What are the possible side effects of Xylanaest 0,5 % mit Epinephrin 1:2000.000?
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Minor redness, burning, irritation, or numbness at the application site; lightheadedness; nausea.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dizziness; fainting; fast, slow, or irregular heartbeat; loss of consciousness; mental or mood changes; nervousness; paleness; redness or warmth of skin; ringing in the ears or hearing changes; seizures; sensation of heat or cold; shortness of breath; swelling or blistering of skin; tremors or twitching; vision changes or double vision; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the.
Side effects of Xylanaest 0,5 % mit Epinephrin 1:2000.000 in details
Adverse experiences following the administration of lignocaine are similar in nature to those observed with other amide local anaesthetic agents. These adverse experiences are in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.
Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System: CNS manifestations are excitatory and/or depressant and may be characterised by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, hyperacusis, blurred vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and/or arrest, agitation, difficulty in swallowing, paraesthesia circumoral, numbness of the tongue and slurred speech.
The excitatory manifestations may be very brief or may not occur at all, in which case the 1st manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following administration of lignocaine is usually an early sign of a high blood level of the drug and may occur as a result of rapid absorption. In unconscious patients, circulatory collapse should be watched for as CNS effects may not be apparent, as an early manifestation of toxicity may, in some cases, progress to frank convulsions and ultimately lead to respiratory depression and/or arrest. It is crucial to have resuscitative equipment and anticonvulsant drugs available to manage such patients.
Cardiovascular: Cardiovascular manifestations are usually depressant and are characterised by bradycardia, hypotension and cardiovascular collapse, which may lead to cardiac arrest.
Cardiac arrhythmias and hypertension have also been observed.
Methaemoglobinaemia can occur following IV administration.
Cardiovascular toxic effects are generally preceded by signs of toxicity in the CNS, unless the patient is receiving a general anaesthetic or is heavily sedated with drugs eg, a benzodiazepine or a barbiturate. In rare cases, cardiac arrest has occurred without prodromal CNS effects.
In children, early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is given during general anaesthesia.
Haemodynamic: Regional anaesthesia may lead to maternal hypotension.
Allergic: Allergic reactions are characterised by cutaneous lesions, urticaria, oedema or anaphylactoid reactions/shock.
Allergy to amide-type local anaesthetics is rare. Sodium metabisulfite (a sulfite), which is included in solutions with adrenaline, may also 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. If such reaction occurs, it should be managed by conventional means.
The detection of sensitivity by skin testing is of doubtful value.
Neurologic: The incidences of adverse reactions associated with the use of local anaesthetics may be related to the total dose of local anaesthetic administered and are also dependent on the particular drug used, the route of administration and the physical status of the patient.
Neurological reactions following regional nerve blocks have included persistent numbness, paraesthesia and other sensory disturbances.
In a prospective review of 10,440 patients who received lignocaine for spinal anaesthesia, the incidences were reported to be about 3% each for positional headaches, hypotension and backache; 2% for shivering; and <1% each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision. Many of these observations may be related to local anaesthetic techniques, with or without a contribution from the local anaesthetic.
In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the amount of drug administered subdurally.
These may include spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months) or incomplete recovery have been reported in rare instances when caudal or lumbar epidural block has been attempted. Backache and headache have also been noted following use of these anaesthetic procedures.
Peripheral nerve injury and arachnoiditis have been observed.
What is the most important information I should know about Xylanaest 0,5 % mit Epinephrin 1:2000.000?
- Xylanaest 0,5 % mit Epinephrin 1:2000.000 is for external use only. Avoid contact with your eyes, nose, and mouth. If you get Xylanaest 0,5 % mit Epinephrin 1:2000.000 your eyes, rinse immediately with cool water.
- Xylanaest 0,5 % mit Epinephrin 1:2000.000 may cause harm if it is swallowed. If you may have taken it by mouth, contact your or emergency room right away.
- Xylanaest 0,5 % mit Epinephrin 1:2000.000 may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Xylanaest 0,5 % mit Epinephrin 1:2000.000 with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Xylanaest 0,5 % mit Epinephrin 1:2000.000 should stay in complete contact with your skin. Avoid body movements that may cause the patch to release from your skin. Tell your doctor at once if your patch comes off.
- Tell your doctor or dentist that you take Xylanaest 0,5 % mit Epinephrin 1:2000.000 before you receive any medical or dental care, emergency care, or surgery.
- Xylanaest 0,5 % mit Epinephrin 1:2000.000 will cause a numbing effect at the application site. Do not scratch, rub, or expose the area to extreme hot or cold temperature until the numbness is gone.
- Use Xylanaest 0,5 % mit Epinephrin 1:2000.000 with caution in the ELDERLY; they may be more sensitive to its effects.
- Xylanaest 0,5 % mit Epinephrin 1:2000.000 should be used with extreme caution in CHILDREN younger than 5 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xylanaest 0,5 % mit Epinephrin 1:2000.000 while you are pregnant. Xylanaest 0,5 % mit Epinephrin 1:2000.000 is found in breast milk. If you are or will be breast-feeding while you use Xylanaest 0,5 % mit Epinephrin 1:2000.000, check with your doctor. Discuss any possible risks to your baby.
Xylanaest 0,5 % mit Epinephrin 1:2000.000 contraindications
Allergy or hypersensitivity to amide-type local anaesthetics, sodium metabisulfite or to any excipients of Xylanaest 0,5 % mit Epinephrin 1:2000.000. Detection of suspected hypersensitivity by skin testing is of limited value.
Local anaesthetics are contraindicated for epidural and spinal anaesthesia in patients with uncorrected hypotension or coagulation disorders or in patients receiving anticoagulation treatment.
Local anaesthetic techniques must not be used when there is inflammation and/or sepsis in the region of the proposed injection and/or in the presence of septicaemia.
General contraindications related to epidural anaesthesia, regardless of the local anaesthetic used, should be taken into account.
Adrenaline is contraindicated in conditions where the production or exacerbation of tachycardia may prove fatal eg, thyrotoxicosis or severe heart disease, or in obstetrics when maternal blood pressure exceeds 130/80 mmHg.
Solutions with adrenaline must not be used for local analgesia in parts of the body with compromised blood supply or supplied by end arteries eg, fingers, toes, nose, ears or penis. There is a possibility of producing arterial vasoconstriction and subsequent ischaemic gangrene distal to the site of injection.
Solutions with adrenaline must not be used for IV regional techniques.
Solutions with adrenaline should not be used in patients with known sensitivity to sympathomimetic amines.
Solutions with adrenaline should not be used in most patients with cerebral arteriosclerosis.
References
- DailyMed. "LIDOCAINE; TETRACAINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "EPINEPHRINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "lidocaine: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Xylanaest 0,5 % mit Epinephrin 1:2000.000 are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Xylanaest 0,5 % mit Epinephrin 1:2000.000. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
