Source: FDA, National Drug Code (US) Revision Year: 2020
Diphenhydramine hydrochloride in the oral form is effective for the following indications:
For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
For active and prophylactic treatment of motion sickness.
For 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 agents.
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.
A single oral dose of Diphen Elixir is quickly absorbed with maximum activity occurring in approximately one hour. The duration of activity following an average dose of Diphen Elixir is from four to six hours.
Always use a calibrated measuring device when administering Diphen Elixir to ensure the dose is measured and administered accurately.
Take 10 mL-20 mL (25mg-50mg) three or four times daily. The nighttime sleep-aid dosage is 20 mL (50mg) at bedtime. Maximum daily dosage not to exceed 120 mL (300mg).
Take 5 mL to 10 mL (12.5mg-25mg) three to four times daily. Maximum daily dosage not to exceed 120 mL (300mg). For physicians who wish to calculate the dose on the basis of body weight or surface area, the recommended dosage is 5 mg/kg/24 hours or 150 mg/m²/24 hours.
Data are not available on the use of Diphen Elixir as a nighttime sleep-aid in children under 12 years.
The basis for determining the most effective dosage regimen will be the response of the patient to medication and the condition under treatment.
In motion sickness, full dosage is recommended for prophylactic use, the first dose to be given 30 minutes before exposure to motion and similar doses before meals and upon retiring for the duration of exposure.
Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Atropine-like signs and symptoms, dry mouth; fixed, dilated pupils; flushing and gastrointestinal symptoms may also occur.
If vomiting has not occurred spontaneously, the patient should be induced to vomit. This is best done by having him drink a glass of water or milk after which he should be made to gag. Precaution against aspiration must be taken, especially in infants and children.
If vomiting is unsuccessful, gastric lavage is indicated within 3 hours after ingestion and even later if large amounts of milk or cream were given beforehand. Isotonic or ½ isotonic saline is the lavage solution of choice.
Saline cathartics, as milk of magnesia, by osmosis draw water into the bowel and therefore are valuable for their action in rapid dilution of bowel content.
Stimulants should not be used.
Vasopressors may be used to treat hypotension.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from freezing and light.
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