Banophen (diphenhydramine 25mg CP
It is used to ease allergy signs.
Drug Class
Antihistamine, Sedative
Pharmacologic Class
First-generation H1-receptor antagonist
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Banophen contains diphenhydramine, an antihistamine that helps relieve allergy symptoms like sneezing and runny nose. It also causes drowsiness, which is why it's often used as a sleep aid. It can also help with motion sickness.
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, take it with food to help minimize this side effect.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. Ensure that all medications are kept in a safe location, out of the 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 with your pharmacist for guidance on the best disposal method. You may also want to check if there are any drug take-back programs available in your area.
Missing a Dose
If you take this medication on a regular schedule 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 normal dosing 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.
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, take it with food to help minimize this side effect.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. Ensure that all medications are kept in a safe location, out of the 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 with your pharmacist for guidance on the best disposal method. You may also want to check if there are any drug take-back programs available in your area.
Missing a Dose
If you take this medication on a regular schedule 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 normal dosing 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.
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 (e.g., tranquilizers, sleeping pills) while taking this medication, as they can increase drowsiness and other side effects.
- Drink plenty of fluids to help with dry mouth and constipation, common side effects.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
25-50 mg orally every 4-6 hours as needed
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
Maximum daily dose:
300 mg/day
For sleep aid:
50 mg at bedtime
Pediatric Dosing
Neonatal:
Not established (contraindicated)
Infant:
Not established (consult physician)
Child:
6 to <12 years: 12.5-25 mg orally every 4-6 hours (Max 150 mg/day); <6 years: Not recommended for cold symptoms, consult physician for other uses.
Adolescent:
âĨ12 years: 25-50 mg orally every 4-6 hours (Max 300 mg/day)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, use with caution.
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, use with caution.
Moderate:
Use with caution, consider lower doses or extended intervals.
Severe:
Use with caution, consider lower doses or extended intervals.
Pharmacology
Mechanism of Action
Diphenhydramine is a first-generation antihistamine that competitively blocks H1 histamine receptors in the periphery and central nervous system (CNS). Its sedative effects are due to its ability to cross the blood-brain barrier and interact with H1 receptors in the CNS. It also possesses significant anticholinergic (muscarinic receptor blockade), antiemetic, and local anesthetic properties.
Pharmacokinetics
Absorption:
Bioavailability:
40-60%
Tmax:
1-4 hours
FoodEffect:
Food 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:
Not readily available as a single rate, primarily hepatic metabolism
ExcretionRoute:
Urine (primarily as metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
15-60 minutes
PeakEffect:
1-4 hours
DurationOfAction:
4-6 hours
Safety & Warnings
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
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, 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.
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
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, 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.
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
- Seizures
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 you experienced, including any 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 medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
* Any health problems you have, as they may interact with this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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 you experienced, including any 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 medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
* Any health problems you have, as they may interact with this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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, adhere strictly to the dosage instructions provided by your doctor. Do not exceed the recommended dose, as this may increase your chance of experiencing severe side effects. Additionally, do not take this medication for a longer duration than prescribed by your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in any activities that require alertness.
You should not use this medication in conjunction with other products that contain diphenhydramine. Furthermore, it is recommended to avoid consuming alcohol while taking this drug, as it may exacerbate side effects.
Before using marijuana, other forms of cannabis, or any prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor to discuss potential interactions.
It is crucial to note that different brands of this medication may be suitable for children of varying ages. Therefore, consult with your doctor before administering this medication to a child. Moreover, this medication should not be used as a means to induce sleep in children; instead, consult with your doctor for appropriate guidance.
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 a child, use it with caution, as children 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.
To minimize the risk of severe side effects, adhere strictly to the dosage instructions provided by your doctor. Do not exceed the recommended dose, as this may increase your chance of experiencing severe side effects. Additionally, do not take this medication for a longer duration than prescribed by your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in any activities that require alertness.
You should not use this medication in conjunction with other products that contain diphenhydramine. Furthermore, it is recommended to avoid consuming alcohol while taking this drug, as it may exacerbate side effects.
Before using marijuana, other forms of cannabis, or any prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor to discuss potential interactions.
It is crucial to note that different brands of this medication may be suitable for children of varying ages. Therefore, consult with your doctor before administering this medication to a child. Moreover, this medication should not be used as a means to induce sleep in children; instead, consult with your doctor for appropriate guidance.
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 a child, use it with caution, as children 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.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Confusion
- Hallucinations
- Dilated pupils
- Dry mouth
- Flushed skin
- Rapid heartbeat (tachycardia)
- Urinary retention
- Seizures
- Coma
What to Do:
If you suspect an overdose, call your local poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Not typically contraindicated with other drugs, but severe additive effects are possible.
Major Interactions
- CNS depressants (e.g., alcohol, opioids, benzodiazepines, sedatives, hypnotics, anxiolytics, muscle relaxants): Increased sedation and respiratory depression.
- Anticholinergics (e.g., tricyclic antidepressants, MAOIs, atropine, some antipsychotics): Increased anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation).
Moderate Interactions
- Other antihistamines (especially first-generation): Additive sedative and anticholinergic effects.
- Potassium chloride (oral): Increased risk of GI ulceration due to decreased GI motility from anticholinergic effects.
Minor Interactions
- Not typically listed for minor interactions.
Monitoring
Baseline Monitoring
Patient history (pre-existing conditions)
Rationale: Identify conditions that may be exacerbated by anticholinergic effects (e.g., narrow-angle glaucoma, prostatic hypertrophy, urinary retention, asthma, cardiovascular disease) or require caution.
Timing: Before initiation of therapy
Routine Monitoring
Symptom relief (e.g., allergy symptoms, sleep onset)
Frequency: As needed, during therapy
Target: Adequate symptom control with tolerable side effects
Action Threshold: Lack of efficacy or occurrence of intolerable side effects
Adverse effects (e.g., drowsiness, dry mouth, blurred vision, urinary retention, constipation)
Frequency: During therapy, especially at initiation or dose changes
Target: Minimal to no adverse effects
Action Threshold: Significant or bothersome adverse effects warranting dose reduction or discontinuation
Symptom Monitoring
- Drowsiness
- Dizziness
- Dry mouth
- Blurred vision
- Urinary retention
- Constipation
- Paradoxical excitation (restlessness, nervousness, especially in children and elderly)
- Confusion
Special Patient Groups
Pregnancy
Generally considered safe for occasional use during pregnancy (Category B), but always consult a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
No increased risk of major birth defects observed in human studies.
Second Trimester:
No increased risk.
Third Trimester:
No increased risk, but caution is advised near term due to potential for neonatal withdrawal symptoms (rare) or anticholinergic effects in the neonate.
Lactation
Diphenhydramine is excreted into breast milk. Use with caution, especially in preterm or jaundiced infants, or with prolonged use. May cause drowsiness or irritability in the infant and may decrease milk supply.
Infant Risk:
L3 (Moderately Safe - some risk, but generally compatible with monitoring)
Pediatric Use
Not recommended for children under 6 years old for cold symptoms. Use with caution in children, as paradoxical excitation (restlessness, nervousness, insomnia) can occur instead of sedation. Always follow age-appropriate dosing guidelines.
Geriatric Use
Elderly patients are more susceptible to anticholinergic side effects (e.g., confusion, urinary retention, constipation, dry mouth, falls) and sedation. Use lower doses and with extreme caution. Avoid in elderly patients with dementia due to increased risk of cognitive impairment.
Clinical Information
Clinical Pearls
- Diphenhydramine is a first-generation antihistamine known for its significant sedative and anticholinergic effects.
- It is often used off-label for insomnia due to its sedative properties, but tolerance to the sedative effect can develop with continued use.
- Due to its anticholinergic profile, it should be used with caution or avoided in patients with conditions like narrow-angle glaucoma, prostatic hypertrophy, or urinary retention.
- Paradoxical excitation (restlessness, nervousness) can occur, particularly in young children and the elderly, rather than sedation.
- For allergy relief, second-generation (non-sedating) antihistamines are generally preferred over diphenhydramine due to a more favorable side effect profile.
Alternative Therapies
- For allergies: Second-generation antihistamines (e.g., loratadine, cetirizine, fexofenadine), nasal corticosteroids (e.g., fluticasone, budesonide).
- For insomnia: Melatonin, doxylamine, non-pharmacological interventions (e.g., Cognitive Behavioral Therapy for Insomnia - CBT-I).
- For motion sickness: Meclizine, scopolamine.
Cost & Coverage
Average Cost:
Price range varies widely by retailer and quantity per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Over-the-counter (OTC), generally not covered by prescription insurance plans unless specifically prescribed for certain conditions.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.