Ampres, L.Molteni & C..dei F.lli Alitti Societa di Esercizio
indications:
Spinal anesthesia in adults for whom a planned surgical procedure should not exceed 40 minutes.
Composition:
1 ml of solution contains 10 mg of chloroprocaine hydrochloride (and 2.8 mg of sodium).
Action:
Local anesthetic drug with ester structure. Chloroprocaine blocks the production and transmission of nerve impulses, presumably by increasing the threshold of electrical stimulation in the nerve, by slowing the spread of the nerve impulse and by reducing the frequency of the growth of the action potential. The onset of spinal anesthesia is very fast (9.6 min ± 7.3 min after a dose of 40 mg, 7.9 min ± 6.0 min after a dose of 50 mg) and the duration of anesthesia can be up to 100 min. The blood concentration should be low after IT intrathecal. Chloroprine is rapidly metabolised in the blood by hydrolysis of the ester bond by pseudocholinesterase. Metabolites (β-diethylaminoethanol and 2-chloro-4-aminobenzoic acid) are excreted via the kidneys. T0,5 is 21 ± 2 s in men, 25 ± 1 s in women, 43 ± 2 s in newborns. It may be longer in the case of pseudocholinesterase deficiency. Elimination of chloroprocaine from the cerebrospinal fluid occurs entirely through diffusion and vascular absorption, both in the nerve tissues in the meningeal space or through the passage through the tire due to the difference in concentration between the cerebrospinal fluid and the epidural space. As a result, chloroprocaine is absorbed by the vessels. The main factors determining the rate of absorption are local blood flow and competing binding to local tissues, but not enzymatic hydrolysis in the cerebrospinal fluid.
Contraindications:
Hypersensitivity to the active substance, drugs with the PABA component (p-aminobenzoic acid) from the ester group, other local anesthetics with ester building or any of the excipients. General and specific contraindications to spinal anesthesia, regardless of the local anesthesia used (eg decompensated heart failure, hypovolemic shock). Intravenous local anesthesia (the anesthetic is introduced into the limb and allows the pressure to stay in the desired place during compression). Severe heart conduction disorders. Severe anemia. It is also necessary to take into account general or special contraindications concerning the technique of performing spinal anesthesia (subarachnoid anesthesia).
Precautions:
Particular caution is required by patients: with a complete or partial block of the heart (anesthetics may inhibit the conductivity of the heart muscle); with decompensated heart failure; with advanced liver or kidney damage; in old age and / or in poor general condition; treated with class III anti-arrhythmics, e.g. Amiodarone (additive effects on the heart may occur, patients should be observed and monitored by ECG); with porphyria (risk of worsening the disease; in patients with acute porphyria, chloroprocaine should only be used if necessary); with advanced liver disease (anesthetics with an ester structure are hydrolyzed by plasma cholinesterase produced by the liver); with genetic deficiency of plasma cholinesterase. Spinal anesthesia is not expected to have an adverse effect on neurological disorders such as multiple sclerosis, hemiplegia, paraplegia or neuromuscular disorders, but should be used with caution (careful consideration of the benefit / risk balance is recommended). A rare but serious side effect of spinal anesthesia is a high or total spinal blockage with cardiovascular and respiratory depression. The increased risk of high or total spinal blockage is particularly present in elderly patients. An unexpected drop in blood pressure as a complication of spinal anesthesia may occur especially in elderly patients. If signs of acute systemic toxicity or total spinal blockage are observed, treatment should be discontinued immediately.
Pregnancy and lactation:
Do not use during pregnancy and in women of childbearing potential who do not use contraception. It is unknown whether chloroprocaine and / or metabolites are excreted in human milk.
Side effects:
Very common: hypotension, nausea. Common: anxiety, restlessness, paresthesia, dizziness, vomiting. Uncommon: symptoms of CNS toxicity (back pain, headache, tremor, convulsions, perioral paresthesia, feeling of tongue numbness, impaired hearing, impaired vision, blurred vision, chills, tinnitus, speech disorders, loss of consciousness), bradycardia, hypertension, hypotension induced by high doses. Rare: allergic reactions due to sensitivity to a local anesthetic (urticaria, pruritus, erythema, angioneurotic edema with possible airway obstruction, including laryngeal edema, tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, increased body temperature, reactions similar to anaphylactoid symptomatology, including severe hypotension), neuropathy, somnolence going into loss of consciousness and respiratory arrest, blockade of various sizes (including total spinal blockage), secondary hypotension after spinal blockage, loss of bladder control and intestines and loss of sensation around the perineum, sexual dysfunction, arachnoiditis, persistent motor deficiency, sensory and / or autonomic (sphincteral control) of some of the lower spinal cord sections with a slow recovery (several months), tail syndrome equine neurological damage, double vision, arrhythmia, myocardial depression, cardiac arrest (risk increases high doses or unintentional intravascular injection), respiratory depression.
Dosage:
Intrathecal. Adults: individually, taking into account the physical condition of the patient and the simultaneous use of other medications. Usually 4-5 ml (40-50 mg), resulting in an average duration of blockage respectively 80-100 min (duration of action is dose dependent). The maximum recommended dose is 5 ml (50 mg).Special groups of patients. It is recommended to reduce the dose in patients with impaired general condition, as well as in patients with concomitant co-morbidities (eg, blood vessel obstruction, atherosclerosis, diabetic polyneuropathy). The drug must not be used in children and adolescents.Way of giving. The drug intrathecal injection into the intervertebral space L2 / L3, L3 / L4 and L4 / L5. Slowly inject the entire dose and check the patient's vital activities. Spinal anesthesia (spinal anesthesia) should not be performed in patients taking anticoagulants or with congenital or acquired blood coagulation disorder. Access to trained personnel, equipment and medicines should be provided for resuscitation.
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