Diphenhydramine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Diphenhydramine Hydrochloride

REMEDYREPACK INC.

Diphenhydramine Hydrochloride Injection, USPRx only


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DIPHENHYDRAMINE HYDROCHLORIDE DESCRIPTION

Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in Water for Injection. pH 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.

The chemical name of diphenhydramine hydrochloride is 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. The structural formula is as follows:

Diphenhydramine Hydrochloride

C17H21NO • HCl MW 291.82

Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol.

 

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 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 & USAGE

Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when 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.

 

DIPHENHYDRAMINE HYDROCHLORIDE CONTRAINDICATIONS

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.

 

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.

 

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.

 

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

 

GENERAL PRECAUTIONS

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.

 

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

Diphenhydramine 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 ADVERSE REACTIONS

The most frequent adverse reactions are italicized.

 

Urticaria; drug rash; anaphylactic shock; photosensitivity; excessive perspiration; chills; dryness of mouth, nose and throat.

 

Hypotension, headache, palpitations, tachycardia, extrasystoles.

 

Hemolytic anemia, thrombocytopenia, agranulocytosis.

 

Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions.

 

Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.

 

Urinary frequency, difficult urination, urinary retention, early menses.

 

Thickening of bronchial secretions, tightness of chest 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 & ADMINISTRATION

THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY.

Diphenhydramine Hydrochloride Injection is indicated when the oral form is impractical.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

 

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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

 

HOW SUPPLIED

Diphenhydramine Hydrochloride Injection, USP 50 mg/mL

1 mL vials packaged in 25s (NDC 0641-0376-25)

 

Protect from light. Keep covered in carton until time of use. Store at 20˚-25˚C (68˚-77˚F), excursions permitted to 15˚-30˚C (59˚-86˚F) [See USP Controlled Room Temperature].

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For Product Inquiry call 1-877-845-0689.

Manufactured by:

Diphenhydramine Hydrochloride

WEST-WARD
PHARMACEUTICALS
Eatontown, NJ 07724 USA

Revised May 2011
462-220-01

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Diphenhydramine Hydrochloride


GENERIC: diphenhydramine hydrochloride


DOSAGE: INJECTION


ADMINSTRATION: INTRAMUSCULAR


NDC: 49349-836-41


ACTIVE INGREDIENT(S):

  • DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1mL


INACTIVE INGREDIENT(S):

  • BENZETHONIUM CHLORIDE
  • SODIUM HYDROXIDE
  • HYDROCHLORIC ACID
  • WATER


PACKAGING: 1 mL in 1 VIAL



Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride

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Diphenhydramine Hydrochloride

diphenhydramine hydrochloride INJECTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-836(NDC:0641-0376)
Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
benzethonium chloride
SODIUM HYDROXIDE
HYDROCHLORIC ACID
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-836-41 1 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080817 2013-06-13


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