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Side Effects & Adverse Reactions
4% XYLOCAINE-MPF STERILE SOLUTION SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT, AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (see also ADVERSE REACTIONS and PRECAUTIONS). DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.
Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.
To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected. 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 guarantee that intravascular injection has been avoided.
4% Xylocaine-MPF Sterile Solution should be used with extreme caution if there is sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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.
History
There is currently no drug history available for this drug.
Other Information
4% Xylocaine-MPF (lidocaine HCl) Sterile Solution (Methylparaben Free) contains a local anesthetic agent and is administered topically or by injection. See INDICATIONS for specific uses.
4% Xylocaine-MPF Sterile Solution contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6- dimethylphenyl)-mono-hydrochloride and has the following structural formula:
4% Xylocaine-MPF Sterile Solution in 5 mL ampules may be autoclaved repeatedly if necessary.
Composition of 4% Xylocaine-MPF Sterile Solution
Each mL contains lidocaine HCl, 40 mg, and sodium hydroxide and/or hydrochloric acid to adjust pH to 5.0 to 7.0.
A sterile, aqueous solution.
Sources
Xylocaine-mpf Manufacturers
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App Pharmaceuticals, Llc
Xylocaine-mpf | App Pharmaceuticals, Llc
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 and DOSAGE AND ADMINISTRATION).
The dosages below are for normal, healthy adults.
RETROBULBAR INJECTION: The suggested dose for a 70 kg person is 3 to 5 mL (120 to 200 mg of lidocaine HCl), ie, 1.7 to 3 mg/kg or 0.9 to 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 to 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.
TOPICAL APPLICATION: For laryngoscopy, bronchoscopy and endotracheal intubation, the pharynx may be sprayed with 1 to 5 mL (40 to 200 mg of lidocaine HCl), ie, 0.6 to 3 mg/kg or 0.3 to 1.5 mg/lb body weight.
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