Histex PD 0.938mg Drops

Manufacturer ALLEGIS 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
First-generation H1-receptor antagonist; Alkylamine antihistamine
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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?

Histex PD Drops contain an antihistamine called triprolidine. It helps relieve allergy symptoms like sneezing, runny nose, and itchy eyes by blocking a natural substance called histamine in your body. It can also help dry up nasal secretions.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, 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 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 secure 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 medications, consult your pharmacist. You may also want to check if there are 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, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • This medication can cause drowsiness. Avoid driving, operating machinery, or engaging in activities requiring mental alertness until you know how it affects you.
  • Avoid alcohol consumption while taking this medication, as it can increase drowsiness and other side effects.
  • Stay hydrated to help with dry mouth, a common side effect.
  • For children, ensure accurate dosing using the provided dropper to prevent accidental overdose.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically used as a single agent in adults for this concentration. Standard adult dose of triprolidine is 2.5 mg every 4-6 hours.
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Pediatric Dosing

Neonatal: Not established
Infant: 6 to 11 months: 0.25 mL (0.2345 mg) every 4-6 hours, not to exceed 4 doses in 24 hours.
Child: 1 to 2 years: 0.5 mL (0.469 mg) every 4-6 hours, not to exceed 4 doses in 24 hours. 2 to 6 years: 0.75 mL (0.7035 mg) every 4-6 hours, not to exceed 4 doses in 24 hours. 6 to 12 years: 1.25 mL (1.1725 mg) every 4-6 hours, not to exceed 4 doses in 24 hours.
Adolescent: Not typically used as a single agent in adolescents for this concentration. Standard adolescent dose of triprolidine is 2.5 mg every 4-6 hours.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: Use with caution; consider reduced dose or extended interval due to potential for increased sedation and anticholinergic effects.
Severe: Use with caution; consider reduced dose or extended interval due to potential for increased sedation and anticholinergic effects.
Dialysis: Not well studied; likely not dialyzable due to high protein binding and volume of distribution. Use with caution.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: Use with caution; consider reduced dose or extended interval due to potential for increased sedation and anticholinergic effects.
Severe: Use with caution; consider reduced dose or extended interval due to potential for increased sedation and anticholinergic effects.

Pharmacology

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Mechanism of Action

Triprolidine is a first-generation alkylamine antihistamine that competitively antagonizes H1-receptors, thereby preventing histamine from binding and exerting its effects (e.g., vasodilation, increased capillary permeability, pruritus, bronchoconstriction). It also possesses significant anticholinergic (antimuscarinic) properties, contributing to its drying effects on nasal and bronchial secretions and sedative effects.
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Pharmacokinetics

Absorption:

Bioavailability: Well absorbed (estimated >90%)
Tmax: 1-2 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect bioavailability.

Distribution:

Vd: Approximately 2.5-3.5 L/kg
ProteinBinding: Approximately 80-90%
CnssPenetration: Yes

Elimination:

HalfLife: 3-6 hours (can be longer in children and elderly)
Clearance: Approximately 0.5-1 L/hr/kg
ExcretionRoute: Primarily renal (urine), with a small amount in feces.
Unchanged: Less than 1% (primarily as metabolites)
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Pharmacodynamics

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

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which may indicate a serious allergic reaction:
- 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, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Drowsiness
- Feeling nervous and excitable
Please note that this list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor.

Reporting Side Effects
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 dizziness
  • Difficulty urinating
  • Blurred vision or eye pain
  • Fast or irregular heartbeat
  • Confusion or hallucinations
  • Unusual excitement or nervousness (especially in children)
  • Signs of an 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, any of 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) medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

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. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Do not exceed the recommended treatment duration, and only take this medication for the length of time specified by your doctor.

Until you are familiar with how this medication affects you, exercise caution when engaging in activities that require alertness, such as driving. Additionally, avoid consuming alcohol while taking this drug, as it may interact with the medication.

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

When administering this medication to children, use caution, as they 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 they will need 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 sedation
  • Dizziness
  • Ataxia (loss of coordination)
  • Dry mouth and skin
  • Flushing
  • Dilated pupils
  • Blurred vision
  • Urinary retention
  • Constipation
  • Tachycardia (rapid heart rate)
  • Hypertension (high blood pressure)
  • Hyperthermia (fever)
  • In severe cases: seizures, coma, respiratory depression, cardiovascular collapse.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive, including gastric lavage, activated charcoal, and symptomatic treatment for CNS and anticholinergic effects. Physostigmine may be considered for severe anticholinergic symptoms under medical supervision.

Drug Interactions

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Major Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): May prolong and intensify the anticholinergic and CNS depressant effects of triprolidine.
  • Other CNS Depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, opioids): Increased risk of profound sedation, respiratory depression, and psychomotor impairment.
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Moderate Interactions

  • Other Anticholinergic Drugs (e.g., tricyclic antidepressants, atropine, some antipsychotics): Increased risk of anticholinergic side effects (e.g., dry mouth, urinary retention, blurred vision, constipation).
  • Potassium Chloride (oral forms): Increased risk of gastrointestinal lesions due to delayed gastric emptying.
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Minor Interactions

  • Antihypertensives: May cause additive hypotensive effects (rare).

Monitoring

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Routine Monitoring

Symptom relief (e.g., sneezing, runny nose, itching)

Frequency: Daily, as needed

Target: Reduction or resolution of symptoms

Action Threshold: Lack of efficacy or worsening symptoms

Sedation/Drowsiness

Frequency: Daily, especially during initial therapy

Target: Minimal or tolerable sedation

Action Threshold: Excessive drowsiness, impaired alertness, or difficulty waking

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

Frequency: Daily, as needed

Target: Absence or mild, tolerable effects

Action Threshold: Severe or bothersome anticholinergic symptoms

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Nervousness or excitability (paradoxical reaction, especially in children)
  • Nausea
  • Vomiting

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.

Trimester-Specific Risks:

First Trimester: Use with caution; avoid if possible due to limited data.
Second Trimester: Use with caution; consider alternatives if available.
Third Trimester: Use with caution; may cause irritability or drowsiness in the newborn if used close to delivery.
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Lactation

Triprolidine is generally not recommended during breastfeeding (Lactation Risk L3 - Moderately Safe). It can be excreted into breast milk and may cause drowsiness or irritability in the infant. It may also decrease milk supply due to its anticholinergic effects.

Infant Risk: Moderate risk of infant sedation, irritability, or decreased milk supply. Observe infant for drowsiness, poor feeding, or unusual fussiness.
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Pediatric Use

Use with caution, especially in infants and young children, as they may be more susceptible to the sedative and anticholinergic effects. Paradoxical excitation (nervousness, restlessness, insomnia) can occur, particularly in young children. Accurate dosing using the provided dropper is crucial to prevent overdose.

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Geriatric Use

Elderly patients are more susceptible to the sedative, anticholinergic, and hypotensive effects of triprolidine. Use with caution, starting with lower doses and monitoring closely for adverse effects such as confusion, dizziness, urinary retention, and constipation. Avoid use in elderly patients with cognitive impairment or benign prostatic hyperplasia.

Clinical Information

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Clinical Pearls

  • Triprolidine is a first-generation antihistamine known for its significant sedative and anticholinergic properties.
  • Due to its sedative effects, it is often preferred for nighttime use or when drowsiness is acceptable.
  • Caution is advised when combining with other CNS depressants or anticholinergic medications.
  • Paradoxical excitation can occur in children, manifesting as restlessness or insomnia.
  • Elderly patients are particularly vulnerable to adverse effects like confusion, urinary retention, and falls.
  • Histex PD 0.938mg Drops is a specific pediatric formulation, requiring careful attention to the prescribed dose in mL.
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Alternative Therapies

  • Second-generation antihistamines (e.g., loratadine, cetirizine, fexofenadine) for less sedation and anticholinergic effects.
  • Nasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis.
  • Cromolyn sodium nasal spray (mast cell stabilizer).
  • Saline nasal sprays for symptomatic relief.
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Cost & Coverage

Average Cost: Varies widely by pharmacy and specific product per bottle
Generic Available: Yes
Insurance Coverage: Often Tier 1 or 2 for generic formulations; brand-specific products may vary.
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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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.