Banophen (diphenhydramine) 25mg Tb

Manufacturer MAJOR PHARMACEUTICALS Active Ingredient Diphenhydramine Capsules and Tablets(dye fen HYE dra meen) Pronunciation dye fen HYE dra meen
It is used to ease allergy signs.
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Drug Class
Antihistamine, Sedative, Hypnotic, Antitussive
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Pharmacologic Class
First-generation H1-receptor antagonist
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Pregnancy 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?

Diphenhydramine is an antihistamine that helps relieve allergy symptoms like sneezing, runny nose, and itchy eyes. It also causes drowsiness, which is why it's often used to help with sleep or to treat motion sickness.
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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, away from light and moisture. Avoid storing it in a bathroom. Ensure all medications are kept in a safe location, 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. You may also want to inquire about 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 scheduled dose, skip the missed dose and continue with your regular dosing 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 significant drowsiness.
  • Avoid alcohol and other sedatives while taking this medication, as they can increase drowsiness.
  • Take with food or milk if stomach upset occurs.
  • Stay hydrated to help with dry mouth.

Dosing & Administration

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Adult Dosing

Standard Dose: 25-50 mg every 4-6 hours as needed
Dose Range: 25 - 50 mg

Condition-Specific Dosing:

Allergy/Cold Symptoms: 25-50 mg every 4-6 hours
Insomnia: 50 mg at bedtime
Motion Sickness: 25-50 mg 30 minutes before travel, then every 4-6 hours as needed
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Pediatric Dosing

Neonatal: Not established (Contraindicated)
Infant: Not established (Generally not recommended under 2 years without physician consultation)
Child: 6-12 years: 12.5-25 mg every 4-6 hours (Maximum 150 mg/day)
Adolescent: 12+ years: 25-50 mg every 4-6 hours (Maximum 300 mg/day)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed
Moderate: Use with caution, consider lower doses or extended intervals
Severe: Use with caution, consider lower doses or extended intervals
Dialysis: Not significantly dialyzable; use with caution, monitor for increased side effects

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: Use with caution, consider lower doses
Severe: Use with caution, consider lower doses or extended intervals

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: 40-60%
Tmax: 1-4 hours
FoodEffect: May delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: 17 L/kg
ProteinBinding: 78-85%
CnssPenetration: Yes (readily crosses the blood-brain barrier)

Elimination:

HalfLife: 2.4-9.3 hours (average 4-8 hours)
Clearance: 600-1300 mL/min
ExcretionRoute: Urine (primarily as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 15-60 minutes
PeakEffect: 1-3 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. 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
Severe dizziness or fainting
Changes in balance
Feeling less alert than usual

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although 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 advice:

Dizziness or drowsiness
Thickening of mucus in the nose or throat
Feeling nervous or excitable
Upset stomach or vomiting

This list is not exhaustive, and you may experience other side effects not mentioned here. 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 drowsiness or dizziness
  • Confusion or hallucinations
  • Difficulty urinating
  • Rapid or irregular heartbeat
  • Blurred vision or eye pain
  • Unusual excitement or restlessness (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. Be sure to describe the allergic reaction and its symptoms.
If you are breastfeeding or plan to breastfeed, as you may need to avoid breastfeeding while taking this medication.
If the patient is a premature baby or newborn, as this form of the medication should not be given to them.

This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:

All prescription and over-the-counter medications you are taking, including natural products and vitamins.
* Any existing health problems you have.

To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication, including this one.
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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 severe side 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 or engaging in activities that require alertness.

Do not use this medication in conjunction with other products containing diphenhydramine. It is also recommended to avoid consuming alcohol while taking this drug.

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

Note that different brands of this medication may be suitable for children of varying ages. Therefore, it is crucial to consult with a doctor before administering this medication to a child. Furthermore, do not use this medication as a means to induce sleep in children; instead, discuss alternative solutions with your doctor.

If you are 60 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Similarly, when administering this medication to children, use it with caution, as they may have a higher risk of experiencing excitability.

If you are pregnant or planning to become pregnant, inform your doctor, as it is necessary to discuss the benefits and risks associated with using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Severe drowsiness or coma
  • Confusion
  • Hallucinations
  • Seizures
  • Dilated pupils
  • Dry mouth and flushed skin
  • Rapid heartbeat
  • Urinary retention

What to Do:

Call 911 or Poison Control (1-800-222-1222) immediately.

Drug Interactions

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Major Interactions

  • CNS depressants (e.g., alcohol, opioids, benzodiazepines, sedatives, hypnotics): Increased risk of profound sedation, respiratory depression.
  • Anticholinergic drugs (e.g., tricyclic antidepressants, antipsychotics, atropine, scopolamine): Increased risk of anticholinergic side effects (e.g., dry mouth, blurred vision, urinary retention, constipation, confusion).
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Moderate Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Can prolong and intensify the anticholinergic and CNS depressant effects of diphenhydramine.
  • Potassium chloride (oral): Increased risk of gastrointestinal lesions due to anticholinergic-induced decreased GI motility.

Monitoring

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Baseline Monitoring

Patient history (e.g., glaucoma, prostatic hypertrophy, asthma, urinary retention)

Rationale: To identify pre-existing conditions that may be exacerbated by diphenhydramine's anticholinergic effects or contraindicate its use.

Timing: Before initiation of therapy

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Routine Monitoring

Symptom relief (e.g., allergy symptoms, sleep onset)

Frequency: As needed, during therapy

Target: N/A

Action Threshold: If symptoms persist or worsen, or if adverse effects are intolerable

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

Frequency: During therapy

Target: N/A

Action Threshold: If adverse effects are severe or persistent, consider dose reduction or discontinuation

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Paradoxical excitation (especially in children and elderly)
  • Confusion

Special Patient Groups

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Pregnancy

Generally considered safe for occasional use during pregnancy (Pregnancy Category B), but always consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Low risk, but generally avoided if possible, especially during organogenesis.
Second Trimester: Low risk, commonly used for nausea or insomnia.
Third Trimester: Low risk, but caution near term due to potential for neonatal withdrawal symptoms (e.g., irritability, tremors) or anticholinergic effects in the neonate.
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Lactation

Excreted into breast milk. Use with caution, as it may cause drowsiness, irritability, or anticholinergic effects (e.g., dry mouth, constipation) in the infant. May also decrease milk supply, especially in the early postpartum period. L3 (Moderately Safe).

Infant Risk: Moderate risk (drowsiness, irritability, anticholinergic effects, potential for decreased milk supply).
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Pediatric Use

Not recommended for children under 2 years of age without physician consultation due to increased risk of respiratory depression and paradoxical excitation. Use with caution in children 2-6 years old; lower doses are recommended. Higher risk of paradoxical excitation (restlessness, agitation) in some children.

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Geriatric Use

Increased risk of adverse effects, particularly sedation, confusion, dizziness, urinary retention, and falls, due to increased sensitivity to anticholinergic effects. Listed on the Beers Criteria as a potentially inappropriate medication for older adults. Use lower doses and with extreme caution, or consider alternative agents.

Clinical Information

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Clinical Pearls

  • Diphenhydramine is a first-generation antihistamine with significant sedative and anticholinergic properties, making it useful for allergy symptoms, insomnia, and motion sickness.
  • Due to its sedative effects, it should be avoided when alertness is required (e.g., driving, operating machinery).
  • It is listed on the Beers Criteria as a potentially inappropriate medication for older adults due to high anticholinergic burden and risk of adverse effects like confusion, falls, and urinary retention.
  • Paradoxical excitation (restlessness, agitation) can occur, especially in young children and some elderly patients.
  • Caution is advised when co-administering with other CNS depressants (e.g., alcohol, opioids) or anticholinergic medications to avoid additive effects.
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Alternative Therapies

  • For allergies: Second-generation antihistamines (e.g., loratadine, cetirizine, fexofenadine) which are less sedating.
  • For insomnia: Melatonin, doxylamine, zolpidem (prescription), eszopiclone (prescription).
  • For motion sickness: Meclizine, scopolamine (prescription patch).
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Cost & Coverage

Average Cost: Highly variable (typically $5-$15) per 30 tablets
Generic Available: Yes
Insurance Coverage: Over-the-counter (OTC) medication; generally not covered by prescription insurance plans, but may be eligible for FSA/HSA reimbursement.
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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 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.