Lignospan Standard
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Questions & Answers
Side Effects & Adverse Reactions
DENTAL PRACTITIONERS WHO EMPLOY LOCAL ANESTHETIC AGENTS SHOULD BE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF EMERGENCIES WHICH MAY ARISE FROM THEIR USE. RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE AVAILABLE FOR IMMEDIATE USE.
To minimize the likelihood of intravascular injection, aspiration should be performed before the local anesthetic solution is injected. If blood is aspirated, the needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not assure that intravascular injection will be avoided.
Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection.
LIGNOSPAN solutions contain potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
LIGNOSPAN, along with other local anesthetics, is capable of producing methemoglobinemia. The clinical signs of methemoglobinemia are cyanosis of the nail beds and lips, fatigue and weakness. If methemoglobinemia does not respond to administration of oxygen, administration of methylene blue intravenously 1-2 mg/kg body weight over a 5 minute period is recommended.
The American Heart Association has made the following recommendations regarding the use of local anesthetics with vasoconstrictors in patients with ischemic heart disease: "Vasoconstrictor agents should be used in local anesthesia solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound. When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection. The minimum possible amount of vasoconstrictor should be used." (Kaplan, EL, editor: Cardiovascular disease in dental practice, Dallas 1986, American Heart Association.)
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
LIGNOSPAN Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques.
Only accepted procedures for these techniques as described in standard textbooks are recommended.
History
There is currently no drug history available for this drug.
Other Information
LIGNOSPAN FORTE and LIGNOSPAN STANDARD are sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula :
C14H22N20•HCl• H20 M.W. 288.8
Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula :
C9H13NO3•C4H606 M.W. 333.3
| PRODUCT IDENTIFICATION | FORMULA | |||
|---|---|---|---|---|
| SINGLE DOSE CARTRIDGE | ||||
| Lidocaine hydrochloride | Epinephrine (as the bitartrate) |
Sodium Chloride | Potassium metabisulfite | Edetate Disodium |
| Concentration % | Dilution | (mg/mL) | (mg/mL) | (mg/mL) |
| The pH of the LIGNOSPAN FORTE and the LIGNOSPAN STANDARD solutions are adjusted to USP limits with sodium hydroxide. | ||||
| 2 | 1:50,000 | 6.5 | 1.2 | 0.25 |
| 2 | 1:100,000 | 6.5 | 1.2 | 0.25 |
Sources
Lignospan Standard Manufacturers
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Novocol Pharmaceutical Of Canada, Inc.
![Lignospan Standard (Lidocaine Hydrochloride And Epinephrine Bitartrate) Injection, Solution [Novocol Pharmaceutical Of Canada, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lignospan Standard | Novocol Pharmaceutical Of Canada, Inc.
The dosage of LIGNOSPAN (lidocaine HCL and epinephrine) depends on the physical status of the patient, the area of the oral cavity to be anesthetized, the vascularity of the oral tissues, and the technique of anesthesia used. The least volume of solution that results in effective local anesthesia should be administered; time should be allowed between injections to observe the patient for manifestations of an adverse reaction. For specific techniques and procedures of a local anesthesia in the oral cavity, refer to standard textbooks.
For most routine dental procedures, LIGNOSPAN STANDARD (lidocaine HCI 2% with a 1:100,000 epinephrine concentration) is preferred. However, when greater depth and a more pronounced hemostasis are required, LIGNOSPAN FORTE (lidocaine HCI 2 % with 1:50,000 epinephrine concentration) should be used.
Dosage requirements should be determined on an individual basis. In oral infiltration and / or mandibular block, initial dosages of 1.0 - 5.0 mL (1/2 to 2.5 cartridges) of LIGNOSPAN (lidocaine HCI 2% solutions with a 1:50,000 or a 1:100,000 epinephrine concentration) are usually effective.
In children under 10 years of age, it is rarely necessary to administer more than one-half cartridge (0.9-1.0 mL or 18-20 mg of lidocaine) per procedure to achieve local anesthesia for a procedure involving a single tooth. In maxillary infiltration, this amount will often suffice to the treatment of two or even three teeth. In the mandibular block, however, satisfactory anesthesia achieved with this amount of drug, will allow treatment of the teeth of an entire quadrant. Aspiration is recommended since it reduces the possibility of intravascular injection, thereby keeping the incidence of side effects and anesthetic failures to a minimum. Moreover, injection should always be made slowly.
Maximum recommended dosages for LIGNOSPAN (lidocaine HCI 2% solutions with a 1:50,000 or a 1:100,000 epinephrine concentration).
AdultFor normal healthy adults, the amount of lidocaine HCI administered should be kept below 500 mg, and in any case, should not exceed 7 mg/kg (3.2 mg/lb) of body weight.
PediatricPediatric patients : It is difficult to recommend a maximum dose of any drug for pediatric patients since this varies as a function of age and weight. For pediatric patients of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in pediatric patients of five years weighing 50 Ibs, the dose of lidocaine hydrochloride should not exceed 75-100mg when calculated according to Clark's rule. In any case, the maximum dose of lidocaine hydrochloride should not exceed 7 mg/kg (3.2 mg/lb) of body weight.
NOTE : Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and / or contain particulate matter should not be used and any unused portion of a cartridge of LINGOSPAN should be discarded.
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