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Special Alerts
Health Canada: Labeling Changes for OTC Cough and Cold Preparations - December, 2008
Health Canada has issued an advisory to Canadian consumers regarding upcoming labeling changes for the use of over-the-counter (OTC) cough and cold medicines in children. Specific labeling changes as well as other important information may be found at http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_184-eng.php.
Manufacturers Voluntarily Change Pediatric OTC Product Labeling - October 7, 2008
Leading manufacturers of over-the-counter (OTC) pediatric cough and cold products, in consultation with the Food and Drug Administration (FDA), have announced that they are voluntarily transitioning product labeling as it relates to children <4 years of age. The decision to change the labeling followed a meeting on October 2, 2008, conducted by the FDA to gather additional information related to the use of these products in children. The safety of the ingredients in these products was not in question. It was found that dosing errors and accidental ingestions were the leading cause of rare adverse events in children. The new product labeling will state “Do not use in children under four years of age.” In addition, products with certain antihistamines will warn parents not to use these products to sedate or make a child sleepy. Labeling of adult products will not change. New product labels will be introduced during the 2008-2009 cough and cold season and some products will have the updated labeling by mid-October. Products with the old labeling will not be removed from the market. Prescription products are not affected.
It is important to note that these medications have not been shown to be unsafe when used correctly. Pharmacists may continue to see health care practitioners recommending these agents for use in pediatric patients, and should help to ensure that they are being used safely and at appropriate dosages. Parents should be advised that OTC cough and cold products are safe and effective when used as directed, but that they should not be used in children <4 years of age unless instructed to do so by their healthcare provider. Counseling tips from the Consumer Healthcare Products Association (CHPA) also include:
• Always follow dosing instructions exactly and use measuring devices provided with the medicine.
• Never give 2 medicines at the same time that contain the same active ingredient.
• Do not give a medicine intended for use in adults to a child.
Additional tips and information related to the labeling changes can be found on the following educational website of the CHPA: http://www.otcsafety.org.
The FDA had previously issued a Public Health Advisory reminding patients and caregivers that OTC cough and cold medications should not be used to treat infants and children <2 years of age. This is in response to the Centers for Disease Control and Prevention (CDC) report which noted that during 2004 and 2005, ~1519 children <2 years of age were seen in emergency departments for adverse effects, including overdose, associated with products containing nasal decongestants (eg, pseudoephedrine), antihistamines (eg, carbinoxamine), and cough suppressants (eg, dextromethorphan). In October of 2007, several manufacturers voluntarily removed these products in order to help reduce dosing errors and overdose in this age group.
For additional information, refer to the following websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094913.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116839.htm
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5601a1.htm, Centers for Disease Control, “Infant Deaths Associated with Cough and Cold Medications - Two States, 2005,” MMWR Morb Mortal Wkly Rep, 2007, 56(01):1-4.
Medication Safety Issues
Institute for Safe Medication Practices (ISMP) has reported cases of patients mistakenly swallowing Benadryl® Itch Stopping [OTC] gel intended for topical application. Unclear labeling and similar packaging of the topical gel in containers resembling an oral liquid are factors believed to be contributing to the administration errors. The topical gel contains camphor which can be toxic if swallowed. ISMP has requested the manufacturer to make the necessary changes to prevent further confusion.
Sound-alike/look-alike issues:
DiphenhydrAMINE may be confused with desipramine, dicyclomine, dimenhyDRINATE
Benadryl® may be confused with benazepril, Bentyl®, Benylin®, Caladryl®
Pronunciation
(dye fen HYE dra meen)
U.S. Brand Names
Index Terms
Generic Available
Yes: Excludes chewable tablet, gel, liquid stick, orally-disintegrating tablet, strip
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Symptomatic relief of allergic symptoms caused by histamine release including nasal allergies and allergic dermatosis; adjunct to epinephrine in the treatment of anaphylaxis; nighttime sleep aid; prevention or treatment of motion sickness; antitussive; management of Parkinsonian syndrome including drug-induced extrapyramidal symptoms; topically for relief of pain and itching associated with insect bites, minor cuts and burns, or rashes due to poison ivy, poison oak, and poison sumac
Use: Dental
Symptomatic relief of nasal mucosal congestion
Pregnancy Risk Factor
B
Pregnancy Considerations
Teratogenic effects were not observed in animal studies. Diphenhydramine crosses the human placenta. One retrospective study showed an increased risk of cleft palate formation following maternal use of diphenhydramine during the 1st trimester of pregnancy; however, later studies have not confirmed this finding. Signs of toxicity and symptoms of withdrawal have been reported in infants following high doses or chronic maternal use close to term. Diphenhydramine has been evaluated for the treatment of hyperemesis gravidarum. It is generally not considered the antihistamine of choice for treating allergic rhinitis or nausea and vomiting during pregnancy.
Lactation
Enters breast milk/contraindicated
Breast-Feeding Considerations
Infants may be more sensitive to the effects of antihistamines. Use while breast-feeding is contraindicated by the manufacturer.
Contraindications
Hypersensitivity to diphenhydramine or any component of the formulation; acute asthma; neonates or premature infants; breast-feeding; use as a local anesthetic (injection)
Warnings/Precautions
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Disease-related concerns:
• Asthma: Use with caution in patients with a history of asthma.
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease).
• Increased intraocular pressure/glaucoma: Use with caution in patients with increased intraocular pressure or angle-closure glaucoma.
• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.
• Pyloroduodenal obstruction: Use with caution in patients with pyloroduodenal obstruction (including stenotic peptic ulcer).
• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Concurrent drug therapy issues:
• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations:
• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects.
• Pediatrics: Antihistamines may cause excitation in young children.
Dosage form specific issues:
• Phenylalanine: Some products may contain phenylalanine.
• Soy protein: Some preparations contain soy protein; avoid use in patients with soy protein or peanut allergies.
Other warnings/precautions:
• Self-medication (OTC use): Do not use with other products containing diphenhydramine, even ones used on the skin. Oral products are not for OTC use in children <6 years of age. Topical products should not be used on large areas of the body, or on chicken pox or measles. Healthcare provider should be contacted if topical use is needed for >7 days. Topical products are not for OTC use in children <2 years of age.
Adverse Reactions
Frequency not defined.
Cardiovascular: Chest tightness, extrasystoles, hypotension, palpitation, tachycardia
Central nervous system: Chills, confusion, convulsion, disturbed coordination, dizziness, euphoria, excitation, fatigue, headache, insomnia, irritability, nervousness, paradoxical excitement, restlessness, sedation, sleepiness, vertigo
Dermatologic: Photosensitivity, rash, urticaria
Endocrine & metabolic: Menstrual irregularities (early menses)
Gastrointestinal: Anorexia, constipation, diarrhea, dry mucous membranes, epigastric distress, nausea, throat tightness, vomiting, xerostomia
Genitourinary: Difficult urination, urinary frequency, urinary retention
Hematologic: Agranulocytosis, hemolytic anemia, thrombocytopenia
Neuromuscular & skeletal: Neuritis, paresthesia, tremor
Ocular: Blurred vision, diplopia
Otic: Labyrinthitis (acute), tinnitus
Respiratory: Nasal stuffiness, thickening of bronchial secretions, wheezing
Miscellaneous: Anaphylactic shock, diaphoresis
Metabolism/Transport Effects
Inhibits CYP2D6 (moderate)
Drug Interactions
Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
Amphetamines: May diminish the sedative effect of Antihistamines. Risk C: Monitor therapy
Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Paliperidone. Risk C: Monitor therapy
Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
Codeine: CYP2D6 Inhibitors (Moderate) may diminish the therapeutic effect of Codeine. These CYP2D6 inhibitors may prevent the metabolic conversion of codeine to its active metabolite morphine. Risk C: Monitor therapy
CYP2D6 Substrates: CYP2D6 Inhibitors (Moderate) may decrease the metabolism of CYP2D6 Substrates. Exceptions: Tamoxifen. Risk C: Monitor therapy
Fesoterodine: CYP2D6 Inhibitors may increase serum concentrations of the active metabolite(s) of Fesoterodine. Risk C: Monitor therapy
Nebivolol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Nebivolol. Risk C: Monitor therapy
Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification
Tamoxifen: CYP2D6 Inhibitors (Moderate) may decrease the metabolism of Tamoxifen. Specifically, CYP2D6 inhibitors may decrease the formation of highly potent active metabolites. Risk D: Consider therapy modification
TraMADol: CYP2D6 Inhibitors (Moderate) may diminish the therapeutic effect of TraMADol. These CYP2D6 inhibitors may prevent the metabolic conversion of tramadol to its active metabolite that accounts for much of its opioid-like effects. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may increase CNS depression).
Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).
Storage
Injection: Store at room temperature of 15°C to 30°C (59°F to 86°F); protect from freezing. Protect from light.
Compatibility
Stable in dextran 6% in dextrose, dextran 6% in NS, D5LR, D51/4NS, D51/2NS, D5NS, D5W, D10W, fat emulsion 10%, LR, 1/2NS, NS.
Y-site administration: Compatible: Acyclovir, aldesleukin, amifostine, amsacrine, aztreonam, ciprofloxacin, cisatracurium, cisplatin, cladribine, cyclophosphamide, cytarabine, docetaxel, doxorubicin, doxorubicin liposome, etoposide phosphate, famotidine, filgrastim, fluconazole, fludarabine, gatifloxacin, gemcitabine, granisetron, heparin, hydrocortisone sodium succinate, idarubicin, linezolid, melphalan, meperidine, meropenem, methotrexate, ondansetron, paclitaxel, piperacillin/tazobactam, potassium chloride, propofol, remifentanil, sargramostim, sufentanil, tacrolimus, teniposide, thiotepa, vinorelbine, vitamin B complex with C. Incompatible: Allopurinol, amphotericin B cholesteryl sulfate complex, cefepime, foscarnet.
Compatibility in syringe: Compatible: Atropine, butorphanol, chlorpromazine, cimetidine, diatrizoate meglumine, diatrizoate meglumine 34.3% and diatrizoate sodium 35%, diatrizoate sodium, diatrizoate sodium 75%, dimenhydrinate, droperidol, fentanyl, fluphenazine, glycopyrrolate, hydromorphone, hydroxyzine, iohexol, iopamidol, iothalamate meglumine, iothalamate meglumine 60%, iothalamate sodium 80%, meperidine, metoclopramide, midazolam, morphine, nalbuphine, pentazocine, perphenazine, prochlorperazine edisylate, promazine, promethazine, ranitidine, scopolamine, sufentanil. Incompatible: Diatrizoate meglumine 52% and diatrizoate sodium 8%, diatrizoate sodium 60%, haloperidol, iodipamide meglumine, iodipamide meglumine 52%, ioxaglate meglumine 39.3% and ioxaglate sodium 19.6%, pentobarbital, thiopental. Variable (consult detailed reference): Dexamethasone sodium phosphate, diatrizoate meglumine 52% and diatrizoate sodium 8%.
Compatibility when admixed: Compatible: Amikacin, aminophylline, ascorbic acid injection, bleomycin, buprenorphine, colistimethate, erythromycin lactobionate, hydrocortisone sodium succinate, lidocaine, methyldopate, nafcillin, netilmicin, penicillin G potassium , penicillin G sodium, polymyxin B, vitamin B complex with C. Incompatible: Amobarbital, amphotericin B, dexamethasone sodium phosphate with lorazepam and metoclopramide, iodipamide meglumine, phenytoin, phenobarbital, thiopental. Variable (consult detailed reference): Heparin in solution.
Mechanism of Action
Competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract; anticholinergic and sedative effects are also seen
Pharmacodynamics/Kinetics
Onset of action: Maximum sedative effect: 1-3 hours
Duration: 4-7 hours
Distribution: Vd: 3-22 L/kg
Protein binding: 78%
Metabolism: Extensively hepatic n-demethylation via CYP2D6; minor demethylation via CYP1A2, 2C9 and 2C19; smaller degrees in pulmonary and renal systems; significant first-pass effect
Bioavailability: Oral: ~40% to 70%
Half-life elimination: 2-10 hours; Elderly: 13.5 hours
Time to peak, serum: 2-4 hours
Excretion: Urine (as unchanged drug)
Dosage
Note: Dosages are expressed as the hydrochloride salt.
Children:
Allergic reactions or motion sickness: Oral, I.M., I.V.: 5 mg/kg/day or 150 mg/m2/day in divided doses every 6-8 hours, not to exceed 300 mg/day
Alternate dosing by age: Oral:
2 to <6 years: 6.25 mg every 4-6 hours; maximum: 37.5 mg/day
6 to <12 years: 12.5-25 mg every 4-6 hours; maximum: 150 mg/day
?12 years: 25-50 mg every 4-6 hours; maximum: 300 mg/day
Night-time sleep aid: Oral: Children ?12 years: 50 mg at bedtime
Antitussive: Oral:
2 to <6 years: 6.25 mg every 4 hours; maximum 37.5 mg/day
6 to <12 years: 12.5 mg every 4 hours; maximum 75 mg/day
?12 years: 25 mg every 4 hours; maximum 150 mg/day
Treatment of dystonic reactions: I.M., I.V.: 0.5-1 mg/kg/dose
Relief of pain and itching: Topical: Children ?2 years: Apply 1% or 2% to affected area up to 3-4 times/day
Adults:
Allergic reactions or motion sickness: Oral: 25-50 mg every 6-8 hours
Antitussive: Oral: 25 mg every 4 hours; maximum 150 mg/24 hours
Nighttime sleep aid: Oral: 50 mg at bedtime
Allergic reactions or motion sickness: I.M., I.V.: 10-50 mg per dose; single doses up to 100 mg may be used if needed; not to exceed 400 mg/day
Dystonic reaction: I.M., I.V.: 50 mg in a single dose; may repeat in 20-30 minutes if necessary
Relief of pain and itching: Topical: Apply 1% or 2% to affected area up to 3-4 times/day
Elderly: Initial: 25 mg 2-3 times/day increasing as needed
Dental Usual Dosing
Symptomatic relief of nasal mucosal congestion: Adults: Oral: 25-50 mg every 6-8 hours
Administration: Oral
When used to prevent motion sickness, first dose should be given 30 minutes prior to exposure.
Administration: I.V.
Injection solution: For I.V. or I.M. administration only. Local necrosis may result with SubQ or intradermal use. For I.V. administration, inject at a rate ?25 mg/minute.
Administration: I.V. Detail
pH: 5-6
Monitoring Parameters
Relief of symptoms, mental alertness
Reference Range
Antihistamine effects at levels >25 ng/mL
Drowsiness at levels 30-40 ng/mL
Mental impairment at levels >60 ng/mL
Therapeutic: Not established
Toxic: >0.1 mcg/mL
Test Interactions
May suppress the wheal and flare reactions to skin test antigens
Dietary Considerations
Benadryl® Allergy strips contain sodium 4 mg per 25 mg strip.
Benadryl® Children's Allergy chewable tablets contain phenylalanine 4.2 mg, magnesium 15 mg, and sodium 2 mg per 12.5 mg tablet.
Benadryl® Children's Allergy Fastmelt® contains phenylalanine 4.5 mg/tablet and soy protein isolate (contraindicated in patients with soy protein allergies; use caution in peanut allergic individuals, ~10% are estimated to also have soy protein allergies).
Dytan™ chewable tablets contain phenylalanine.
Patient Education
Take as directed; do not exceed recommended dose. Avoid use of other depressants, alcohol, or sleep-inducing medications unless approved by prescriber. You may experience drowsiness or dizziness (use caution when driving or engaging in tasks requiring alertness until response to drug is known); or dry mouth, nausea, or vomiting (small frequent meals, frequent mouth care, chewing gum, or sucking hard candy may help). Report persistent sedation, confusion, or agitation; changes in urinary pattern; blurred vision; sore throat, respiratory difficulty, or expectorating (thick secretions); or lack of improvement or worsening or condition. Breast-feeding precaution: Do not breast-feed.
Geriatric Considerations
Diphenhydramine has high sedative and anticholinergic properties, so it may not be considered the antihistamine of choice for prolonged use in the elderly. Its use as a sleep aid is discouraged due to its anticholinergic effects; interpretive guidelines from the Centers for Medicare and Medicaid Services (CMS) discourage the use of diphenhydramine as a sedative or anxiolytic in long-term care facilities.
Additional Information
Diphenhydramine citrate 19 mg is equivalent to diphenhydramine hydrochloride 12.5 mg
Anesthesia and Critical Care Concerns/Other Considerations
Clinical Pearls/Comments: Diphenhydramine's use as a sleep aid is discouraged due to its anticholinergic effects.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation) and dry mucous membranes. Chronic use of antihistamines will inhibit salivary flow, particularly in elderly patients; may contribute to periodontal disease and oral discomfort. See Dental Health Professional Considerations.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Dental Comment
25-50 mg of diphenhydramine orally every 4-6 hours can be used to treat mild dermatologic manifestations of allergic reactions to penicillin and other antibiotics. Diphenhydramine is not recommended as local anesthetic for either infiltration route or nerve block since the vehicle has caused local necrosis upon injection. A 50:50 mixture of diphenhydramine liquid (12.5 mg/5 mL) in Kaopectate® or Maalox® is used as a local application for recurrent aphthous ulcers; swish 1 tablespoonful for 2 minutes 4 times/day.
Mental Health: Comment
Along with benztropine, considered the drug of choice for patients with acute dystonic reactions. The usual adult dosage is I.M. 50 mg. In an emergency situation (laryngeal spasm), it should be given intravenously. It is the most sedating antihistamine used to treat drug-induced EPS. Generally not a first-line agent for insomnia, but often utilized in individuals where benzodiazepines are contraindicated (eg, patients with a history of substance abuse).
Nursing: Physical Assessment/Monitoring
Assess effectiveness and interactions of other medications patient may be taking. Monitor effectiveness of therapy and adverse reactions at beginning of therapy and periodically with long-term use. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Caplet, as hydrochloride: 25 mg, 50 mg
Aler-Dryl, AllerMax®, Compoz® Nighttime Sleep Aid, Sleep-ettes D, Sominex® Maximum Strength, Twilite®: 50 mg
Anti-Hist, Histaprin, Nytol® Quick Caps: 25 mg
Simply Sleep™: 25 mg [contains calcium 20 mg/caplet]
Capsule, as hydrochloride: 25 mg, 50 mg
Aler-Cap, Banophen™, Diphen, Diphenhist®, Genahist™: 25 mg
Benadryl® Allergy: 25 mg [contains calcium 35 mg/capsule]
Sleepinal®: 50 mg
Capsule, softgel, as hydrochloride: 50 mg
Benadryl® Dye-Free Allergy: 25 mg [dye-free]
Compoz® Nighttime Sleep Aid, Nytol® Quick Gels, Unisom® SleepGels® Maximum Strength: 50 mg
Captab, as hydrochloride:
Diphenhist®: 25 mg
Cream, as hydrochloride: 2% (30 g)
Banophen™ Anti-Itch: 2% (30 g) [contains zinc acetate 0.1%]
Benadryl® Itch Stopping: 1% (15 g, 30 g) [contains zinc acetate 0.1%]
Benadryl® Itch Stopping Extra Strength: 2% (15 g, 30 g) [contains zinc acetate 0.1%]
Diphenhist®: 2% (30 g) [contains zinc acetate 0.1%]
Elixir, as hydrochloride: 12.5 mg/5 mL
Altaryl: 12.5 mg/5 mL (120 mL, 480 mL, 3840 mL) [ethanol free; cherry flavor]
Banophen™: 12.5 mg/5 mL (120 mL)
Gel, topical, as hydrochloride:
Benadryl® Itch Stopping Extra Strength: 2% (120 mL)
Injection, solution, as hydrochloride: 50 mg/mL (1 mL, 10 mL)
Liquid, oral, as hydrochloride:
AllerMax®: 12.5 mg/5 mL (120 mL)
Benadryl® Children's Allergy: 12.5 mg/5 mL (120 mL, 240 mL) [ethanol free; contains sodium 14 mg/5 mL, sodium benzoate; cherry flavor]
Benadryl® Children's Allergy Perfect Measure™: 12.5 mg/5 mL (5 mL) [ethanol free; contains sodium 14 mg/5 mL, sodium benzoate; cherry flavor]
Benadryl® Children's Dye-Free Allergy: 12.5 mg/5 mL (120 mL) [ethanol free, dye free, sugar free; contains sodium 11 mg/5 mL, sodium benzoate; bubble gum flavor]
Genahist™: 12.5 mg/5 mL (120 mL) [ethanol free, sugar free; contains sodium benzoate; cherry flavor]
Hydramine: 12.5 mg/5 mL (120 mL, 480 mL) [ethanol free]
Siladryl Allergy: 12.5 mg/5 mL (120 mL, 240 mL, 480 mL) [ethanol free, sugar free; black cherry flavor]
Liquid, topical, as hydrochloride [spray]:
Benadryl® Itch Stopping Extra Strength: 2% (60 mL) [contains zinc acetate 0.1% and ethanol]
Dermamycin®: 2% (60 mL) [contains menthol 1%]
Liquid, topical, as hydrochloride [stick]:
Benadryl® Itch Relief Extra Strength: 2% (14 mL) [contains zinc acetate 0.1% and ethanol]
Solution, oral, as hydrochloride:
Diphenhist®: 12.5 mg/5 mL (120 mL, 480 mL) [ethanol free; contains sodium benzoate]
Strips, orally disintegrating, as hydrochloride:
Benadryl® Allergy Quick Dissolve: 25 mg (10s) [contains sodium 4 mg/strip; vanilla mint flavor]
Benadryl® Children's Allergy Quick Dissolve: 12.5 mg (10s) [vanilla mint flavor] [DSC]
Theraflu® Thin Strips® Multi Symptom: 25 mg (12s) [contains ethanol; cherry flavor]
Triaminic Thin Strips® Children's Cough and Runny Nose: 12.5 mg (14s) [contains ethanol; grape flavor]
Suspension, as tannate:
Ben-Tann: 25 mg/5 mL (120 ml) [contains sodium benzoate; strawberry flavor] [DSC]
Syrup, as hydrochloride:
PediaCare® Children's Allergy: 12.5 mg/5 mL (120 mL) [contains sodium 14 mg/5 mL, sodium benzoate; cherry flavor]
PediaCare® Children's NightTime Cough: 12.5 mg/5 mL (120 mL) [ethanol free; contains sodium 15 mg/5 mL, sodium benzoate; cherry flavor]
Silphen Cough: 12.5 mg/5 mL (120 mL, 240 mL, 480 mL) [contains ethanol 5%; strawberry flavor]
Tablet, as hydrochloride: 25 mg, 50 mg
Aler-Tab, Banophen™, Benadryl® Allergy, Genahist™, Sominex®, Sleep-Tabs: 25 mg
Tablet, chewable, as hydrochloride:
Benadryl® Children's Allergy: 12.5 mg [contains phenylalanine 4.2 mg, magnesium 15 mg, and sodium 2 mg per tablet; grape flavor] [DSC]
Tablet, chewable, as tannate:
Dytan™: 25 mg [contains phenylalanine; strawberry flavor]
Tablet, orally disintegrating, as citrate:
Benadryl® Children's Allergy Fastmelt®: 19 mg [equivalent to diphenhydramine hydrochloride 12.5 mg; contains phenylalanine 4.5 mg/tablet and soy protein isolate; cherry flavor] [DSC]
Tablet, orally dissolving, as hydrochloride:
Benadryl® Children's Allergy Fastmelt®: 12.5 mg [cherry and grape flavors]
Unisom® SleepMelts™: 25 mg [cherry flavor]
Pricing: U.S. (www.drugstore.com)
Capsules (DiphenhydrAMINE HCl)
50 mg (100): $13.99
Chewable (Dytan)
25 mg (60): $76.55
Liquid (Q-Dryl)
12.5 mg/5 mL (473): $13.01
Solution (DiphenhydrAMINE HCl)
50 mg/mL (25): $35.99
References
ACOG (American College of Obstetricians and Gynecologists) “Practice Bulletin: Nausea and Vomiting of Pregnancy,” Obstet Gynecol, 2004, 103(4):803-14.
Akutsu T, Kobayashi K, Sakurada K, et al, “Identification of Human Cytochrome P450 Isozymes Involved in Diphenhydramine N-Demethylation,” Drug Metab Dispos, 2007, 35(1):72-8.
Becker DE, “Management of Immediate Allergic Reactions,” Dent Clin North Am, 1995, 39(3):577-86
Blyden GT, Greenblatt DJ, Scavone JM, et al, “Pharmacokinetics of Diphenhydramine and a Demethylated Metabolite Following Intravenous and Oral Administration,” J Clin Pharmacol, 1986, 26(7):529-33.
Corre KA, Niemann JT, Bessen HA, et al, “Extended Therapy for Acute Dystonic Reactions,” Ann Emerg Med, 1984, 13(3):194:7.
Doenecke AL and Heuermann RC, “Treatment of Haloperidol Abuse With Diphenhydramine,” Am J Psychiatry, 1980, 137(4):487-8.
Eigenmann, PA, Burks, AW, Bannon GA, et al, “Identification of Unique Peanut and Soy Allergens in Sera Adsorbed With Cross-Reacting Antibodies,” J Allergy Clin Immunol, 1996, 98 (5 Pt 1):969-78.
Garnett WR, “Diphenhydramine,” Am Pharm, 1986, NS26(2):35-40.
Lindsay CA, Williams GD, and Levin DL, “Fatal Adult Respiratory Distress Syndrome After Diphenhydramine Toxicity in a Child: A Case Report,” Crit Care Med, 1995, 23(4):777-81.
Miller AA, “Diphenhydramine Toxicity in a Newborn: A Case Report,” J Perinatol, 2000, 20(6):390-1.
Parkin DE, “Probable Benadryl Withdrawal Manifestations in a Newborn Infant,” J Pediatr, 1974, 85(4):580.
Sampson HA, Munoz-Furtong A, Campbell RL, et al, “Second Symposium on the Definition and Management of Anaphylaxis: Summary Report -- Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network Symposium,” Ann Emerg Med, 2006, 7(4):373-80.
Saxen I, “Letter: Cleft Palate and Maternal Diphenhydramine Intake,” Lancet, 1974, 1(7854):407-8.
Seto A, Einarson T, and Koren G, “Pregnancy Outcome Following First Trimester Exposure to Antihistamines: meta-analysis,” Am J Perinatol, 1997, 14(3):119-24.
Simons KJ, Watson WT, Martin TJ, et al, “Diphenhydramine: Pharmacokinetics and Pharmacodynamics in Elderly Adults, Young Adults, and Children,” J Clin Pharmacol, 1990, 30(7):665-71.
Sridhar KS and Donnelly E, “Combination Antiemetics for Cisplatin Chemotherapy,” Cancer, 1988, 61(8):1508-17.
Stancavage M, Osterhoudt KC, and Henretig FM, “Caladryl Ingestion: A New Poisoning From a Common Household Product,” Clin Toxicol, 1995, 33(5):520.
Tsavaris N, Zamanis N, Zinelis A, et al, “Diphenhydramine for Nausea and Vomiting Related to Cancer Chemotherapy With Cisplatin,” J Pain Symptom Manage, 1991, 6(8):461-5.
Weston MV, “Lovelorn and Snakebite,” Hosp Pract (Off Ed), 1986, 21(3A):140-3.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2009
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