Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Diphenhydramine Hydrochloride Injection, USP 50 mg/mL is a sterile, nonpyrogenic, clear colourless solution, and is supplied as 1 mL single dose vial in package of 25s NDC: 70518-4536-00 NDC: 70518-4536-01 PACKAGING: 25 in 1 PACKAGE PACKAGING: 1 mL in 1 VIAL,GLASS Type 0 Storage Discard unused portion Protect from light. Keep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784), or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762; DRUG: Diphenhydramine Hydrochloride GENERIC: Diphenhydramine Hydrochloride DOSAGE: INJECTION ADMINSTRATION: INTRAMUSCULAR NDC: 70518-4536-0 NDC: 70518-4536-1 PACKAGING: 1 mL in 1 VIAL, GLASS OUTER PACKAGING: 25 in 1 PACKAGE ACTIVE INGREDIENT(S): DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1mL INACTIVE INGREDIENT(S): WATER SODIUM HYDROXIDE HYDROCHLORIC ACID Remedy_Label MM2
- HOW SUPPLIED Diphenhydramine Hydrochloride Injection, USP 50 mg/mL is a sterile, nonpyrogenic, clear colourless solution, and is supplied as 1 mL single dose vial in package of 25s NDC: 70518-4536-00 NDC: 70518-4536-01 PACKAGING: 25 in 1 PACKAGE PACKAGING: 1 mL in 1 VIAL,GLASS Type 0 Storage Discard unused portion Protect from light. Keep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784), or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
- DRUG: Diphenhydramine Hydrochloride GENERIC: Diphenhydramine Hydrochloride DOSAGE: INJECTION ADMINSTRATION: INTRAMUSCULAR NDC: 70518-4536-0 NDC: 70518-4536-1 PACKAGING: 1 mL in 1 VIAL, GLASS OUTER PACKAGING: 25 in 1 PACKAGE ACTIVE INGREDIENT(S): DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1mL INACTIVE INGREDIENT(S): WATER SODIUM HYDROXIDE HYDROCHLORIC ACID Remedy_Label MM2
Overview
Diphenhydramine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg in Water for Injection. pH 4.0 to 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: C 17 H 21 NO • HCl MW 291.82 Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol. structure
Indications & Usage
Diphenhydramine hydrochloride injection, USP is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when 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 combination with centrally acting anticholinergic agents.
Dosage & Administration
THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY. Diphenhydramine hydrochloride injection, USP is indicated when the oral form is impractical. 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 hours or 150 mg/m 2 /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. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
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. 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.
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.
Adverse Reactions
The most frequent adverse reactions are italicized. General Urticaria; drug rash; anaphylactic shock; photosensitivity; excessive perspiration; chills; dryness of mouth, nose and throat. Cardiovascular System Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic System Hemolytic anemia, thrombocytopenia, agranulocytosis. 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. Gastrointestinal System Epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation. Genitourinary System Urinary frequency, difficult urination, urinary retention, early menses. Respiratory System Thickening of bronchial secretions , tightness of chest and wheezing, nasal stuffiness.
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.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.