Extencilline (benzathine benzylpenicillin) Powder and diluent for reconstitution for injection

Products > Extencilline (benzathine benzylpenicillin) Powder and diluent for reconstitution for injection

Prescribing Information : Click here

NDC

81284-522-01
Safety Data Sheet

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Pack Size

20 mL vial of powder for suspension + 5 mL of water for injection in ampule
Strength

2,400,000 units
Form

Powder and solvent for suspension for injection
Therapeutic Class

Antibacterial agents for systemic use, Penicillin sensitive to beta-lactams, (ATC code: J01CE08)
Preservative Free

YES
Gluten Free

YES
ITEM CODES

Disclaimer: Due to the ongoing shortages of Bicillin® L-A (penicillin G benzathine injectable suspension) in the United States, Laboratoires Delbert in conjunction with Provepharm Inc. (Provepharm) and Direct Success, Inc. (Direct Success) is coordinating with the U.S. Food and Drug Administration (FDA) to temporarily import Extencilline, (benzathine benzylpenicillin) Powder and diluent for reconstitution for injection, 1,200,000 units and 2,400,000 units into the U.S. market. Delbert’s Extencilline, (benzathine benzylpenicillin) Powder and diluent for reconstitution for injection, 1,200,000 units and 2,400,000 units marketed in France and manufactured in Italy for Delbert, is not FDA-approved. Benzathine benzylpenicillin is another name for Penicillin G benzathine. <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a026d0c-6f91-4ee3-b193-b2186a37e7ca">For more information, click here.</a>

Extencilline (benzathine benzypenicillin) Powder and diluent for reconstitution for injection   <table class="Table" style="width:100.0%" width="100%"> <tbody> <tr> <td style="padding:.100px .100px .100px .100px"> WARNING NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling. </td> </tr> </tbody> </table>   INDICATIONS AND IMPORTANT SAFETY INDICATION AND USAGE Benzylpenicillin benzathine is indicated in adults, adolescents, children and neonates for the treatment and prophylaxis of the following infections For the treatment of: -           erysipelas -           syphilis: early syphilis (primary and secondary) -           latent syphilis (except for neurosyphilis and presence of pathological CSF findings) -           yaws -           pinta For the prophylaxis of: -           rheumatic fever (chorea, rheumatic carditis) -           poststreptococcal glomerulonephritis -           erysipelas   CONTRAINDICATIONS Extencilline is contraindicated in patients with a history of a previous hypersensitivity reaction to any of the penicillins. Extencilline contains soy phospholipids and may cause hypersensitivity reactions (urticaria, anaphylactic shock) in patients with a history of allergy to soybeans.   WARNINGS AND PRECAUTIONS Do Not Administer Intravenously: Do not inject intravenously or admix with other intravenous solutions. There have been reports of inadvertent intravenous administrations which has been associated with cardiorespiratory arrest and death. Anaphylaxis: SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH EXTENCILLINE, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, EXTENCILLINE SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED. Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in patients taking benzathine benzylpenicillin (the active moiety in Extencilline). When SCAR is suspected, Extencilline should be discontinued immediately and an alternative treatment should be considered. Clostridioides difficile Associated Diarrhea Clostridioides difficile associated-diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Extencilline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.   Injection into or near a nerve may result in permanent neurological damage. Inadvertent intravascular administration, including inadvertent direct intra-arterial injection or injection immediately adjacent to arteries, of Extencilline and other penicillin preparations has resulted in severe neurovascular damage, including transverse myelitis with permanent paralysis, gangrene requiring amputation of digits and more proximal portions of extremities, and necrosis and sloughing at and surrounding the injection site consistent with the diagnosis of Nicolau syndrome. Such severe effects have been reported following injections into the buttock, thigh, and deltoid areas. Other serious complications of suspected intravascular administration which have been reported include immediate pallor, mottling, or cyanosis of the extremity both distal and proximal to the injection site, followed by bleb formation; severe edema requiring anterior and/or posterior compartment fasciotomy in the lower extremity. The above-described severe effects and complications have most often occurred in infants and small children. Prompt consultation with an appropriate specialist is indicated if any evidence of compromise of the blood supply occurs at, proximal to, or distal to the site of injection.(See PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of full prescribing information)   Method of Administration: Do not inject into or near an artery or nerve. See administration instructions below. FOR DEEP INTRAMUSCULAR INJECTION ONLY. There have been reports of inadvertent intravenous administration of benzathine benzylpenicillin which has been associated with cardiorespiratory arrest and death. Therefore, do not inject intravenously or admix with other intravenous solutions. (See DOSAGE AND ADMINISTRATION section of full prescribing information.) Administer by DEEP INTRAMUSCULAR INJECTION ONLY in the upper, outer quadrant of the buttock (dorsogluteal) or the ventrogluteal site. Quadriceps femoris fibrosis and atrophy have been reported following repeated intramuscular injections of penicillin preparations into the anterolateral thigh. Because of these adverse effects and the vascularity of this region, administration in the anterolateral thigh is not recommended.   ADVERSE REACTIONS As with other penicillins, untoward reactions of the sensitivity phenomena are likely to occur, particularly in individuals who have previously demonstrated hypersensitivity to penicillins or in those with a history of allergy, asthma, hay fever, or urticaria. As with other treatments for syphilis, the Jarisch-Herxheimer reaction, an acute self-limited systemic febrile reaction accompanied by headache, myalgia, tachycardia, hyperventilation, and mild hypotension that occurs within 1 to 2 hours and lasts 12 to 24 hours, has been reported. The following have been reported with parenteral benzathine benzylpenicillin (the active moiety in Extencilline): General: Hypersensitivity reactions including the following: skin eruptions (maculopapular to exfoliative dermatitis), urticaria, laryngeal edema, fever, eosinophilia; other serum sickness-like reactions (including chills, fever, edema, arthralgia, and prostration); and anaphylaxis including shock and death: severe cutaneous adverse reactions (SCAR), such as toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP). Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, benzathine benzylpenicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to therapy with benzathine benzylpenicillin. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated. Gastrointestinal: Pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. Hematologic: Hemolytic anemia, leukopenia, thrombocytopenia. Neurologic: Neuropathy. Urogenital: Nephropathy. The following adverse events have been temporally associated with parenteral administration of benzathine benzylpenicillin (the active moiety in Extencilline): Body as a Whole: Hypersensitivity reactions including allergic vasculitis, pruritus, fatigue, asthenia, and pain; aggravation of existing disorder; headache, Nicolau syndrome (ischemic necrosis of the skin). Cardiovascular: Cardiac arrest; hypotension; tachycardia; palpitations; pulmonary hypertension; pulmonary embolism; vasodilation; vasovagal reaction; cerebrovascular accident; syncope. Gastrointestinal: Nausea, vomiting; blood in stool; intestinal necrosis. Hemic and Lymphatic: Lymphadenopathy. Injection Site: Injection site reactions including pain, inflammation, lump, abscess, necrosis, edema, hemorrhage, cellulitis, hypersensitivity, atrophy, ecchymosis, and skin ulcer. Neurovascular reactions including warmth, vasospasm, pallor, mottling, gangrene, numbness of the extremities, cyanosis of the extremities, and neurovascular damage. Metabolic: Elevated BUN, creatinine, and SGOT. Musculoskeletal: Joint disorder; periostitis; exacerbation of arthritis; myoglobinuria; rhabdomyolysis. Nervous System: Nervousness; tremors; dizziness; somnolence; confusion; anxiety; euphoria; transverse myelitis; seizures; coma. A syndrome manifested by a variety of CNS symptoms such as severe agitation with confusion, visual and auditory hallucinations, and a fear of impending death (Hoigne's syndrome), has been reported after administration of penicillin G procaine and, less commonly, after injection of the combination of penicillin G benzathine and penicillin G procaine. Other symptoms associated with this syndrome, such as psychosis, seizures, dizziness, tinnitus, cyanosis, palpitations, tachycardia, and/or abnormal perception in taste, also may occur. Respiratory: Hypoxia; apnea; dyspnea. Skin: Diaphoresis. Special Senses: Blurred vision; blindness. Urogenital: Neurogenic bladder; hematuria; proteinuria; renal failure; impotence; priapism.   IMPORTANT PREPARATION / ADMINISTRATION INSTRUCTIONS Instructions for the preparation of an intramuscular injection of a dose of 1,200,000 units of benzathine benzylpenicillin: The suspension must be prepared aseptically. 1/ With a graduated syringe for intramuscular injection (needle gauge: 22, 21 or 20), take 4 mL of water for injections from the ampule of diluent contained in the box.  The compatibility data are only available with water for injectable preparations and 1% or 0.5% lidocaine injectable solution. Warning: the ampule of diluent provided in the box contains 5 mL of water for injections. It is not necessary to use all the contents for the preparation of this suspension. 2/ Into the vial of powder of 1,200,000 units, add the 4 mL of water for injections taken from the ampule of diluent, or the 4 mL of 1.0% or 0.5% lidocaine injectable solution. 3/ Agitate this suspension carefully for at least 20 seconds until a homogenous suspension is obtained, then use the suspension immediately as soon as it is prepared. The suspension obtained in this way corresponds to a dose of 1,200,000 units.   This reconstitution must only be done for one single injection. For doses of Extencilline less than 1,200,000 units, withdraw the appropriate volume of the reconstituted product and discard the remainder. For example, withdraw half the volume of the reconstituted 1,200,000 units for a 600,000 unit dose of Extencilline.   Instructions for the preparation of an intramuscular injection of a dose of 2,400,000 units of benzathine benzylpenicillin: The suspension must be prepared aseptically. 1/ With a graduated syringe for intramuscular injection (needle gauge: 22, 21 or 20), take 5 mL of water for injections from the ampule of diluent contained in the box, or 5 mL of 1% or 0.5% lidocaine injectable solution. 2/ Into the vial of powder 2,400,000 units, add the 5 mL of water for injections taken from the ampule of diluent, or 5 mL of 1% or 0.5%. lidocaine injectable solution. 3/ Agitate this for suspension carefully for at least 20 seconds until a homogenous for suspension is obtained, then use the for suspension immediately as soon as it is prepared. The suspension obtained in this way corresponds to a dose of 2,400,000 units.   This reconstitution must only be done for one single injection. For doses of Extencilline less than 2,400,000 units, withdraw the appropriate volume of the reconstituted product and discard the remainder.   EXTENCILLINE must not be mixed in the same syringe with any other medicine than the water for injectable preparations or a lidocaine for suspension for intramuscular injection.   See DOSAGE AND ADMINISTRATION sections of full prescribing information for complete full preparation instructions.   USE IN SPECIFIC POPULATIONS Pregnancy and Lactation: Safe use in pregnancy and lactation has not been established; therefore, use in pregnant women, nursing mothers or women who may become pregnant requires that possible benefits be weighed against possible hazards to mother and child. Benzylpenicillin benzathine is excreted in human milk in small amounts.   OVERDOSAGE Penicillin in overdosage has the potential to cause neuromuscular hyperirritability or convulsive seizures.   For additional Safety Information, please see Full Prescribing Information.   You are encouraged to report adverse drug events to Provepharm at 1-833-727-6556 or to the FDA by visiting <a href="www.fda.gov/medwatch">www.fda.gov/medwatch</a> or by calling 1-800-FDA-1088.