Patient Medication Information: uses, side effects, how to take - Dimenhydrinate Injection USP (Hikma Canada)
What is Dimenhydrinate Injection USP used for?
Dimenhydrinate Injection USP is used to prevent and relieve symptoms such as:
- nausea
- vomiting and/or
- vertigo
These symptoms may be the result of:
- motion sickness
- radiation sickness
- postoperative recovery
- taking other drugs
- an ear condition (Menière’s disease and other labyrinthine disturbances)
How does Dimenhydrinate Injection USP work?
Dimenhydrinate Injection USP belongs to a family of drugs called antiemetics. They work by:
- affecting the brain and inner ear to help prevent problems with the body’s balance
- blocking processes that are involved in the vomiting reflex
What are the ingredients in Dimenhydrinate Injection USP?
Medicinal ingredient: dimenhydrinate
Non-medicinal ingredients:
Dimenhydrinate Injection USP,
single use ampoules
50% propylene glycol, water for injection, and hydrochloric acid for pH adjustment
Dimenhydrinate Injection USP,
multidose vials
50% propylene glycol, water for injection, hydrochloric acid for pH adjustment, and methylparaben (as sodium methylparaben) and propylparaben (as sodium propylparaben) as preservatives
Dimenhydrinate Injection USP comes in the following dosage forms:
- 50 mg / mL, sterile solution for IM administration or IV administration if diluted, 1 mL single use ampoule
- 250 mg / 5 mL (50 mg / mL), sterile solution for IM administration or IV administration if diluted, 5 mL multidose vial
Do not use Dimenhydrinate Injection USP if you:
- are allergic to dimenhydrinate or any of the other ingredients (see What are the ingredients in Dimenhydrinate Injection USP)
take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid and methylene blue. Do not:
- Take an MAOI within 2 weeks of stopping Dimenhydrinate Injection USP use unless told to do so by your doctor
- Start taking Dimenhydrinate Injection USP if you stopped taking an MAOI in the last 2 weeks unless told to do so by your doctor
- Have glaucoma
Have chronic lung disease including:
- asthma
- chronic obstructive pulmonary disease
- lower respiratory tract symptoms
- Have difficulty urinating due to an enlarged prostate
- Are 2 years old or younger
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Dimenhydrinate Injection USP. Talk about any health conditions or problems you may have, including if you:
- have a history of heart problems, including high blood pressure
- have a history of seizures
- have problems with your thyroid
- have or had liver problems
- are pregnant or planning to become pregnant
- are breastfeeding or planning to breastfeed
- have porphyria (a condition that affects your hemoglobin)
Other warnings you should know about:
Do not take more than the recommended dose. At high doses, Dimenhydrinate Injection USP can cause:
- confusion
- hallucinations
- temporary amnesia
- paranoia
Abuse: chronic abuse of Dimenhydrinate Injection USP can lead to accidents, overdose, and in extreme cases to death. Dimenhydrinate Injection USP should not be used for prolonged periods except on the advice of your doctor.
Driving and using machines: Before doing tasks that require special attention, wait until you know how you respond to Dimenhydrinate Injection USP.
Pregnancy: Do not take Dimenhydrinate Injection USP for nausea or vomiting while pregnant unless told to do so by your doctor.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Dimenhydrinate Injection USP:
Alcohol
- Some drugs used to treat depression (MAO inhibitors)
Drugs used to help you sleep such as:
- barbiturates
- sedatives
- hypnotics
- Drugs used to reduce tension or anxiety (such as tranquilizers)
To avoid an overdose, you should use caution when taking Dimenhydrinate Injection USP with these types of drugs.
- Drugs used to treat allergies or allergic reactions (antihistamines)
- Drugs that can cause damage to the ear (called ototoxic drugs). If you take dimenhydrinate in combination with certain antibiotics or other drugs that can cause damage to the ear, you may not be able to see the early symptoms of ototoxicity.
Dimenhydrinate Injection USP in 5 mL multidose vials contains the preservatives methylparaben and propylparaben. They are known to be associated with undesirable reactions produced by the normal immune system in single or repeated uses.
How to take Dimenhydrinate Injection USP:
Dimenhydrinate Injection USP is for intramuscular use only.
If used for intravenous (IV) administration, it must be diluted at least one to ten with a compatible physiological solution (such as sterile saline). Diluted Dimenhydrinate Injection
USP, prepared for IV use, should be administered by SLOW INTRAVENOUS INJECTION ONLY (over 2 minutes).
Adults:
Usual dose: 25 mg - 100 mg given IM or by IV every 4 to 6 hours.
Maximum daily dose: This dose can be given again up to 400 mg a day.
Children:
Usual dose for 2 to 5 years of age: 12.5 mg - 25 mg given IM or by IV every 6 to 8 hours. This dose can be given again up to 75 mg a day.
Usual dose for 6 to 11 years of age: 25 mg - 50 mg given IM or by IV every 6 to 8 hours. This dose can be given again up to 150 mg a day.
Usual dose for 12 to 17 years of age: 25 mg - 100 mg given IM or by IV every 4 – 6 hours. This dose can be given again up to 300 mg a day.
Overdose:
If you think you have taken too much Dimenhydrinate Injection USP, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed dose:
If you miss a dose and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not exceed the maximum daily dose.
What are possible side effects from using Dimenhydrinate Injection USP?
These are not all the possible side effects you may feel when taking Dimenhydrinate Injection USP. If you experience any side effects not listed here, contact your healthcare professional.
- drowsiness
- dizziness
- pain may occur at the site of IM injection
- dry mouth
- fatigue
- excitement
- nausea
Skin Rash: If you experience a skin rash after taking Dimenhydrinate Injection USP, you should contact your doctor or pharmacist for assessment and advice.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Dimenhydrinate Injection USP should be stored at controlled room temperature (15°C – 30°C). Protect from freezing. The 5 mL multidose vial should also be protected from light.
Keep out of reach and sight of children.
If you want more information about Dimenhydrinate Injection USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-800-656-0793.