SCANDONEST 3% PLAIN Solution for injection (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
Septodont, Inc.
Λέξεις κλειδιά
0362-1098
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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1. Description
Mepivacaine Hydrochloride, a tertiary amine used as a local anesthetic, is 1-methyl-2', 6'-pipecoloxylidide monohydrochloride with the following structural formula: It is a white, crystalline, odorless ...
2. Clinical Pharmacology
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 ...
3. Indications and Usage
Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.
4. Contraindications
SCANDONEST is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.
5. 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 ...
6. Precautions
The safety and effectiveness of Mepivacaine depend upon proper dosage, correct technique, adequate precautions, and readiness for emergencies. The lowest dose that results in effective anesthesia should ...
6.2. Information for Patients
The patient should be cautioned against loss of sensation and possibility of biting trauma should the patient attempt to eat or chew gum prior to return of sensation. Inform patients that use of local ...
6.4. Drug Interactions
Clinically Significant Drug Interactions The administration of local anesthetic solutions containing vasopressors, such as Levonordefrin, Epinephrine or Norepinephrine, to patients receiving tricyclic ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies of Mepivacaine HCl in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.
6.7. Pregnancy
Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with this solution. It is also not known whether this solution can cause fetal harm when administered to a ...
6.9. Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this solution is administered to a nursing woman.
6.10. Pediatric Use
Great care must be exercised in adhering to safe concentrations and dosages for pedodontic administration (see DOSAGE AND ADMINISTRATION).
7. 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 ...
9. Overdosage
Treatment of a patient with toxic manifestations consists of assuring and maintaining a patent airway and supporting ventilation (respiration) as required. This usually will be sufficient in the management ...
10. 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 ...
11. How Supplied
SCANDONEST 3% (30 mg/mL) Plain; (Mepivacaine Hydrocholoride Injection USP) (NDC 0362-1098-90) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL single-dose dental cartridges, 50 per ...
12. Storage and Handling
Both solutions should be stored at controlled room temperature, below 25°C (77°F). Protect from light. Do not permit to freeze. BOXES: For protection from light, retain in box until time of use. Once opened, ...