Scandonest

Get emergency medical help if you have any of these signs of an allergic reaction: hives, itching, skin redness; nausea, vomiting, sweating, feeling hot; fast heartbeats; sneezing, difficult breathing; dizziness, fainting; swelling of your face, lips, tongue, or throat.

Tell your caregiver right away if you have:

• numbness and tingling in your mouth or lips, metallic taste in your mouth;
• ringing in your ears, blurred vision, slurred speech, headache;
• confusion, depression, severe drowsiness, feeling like you might pass out;
• slow heart rate, weak pulse, weak or shallow breathing;
• fever, neck stiffness, increased sensitivity to light;
• tremors or muscle twitching, feeling anxious or restless;
• ongoing numbness, weakness, or loss of movement in your legs or feet;
• loss of bladder or bowel control;
• loss of feeling in your lower stomach, groin, or genitals;
• painful or difficult urination; or
• fast heart rate, rapid breathing, feeling hot.

Common side effects may include:

• anxiety, feeling restless or excited;
• depression, dizziness;
• tremors; or
• blurred vision, ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For an epidural or spinal block, mepivacaine is injected into an area of your lower back near your spine. You will receive this injection in a hospital or surgical setting.

For a dental procedure, mepivacaine is injected into the gum area inside your mouth. You will receive this injection in a dentist's office or oral surgery setting.

Your breathing, blood pressure, oxygen levels, and other vital signs may be watched closely while you are receiving mepivacaine.

Spinal numbing medications can have long-lasting or permanent effects on certain body processes. This includes sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from mepivacaine.

Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include extreme drowsiness, seizure (convulsions), shallow breathing, or slow heart rate.

Since mepivacaine is given as needed before a surgery or other medical procedure, you are not likely to be on a dosing schedule.

• Novocol Pharmaceutical of Canada, Inc.

• Septodont, Inc.

Since mepivacaine is given as needed before a surgery or other medical procedure, you are not likely to be on a dosing schedule.

Rx Only

THESE SOLUTIONS ARE INTENDED FOR DENTAL USE ONLY.

Scandonest stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia.

Scandonest is rapidly metabolized, with only a small percentage of the anesthetic (5 to 10 percent) being excreted unchanged in the urine. Scandonest because of its amide structure, is not detoxified by the circulating plasma esterases. The liver is the principal site of metabolism, with over 50 percent of the administered dose being excreted into the bile as metabolites. Most of the metabolized Mepivacaine is probably resorbed in the intestine and then excreted into the urine since only a small percentage is found in the feces. The principal route of excretion is via the kidney. Most of the anesthetic and its metabolites are eliminated within 30 hours. It has been shown that hydroxylation and N-demethylation, which are detoxification reactions, play important roles in the metabolism of the anesthetic. Three metabolites of Mepivacaine have been identified from adult humans: two phenols, which are excreted almost exclusively as their glucuronide conjugates, and the N-demethylated compound (2', 6' - pipecoloxylidide).

The onset of action is rapid (30 to 120 seconds in the upper jaw; 1 to 4 minutes in the lower jaw) and Scandonest 3% Plain will ordinarily provide operating anesthesia of 20 minutes in the upper jaw and 40 minutes in the lower jaw.

Scandonest 2% L with Levonordefrin 1:20,000 provides anesthesia of longer duration for more prolonged procedures, 1 hour to 2.5 hours in the upper jaw and 2.5 hours to 5.5 hours in the lower jaw.

Scandonest does not ordinarily produce irritation or tissue damage.

Levonordefrin is a sympathomimetic amine used as a vasoconstrictor in local anesthetic solutions. It has pharmacologic activity similar to that of Epinephrine but it is more stable than Epinephrine. In equal concentrations, Levonordefrin is less potent than Epinephrine in raising blood pressure, and as a vasoconstrictor.

Reactions to Scandonest are characteristic of those associated with other amide-type local anesthetics. Systemic adverse reactions involving the central nervous system and the cardiovascular system usually result from high plasma levels (which may be due to excessive dosage, rapid absorption, inadvertent intravascular injection, or slow metabolic degradation), injection technique, or volume of injection.

A small number of reactions may result from hypersensitivity, idiosyncrasy or diminished tolerance to normal dosage on the part of the patient.

Persistent paresthesias of the lips, tongue, and oral tissues have been reported with the use of mepivacaine, with slow, incomplete, or no recovery. These post-marketing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches.

Reactions involving the central nervous system are characterized by excitation and/or depression. Nervousness, dizziness, blurred vision, or tremors may occur followed by drowsiness, convulsions, unconsciousness, and possible respiratory arrest. Since excitement may be transient or absent, the first manifestations may be drowsiness merging into unconsciousness and respiratory arrest.

Cardiovascular reactions are depressant. They may be the result of direct drug effect or more commonly in dental practice, the result of vasovagal reaction, particularly if the patient is in the sitting position. Failure to recognize premonitory signs such as sweating, feeling of faintness, changes in pulse or sensorium may result in progressive cerebral hypoxia and seizure or serious cardiovascular catastrophe. Management consists of placing the patient in the recumbent position and administration of oxygen. Vasoactive drugs such as Ephedrine or Methoxamine may be administered intravenously.

Allergic reactions are rare and may occur as a result of sensitivity to the local anesthetic and are characterized by cutaneous lesions of delayed onset or urticaria, edema and other manifestations of allergy. The detection of sensitivity by skin testing is of limited value. As with other local anesthetics, anaphylactoid reactions to Mepivacaine have occurred rarely. The reaction may be abrupt and severe and is not usually dose related. Localized puffiness and swelling may occur.

As with all local anesthetics, the dose varies and depends upon the area to be anesthetized, the vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dose needed to provide effective anesthesia should be administered. For specific techniques and procedures refer to standard dental manuals and textbooks.

For infiltration and block injections in the upper or lower jaw, the average dose of 1 cartridge will usually suffice.

Each cartridge contains 1.7 mL (34 mg of 2% or 51 mg of 3%).

5.3 cartridges (180 mg of the 2% solution or 270 mg of the 3% solution) are usually adequate to effect anesthesia of the entire oral cavity. Whenever a larger dose seems to be necessary for an extensive procedure, the maximum dose should be calculated according to the patient's weight. A dose of up to 3 mg per pound of body weight may be administered. At any single dental sitting the total dose for all injected sites should not exceed 400 mg in adults.

The maximum pediatric dose should be carefully calculated.

Maximum dose for pediatric population =

The following table, approximating these calculations, may also be used as a guide. This table is based upon a recommended maximum for larger pediatric population of 5.3 cartridges (the maximum recommended adult dose) during any single dental sitting, regardless of the pediatric patient's weight or (for 2% mepivacaine) calulated maximum amount of drug:

When using Scandonest for infiltration or regional block anesthesia, injection should always be made slowly and with frequent aspiration.

Any unused portion of a cartridge should be discarded.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

NDC 51004-1098-9

Scandonest 3% plain

septodont

Mepivacaine Hydrochloride 3% without Vasoconstrictor

(MEPIVACAINE HYDROCHLORIDE INJECTION, USP)

50 Cartridges • 1.7 mL each

Manufactured for SEPTODONT, Louisville, CO, 80027

by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada, N1R 6X3