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NDC 67457-0124-10 Diphenhydramine Hydrochloride 50 mg/mL Details

Diphenhydramine Hydrochloride 50 mg/mL

Diphenhydramine Hydrochloride is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 67457-0124-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Diphenhydramine injection is used to treat allergic reactions, especially for people who are unable to take diphenhydramine by mouth. It is used also to treat motion sickness. Diphenhydramine injection is also used alone or along with other medications to control abnormal movements in people who have Parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Diphenhydramine injection should not be used in newborn or premature infants. Diphenhydramine injection is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 67457-0124-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine Injection

Product Information

NDC	67457-0124
Product ID	67457-124_0430e5e0-3024-42f5-9c97-073a5d71fb3f
Associated GPIs	41200030102010
GCN Sequence Number	011590
GCN Sequence Number Description	diphenhydramine HCl VIAL 50 MG/ML INJECTION
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	46013
HICL Sequence Number	004480
HICL Sequence Number Description	DIPHENHYDRAMINE HCL
Brand/Generic	Generic
Proprietary Name	Diphenhydramine Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	diphenhydramine hydrochloride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	INJECTION, SOLUTION
Route	INTRAMUSCULAR; INTRAVENOUS
Active Ingredient Strength	50
Active Ingredient Units	mg/mL
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Mylan Institutional LLC
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA040498
Listing Certified Through	2024-12-31

Package

Package Images

NDC 67457-0124-10 (67457012410)

Pricing Information	N/A
NDC Package Code	67457-124-10
Billing NDC	67457012410
Package	1 VIAL, GLASS in 1 CARTON (67457-124-10) / 10 mL in 1 VIAL, GLASS
Marketing Start Date	2013-05-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 82cd7a3c-acd6-44dc-8c95-f066162a510c Details

DESCRIPTION

Diphenhydramine hydrochloride 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 C17H21NO • HCl. The structural formula is as follows:

Diphenhydramine hydrochloride in the parenteral form is a sterile, pyrogen-free solution available in a concentration of 50 mg of diphenhydramine hydrochloride per mL. The solutions for parenteral use have been adjusted to a pH between 5.0 and 6.0 with either sodium hydroxide or hydrochloric acid and contains 0.1 mg/mL benzethonium chloride as a germicidal agent.

CLINICAL PHARMACOLOGY

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.

INDICATIONS AND USAGE

Diphenhydramine hydrochloride injection, 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.

Antihistaminic

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.

Motion sickness

For active treatment of motion sickness.

Antiparkinsonism

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 combinations with centrally acting anticholinergic agents.

CONTRAINDICATIONS

Use in Neonates or Premature Infants

This drug should not be used in neonates or premature infants.

Use in Nursing Mothers

Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

Use as a Local Anesthetic

Because of the risk of local necrosis, this drug should not be used as a local anesthetic.

Antihistamines are also contraindicated in the following conditions:

Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

WARNINGS

Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction.

Local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous diphenhydramine hydrochloride.

Use in Pediatric Patients

In pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.

As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young pediatric patient, particularly, they may produce excitation.

Use in the Elderly (approximately 60 years or older)

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

PRECAUTIONS

General

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.

Information for Patients

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.

Drug Interactions

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed.

Pregnancy

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.

Pediatric Use

Diphenhydramine hydrochloride should not be used in neonates and premature infants (see CONTRAINDICATIONS).

Diphenhydramine hydrochloride 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

ADVERSE REACTIONS

The most frequent adverse reactions are underscored.

1.: General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose, and throat
2.: Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles
3.: Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis
4.: Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions
5.: GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation
6.: GU System: Urinary frequency, difficult urination, urinary retention, early menses
7.: Respiratory System: Thickening of bronchial secretions, tightness of chest or throat and wheezing, nasal stuffiness

OVERDOSAGE

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.

Stimulants should not be used.

Vasopressors may be used to treat hypotension.

DOSAGE AND ADMINISTRATION

THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY.

Diphenhydramine hydrochloride injection, 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.

Pediatric Patients, other than premature infants and neonates

5 mg/kg/24 hr or 150 mg/m2/24 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.

Adults

10 mg 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.

HOW SUPPLIED

Diphenhydramine Hydrochloride Injection, USP is supplied as a sterile solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution with 0.1 mg/mL benzethonium chloride as a germicidal agent. Available in multi-dose 10 mL (NDC 67457-124-10) vials.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from freezing and light.

Manufactured for:

Mylan Institutional LLC

Morgantown, WV 26505 U.S.A.

Manufactured by:

Mylan Institutional

Galway, Ireland

1012L101

MI:DIHYIJ:R4

Revised: 6/2021

PRINCIPAL DISPLAY PANEL - 50 mg/mL

NDC 67457-124-10 10 mL

diphenhydrAMINE

Hydrochloride

Injection, USP

500 mg/10 mL

(50 mg/mL)

For Intravenous or

Intramuscular Use

HIGH POTENCY

Rx only Multi-Dose Vial

Usual Adult Dosage:

0.2 mL to 1 mL

intravenously or

intramuscularly, or more

as required. See

accompanying

prescribing information.

Store at 20° to 25°C

(68° to 77°F). [See USP

Controlled Room

Temperature.]

Protect from freezing

and light.

MI:124:1C:R6

Sterile. Pyrogen-Free.

Each mL contains:

Diphenhydramine

Hydrochloride 50 mg,

Benzethonium Chloride

0.1 mg, as a germicidal

agent in Water for

Injection. The pH may

have been adjusted

with Sodium Hydroxide

and/or Hydrochloric

Acid.