What happens if I overdose Lidocaine 2% Epinephrine Normon?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Lidocaine 2% Epinephrine Normon iontophoretic patch:
Store Lidocaine 2% Epinephrine Normon iontophoretic patch at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat and light. Keep the child-resistant envelope sealed at all times when not in use. Keep Lidocaine 2% Epinephrine Normon iontophoretic patch out of the reach of children and away from pets.
Overdose of Lidocaine 2% Epinephrine Normon in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
Symptoms: Acute emergencies associated with the use of local anaesthetics are generally related to high plasma levels or to unintended subarachnoid injection of the local anaesthetic solution.
With accidental intravascular injections, the toxic effect will be obvious within 1-3 min. With overdosage, peak plasma concentrations may not be reached for 20-30 min depending on the site of injection and toxic signs will be delayed. Toxic reactions mainly involve the CNS and cardiovascular system.
In children, early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is given during general anaesthesia.
Acute Toxicity: CNS toxicity is a graded response with symptoms and signs of escalating severity. The 1st symptoms are circumoral paraesthesia, numbness of the tongue, lightheadedness, hyperacusis and tinnitus. Visual disturbance and muscular tremors are more serious and precede the onset of generalised convulsions. These signs must not be mistaken for neurotic behaviour.
Unconsciousness and grand mal convulsions may follow. These may last from a few seconds to several minutes. Hypoxia and hypercarbia occur rapidly following convulsions due to the increased muscular activity, together with the interference with normal respiration and loss of the airway. In severe cases, apnoea may occur. Acidosis increases the toxic effects of local anaesthetics.
Recovery is due to re-distribution of the local anaesthetic drug from the CNS and metabolism. Recovery may be rapid unless large amounts of the drug have been injected.
Cardiovascular toxicity indicates a more severe situation. Hypotension, bradycardia, decreased cardiac output, heart block, arrhythmia and even ventricular arrhythmias, ventricular fibrillation and cardiac arrest may occur as a result of huge systemic concentrations of local anaesthetics.
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.
Treatment: If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped immediately. If convulsions occur, then immediate attention is required for the maintenance of a patent airway and assisted or controlled ventilation with oxygen, via a positive airway pressure delivery system mask. Adequacy of the circulation should then be evaluated, bearing in mind that drugs used to treat convulsions depress the circulation when administered IV.
Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, appropriate anticonvulsant medication eg, an ultrashort-acting barbiturate (eg, thiopentone) or a benzodiazepine (eg, diazepam) may be administered IV. The clinician should be familiar with these anticonvulsant drugs prior to use of local anaesthetics.
Suxamethonium will stop the muscle convulsions rapidly but will require tracheal intubation and controlled ventilation, and should only be used by those familiar with procedures.
If ventricular fibrillation or cardiac arrest occurs, effective cardiovascular resuscitation treatment must be instituted and maintained for a prolonged period if necessary. Optimal oxygenation and ventilation, and circulatory support as well as treatment of acidosis are of vital importance.
If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with IV fluids, vasopressor, chronotropic and/or inotropic agents should be considered. Children should be given doses commensurate with age and weight.
Dialysis is of negligible value in the treatment of acute overdosage with lignocaine.
To counteract the pressor effects of adrenaline, use rapidly-acting vasodilators eg, nitrates or α-blocking agents.
For treatment of reactions caused by adrenaline, consult standard textbooks.
Lidocaine 2% Epinephrine Normon warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Do not use this medication if you are allergic to lorazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), or oxazepam (Serax). This medication can cause birth defects in an unborn baby. Do not use lorazepam if you are pregnant.
Before taking lorazepam, tell your doctor if you have any breathing problems, glaucoma, kidney or liver disease, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.
Do not drink alcohol while taking lorazepam. This medication can increase the effects of alcohol.
Avoid using other medicines that make you sleepy. They can add to sleepiness caused by lorazepam.
Lorazepam may be habit-forming and should be used only by the person it was prescribed for. Lorazepam should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.
It is dangerous to try and purchase this medicine on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of lorazepam purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects.
FDA pregnancy category D. Lorazepam can cause birth defects in an unborn baby. Do not use lorazepam without your doctor’s consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. It is not known whether lorazepam passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Do not drink alcohol while taking lorazepam. This medication can increase the effects of alcohol. Lorazepam can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by lorazepam. Tell your doctor if you regularly use any of these other medicines.
What should I discuss with my healthcare provider before taking Lidocaine 2% Epinephrine Normon?
Some medical conditions may interact with Lidocaine 2% Epinephrine Normon iontophoretic patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any anesthetic medicine (eg, benzocaine)
if you have broken, damaged, or inflamed skin at the application site
if you have heart problems, irregular heartbeat, liver problems, kidney problems, blood vessel problems, high blood pressure, poor circulation, or very poor health
Some MEDICINES MAY INTERACT with Lidocaine 2% Epinephrine Normon iontophoretic patch. Tell your health care provider if you are taking any other medicines, especially any of the following:
Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure and fast heartbeat may be increased
Beta-blockers (eg, propranolol), cimetidine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), mexiletine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), or tricyclic antidepressants (eg, imipramine) because they may increase the risk of Lidocaine 2% Epinephrine Normon iontophoretic patch's side effects.
Antiarrhythmics (eg, amiodarone, tocainide), bromocriptine, or other local anesthetics (eg, benzocaine) because the risk of their side effects may be increased by Lidocaine 2% Epinephrine Normon iontophoretic patch
Furazolidone or guanethidine because they may decrease Lidocaine 2% Epinephrine Normon iontophoretic patch's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Lidocaine 2% Epinephrine Normon iontophoretic patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Lidocaine 2% Epinephrine Normon precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
When any local anaesthetic agent is used, resuscitative equipment and drugs, including oxygen, should be immediately available in order to manage possible adverse reactions involving the cardiovascular, respiratory or CNS. Because of the possibility of hypotension and bradycardia following major blocks, an IV cannula should be inserted before the local anaesthetic is injected. Delay in proper management of dose-related toxicity, under-ventilation from any cause and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and death.
Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection which can produce cerebral symptoms even at low doses.
Although intra-articular continuous infusions of local anaesthetic following arthroscopic and other surgical procedures is an unapproved use, 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 glenohumeral chondrolysis have been described in paediatric and adult patients following intra-articular continuous infusions of local anaesthetics with and without adrenaline for periods of 48-72 hrs. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms eg, 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. Therefore, Lidocaine 2% Epinephrine Normon should not be used for postoperative intra-articular continuous infusion.
Careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness should be accomplished after each local anaesthetic injection. It should be kept in mind that at such times, restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression or drowsiness may be early warning signs of CNS toxicity.
Low Molecular Weight Heparins and Heparinoids (Spinal/Epidural Haematomas): When neuraxial anaesthesia (epidural/spinal anaesthesia) is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis. The risk of these events is increased by the use of indwelling epidural catheters, traumatic or repeated epidural/spinal puncture, and the concomitant use of drugs affecting haemostasis eg, NSAIDs, platelet inhibitors or other anticoagulants. Patients should be frequently monitored for signs and symptoms of neurological impairment.
The safety and effectiveness of Xylocaine depends on the proper dosage, correct technique and adequate precautions. Standard textbooks should be consulted regarding specific techniques and precautions for various regional anaesthetic procedures.
The lowest dosage that results in effective anaesthesia should be used. Repeated injection of Lidocaine 2% Epinephrine Normon may cause accumulation of lignocaine or its metabolites and result in toxic effects.
Tolerance to elevated blood levels varies with the status of the patient. Elderly, young or debilitated patients, including those with advanced liver disease or severe renal dysfunction, should be given reduced doses commensurate with their age and physical condition.
Lignocaine should be given with great caution to patients with epilepsy, impaired cardiac conduction, bradycardia, severe shock or digitalis intoxication. It should also be administered with great caution to patients with impaired cardiovascular function as they may be less able to compensate for functional changes associated with the prolongation of AV-conduction produced by these drugs. In patients with Stokes-Adams syndrome or Wolff-Parkinson-White syndrome, extreme care should be taken to avoid accidental arteriovenous injection.
Central nerve blocks may cause cardiovascular depression, especially in the presence of hypovolaemia. Epidural anaesthesia should be used with caution in patients with impaired cardiovascular function. Epidural anaesthesia may lead to hypotension and bradycardia. Hypotension should be treated promptly with sympathomimetic IV and repeated as necessary.
Local anaesthetics should be given with great caution (if at all) to patients with preexisting abnormal neurological pathology eg, myasthenia gravis. Use with extreme caution in epidural, caudal and spinal anaesthesia when there are serious diseases of the CNS or of the spinal cord eg, meningitis, spinal fluid block, cranial or spinal haemorrhage, tumours, poliomyelitis, syphilis, tuberculosis or metastatic lesions of the spinal cord.
Since lignocaine is metabolised in the liver and excreted via the kidneys, the possibility of drug accumulation should be considered in patients with hepatic and/or renal impairment.
Inadvertent intravascular or subarachnoid injection of small doses of local anaesthetics injected into the head and neck area including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses.
Clinicians who perform retrobulbar blocks should be aware that there have been reports of cardiovascular collapse and apnoea following the use of local anaesthetic injections for retrobulbar block. Prior to retrobulbar block, necessary equipment, drugs and personnel should be immediately available as with all other regional procedures. Retrobulbar injections may very occasionally reach the subarachnoid space causing temporary blindness, cardiovascular collapse, apnoea, convulsions, etc. These must be diagnosed and treated promptly.
Retro- and peribulbar injections of local anaesthetics carry a low risk of persistent ocular muscle dysfunction. The primary causes include trauma and/or local toxic effects on muscles and nerves. The severity of such tissue reactions is related to the degree of trauma, the concentration of the local anaesthetic and the duration of exposure of the tissue to the local anaesthetic. For this reason, as with all local anaesthetics, the lowest effective concentration and dose of local anaesthetic should be used. Vasoconstrictors may aggravate tissue reactions and should be used only when indicated.
Foetal bradycardia/tachycardia frequently follows paracervical block and may be associated with foetal acidosis and hypoxia. Occasional cases of perinatal morbidity and mortality have been reported. When the recommended dose is exceeded, the risk of foetal bradycardia increases. Careful monitoring of the foetal heart rate is necessary.
Lignocaine should be used with caution in patients with known drug sensitivities.
Patients being treated with antiarrhythmic drugs class III (eg, amiodarone) should be under close surveillance and ECG monitoring since cardiac effects may be additive.
Solutions with adrenaline should be used with extreme caution in patients with severe or untreated hypertension, arteriosclerotic heart disease, cerebral vascular insufficiency, heart block, advanced diabetes, poorly controlled thyrotoxicosis or any other pathological conditions that might be aggravated by the effects of adrenaline. Adrenaline may induce anginal pain in patients suffering from ischaemic heart disease.
Solutions containing adrenaline should be used with caution in patients with ventricular fibrillation, pre-fibrillatory rhythm, tachycardia, myocardial infarction, phenothiazine-induced circulatory collapse and prostatic hypertrophy.
Solutions containing adrenaline also contain sodium metabisulfite which may cause allergic-type reactions including anaphylactic-type 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 non-asthmatic people.
Lidocaine 2% Epinephrine Normon solutions for injection are probably porphyrinogenic and should only be prescribed to patients with acute porphyria on strong or urgent indications. Appropriate precautions should be taken for all porphyric patients.
Effects on the Ability to Drive or Operate Machinery: Depending on dosage, local anaesthetics may have a very mild effect on mental function and may temporarily impair locomotion and coordination.
Carcinogenicity, Mutagenicity & Impairment of Fertility: A 2-year oral toxicity study of 2,6-xylidine, a metabolite of lignocaine, has shown that in both male and female rats, 2,6-xylidine in daily doses of 900 mg/m2 (150 mg/kg) resulted in carcinomas and adenomas of the nasal cavity. No nasal tumours were observed in the low dose (15 mg/kg or control animals). In addition, the compound also caused SC fibromas and/or fibrosarcomas in male and female rats (significant at 150 mg/kg).
The genotoxic potential of 2,6-xylidine has been studied with mixed results: Positive results were reported in assays for gene mutations (weakly positive in the Ames test with metabolic activation and in the mouse lymphoma assay) and chromosomal damage (chromosomal aberrations in Chinese hamster ovary cells at concentrations at which the drug precipitated from solution). No evidence of genotoxicity was found in in vivo assays for chromosomal damage (micronucleus assay) and DNA damage (unscheduled DNA synthesis). Covalent binding studies of DNA from liver and ethmoid turbinates in rats indicate that 2,6-xylidine may be genotoxic under certain conditions in vivo.
Use in pregnancy: Pregnancy Category A: The safe use of lignocaine during pregnancy has not been established. Although lignocaine has been used extensively for surgical procedures during pregnancy with no reports of ill effects to mother or foetus, there are no adequate or well-controlled studies in pregnant women of the effect of lignocaine on the developing foetus.
Lignocaine has been effectively used for obstetrical analgesia and adverse effects on the course of labour or delivery are rare. After epidural administration of lignocaine to women in labour, lignocaine crosses the placental barrier. However, concentrations in umbilical veins are lower than those found in the maternal circulation. It has been suggested that blood glucose levels should be checked in newborns after obstetric regional anaesthesia.
Adrenaline has been given to a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other indirect harmful effects on the foetus having been observed.
The addition of adrenaline may potentially decrease uterine blood flow and contractility, especially after inadvertent injection into maternal blood vessels.
Adrenaline may delay the 2nd stage of labour by inhibiting uterine contractions.
Adrenaline-free solutions should be used during labour for paracervical or pudendal blocks.
Note: Paracervical blocks may be associated with foetal bradycardia.
Use in lactation: Lignocaine passes into breast milk. The amount of lignocaine appearing in breast milk from a nursing mother receiving parenteral lignocaine is unlikely to lead to a significant accumulation of the parent drug in the breastfed infant. The remote possibility of an idiosyncratic or allergic reaction in the breastfed infant from lignocaine remains to be determined.
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).