DailyMed Label: DIPHENHYDRAMINE

DailyMed Label: DIPHENHYDRAMINE

2022

DailyMed Prescription

DIPHENHYDRAMINE

Diphenhydramine Hydrochloride

Micro Labs Limited

NDC: 42571-169

NDC: 42571-337

NDC: 42571-169

NDC: 42571-337

NDC: 42571-169

NDC: 42571-337

NDC: 42571-169

NDC: 42571-337

NDC: 42571-169

NDC: 42571-169

NDC: 42571-337

NDC: 42571-337

Diphenhydramine hydrochloride USP is an antihistamine drug having the chemical name 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. It occurs as a white, crystalline powder, is freely soluble in water and alcohol and has a molecular weight of 291.82. The molecular formula is C 17 H 21 NO • HCI. The structural formula is as follows: Diphenhydramine hydrochloride USP in the parenteral form is a sterile, pyrogen-free solution available in a concentration of 50 mg of diphenhydramine hydrochloride USP per mL. The solutions for parenteral use have been adjusted to a pH between 4 and 6.5 with either sodium hydroxide or hydrochloric acid. structure

Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical. For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. For active treatment of motion sickness. For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.

THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY. Diphenhydramine hydrochloride in the injectable form is indicated when the oral form is impractical. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. 5 mg/kg/24 hr or 150 mg/m 2 /24 hr. Maximum daily dosage is 300 mg. Divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly. 10 to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly, 100 mg if required; maximum daily dosage is 400 mg.

This drug should not be used in neonates or premature infants. Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Because of the risk of local necrosis, this drug should not be used as a local anesthetic. 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 bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension. Use with caution in patients with lower respiratory disease including asthma. 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. Pregnancy Category B. 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. Diphenhydramine hydrochloride should not be used in neonates and premature infants (see CONTRAINDICATIONS ). Diphenhydramine hydrochloride injection may diminish mental alertness, or, in the young pediatric patient, cause excitation. Overdosage may cause hallucinations, convulsions, or death (see WARNINGS and OVERDOSAGE ). See also DOSAGE AND ADMINISTRATION section.

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 Injection, USP in parenteral form is supplied as: Sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride USP in a 1 mL amber color glass ampule with yellow bands and white OPC mark, and available in packages of ten packed in a PVC rondo tray in a single carton. 1 mL fill in 1 mL Ampule                               NDC 42571-169-54 Carton of 10 x 1 mL Ampule                         NDC 42571-169-55 Clear, colorless solution, free from any visible particles, no visible leaks or damage to the container closure system filled in tubular USP Type I glass vials. 1 mL fill in 2 mLVial                                       NDC 42571-337-95 Carton of 25 x 1 mL Vial                              NDC 42571-337-87 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and light. Retain in carton until time of use. Rx only Manufactured by:       Micro Labs Limited Bangalore-560 099, India. Manufactured for: Micro Labs USA Inc. Basking Ridge, NJ 07920 Revised: September 2018

Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. Diphenhydramine hydrochloride in the injectable form has a rapid onset of action. Diphenhydramine hydrochloride is widely distributed throughout the body, including the CNS. A portion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver. Detailed information on the pharmacokinetics of Diphenhydramine Hydrochloride Injection is not available.

NDC 42571-169-54 DiphenhydrAMINE HCl Injection, USP 50 mg/mL Rx Only HIGH POTENCY IV or DEEP IM 1 mL MICRO LABS NDC 42571-337-95 DiphenhydrAMINE HCl Injection, USP 50 mg/mL Rx Only HIGH POTENCY IV or DEEP IM 1 mL Single-Dose Vial MICRO LABS ampule label vial label