Patient Medication Information: uses, side effects, how to take - Articaine Hydrochloride and Epinephrine Injection - N
What is Articaine Hydrochloride and Epinephrine Injection used for?
Articaine Hydrochloride and Epinephrine Injection is used in adults and children (4 years of age and older) to reduce pain during dental procedures.
How does Articaine Hydrochloride and Epinephrine Injection work?
Articaine Hydrochloride and Epinephrine Injection belong to a group of medicines known as “local anesthetics”. Articaine Hydrochloride and Epinephrine Injection is a combination of two medicinal ingredients:
- Articaine hydrochloride: This works by blocking nerve signals at the site of injection to numb a specific area.
- Epinephrine: This works by narrowing the blood vessels at the site of injection to enhance the effects of articaine hydrochloride and reduce bleeding during your procedure.
What are the ingredients in Articaine Hydrochloride and Epinephrine Injection?
Medicinal ingredients: articaine hydrochloride and epinephrine bitartrate.
Non-medicinal ingredients: sodium chloride, sodium metabisulfite, water for injection, and hydrochloric acid and/or sodium hydroxide to adjust the pH.
Articaine Hydrochloride and Epinephrine Injection come in the following dosage forms:
- Articaine Hydrochloride and Epinephrine Injection - SP (sterile solution): 40 mg/mL of articaine hydrochloride (4%) and 0.01 mg/mL of epinephrine as epinephrine bitartrate (1:100,000).
- Articaine Hydrochloride and Epinephrine Injection - N (sterile solution): 40 mg/mL of articaine hydrochloride (4%) and 0.005 mg/mL of epinephrine as epinephrine bitartrate (1:200,000).
Do not use Articaine Hydrochloride and Epinephrine Injection if:
- you are allergic to articaine hydrochloride, epinephrine, or any of the other ingredients in Articaine Hydrochloride and Epinephrine Injection.
- you are allergic or have had allergic reaction to sulphite.
- you have untreated epilepsy or seizures.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Articaine Hydrochloride and Epinephrine Injection. Talk about any health conditions or problems you may have, including if you:
- have low or high blood pressure.
- have any heart or blood vessel problems.
- have liver problems.
- have kidney problems.
- have asthma.
- have plasma cholinesterase deficiency (low levels of enzymes necessary for the metabolism of certain medications).
- have myasthenia gravis (a chronic autoimmune disorder that causes muscle weakness).
- have pheochromocytoma (a tumour in the adrenal gland).
- have glaucoma (increased pressure within your eyes).
are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed. It is not known if Articaine Hydrochloride and Epinephrine Injection is excreted in breast milk.
- have diabetes.
Other warnings you should know about:
Driving or using machinery: Articaine Hydrochloride and Epinephrine Injection can affect your judgement, coordination, and alertness. You should be careful when driving or doing tasks that require special attention after receiving Articaine Hydrochloride and Epinephrine Injection.
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 Articaine Hydrochloride and Epinephrine Injection:
- acetaminophen, a medicine used to relive pain and reduce fever.
alcohol.
- antiarrhythmics, medicines used for heart rhythm disorders (e.g., digitalis, digital glucosides, and quinidine).
- antibiotics, medicines used to treat bacterial infections (e.g., dapsone, nitrofurantoin, para-aminosalicylic acid, and sulfonamides).
- anticonvulsants, medicines used for seizures (e.g., phenobarbital, phenytoin, and sodium valproate).
- antidepressants, medicines used to treat depression and anxiety (e.g., monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, amitriptyline, clomipramine, desipramine, imipramine, nortriptyline, trimipramine, milnacipran, and venlafaxine).
- antihistamines, medicines used to treat allergies (e.g., chlorpheniramine and diphenhydramine).
- antihypertensives, medicines used for high blood pressure (e.g., guanadrel, guanethidine, and rauwolfia alkaloids).
- antimalarials, medicines used to treat malaria (e.g., chloroquine and primaquine).
- antineoplastic agents, medicines used to treat cancer (e.g., cyclophosphamide, flutamide, hydroxyurea, ifosfamide, and rasburicase).
- antiparkinsonian drugs, medicines used for Parkinson’s disease (e.g., entacapone and tolcapone).
- beta blockers, medicines used to treat high blood pressure and certain heart conditions (e.g., propranolol and nadolol).
- local anesthetics, medicines used for pain relief and local anesthesia (e.g., articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine).
- medicines used to treat migraines (e.g., methysergide, ergotamine, and ergonovine).
- metoclopramide, a medicine used to relieve nausea, vomiting, and indigestion.
- neuroleptics, medicines used to treat mental and emotional disorders (e.g., phenothiazines).
- nitrates and nitrites, medicines used to dilate blood vessels and treat certain heart conditions (e.g., nitric oxide, nitroglycerin, nitroprusside, and nitrous oxide).
- other anesthetics, medicines used for general anesthesia (e.g., chloroform, halothane, cyclopropane, and trichloroethylene).
- quinine, a medicine used to treat and prevent malaria.
- sedatives, medicines used for sleep and anxiety relief (e.g., benzodiazepine and opioids).
- sulfasalazine, a medicine used to treat bowel problems.
- sympathomimetics, medicines used to increase blood pressure, open airways, and relieve congestion (e.g., cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline, levothyroxine, and methyldopa).
How to take Articaine Hydrochloride and Epinephrine Injection:
Your healthcare professional will prepare and give you Articaine Hydrochloride and Epinephrine Injection in a healthcare setting.
- You will receive Articaine Hydrochloride and Epinephrine Injection by an injection into the area around a tooth or gums (infiltration) or near a nerve (nerve block). Any other route of administration will not be used due to the risk of dangerous side effects.
- Follow all instructions given to you by your healthcare professional.
Usual dose:
Your healthcare professional will decide the right dose for you. It will depend on your age, health, weight, and the procedure you are having. The lowest dose that produces the desired results for you will be used.
Overdose:
If you think you, or a person you are caring for, have taken too much Articaine Hydrochloride and Epinephrine Injection, contact a healthcare professional, hospital emergency department, or regional poison control center immediately, even if there are no symptoms.
What are possible side effects from using Articaine Hydrochloride and Epinephrine Injection?
These are not all the possible side effects you may have when taking Articaine Hydrochloride and Epinephrine Injection. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of Articaine Hydrochloride and Epinephrine Injection include:
- agitation or restlessness;
- anxiety or nervousness;
- bruising;
- enlarged lymph nodes;
- gum and mouth discomfort or pain, including sores or ulcers in the mouth;
- increased saliva;
- increased sensitivity;
- indigestion or upset stomach;
- loss of movement or weakness of the muscles of the face ;
- migraine;
- muscle twitching;
- neck pain;
- numbness of the lips, tongue, and mouth;
- pain or swelling at the injection site;
- ringing in the ear or ear pain;
- shaky or trembling movements (tremor);
- shivering or feeling cold (chills);
- sleepiness or drowsiness;
- sore throat;
- tooth problems.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
| Angioedema (swelling of tissue under the skin): swelling of face, tongue, cheek, lips, throat, hands, feet, around the eyes, or difficulty breathing. | X | ||
| Bradycardia or tachycardia (abnormally slow or fast heartbeat) | X | ||
| Dizziness | X | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, or fatigue (may occur when you go from lying or sitting to standing up). | X | ||
| Syncope (fainting): a temporary loss of consciousness due to a sudden drop in blood pressure. | X | ||
| UNCOMMON | |||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness, fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse, or heart palpitations. | X | ||
| Injection site exfoliation or necrosis (peeling or death of the skin at the injection area): peeling or flaking of the skin, discoloration, severe pain, open sores, chills, or ulcers near the injection site. | X | ||
| RARE | |||
| Allergic reactions: rash, hives, itchiness, pink eye, sneezing, stuffy nose, congestion, runny nose, difficulty swallowing, difficulty breathing, wheezing, drop in blood pressure, nausea, vomiting, or swelling of face, tongue, lip, throat, or eyes. | X | ||
| Bronchospasm (when there is a sudden narrowing of the airway): difficulty breathing, wheezing, coughing, chest tightness, or fatigue. | X | ||
| Dyspnea (shortness of breath) | X | ||
| Eye problems: seeing double, blurred vision, temporary or full loss of vision, itching of the eyelids, one or both pupils are larger or smaller than normal, or drooping eyelid over the eye. | X | ||
| VERY RARE | |||
| Paraesthesia (pins and needles): sensation of tingling, pain, or numbness in the hands, fingers and toes. | X | ||
| UNKNOWN | |||
| Heart conduction disorders (irregular heart rhythm): slow or irregular heartbeat, fatigue, weakness, dizziness, | X | ||
| fainting, shortness of breath, or chest pain. | |||
| Methemoglobinemia (blood disorder where not enough oxygen getting to the cells of the body): pale, gray, or blue coloured skin, headache, rapid heart rate, shortness of breath, light-headed, or fatigue. | X | ||
| Vasoconstriction (narrowing of blood vessels): cold hands or feet, pale or bluish skin, high blood pressure, numbness, tingling, or increased heart rate. | X | ||
| Vasodilatation (widening of blood vessels): dizziness, light-headedness, headache, warm or flushed skin, redness in the face or body, or low blood pressure. | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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/adverse-reaction-reporting.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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Your healthcare professional will store Articaine Hydrochloride Epinephrine Injection at or below 25oC. It will be protected from light and freezing. Keep out of reach and sight of children.
If you want more information about Articaine Hydrochloride and Epinephrine Injection:
•
- Talk to your healthcare professional
•
- Find the full Product Monograph that is prepared for healthcare professionals and includes the 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); the manufacturer’s website (https://www.septodont-en.ca) or by calling 1-800-647-0643.