Diphenhydramine Injection

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.

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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.

The structural formula is as follows:

Diphenhydramine hydrochloride  in  the  par­ enteral  form is a sterile,  pyrogen-free solution available in a concentration of 50 mg of diphen­ hydramine hydrochloride per  ml. pH 4.0 to 6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.

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.

Antihistamines should be used  with consider­able caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduo­ denal 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.

It is supplied as a sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochlo­ ride in each milliliter of solution, and available in packages of 25.

Vial stoppers do  not  contain natural rubber latex.

Store  at 20° to  25°C  (68°  to  7rF) [see  USP Controlled Room Temperature] .

Protect  from freezing and light.

APP Pharmaceuticals, LLC

Schaumburg, IL 60173

45954C

Revised: April 2008

Diphenhydramine injection is an antihistamine used to treat life-threatening allergic reactions (anaphylaxis) along with epinephrine and other treatments. It is also used to relieve symptoms of household allergies, hay fever and the common cold when medication cannot be given by mouth. Common allergy symptoms relieved by antihistamines include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose and sneezing.

It is also used to treat nausea, vomiting and dizziness caused by motion sickness when medication cannot be given by mouth. Diphenhydramine works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine).

Diphenhydramine should not be used in newborns or premature infants because of an increased risk of side effects.

How to use Diphenhydramine Hcl Syringe

This medication is injected into a vein (IV) no faster than 25 milligrams per minute, or deeply into a muscle as directed by your doctor. Be very careful to inject into a vein or muscle and not into the skin or just under the skin. If this medication is injected into or just under the skin, it can destroy the skin and tissues around the injection site (necrosis).

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Do not use this medication more often than prescribed. Your dosage is based on your medical condition and response to therapy. Inform your doctor if your condition does not improve or if it worsens.

Drowsiness, dizziness, headache, irritability, stomach upset, vision changes (e.g., blurred vision), decreased coordination, constipation, or dry mouth/nose/throat may occur. These effects may decrease as your body adjusts to the medication. If they persist or become bothersome, inform your doctor.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute. Diphenhydramine can dry up and thicken the mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, be sure to drink plenty of fluids unless otherwise directed by your physician.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as restlessness, confusion), pounding/irregular heartbeat, ringing in the ears, seizure, difficulty urinating.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using diphenhydramine, tell your doctor or pharmacist if you are allergic to it; or to dimenhydrinate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, emphysema), glaucoma, heart problems, high blood pressure, liver disease, mental/mood disorders, seizures, stomach problems (e.g., ulcers, obstruction), overactive thyroid, difficulty urinating (e.g., enlarged prostate, urinary retention).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit the use of alcohol and certain other medications that cause drowsiness. (See also Drug Interactions.)

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using this drug in children because they are more sensitive to the effects of antihistamines. This drug can often cause excitement in young children instead of drowsiness.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, low blood pressure, confusion, constipation, or trouble urinating. Drowsiness, dizziness, and confusion can increase the risk of falling.

This medication should be used only when clearly needed during pregnancy. Tell your doctor if you are pregnant before using this medication.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), antispasmodics (e.g., atropine, belladonna alkaloids), drugs for Parkinson's disease (e.g., anticholinergics such as benztropine, trihexyphenidyl), MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), tricyclic antidepressants (e.g., amitriptyline).

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, chlorpheniramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.