Lidocaine and prilocaine (Gingival)

Lidocaine and prilocaine periodontal (gingival) gel is applied to the gums to create numbness or loss of feeling during dental treatments. This medication contains a combination of two topical local anesthetics (numbing medicines) that block the nerve endings in the gum.

This medicine should only be provided by or under the direct supervision of your dentist.

It is very important that your dentist checks your progress closely for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your dentist right away if you have a rash, itching, hoarseness, trouble with breathing or swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. Call your dentist right away if you notice a blue or bluish purple color on your lips, fingernails, or skin, or if you have headaches, dizziness, fainting, sleepiness, or trouble with breathing after you receive this medicine.

While your gum feels numb, serious injury can happen. Be especially careful to avoid injury until the numbness goes away and you have normal feeling in the area. Avoid very hot or very cold foods or liquids. Do not chew gum or food while your mouth feels numb. You may accidentally bite your tongue or the inside of your cheeks.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. Here are important points to keep in mind for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other allergies you may have, like allergies to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how age affects the use of lidocaine and prilocaine periodontal gel in children. Safety and effectiveness have not been established.

Geriatric

Studies done so far have not found specific problems in older adults that would limit the use of lidocaine and prilocaine periodontal gel. However, older patients may be more likely to have age-related liver, kidney, or heart issues, which might require careful monitoring and dose adjustments for those using lidocaine and prilocaine periodontal gel.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together, even if interactions could happen. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are receiving this medicine. The following interactions are significant but may not be all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication or change some of your other medicines.

• Dihydroergotamine
• Dronedarone
• Saquinavir
• Vernakalant

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Acecainide
• Amifampridine
• Amiodarone
• Amprenavir
• Arbutamine
• Bretylium
• Bupivacaine Liposome
• Bupropion
• Cobicistat
• Darunavir
• Dasabuvir
• Delavirdine
• Disopyramide
• Dofetilide
• Donepezil
• Dronedarone
• Encainide
• Etravirine
• Flecainide
• Fosamprenavir
• Fosphenytoin
• Hyaluronidase
• Ibutilide
• Lopinavir
• Metoprolol
• Mexiletine
• Moricizine
• Nadolol
• Phenytoin
• Procainamide
• Propafenone
• Quinidine
• Sotalol
• Succinylcholine
• Telaprevir
• Tocainide

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs might be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Cimetidine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency, or
• Heart problems, or
• Lung or breathing problems, or
• Methemoglobinemia (blood disorder), whether hereditary or idiopathic (unknown cause)—Use cautiously. May increase risk of methemoglobinemia.

• Severe liver disease—Use cautiously. Effects may be increased due to slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Gum numbness that continues
• gum swelling or irritation
• nausea

Rare

• Hoarseness
• rash
• swelling of the eyelids, face, lips, or tongue
• tightness in the chest
• trouble with breathing
• trouble with swallowing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blue or blue-purple color of the lips, fingernails, mouth, or skin
• blurred or double vision
• dark urine
• dizziness or drowsiness
• fainting
• feeling hot, cold, or numb
• headache
• irregular or fast heartbeat
• muscle twitching or trembling
• ringing or buzzing in the ears
• seizures
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bad or bitter taste
• mouth pain or soreness
• mouth ulcers

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Oraqix

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Anesthetic, Amino Amide Combination

Chemical Class: Amino Amide

A dentist or other trained health professional will give you this medicine in an office or clinic setting. The medicine is applied to the gums using an applicator and a special dispenser.