Penicillin G Benzathin

Lentocilin S suspension for injection should ONLY be administered by INTRAMUSCULAR ROUTE. To avoid injury, Lentocilin S suspension should not be administered by intravenous, intraarterial or subcutaneous route, in the adipose layer, into or near a peripheral nerve or blood vessel. Before injecting the suspension, the position of the needle should be controlled by aspiration. If blood shows up in the syringe, pull back the needle and inject on another site. Administer Lentocilin S suspension EXCLUSIVELY by DEEP INTRAMUSCULAR INJECTION in the external upper quadrant of the buttock. In children and infants, the IM injections should be done, preferably, in the middle of the external lateral side of the thigh. In infants younger than 2 years, and if considered necessary, the dosage may be divided and administered in two separate sites. The IM injection site should be changed in case of repeated doses. Deep IM administration of this medicine requires a rigorous technique and should be performed only by experienced health technicians and in places prepared for the emergency treatment of a possible anaphylactic reaction. A needle to use in the administration of the injectable suspensions should have a minimum internal diameter of 0.8 mm (caliber: 18 gauge). The deep IM injection should be made slowly and with a constant flow rate to prevent needle blockage. If the needle is clogged, replace it with a new needle. The deep IM injection should be discontinued if there are signs or symptoms of immediate acute pain, especially in children and infants. Serious hypersensitivity reactions (anaphylactic reactions), sometimes fatal, have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs, therapy with Lentocillin S should be discontinued immediately and the appropriate therapy instituted. In case of severe anaphylactic reaction, immediate emergency treatment (including adrenaline, corticosteroids, airway management, oxygen) is required. Usually, subcutaneous, or intravenous adrenaline is the treatment of choice for an immediate or accelerated hypersensitivity reaction to a penicillin. Before initiating therapy with benzylpenicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillin, cephalosporins, and other beta-lactam antibiotics. Contact with the penicillin during handling the product should be avoided due to the possibility of skin sensitization. To minimize the overgrowth of resistant bacteria and maintain the effectiveness of benzylpenicillin, this medicine should only be used in the treatment of infections proven to be caused by susceptible bacteria. Therapy should be based on bacteriological studies (including sensitivity tests) and the patient's clinical response. Prolonged administration of Lentocilin S can occasionally result in overgrowth of non-susceptible organisms particularly Candida, Pseudomonas or Enterobacter. Antibiotic treatment modifies the commensal flora of the colon, allowing the growth of Clostridium difficile. This microorganism produces toxins, which are responsible for diarrhea associated to antibiotherapy, which can range from mild diarrhea to fatal colitis. Patients with diarrhea during or even up to two months after treatment with antibiotics should be subject to investigation and differential diagnosis. Confirming pseudomembranous colitis, treatment should be discontinued and, if necessary, use supportive hydro-electrolyte measures, recommended antibiotherapy and protein supplement. Because of the risk of neurotoxicity, caution is recommended especially in the case of administration of high doses of benzylpenicillin to renal impaired patients. During prolonged treatment with high doses of benzylpenicillin is recommended to monitor the renal and haematological functions. The use of benzylpenicillin for more than 2 weeks may be associated with an increased risk of neutropenia and incidence of immune complex self-limited sickness-like reactions. Special precautions should be taken in order to avoid intravenous and intraarterial administration or injection into or near major peripheral nerve or blood vessel, since such injections may produce severe and/or permanent neuromuscular damage. In case of evidence of impaired blood flow at the injection site - proximal or distal – an appropriate specialized physician should be immediately consulted. Special caution is recommended when treating patients with spirochetal infections, particularly syphilis, due to the possibility of a Jarisch - Herxheimer reaction. This is a very common reaction when benzylpenicillin is used to treat syphilis, occurring in 50% of patients with primary syphilis, 75% of those treated for secondary syphilis and 30% of those treated for neurosyphilis. This reaction usually occurs 2-12 hours after initiation of penicillin therapy and is characterized by the occurrence of headache, fever, chills, sweating, sore throat, myalgia, arthralgia, malaise, increased heart rate and an increase in blood pressure followed by its decrease. This reaction is probably caused by the release of endotoxins from the treponemes and should not be confused with a hypersensitivity reaction. The reaction may be dangerous in cardiovascular syphilis or when there is a serious risk of increased local lesions such as optic atrophy. It is recommended the use of oxidative enzymatic methods when testing glucose in urine during therapy with benzylpenicillin. False positive results can occur with the use of non-enzymatic methods. Benzylpenicillin may interfere with other diagnostic tests such as the Coombs test, tests for the determination of proteins in plasma and urine and the test for the determination of plasmatic uric acid (copper-chelate method). Due to the lidocaine content (present in the ampoule), Lentocilin S should be used with caution in the following situations: - presence of cardiovascular, hepatic or renal dysfunction, inflammation and/or infection at the injection site or sensitivity to local anesthetics of the amide type, - children, the elderly and patients with acute illnesses or debilitated, - patients on concomitant CNS depressant drugs.