Scandonest 3% Plain 30 mg/mL
Mepivacaine Hydrochloride · INJECTION, SOLUTION · Septodont, Inc.
Scandonest 3% Plain is a injection, solution containing mepivacaine hydrochloride at 30 mg/mL, taken subcutaneous. Manufactured by Septodont, Inc..
Key Facts
- Brand Name
- Scandonest 3% Plain
- Generic Name
- Mepivacaine Hydrochloride
- NDC Code (Product)
0362-1098- Manufacturer
- Septodont, Inc.
- Strength
- 30 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA088387
- Marketing Start
- 12/22/2017
Recall History
Novocol Pharmaceutical of Canada, Inc.
Labeling: Label mix-up
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.
Dosage & Administration
DOSAGE AND ADMINISTRATION: 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 (51 mg of mepivacaine). 270 mg of mepivacaine (5.3 cartridges of Scandonest 3%) is 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 = Child’s Weight (lbs.) X Maximum Recommended Dose 150 for Adults (400 mg) The following table, approximating these …
Warnings
WARNINGS: RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE. (See ADVERSE REACTIONS ). Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity. Fatalities may occur with use of local anesthetics in the head and neck region as the result of retrograde arterial flow to vital CNS areas even when maximum recommended doses are observed. The practitioner should be alert to early evidences of alteration in sensorium or vital signs. SCANDONEST ® 3% Plain is SULFITE FREE. Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use; SCANDONEST ® , along with other local anesthetics, is capable of producing this condition. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, cl…
Contraindications
CONTRAINDICATIONS: SCANDONEST ® is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.
Drug Interactions
Clinically Significant Drug Interactions: Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: EXAMPLES OF DRUGS ASSOCIATED WITH METHEMOGLOBINEMIA: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic Agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine MEPIVACAINE SHOULD BE USED WITH CAUTION IN PATIENTS WITH KNOWN DRUG ALLERGIES AND SENSITIVITIES. A thorough history of the patient’s prior experience with mepivacaine or other local anesthetics as well as concomitant or recent drug use should be taken (see CONTRAINDICATIONS ). Patients allergic to methylparaben or para-aminobenzoic acid derivatives (procaine, tetr…
Adverse Reactions
ADVERSE REACTIONS: 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 drow…
Frequently Asked Questions
What is Scandonest 3% Plain used for?
Scandonest 3% Plain contains Mepivacaine Hydrochloride. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Scandonest 3% Plain a controlled substance?
Scandonest 3% Plain is not classified as a controlled substance by the DEA.
What is the generic name for Scandonest 3% Plain?
The generic name for Scandonest 3% Plain is Mepivacaine Hydrochloride. There are 11 other brand versions of Mepivacaine Hydrochloride.
What is the NDC code for Scandonest 3% Plain 30 mg/mL?
The NDC (National Drug Code) for Scandonest 3% Plain 30 mg/mL is 0362-1098, listed by Septodont, Inc..
Other Mepivacaine Brands
See all →- Polocaine30 mg/mL66312-441
- Mepivacaine Hydrochloride30 mg/mL0404-6730
- Mepivacaine30 mg/mL51004-0005
- Carbocaine30 mg/mL0362-0753
- Mepivacaine30 mg/mL43128-005
- Mepivacaine30 mg/mL50227-1080
- Polocaine-MPF10 mg/mL63323-260
- Polocaine20 mg/mL63323-296
- Polocaine10 mg/mL63323-283
- MEPIVACAINE HYDROCHLORIDE30 mg/mL67239-0201
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)