Orofar lidocaine hcl 1mg
Intramuscular Lidocaine may increase creatinine phosphokinase concentrations which can interfere with the diagnosis of acute myocardial infarction. Lidocaine has been shown to be porphyrinogenic in animals and should be avoided in persons suffering from porphyria. Hameln Lidocaine Injection is not recommended for use in neonates.
The optimum serum concentration of lidocaine required to avoid toxicity, such as convulsions and cardiac arrhythmias, in this age group is not known. Specific interaction studies with lidocaine and class III anti-arrhythmic drugs e. There may be an increased risk of enhanced and prolonged neuromuscular blockade in patients treated concurrently with muscle relaxants e.
Effects of other medicinal products on Lidocaine The clearance of Lidocaine may be reduced by beta-adrenoceptor blocking agents e. Increase in serum levels of lidocaine may also occur with anti-viral agents e. There may be an increased risk of ventricular arrhythmia in patients treated concurrently with antipsychotics which prolong or may prolong the QT interval e. While adrenaline epinephrine when used in conjunction with lidocaine might decrease vascular absorption, it greatly increases the danger of ventricular tachycardia and fibrillation if accidentally injected intravenously.
Cardiovascular collapse has been reported following the use of bupivacaine in patients on treatment with verapamil and timolol; Lidocaine is closely related to bupivacaine. Hypokalaemia produced by acetazolamide, loop diuretics and thiazides may antagonize the effect of lidocaine if administered concomitantly see section 4.
Inhibition of CYP1A2 by fluvoxamine considerably reduces elimination of lidocaine and increases the risk of lidocaine toxicity. Concomitant use of both fluvoxamine and a CYP3A4 inhibitor such as erythromycin can further increase lidocaine concentrations. Because lidocaine possesses a narrow therapeutic window, doses of lidocaine may need to be adjusted accordingly. Conversely, reduced serum lidocaine concentrations may result from drugs that may stimulate the hepatic metabolism of lidocaine e.
Narcotics are probably proconvulsants and this would support the evidence that lidocaine reduces the seizure threshold to fentanyl in man. Opioid-antiemetic combination sometimes used for sedation in children could reduce the convulsant threshold to lidocaine and increase the CNS depressant effect.
AAG concentrations may be reduced by oestrogens leading to a higher free fraction of lidocaine in women than in men and the free fraction is further increased during pregnancy and in women taking oral contraceptives or HRT. Lidocaine given by epidural or paracervical block, especially in large doses, or by local perineal infiltration prior to delivery crosses rapidly into the foetal circulation.
Elevated lidocaine levels may persist in the newborn for at least 48 hours after delivery. Foetal bradycardia or neonatal bradycardia, hypotonia or respiratory depression may occur. Lactation Small amounts of Lidocaine are secreted into breast milk and the possibility of an allergic reaction in the infant, albeit remote, should be borne in mind when using Lidocaine in nursing mothers.
Following regional blockade as when lidocaine is injected intrathecally or extradurally, hypotension, hypoventilation, Horners Syndrome and hypoglycaemia may be seen. The degree of these effects will depend on the dose and the height of the block.
Urinary retention may occur following sacral or lumbar epidural block. It should not outlast the duration of the block. Apnoea and hemiparesis may occur following stellate ganglion block. The probable cause is a direct injection of lidocaine into the vertebral or carotid arteries. Nervous system reactions may be excitatory and or depressant. Signs of CNS stimulation may be brief, or may not occur at all, so that the first signs of toxicity may be confusion and drowsiness, followed by coma and respiratory failure.
Neurological complications of spinal anaesthesia include transient neurological symptoms such as pain of the lower back, buttock and legs. These symptoms usually develop within twenty-four hours of anaesthesia and resolve within a few days.
Isolated cases of arachnoiditis or cauda equina syndrome, with persistent paraesthesia, bowel and urinary dysfunction, or lower limb paralysis have been reported following spinal anaesthesia with lidocaine and other similar agents. The majority of cases have been associated with hyperbaric concentrations of lidocaine or prolonged spinal infusion. Eye disorders Blurred vision, diplopia and transient amaurosis may be signs of lidocaine toxicity.
Bilateral amaurosis may also be a consequence of accidental injection of the optic nerve sheath during ocular procedures. Orbital inflammation and diplopia have been reported following retro- or peribulbar anaesthesia see section 4. Ear and labyrinth disorders Tinnitus, hyperacusis Cardiac and vascular disorders Cardiovascular reactions are depressant and may manifest as hypotension, bradycardia, myocardial depression, cardiac arrhythmias and possibly cardiac arrest or circulatory collapse.
Hypotension may accompany spinal and epidural anaesthesia. Isolated cases of bradycardia and cardiac arrest have also been reported. Patients allergic to para-aminobenzoic acid derivatives procaine, tetracaine, benzocaine, etc.
Use in the Head and Neck Area Small doses of local anesthetics 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. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed.
Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Information for Patients When appropriate, patients should be informed in advance that they may experience temporary loss of sensation and motor activity, usually in the lower half of the body, following proper administration of epidural anesthesia.
Clinical Significant Drug Interactions The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent use of these agents should generally be avoided.
In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs for the treatment of hypotension related to obstetric blocks and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
Thus, the use of this enzyme determination, without isoenzyme separation, as a diagnostic test for the presence of acute myocardial infarction may be compromised by the intramuscular injection of Lidocaine HCl.
Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of Lidocaine HCl in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted. Reproduction studies have been performed in rats at doses up to 6. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response.
General consideration should be given to this fact before administering Lidocaine HCl to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. Labor and Delivery Local anesthetics rapidly cross the placenta and when used for epidural, paracervical, pudendal or caudal block anesthesia, can cause varying degrees of maternal, fetal and neonatal toxicity.
The potential for toxicity depends upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal hypotension has resulted from regional anesthesia.
Local anesthetics produce vasodilation by blocking sympathetic nerves. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable.
Epidural, spinal, paracervical, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. In one study, paracervical block anesthesia was associated with a decrease in the mean duration of first stage labor and facilitation of cervical dilation.
The use of obstetrical anesthesia may increase the need for forceps assistance. The use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life.
The long-term significance of these observations is unknown. Fetal bradycardia may occur in 20 to 30 percent of patients receiving paracervical nerve block anesthesia with the amide-type local anesthetics and may be associated with fetal acidosis.
Fetal heart rate should always be monitored during paracervical anesthesia. The physician should weigh the possible advantages against risks when considering a paracervical block in prematurity, toxemia of pregnancy, and fetal distress. Careful adherence to recommended dosage is of the utmost importance in obstetrical paracervical block.
Failure to achieve adequate analgesia with recommended doses should arouse suspicion of intravascular or fetal intracranial injection. Cases compatible with unintended fetal intracranial injection of local anesthetic solution have been reported following intended paracervical or pudendal block or both. Babies so affected present with unexplained neonatal depression at birth, which correlates with high local anesthetic serum levels, and often manifest seizures within six hours. Prompt use of supportive measures combined with forced urinary excretion of the local anesthetic has been used successfully to manage this complication.
Case reports of maternal convulsions and cardiovascular collapse following use of some local anesthetics for paracervical block in early pregnancy as anesthesia for elective abortion suggest that systemic absorption under these circumstances may be rapid. The recommended maximum dose of each drug should not be exceeded.
Injection should be made slowly and with frequent aspiration. Allow a 5- minute interval between sides. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lidocaine HCl is administered to a nursing woman. Adverse Reactions Systemic Adverse experiences following the administration of Lidocaine HCl are similar in nature to those observed with other amide local anesthetic agents.
These adverse experiences are, in general, dose- related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, 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: The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.
Drowsiness following the administration of Lidocaine HCl is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular System Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions.
Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to the methylparaben used as a preservative in the multiple dose vials. Allergic reactions, including anaphylactic reactions, may occur as result of sensitivity to Lidocaine, but are infrequent.
If allergic reactions do occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. There have been no reports of cross sensitivity between Lidocaine hydrochloride and procainamide or between Lidocaine hydrochloride and quinidine. Neurologic The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient.
In a prospective review of 10, patients who received Lidocaine HCl for spinal anesthesia, the incidences of adverse reactions were reported to be about 3 percent each for positional headaches, hypotension and backache; 2 percent for shivering; and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision.
Many of these observations may be related to local anesthetic techniques, with or without a contribution from the local anesthetic. 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.
Backache and headache have also been noted following use of these anesthetic procedures. There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration. Management of Local Anesthetic Emergencies The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic injection.
At the first sign of change, oxygen should be administered. The first step in the management of convulsions, as well as underventilation or apnea due to unintended subarachnoid injection of drug solution, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask.
Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate such as thiopental or thiamylal or a benzodiazepine such as diazepam may be administered intravenously.
The clinician should be familiar, prior to the use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation eg, ephedrine.
If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. Underventilation or apnea due to unintentional subarachnoid injection of local anesthetic solution may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted.
If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support assisted or controlled is indicated.
Dialysis is of negligible value in the treatment of acute overdosage with Lidocaine HCl. Lidocaine Dosage and Administration Table 1 Recommended Dosages summarizes the recommended volumes and concentrations of Lidocaine Hydrochloride Injection, USP for various types of anesthetic procedures.
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Concurrent administration of vasopressor drugs for lidocaine treatment of hypotension related to obstetric blocks and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-fee solutions. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use. For percutaneous infiltration anaesthesia: The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. In all cases the lowest concentration and 1mg dose that will produce the desired result should be given. While adrenaline epinephrine when used in conjunction with lidocaine might decrease vascular absorption, it greatly increases the danger orofar ventricular tachycardia and fibrillation if accidentally injected intravenously. Cardiovascular System Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, hcl cardiovascular collapse, orofar lidocaine hcl 1mg, which may lead to cardiac arrest. Drowsiness following the administration of Lidocaine HCl is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Ear and labyrinth disorders Tinnitus, hyperacusis Cardiac and vascular disorders Cardiovascular reactions are depressant and may manifest as hypotension, bradycardia, myocardial depression, cardiac arrhythmias and possibly cardiac arrest or circulatory collapse. Clinical Significant Drug Interactions The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors or paxil tm 20mg antidepressants may produce severe, prolonged hypertension. This application can be implemented as a safety purchase prednisolone tablets comfort measure for patients who have to be intubated, as it reduces the incidence of coughing and any tracheal damage it might cause when emerging from anaesthesia.
Lidocaine Hydrochloride Injection BP 1% w/v
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Elderly patients and those with congestive heart failure or cardiogenic shock may require smaller bolus doses. Lidocaine Hydrochloride Injection, USP is a orofar, nonpyrogenic, isotonic solution containing sodium chloride, orofar lidocaine hcl 1mg. Inhibition of CYP1A2 by fluvoxamine considerably reduces elimination of lidocaine and increases the risk of lidocaine toxicity. Concurrent administration of vasopressor drugs for the treatment 1mg hypotension related to obstetric blocks and lidocaine oxytocic drugs may cause severe, orofar lidocaine hcl 1mg, persistent hypertension or cerebrovascular accidents. These may include spinal block of varying magnitude 1mg total spinal blockhypotension hcl to spinal lidocaine, loss of bladder and bowel control, and loss of perineal sensation and sexual function. Cervical stellate ganglion nerve block: Not intended hcl use in the eye. Syringe aspirations should also be performed before and orofar each supplemental injection when using indwelling catheter techniques. In Local Anaesthesia Usual doses should generally be reduced in children and in price for oxycodone 30mg or debilitated patients, orofar lidocaine hcl 1mg.