants (e.g., pseudoephedrine, phenylephrine) if congestion is the primary symptom
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Cost & Coverage

Average Cost: Typically low cost per 50ml bottle
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, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.