XYLOCARD Solution for injection (2021)
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Περιεχόμενα
Name of the medicinal product
XYLOCARD Lidocaine hydrochloride Solution, 20 mg/mL, Intravenous.
Indications and clinical use
XYLOCARD (lidocaine hydrochloride) by intravenous administration is indicated for: the treatment of ventricular tachycardia occurring during cardiac manipulation (such as surgery or catheterization) or ...
Contraindications
XYLOCARD is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete ...
Warnings and precautions
General This drug requires administration by experienced healthcare professionals. Constant ECG monitoring is essential for the proper administration of XYLOCARD intravenously. Signs of excessive depression ...
Adverse reactions
Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide type agents. These adverse experiences are, in general, doserelated and may result ...
Drug interactions
8.1 Drug-Drug Interactions The drugs listed in this table are based on either drug interaction case reports or studies, or potential interactions due to the expected magnitude and seriousness of the interaction ...
Dosage and administration
3.1 Dosing Considerations The onset of action following a single intravenous injection varies from 45 to 90 seconds. Duration of action is 10 to 20 minutes. No more than 200 to 300 mg of XYLOCARD should ...
Overdosage
Symptoms of idiosyncratic reactions are described under ADVERSE REACTIONS. Toxicity is initially manifested as CNS excitation and may result in a slow onset of nervousness, dizziness, delirium, blurred ...
Action and clinical pharmacology
9.1 Mechanism of Action The mode of action of the antiarrhythmic effect of XYLOCARD (lidocaine hydrochloride) appears to be similar to that of procaine, procainamide, and quinidine. Ventricular excitability ...
Storage and stability
Store at room temperature (15-25°C). XYLOCARD solutions are preservative free and are for single use. Discard unused portion after a maximum of 12 hours.
Dosage forms, composition and packaging
<b>Table 2. Dosage Forms, Strengths, Composition and Packaging:</b> Route of Administration Dosage Form/Strength/Composition Non-medicinal Ingredients Intravenous 20 mg/mL Sodium chloride, sodium hydroxide ...
Pharmaceutical information
Drug Substance Proper name: Lidocaine hydrochloride Chemical name: 2-(Diethylamino)-2',6'-acetoxylidide monohydro-chloride monohydrate Molecular formula and molecular mass: C<sub>14</sub>H<sub>22</sub> ...
Toxicology
Acute Toxicity SPECIES SEX ROUTE LD<sub>50</sub> (mg/kg) mice F i.v. 17.9 mice F i.p. 164 mice F i.m. 200 mice M i.m. 154 rat F i.v. 19.7 rat M i.v. 21.4 dog M & F i.m. 100 guinea pig F i.m. ...
Marketing authorization holder
Aspen Pharmacare Canada Inc., 8 1155 North Service Road West, Oakville, ON, L6M 3E3
Submission control number
246218
Date of approval
December 31, 1974
Date of revision
May 21, 2021
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