Xylocaine MPF Sterile Solution
"Potential drug treatments are tested on paper, in laboratories and eventually in thousands of people. But every drug that goes through this cycle â€“ every drug that FDA approves â€“ carries some risk. One of the first lines of defense against "...
Xylocaine MPF Sterile Solution
4% Xylocaine-MPF (lidocaine HCl) Sterile Solution is indicated for the production of topical anesthesia of the mucous membranes of the respiratory tract or the genito-urinary tract. It may be injected transtracheally to anesthetize the larynx and trachea, and it may be administered by retrobulbar injection to provide anesthesia for ophthalmic surgery.
DOSAGE AND ADMINISTRATION
When 4% Xylocaine-MPF Sterile Solution is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.
The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients.
Although the incidence of adverse effects with 4% Xylocaine-MPF Sterile Solution is quite low, caution should be exercised, particularly when employing large volumes and concentrations of 4% Xylocaine-MPF Sterile Solution since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered. For specific techniques and procedures refer to standard textbooks.
There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. 4% Xylocaine-MPF is not approved for this use (see WARNINGS).
The dosages below are for normal, healthy adults.
RETROBULBAR INJECTION: The suggested dose for a 70 kg person is 3-5 mL (120200 mg of lidocaine HCl), ie, 1.7-3 mg/kg or 0.9-1.5 mg/lb body weight. A portion of this is injected retrobulbarly and the rest may be used to block the facial nerve.
TRANSTRACHEAL INJECTION: For local anesthesia by the transtracheal route 2-3 mL should be injected through a large enough needle so that the injection can be made rapidly. By injecting during inspiration some of the drug will be carried into the bronchi and the resulting cough will distribute the rest of the drug over the vocal cords and the epiglottis.
Occasionally it may be necessary to spray the pharynx by oropharyngeal spray to achieve complete analgesia. For the combination of the injection and spray, it should rarely be necessary to utilize more than 5 mL (200 mg of lidocaine HCl), ie, 3 mg/kg or 1.5 mg/lb body weight.
Maximum Recommended Dosages
Normal Healthy Adults: The maximum recommended dose of 4% Xylocaine-MPF Sterile Solution should be such that the dose of lidocaine HCl is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.
It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children 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 (eg, Clark's rule). For example, in a child of five years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg when calculated according to Clark's rule. In any case, the maximum dose of Xylocaine Solution with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Xylocaine Solution administered should be such that the dose of lidocaine is kept below 300 mg and in any case should not exceed 4.5 mg/kg (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.
4% Xylocaine-MPF (lidocaine HCl) Sterile Solution, 5 mL ampule.
|Product No.||NDC No.||Strength|
|491089||63323-490-89||4%||5mL ampule packaged in tens.|
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 6017. Revised: February 2010
Last reviewed on RxList: 3/9/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Xylocaine MPF Sterile Solution Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.