DailyMed Label: DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed Label: Diphenhydramine Hydrochloride

2010

DailyMed Prescription

Diphenhydramine Hydrochloride

DIPHENHYDRAMINE HYDROCHLORIDE

State of Florida DOH Central Pharmacy

NDC: 53808-0238

NDC: 53808-0238

Diphenhydramine Hydrochloride is an antihistamine drug having the chemical name 2-(diphenylmethoxy)- N , N -dimethylethylamine hydrochloride. It occurs as a white, odorless crystalline powder and is freely soluble in water and alcohol. The structural formula is as follows: C 17 H 21 NO • HCl Molecular Weight: 291.82 Each capsule contains 50 mg of diphenhydramine hydrochloride for oral administration. Anhydrous lactose, lactose monohydrate and magnesium stearate. The 50 mg capsule shell contains D&C red no. 28, FD&C blue no. 1, FD&C red no. 40, gelatin, silicon dioxide and sodium lauryl sulfate. The imprinting ink contains D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, pharmaceutical glaze, propylene glycol and synthetic black iron oxide. Structural Formula

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. Nighttime sleep-aid.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT. A single oral dose of diphenhydramine hydrochloride is quickly absorbed with maximum activity occurring in approximately one hour. The duration of activity following an average dose of diphenhydramine hydrochloride is from four to six hours. 25 to 50 mg three or four times daily. The nighttime sleep-aid dosage is 50 mg at bedtime. (over 20 lb): 12.5 to 25 mg three to four times daily. Maximum daily dosage not to exceed 300 mg. 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/m 2 /24 hours. Data are not available on the use of diphenhydramine hydrochloride 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.

This drug should not be used in newborn or premature infants. Because of the higher risk of antihistamines for infants generally, and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Antihistamines are also contraindicated in the following conditions: Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

Diphenhydramine hydrochloride has an atropine-like action and therefore should be used with caution in patients with a history of lower respiratory disease including asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension. Patients taking diphenhydramine hydrochloride should be advised that this drug may cause drowsiness and has an additive effect with alcohol. Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc. Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed. Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

The most frequent adverse reactions are underscored.

Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

Diphenhydramine Hydrochloride Capsules, USP are supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod. Code 53808-0238-1 50 mg 30 Capsules in a Blister Pack PINK 0555-0059 Store at controlled room temperature 15°-30°C (59°-86°F).

Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. A single oral dose of diphenhydramine hydrochloride is quickly absorbed with maximum activity occurring in approximately one hour. The duration of activity following an average dose of diphenhydramine hydrochloride is from four to six hours. Diphenhydramine is widely distributed throughout the body, including the CNS. Little, if any, is excreted unchanged in the urine; most appears as the degradation products of metabolic transformation in the liver, which are almost completely excreted within 24 hours.

Label Image 50mg