Community Pharm PCL


Community Pharm PCL
Full Prescribing Info
Diphenhydramine hydrochloride.
Each tablet contains Diphenhydramine hydrochloride 50 mg.
Diphenhydramine hydrochloride is ethanolamine-derivative, first generation antihistamines; anticholinergic and sedative effects by competing with antihistamine for H1-receptor sites on effector cells.
Hypersensitivity reactions. Type I (immediate): perennial and seasonal allergic rhinitis, allergic conjunctivitis due to inhalant allergens and foods; mild, uncomplicated allergic skin manifestation of urticaria and angioedema; amelioration of allergic reactions to blood or plasma with a known history of reactions; demographism; as adjunctive anaphylactic therapy.
Effective for prevention and treatment of nausea, vomiting, and/or vertigo associated with motion sickness.
Antiparkinsonism: parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced in other age groups; in other cases of parkinsonism (including drug-induced) in combination with centrally acting anticholinergic agent.
Sleep disorders (oral only): as a nighttime sleep aid.
Dosage/Direction for Use
Hypersensitivity reactions (nasal allergies and allergic dermatosis).
Antiparkinsonism: Adults and children 12 years of age and over: ½-1 tablet (25 to 50 mg) every 4-6 hours, not to exceed 6 tablets (300 mg) in 24 hours.
Children 6 to 12 years of age: ¼ to ½ tablet (12.5 to 25 mg) every 4-6 hours, or 5 mg/kg/day, not exceed 3 tablets (150 mg) in 24 hours.
Motion sickness: Adults and children 12 years of age and over: 1 tablet (50 mg) before exposure to motion or before meals and at bedtime.
Children 6 to 12 years of age: ½ tablet (25 mg) before exposure to motion or before meals and at bedtime.
Sleep disorders: Adults and children 12 years of age and over: 1 tablet (50 mg) at bedtime.
Children 2 to 12 years: 1 mg/kg given 30 minutes before retiring.
Hypersensitivity to an ingredient of the product or any component of the formulation.
Causes sedation, caution must be used in performing tasks which require alertness (ie, operating machinery or driving).
Sedative effects of CNS depressants or ethanol are potentiated. Use with caution in patients with angle-closure glaucoma, pyloroduodenal obstruction (including stenotic peptic ulcer), urinary tract obstruction (including bladder-neck obstruction and symptomatic prostatic hypertrophy), hyperthyroidism, increased intraocular pressure, and cardiovascular disease (including hypertension and tachycardia). Diphenhydramine has high sedative and anticholinergic properties, so it may not be considered the antihistamine of choice for prolonged use in elderly.
Store at 20-28°C.
ATC Classification
R06AA02 - diphenhydramine ; Belongs to the class of aminoalkyl ethers used as systemic antihistamines.
Tab 50 mg x 1 x 10's.
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