Drug: Bicillin C-R Tubex

Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) contains equal amounts of the benzathine and procaine salts of penicillin G. It is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designated as (2S,5R,6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]hep-tane-2-carboxylic acid compound with N,N'-dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a white, crystalline powder and is very slightly soluble in water and sparingly soluble in alcohol. Its chemical structure is as follows: Penicillin G procaine, (2S,5R,6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with 2-(diethylamino)ethyl p-aminobenzoate (1:1) monohydrate, is an equimolar salt of procaine and penicillin G. It occurs as white crystals or a white, microcrystalline powder and is slightly soluble in water. Its chemical structure is as follows: Each TUBEX®‚ cartridge (1 mL size) contains the equivalent of 600,000 units of penicillin G comprising: the equivalent of 300,000 units penicillin G as the benzathine salt and the equivalent of 300,000 units penicillin G as the procaine salt in a stabilized aqueous suspension with sodium citrate buffer; and as w/v, approximately 0.5% lecithin, 0.55% carboxymethylcellulose, 0.55% povidone, 0.1% methylparaben, and 0.01% propylparaben. Each TUBEX‚ cartridge (2 mL size) contains the equivalent of 1,200,000 units of penicillin G comprising: the equivalent of 600,000 units of penicillin G as the benzathine salt and the equivalent of 600,000 units of penicillin G as the procaine salt in a stabilized aqueous suspension with sodium citrate buffer; and as w/v, approximately 0.5% lecithin, 0.55% carboxymethylcellulose, 0.55% povidone, 0.1% methylparaben, and 0.01% propylparaben. Bicillin C-R injectable suspension in the TUBEXformulation is viscous and opaque. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use.

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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. The following have been reported with parenteral penicillin G: 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 death. Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, penicillin G should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to therapy with penicillin G. 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. (See WARNINGS section.) Hematologic Hemolytic anemia, leukopenia, thrombocytopenia. Neurologic Neuropathy. Urogenital Nephropathy. The following adverse events have been temporally associated with parenteral administrations of penicillin G benzathine: Body as a Whole: Hypersensitivity reactions including allergic vasculitis, pruritis, fatigue, asthenia, and pain; aggravation of existing disorder; headache. 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 neurovascu-lar 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 benza-thine 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. Read the Bicillin C-R Tubex (penicillin g benzathine and penicillin g procaine injection) Side Effects Center for a complete guide to possible side effectsLearn More »

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Streptococcal Infections Group A Infections of the upper-respiratory tract, skin and soft-tissue infections, scarlet fever, and erysipelas. The following doses are recommended: Adults and pediatric patients over 60 lbs. in weight: 2,400,000 units. Pediatric patients from 30 to 60 lbs.: 900,000 units to 1,200,000 units. Pediatric patients under 30 lbs.: 600,000 units. NOTE: Treatment with the recommended dosage is usually given at a single session using multiple IM sites when indicated. An alternative dosage schedule may be used, giving one-half (1/2) the total dose on day 1 and one-half (1/2) on day 3. This will also insure the penicillinemia required over a 10-day period; however, this alternate schedule should be used only when the physician can be assured of the patient's cooperation. Pneumococcal Infections (except pneumococcal meningitis) 600,000 units in pediatric patients and 1,200,000 units in adults, repeated every 2 or 3 days until the temperature is normal for 48 hours. Other forms of penicillin may be necessary for severe cases. Method of Administration Bicillin C-R is intended for Intramuscular Injection ONLY. Do not inject into or near an artery or nerve, or intravenously or admix with other intravenous solutions. (See WARNINGS section). Administer by DEEP INTRAMUSCULAR INJECTION in the upper, outer quadrant of the buttock. In neonates, infants and small children, the midlateral aspect of the thigh may be preferable. When doses are repeated, vary the injection site. The TUBEX® cartridge for this product incorporates several features that are designed to facilitate the visualization of blood on aspiration if a blood vessel is inadvertently entered. The design of this cartridge is such that blood which enters its needle will be quickly visualized as a red or dark-colored “spot.” This “spot” will appear on the barrel of the glass cartridge immediately proximal to the blue hub. The TUBEX is designed with two orientation marks, in order to determine where this “spot” can be seen. First insert and secure the cartridge in the TUBEX injector in the usual fashion. Locate the yellow rectangle at the base of the blue hub. This yellow rectangle is aligned with the blood visualization “spot” An imaginary straight line, drawn from this yellow rectangle to the shoulder of the glass cartridge, will point to the area on the cartridge where the “spot” can be visualized. When the needle cover is removed, a second yellow rectangle will be visible. The second yellow rectangle is also aligned with the blood visualization “spot” to assist the operator in locating this “spot” If the 2 mL metal or plastic syringe is used, the glass cartridge should be rotated by turning the plunger of the syringe clockwise until the yellow rectangle is visualized. If the 1 mL metal syringe is used, it will not be possible to continue to rotate the glass cartridge clockwise once it is properly engaged and fully threaded; it can, however, then be rotated counterclockwise as far as necessary to properly orient the yellow rectangles and locate the observation area. (In this same area in some cartridges, a dark spot may sometimes be visualized prior to injection. This is the proximal end of the needle and does not represent a foreign body in, or other abnormality of, the suspension.) Thus, before the needle is inserted into the selected muscle, it is important for the operator to orient the yellow rectangles so that any blood which may enter after needle insertion and during aspiration can be visualized in the area on the cartridge where it will appear and not be obscured by any obstructions. After selection of the proper site and insertion of the needle into the selected muscle, aspirate by pulling back on the plunger. While maintaining negative pressure for 2 to 3 seconds, carefully observe the neck of the glass TUBEXcartridge immediately proximal to the blue plastic needle hub for appearance of blood or any discoloration. Blood or “typical blood color” may not be seen if a blood vessel has been entered—only a mixture of blood and Bicillin CR. The appearance of any discoloration is reason to withdraw the needle and discard the TUBEX. If it is elected to inject at another site, a new TUBEX cartridge should be used. If no blood or discoloration appears, inject the contents of the TUBEXslowly. Discontinue delivery of the dose if the subject complains of severe immediate pain at the injection site or if, especially in neonates, infants and young children, symptoms or signs occur suggesting onset of severe pain. Some TUBEX cartridges may contain a small air bubble which should be disregarded, since it does not affect administration of the product. DO NOT clear any air bubbles from the cartridge or needle as this may interfere with the visualization of any blood or discoloration during aspiration. Because of the high concentration of suspended material in this product, the needle may be blocked if the injection is not made at a slow, steady rate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

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Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided. Concurrent administration of penicillin and probenecid increases and prolongs serum penicillin levels by decreasing the apparent volume of distribution and slowing the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Last reviewed on RxList: 2/25/2009
This monograph has been modified to include the generic and brand name in many instances.

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This drug is indicated in the treatment of moderately severe infections due to penicillin- G-susceptible microorganisms that are susceptible to serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including susceptibility testing) and by clinical response. Bicillin C-R is indicated in the treatment of the following in adults and pediatric patients: Moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and skin and soft-tissue infections due to susceptible streptococci. NOTE: Streptococci in Groups A, C, G, H, L, and M are very sensitive to penicillin G. Other groups, including Group D (enterococci), are resistant. Penicillin G sodium or potassium is recommended for streptococcal infections with bacteremia. Moderately severe pneumonia and otitis media due to susceptible pneumococci. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, peritonitis, and arthritis of pneumococcal etiology are better treated with penicillin G sodium or potassium during the acute stage. When high, sustained serum levels are required, penicillin G sodium or potassium, either IM or IV, should be used. This drug should not be used in the treatment of venereal diseases, including syphilis, gonorrhea, yaws, bejel, and pinta.

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A previous hypersensitivity reaction to any penicillin or to procaine is a contraindication.Last reviewed on RxList: 2/25/2009
This monograph has been modified to include the generic and brand name in many instances.

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Penicillin in overdosage has the potential to cause neuromuscular hyperirritability or convulsive seizures.

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Bicillin® C-R (penicillin G benzathine and penicillin G procaine injectable suspension) is supplied in packages of 10 TUBEX® Sterile Cartridge-Needle Units as follows: 1 mL size, containing 600,000 units per TUBEX® (21 gauge, thin-wall 1 inch needle for pediatric use), NDC 61570-139-10. 2 mL size, containing 1,200,000 units per TUBEX® (21 gauge, thin-wall 1 inch needle for pediatric use), NDC 61570-141-10. 2 mL size, containing 1,200,000 units per TUBEX® (21 gauge, thin-wall 1-1/4 inch needle), NDC 61570-140-10. Store in a refrigerator, 2° to 8°C (36° to 46°F). Keep from freezing. Also Available Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) is also available in packages of 10 disposable syringes as follows: 4 mL size, containing 2,400,000 units per syringe (18 gauge x 2 inch needle), NDC 61570-142-10. PLEASE NOTE: THE METAL TUBEX HYPODERMIC SYRINGEAND TUBEX FAST-TRAK SYRINGE HAVE BEEN DISCONTINUED AND REPLACED BY THE TUBEX INJECTOR. EXCHANGE OF THESE DISCONTINUED SYRINGES IS AVAILABLE, FREE OF CHARGE, FROM WYETH-AYERST DIRECTLY. FOR LOADING AND UNLOADING INFORMATION ON THESE DISCONTINUED SYRINGES, CONTACT THE MEDICAL AFFAIRS DEPARTMENT AT WYETH-AYERST LABORATORIES, P.O. BOX 8299, PHILADELPHIA, PA 19101. TUBEX® Injector NOTE: The TUBEX Injector is REUSABLE: do not discard. DIRECTIONS FOR USE: BEFORE PROCEEDING, SEE IMPORTANT INFORMATION UNDER DOSAGE AND ADMINISTRATION SECTION. NOTE: USE ASEPTIC TECHNIQUE FOR ALL MANIPULATIONS OF STERILE PARTS. To load a TUBEX Sterile Cartridge-Needle Unit into the TUBEX Injector 1. Turn the ribbed collar to the “OPEN” position until it stops. 2. Hold the Injector with the open end up and fully insert the TUBEX Sterile Cartridge-Needle Unit. Firmly tighten the ribbed collar in the direction of the “CLOSE” arrow. 3. Thread the plunger rod into the plunger of the TUBEX Sterile Cartridge-Needle Unit until slight resistance is felt. The Injector is now ready for use in the usual manner. To load an E.S.I. DOSETTE® Sterile Cartridge-Needle Unit into the TUBEX Injector 1. Turn the ribbed collar to the “OPEN” position until it stops. 2. Hold the Injector with the open end up and fully insert the E.S.I. DOSETTE Sterile Cartridge-Needle Unit. Firmly tighten the ribbed collar in the direction of the “CLOSE” arrow. 3. Thread the plunger rod into the plunger of the E.S.I. DOSETTE Sterile Cartridge-Needle Unit until slight resistance is felt. 4. Engage the needle-cap assembly by pulling the cap down over the silver cartridge hub. The needle is fully engaged when the silver hub is completely covered. The Injector is now ready for use in the usual manner. To administer TUBEX/DOSETTE Sterile Cartridge-Needle Units Method of administration is the same as with conventional syringe. Remove needle cover by grasping it securely; twist and pull. Introduce needle into patient, aspirate by pulling back slightly on the plunger, and inject. To remove the empty TUBEX/DOSETTE Cartridge-Needle Unit and dispose into a vertical needle disposal container 1. Do not recap the needle. Disengage the plunger rod. 2. Hold the Injector, needle down, over a vertical needle disposal container and loosen the ribbed collar. TUBEX/DOSETTE Cartridge-Needle Unit will drop into the container. 3. Discard the needle cover. To remove the empty TUBEX/DOSETTE Cartridge-Needle Unit and dispose into a horizontal (mailbox) needle disposal container Do not recap the needle. Disengage the plunger rod. Open the horizontal (mailbox) needle disposal container. Insert TUBEX/DOSETTE Cartridge-Needle Unit, needle pointing down, halfway into container. Close the container lid on cartridge. Loosen ribbed collar; TUBEX/DOSETTE Cartridge-Needle Unit will drop into the container. Discard the needle cover. The TUBEXInjector is reusable and should not be discarded. Used TUBEX/DOSETTE Cartridge-Needle Units should not be employed for successive injections or as multiple-dose containers. They are intended to be used only once and discarded. NOTE: Any graduated markings on TUBEX/DOSETTE Sterile Cartridge-Needle Units are to be used only as a guide in administering doses. Wyeth-Ayerst does not recommend and will not accept responsibility for the use of any cartridge-needle units other than TUBEX or E.S.I. DOSETTE Cartridge-Needle Units in the TUBEX Injector. Prescribing Information as of November 2004. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. (A wholly owned subsidiary of King Pharmaceuticals, Inc.) Manufactured by: Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101.Last reviewed on RxList: 2/25/2009
This monograph has been modified to include the generic and brand name in many instances.

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General Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma. Care should be taken to avoid intravenous or intra-arterial administration, or injection into or near major peripheral nerves or blood vessels, since such injections may produce neurovascular damage. (See WARNINGS, and DOSAGE AND ADMINISTRATIONsections.) A small percentage of patients are sensitive to procaine. If there is a history of sensitivity, make the usual test: Inject intradermally 0.1 mL of a 1 to 2 percent procaine solution. Development of an erythema, wheal, flare, or eruption indicates procaine sensitivity. Sensitivity should be treated by the usual methods, including barbiturates, and procaine penicillin preparations should not be used. Antihistaminics appear beneficial in treatment of procaine reactions. The use of antibiotics may result in overgrowth of nonsusceptible organisms. Constant observation of the patient is essential. If new infections due to bacteria or fungi appear during therapy, the drug should be discontinued and appropriate measures taken. Whenever allergic reactions occur, penicillin should be withdrawn unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to penicillin therapy. In prolonged therapy with penicillin, and particularly with high-dosage schedules, periodic evaluation of the renal and hematopoietic systems is recommended. Laboratory Tests In streptococcal infections, therapy must be sufficient to eliminate the organism; otherwise, the sequelae of strepto-coccal disease may occur. Cultures should be taken following completion of treatment to determine whether streptococci have been eradicated. Pregnancy Category B Reproduction studies performed in the mouse, rat, and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to penicillin G. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate and well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Soluble penicillin G is excreted in breast milk. Caution should be exercised when penicillin G benzathine and penicillin G procaine are administered to a nursing woman. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been conducted with these drugs. Pediatric Use (See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION section.) Geriatric Use Clinical studies of penicillin G benzathine and penicillin G procaine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see CLINICAL PHARMACOLOGY). Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. REFERENCES 1. SHAW, E.: Transverse myelitis from injection of penicillin. Am. J. Dis. Child., 111:548, 1966. 2. KNOWLES, J.: Accidental intra-arterial injection of penicillin. Am. J. Dis. Child., 111:552, 1966. 3. DARBY, C. et al: Ischemia following an intragluteal injection of benzathine-procaine penicillin G mixture in a one-year-old boy. Clin. Pediatrics, 12:485, 1973. 4. BROWN, L. & NELSON, A.: Postinfectious intravascular thrombosis with gangrene. Arch. Surg., 94:652, 1967. 5. BORENSTINE, J.: Transverse myelitis and penicillin (Correspondence). Am. J. Dis. Child., 112:166, 1966. 6. ATKINSON, J.: Transverse myelopathy secondary to penicillin injection. J. Pediatrics, 75:867, 1969. 7. TALBERT, J. et al: Gangrene of the foot following intramuscular injection in the lateral thigh: A case report with recommendations for prevention. J. Pediatrics, 70:110, 1967. 8. FISHER, T.: Medicolegal affairs. Canad. Med. Assoc. J., 112:395, 1975. 9. SCHANZER, H. et al: Accidental intra-arterial injection of penicillin G. JAMA, 242:1289, 1979.Last reviewed on RxList: 2/25/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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