Details for: ORAQIX
Company: DENTSPLY CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02325993 | ORAQIX | PRILOCAINE; LIDOCAINE | 2.5 %; 2.5 % | GEL | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Oraqix® is an injection free kind of freezing (anesthetic) for adult patients during scaling and/or root planning procedures. Oraqix® is only given to you by a dental health care professional.
What it does
Oraqix® is an anesthetic used in dentistry that causes freezing or loss of feeling in the gums and surrounding tissues. It is used to numb the area before selected periodontal procedures. It starts to freeze the area in about 30 seconds and lasts on average for 20 minutes. Oraqix® does not prevent gum disease or periodontitis.
When it should not be used
Oraqix® should not be used:
- If you are allergic to lidocaine or prilocaine or other similar local anesthetics
- If you are allergic to any ingredients in Oraqix®.
- If you have congenital or idiopathic methemoglobinemia (a blood disorder that can exist at birth or have an unknown cause)
What the medicinal ingredient is
lidocaine and prilocaine
What the non-medicinal ingredients are
Poloxamers, Hydrochloric acid, Poloxamer 188 purified,
Poloxamer 407 purified, hydrochloric acid, Purified
water
If you think you might be sensitive or allergic to any of
these ingredients, check with your dentist before using
Oraqix®.
What dosage form it comes in
Oraqix® is packaged in dental glass cartridges intended for single use. Each cartridge contains 1.7g gel.
Oraqix® is a topical anesthetic for periodontal use. It comes in a gel containing lidocaine 25 mg/ml and prilocaine 25 mg/ml.
Warnings and precautions
Oraqix® must not be injected. It is applied to the gums and surrounding tissues by a dental health care professional using a blunt tipped applicator
Oraqix® must be kept away from your eyes, as it may cause irritation. If you accidentally get Oraqix® in the eye, ask your dentist to rinse it well immediately with water or saline solution. Wear glasses to protect your eye from injury (irritations) and avoid scratching, rubbing, or exposing the eye to hot or cold temperatures until normal feeling has returned.
Oraqix® must be kept away from the ears.
Methemoglobinemia is a condition where an excess of hemoglobin has changed into methemoglobin. If too much methemoglobin is formed, it becomes more difficult for the blood to provide the tissue with oxygen. Oraqix® may increase the risk of methemoglobinemia.
To minimize the risk of methemoglobinemai,
BEFORE you use Oraqix® talk to your dentist/dental hygienist if:
- you have ever had a bad, unusual or allergic reaction to lidocaine or prilocaine, or similar products that are available under brand names such as EMLA, Xylocaine® (lidocaine), and Citanest® (prilocaine).
- you have glucose 6-phosphate deficiencies.
- you have heart problems called AV Block, severe kidney or liver disease.
- you are pregnant or breast-feeding.
Oraqix® may occasionally block all feeling in the treated area. Be careful to avoid injury to the treated area while it is numb and you are not aware of pain. Avoid scratching, rubbing, or exposing the treated area to hot or cold temperatures until complete sensation has returned. The numb feeling will wear off after a few hours.
Oraqix® is not recommended to be used in children and adolescents less than 18 years old
Interactions with this medication
Tell your dentist about any other drugs you take, including the ones you can buy without a prescription.
Proper use of this medication
Usual dose
A dentist or dental hygienist will give you Oraqix®. The dosage is decided by the dentist/dental hygienist and depends on how many and which teeth are to be treated. The maximum dose in a single treatment is 5 cartridges. The gel is applied on the gum line and inside the tooth pocket with the Oraqix® Dispenser. The full effect is achieved after about half a minute and the dentist or dental hygienist can start further treatment.
Oraqix® is not recommended to be used in children and adolescents less than 18 years old.
Oraqix® is not intended for injection.
Overdose
If you are accidentally given a higher than usual dose of dental anesthetics, you may experience the following symptoms numbness of the lips and around the mouth, light-headedness, dizziness or sometimes blurred vision.
Tell your dentist or dental hygienist immediately if you have any of the above symptoms.
If you are given a higher than usual dose of prilocaine, you may develop methemoglobinemia with symptoms such as a bluish-grey discoloration of the lips, nails and skin, headaches, tiredness, dizziness, shortness of breath, seizures (fits), irregular heart beat and shock. This may appear hours after you have been treated using Oraqix®
Side effects and what to do about them
The following side effects usually do not require medical attention (report to your dental health care professional if they continue to be bothersome):
- numbness of mouth or throat
- changes in ability to feel hot or cold
- redness and swelling at the application site
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Seek immediate medical assistance |
|---|---|---|---|
| Common | |||
| Numbness of mouth or throat | ✔ | ||
| Changes in ability to feel hot or cold | ✔ | ||
| Redness and swelling at the application site | ✔ | ||
| Rare | |||
| Numbness of the lips and around the mouth | ✔ | ||
| Light-headedness, dizziness | ✔ | ||
| Blurred vision | ✔ | ||
| Allergic reaction (skin rash or itching, swelling of your throat, lips or face, fever, breathing difficulties, dizziness) | ✔ | ||
| Chest pain | ✔ | ||
| Drowsiness | ✔ | ||
| Fast or irregular heartbeat | ✔ | ||
| Trembling | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Oraqix®, contact your doctor or pharmacist.
How to store
This medicine is given by a health care professional in a clinic or office setting. You will not need to take this medicine at home.
Reporting side effects
To monitor drug safety, Health Canada through the Canada
Vigilance Program collects information on serious and
unexpected side effects of drugs. If you suspect you have had a
serious or unexpected reaction to this drug you may notify
Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect
By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and
Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the
management of the side effect, please contact your health care
provider before notifying Canada Vigilance. The Canada
Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
www.dentsply.ca or by contacting DENTSPLY Canada Ltd. the
sponsor of Oraqix®, at:
1-800-263-1437
This leaflet was prepared by DENTSPLY Canada Ltd.
Last revised: April 30, 2009