Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for intravenous administration. However, the efficacy of ceftriaxone in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. Pediatr Radiol. All injections in AVIVA plastic containers are intended for intravenous administration using sterile equipment. hYr8. Multiple IV or IM doses ranging from 0.5 to 2 g at 12- to 24-hour intervals resulted in 15% to 36% accumulation of ceftriaxone above single dose values. Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage. WARNING: Do not use plastic containers in series connections. Intravenously, a dose of 4 to 5 g in 250 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP may be infused. Package insert and Container label: Each 100 mL contains 900 mg Sodium Chloride, USP. The container does not require entry of external air during administration. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ceftriaxone for injection or other antibacterial drugs in the future. For the treatment of serious miscellaneous infections other than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. Preservative-free Morphine Sulfate Injection contains morphine sulfate, (pentahydrate) 1 mg and sodium chloride, USP, 9 mg in water for injection, USP. calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. No dosage adjustment is necessary for patients with impairment of renal or hepatic function (see PRECAUTIONS). Patients with previous hypersensitivity reactions to penicillin and other beta lactam antibacterial agents may be at greater risk of hypersensitivity to ceftriaxone (see WARNINGS Hypersensitivity). 52 0 obj <>stream Mukilteo, WA 98275, Also supplied in the following manufacture supplied dosage forms. Early Hum Dev. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and CNS depression proceeding to respiratory paralysis. Continuous administration of magnesium sulfate is an unapproved treatment for preterm labor. It contains no antimicrobial agents. Urine output should be maintained at a level of 100 mL or more during the four hours preceding each dose. Ceftriaxone for injection is contraindicated in premature neonates (see CONTRAINDICATIONS). In an in vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone. 0000003200 00000 n Alternatively, the initial IV dose of 4 g may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 mL of a 10% solution or 20 mL of a 20% solution) may then be injected IV over a period of three to four minutes. 0000010220 00000 n Parenteral drug products should be inspected visually for particulate matter institute appropriate therapeutic countermeasures and save the remainder of Symptomatic precipitation of ceftriaxone calcium salt in the gallbladder, kernicterus, oliguria, and anaphylactic or anaphylactoid reactions. McGuinness GA, Weinstein MM, Cruikshank DP, et al. Caution must be exercised in the administration of Sodium Chloride Injection, home 0000010078 00000 n Caution must be exercised in the administration of Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) to patients receiving corticosteroids or corticotropin. Ceftriaxone for injection should be administered intravenously by infusion over a period of 30 minutes, except in neonates where administration over 60 minutes is recommended to reduce the risk of bilirubin encephalopathy. If, in the informed judgment of the physician, it is deemed advisable The total daily dose should not exceed 2 grams. When any of these drugs are to be administered concomitantly with ceftriaxone by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers. Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/L. 0000006702 00000 n If an adverse reaction does occur, discontinue the infusion, evaluate the When given by injection, effects typically begin within a few Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Dextrose and Sodium The adverse effects of parenterally administered magnesium usually are the result of magnesium intoxication. It has a calculated molecular weight of 661.59 and the following structural formula: Ceftriaxone for injection USP is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Magnesium sulfate heptahydrate is chemically designated MgSO 47H 2O, with a molecular weight of 246.47 and occurs as colorless crystals or white powder freely soluble in water. After reconstitution, protection from normal light is not necessary. Ceftriaxone for injection must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. as. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone for injection is mixed with calcium-containing solutions in the same IV administration line. Nassar AH, Sakhel K, Maarouf H, et al. Ceftriaxone is excreted via both biliary and renal excretion (see CLINICAL PHARMACOLOGY). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 2.5% Dextrose and 0.45% Sodium Chloride Injection, Do not administer unless solution is clear and seal is intact. AVIVA are trademarks of Baxter International Inc. For Product Information 1-800-933-0303. 6. WebDiltiazem, sold under the brand name Cardizem among others, is a calcium channel blocker medication used to treat high blood pressure, angina, and certain heart arrhythmias. The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. What Are the Best PsA Treatments for You? IV use in eclampsia should be reserved for immediate control of life-threatening convulsions. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. May contain sodium hydroxide and/or hydrochloric acid for pH adjustments. port and inject. Intravenously, a dose of 4 to 5 g in 250 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP may be infused. Simultaneously, IM doses of up to 10 g (5 g or 10 mL of the undiluted 50% solution in each buttock) are given. Manufactured by: Novo Nordisk Inc., Plainsboro, NJ 08536 U.S. License Number 1261 A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving ceftriaxone for injection and calcium-containing fluids. In patients with diminished renal function, administration of Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP may result in sodium retention. endstream endobj 11 0 obj <> endobj 12 0 obj <> endobj 13 0 obj <>stream Urolithiasis and Post-Renal Acute Renal Failure. 1989; 152(5):1071-2. Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. Instruct patients or their caregivers to inform their healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including somnolence, lethargy, and confusion), seizures, myoclonus, and nonconvulsive status epilepticus, for immediate treatment, or discontinuation of Ceftriaxone for Injection (see. startxref Bone mineralization in newborns whose mothers received magnesium sulphate for tocolysis of premature labor. The opacity will diminish gradually. Serum concentrations of uric acid increased by an average of 0.69 mg/100 mL in patients treated with indapamide 1.25 mg, and by an average of 1.0 mg/100 mL in patients treated with indapamide 2.5 mg and 5.0 mg, and frank gout may be precipitated in certain caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. Ceftriaxone is reversibly bound to human plasma proteins, and the binding decreased from a value of 95% bound at plasma concentrations of <25 mcg/mL to a value of 85% bound at 300 mcg/mL. It contains no antimicrobial agents. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Since magnesium is distributed into milk during parenteral magnesium sulfate administration, the drug should be used with caution in nursing women. In TPN, maintenance requirements for magnesium are not precisely known. Mix thoroughly when additives WebPreparation Instructions for EMEND for Injection . Return container to in-use position and continue administration. If supplemental medication is desired, follow directions below. Monograph names listed before April 1, 2021 contain a combined notice and documentary standard; postings after April 1, 2021 provide separate links for the notice and for the standard content. Alterations in prothrombin times have occurred in patients treated with ceftriaxone for injection. Ceftriaxone for injection is contraindicated in patients with known hypersensitivity to ceftriaxone, any of its excipients or to any other cephalosporin. The safety and efficacy of such use have not been established. These precipitates appear on sonography as an echo without acoustical shadowing suggesting sludge or as an echo with acoustical shadowing which may be misinterpreted as gallstones. You may report side effects to FDA at 1-800-FDA-1088. Less frequently reported (<1%) were pruritus, fever or chills. Neuromuscular Blocking AgentsExcessive neuromuscular block has occurred in patients receiving parenteral magnesium sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution. Magnesium sulfate injection (50%) must be diluted to a concentration of 20% or less prior to IV infusion. Serious acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other emergency measures. Ceftriaxone for injection is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age). 0.9% Sodium Chloride Irrigation, USP is a sterile nonpyrogenic, isotonic solution in a single dose ARTHROMATIC plastic container for use as an arthroscopic irrigating solution. The preoperative administration of a single 1 g dose of ceftriaxone for injection USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Wedig KE, Kogan J, Schorry EK et al. 0.9% Sodium Chloride Injection USP is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. Concomitant use of ceftriaxone with Vitamin K antagonists may increase the risk of bleeding. In addition, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of all drugs deemed compatible with existing polyvinyl chloride container systems. Cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving ceftriaxone for injection and calcium- containing fluids. Dextrose and Sodium Chloride Injection, USP is indicated as a source of water, electrolytes, and calories.. When lidocaine solution is used as a solvent with ceftriaxone for intramuscular injection, exclude all contraindications to lidocaine. caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. Ceftriaxone is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Two in vitro studies, one using adult plasma and the other neonatal plasma from umbilical cord blood have been carried out to assess interaction of ceftriaxone and calcium. Lamm CL, Norton KL, Murphy RJ. Magnesium sulfate should be used during pregnancy only if clearly needed. See additional information. endstream endobj startxref The results of this study are tabulated as follows: Week 2 and 4 Bacteriologic Eradication Rates in the Per Protocol Analysis in the Roche Bacteriologic Study by pathogen: Table 6 Bacteriologic Eradication Rates by Pathogen. WebSodium Chloride Injection, USP 5% or 10% Dextrose Injection, USP 5% Dextrose in Lactated Ringer's Injection, USP 5% Dextrose and 0.9% Sodium Chloride Injection, USP 5% Dextrose and 0.45% Sodium Chloride Injection, USP 5% Dextrose and 0.2% Sodium Chloride Injection, USP Lactated Ringer's Injection, USP Invert Sugar 5% or 10% in Studies with Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. News. Hyperbilirubinemic neonates should not be treated with ceftriaxone for injection. Detailed guidance, regulations and rules WebIn severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. 1994;14(2):249-53. The primary function of the overwrap is to protect the container from the physical environment. Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. Riaz M, Porat R, Brodsky NL, et al. No compatibility studies have been conducted with the Flagyl IV RTU(metronidazole) formulation or using other diluents. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations.. Parenteral drug products should be Sodium Bicarbonate Description. Caution should be exercised when ceftriaxone for injection is administered to a nursing woman. Gynecol Obstet Invest. to a pregnant woman or can affect reproduction capacity. Do not store solutions containing additives. Return container to in use position and continue administration. Refer to the prescribing information of lidocaine. SruvzD]0qham$N|qdlE/PsBj43D]ULpZ]2ZP Deep IM injection of the undiluted (50%) solution is appropriate for adults, but the solution should be diluted to a 20% or less concentration prior to such injection in children. Please refer to the WARNINGS Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams of ceftriaxone activity. Magnesium tocolysis and neonatal bone abnormalities: a controlled study. Artificial respiration is often required. For the treatment of uncomplicated gonococcal infections, a single intramuscular dose of 250 mg is recommended. The opacity will diminish gradually. Box of 10 (NDC 68180-644-10). Ceftriaxone for injection may be administered intravenously or intramuscularly. Based on middle ear fluid ceftriaxone concentrations in the 23 to 25 hour and the 46 to 50 hour sampling time intervals, a half-life of 25 hours was calculated. After a 1 g IV dose, average concentrations of ceftriaxone, determined from 1 to 3 hours after dosing, were 581 mcg/mL in the gallbladder bile, 788 mcg/mL in the common duct bile, 898 mcg/mL in the cystic duct bile, 78.2 mcg/g in the gallbladder wall and 62.1 mcg/mL in the concurrent plasma. 2. What Are the Best PsA Treatments for You? Vials containing 1 g equivalent of ceftriaxone. To add medication before solution administration, To add medication during solution administration, Baxter HealthcareCorporation Deerfield, IL 60015 USA 07-19-51-541. Safety and effectiveness of ceftriaxone for injection in neonates, infants and pediatric patients have been established for the dosages described in the DOSAGE AND ADMINISTRATION section. Discard unused portion. Therapy should continue until paroxysms cease. After thawing, unused portions should be discarded. Vials containing 500 mg equivalent of ceftriaxone. Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Ensure adequate hydration in patients receiving ceftriaxone for injection. Caution: Use only with a non-vented set or a vented set with the vent Skeletal demineralization and fractures caused by fetal magnesium toxicity. Complete information is not available. Oliguria, ureteric obstruction, post-renal acute renal failure. It contains no antimicrobial agents. J Pediatr Orthop. Magnesium is said to have a depressant effect on the central nervous system (CNS), but it does not adversely affect the woman, fetus or neonate when used as directed in eclampsia or pre-eclampsia. Before therapy with ceftriaxone for injection is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins and other beta-lactam agents or other drugs. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection USP provides protection from most infections due to susceptible organisms throughout the course of the procedure. Additives may be incompatible. Effects of magnesium sulfate treatment on perinatal calcium metabolism. DOSAGE AND ADMINISTRATION. For the treatment of acute bacterial otitis media, a single intramuscular dose of 50 mg/kg (not to exceed 1 gram) is recommended (see INDICATIONS AND USAGE). Discontinue ceftriaxone for injection in patients who develop signs and symptoms suggestive of urolithiasis, oliguria or renal failure and/or the sonographic findings described above. II. Ceftriaxone showed no potential for mutagenic activity in these studies. Genetic toxicology tests included the Ames test, a micronucleus test and a test for chromosomal aberrations in human lymphocytes cultured in vitro with ceftriaxone. In some of these cases, the same intravenous infusion line was used for both cefrtiaxone for injection and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. If seizures associated with drug therapy occur, the drug should be discontinued. The maintenance dose used in adults ranges from 8 to 24 mEq (1 to 3 g) daily; for infants, the range is 2 to 10 mEq (0.25 to 1.25 g) daily. IM administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas IV doses will provide a therapeutic level almost immediately. The container label for these injections bears the statement: Do not administer simultaneously with blood. Baxter and The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS). Santi MD, Henry GW, Douglas GL. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. Please refer to instructions for use for each system. As plasma magnesium rises above 4 mEq/L, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 mEq/L. Clinical studies of Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. These tests confirm the biological safety of the container system. However, in patients other than neonates, ceftriaxone for injection and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. Because magnesium is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Cumming WA, Thomas VJ. News stories, speeches, letters and notices. Parenteral drug products should be inspected visually for particulate matter Make appropriate dosage adjustments in patients with severe renal impairment (see DOSAGE AND ADMINISTRATION). hemorrhage. Guidance and regulation. 1997;43(4):236-41. Those additives known to be incompatible should not be used. Ceftriaxone for injection is contraindicated in neonates ( 28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium- containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see CLINICAL PHARMACOLOGY, WARNINGS and DOSAGE AND ADMINISTRATION). There are, however, no adequate and well-controlled studies in pregnant women. USP, 10% Dextrose and 0.9% Sodium Chloride Injection, The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication (See Directions for Use). Other reported clinical experience has not identified differences in the responses between elderly and younger patients. Tissue loading may occur at even lower rates of administration. Methylprednisolone Sodium Succinate for Injection Notice and Monograph (posted 04May2022; Oxybutynin Chloride Tablets (posted Ceftriaxone is not removed by peritoneal- or hemodialysis. When barbiturates, narcotics or other hypnotics (or systemic anesthetics) are to be given in conjunction with magnesium, their dosage should be adjusted with caution because of additive CNS depressant effects of magnesium. Heparin (10 and 50 units/mL) in 0.9% w/v Sodium Chloride Injection; Potassium Chloride (10 and 40 mEqL) in 0.9% w/v Sodium Chloride Injection. *IV doses were infused at a constant rate over 30 minutes. Patients should be counseled that antibacterial drugs including ceftriaxone for injection should only be used to treat bacterial infections. Ceftriaxone is lower than control at study day 14 and 28. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products. 0 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. However, in patients other than neonates, ceftriaxone for injection and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. In the presence of severe renal insufficiency, the maximum dosage of magnesium sulfate is 20 grams/48 hours and frequent serum magnesium concentrations must be obtained. A cofactor role of ceftriaxone for injection-related biliary precipitation cannot be ruled out. It is administered by the intravenous (IV) or intramuscular (IM) routes as an electrolyte replenisher or anticonvulsant. Continuous use of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities. Check for minute leaks by squeezing inner bag firmly. As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions (i.e., anaphylaxis) have been reported. A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures. Reactions have included neurological outcomes, including encephalopathy, seizures, myoclonus, and non convulsive status epilepticus. Revision Bulletins are published in USPNF Online by the first of each month. The following intravenous ceftriaxone for injection solutions are stable at room temperature (25C) for 24 hours, at concentrations between 10 mg/mL and 40 mg/mL: Sodium Lactate (PVC container), 10% Invert Sugar (glass container), 5% Sodium Bicarbonate (glass container), Freamine III (glass container), Normosol-M in 5% Dextrose (glass and PVC containers), Ionosol-B in 5% Dextrose (glass container), 5% Mannitol (glass container), 10% Mannitol (glass container). WebReconstitute by aseptically adding 5 mL of preservative-free 0.9% Sodium Chloride Injection, USP to a vial of lyophilized levothyroxine sodium for injection. In case of severe hypersensitivity reactions, treatment with ceftriaxone must be discontinued immediately and adequate emergency measures must be initiated. Sodium Chloride Injection, USP has value as a source of water and electrolytes. 3. These appeared as a gritty sediment in dogs that received 100 mg/kg/day for 4 weeks. Less frequently reported (<1%) were nausea or vomiting, and dysgeusia. 10 Things People With Depression Wish You Knew, 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP, 5% Dextrose and 0.2% Sodium Chloride Injection, USP, 5% Dextrose and 0.33% Sodium Chloride Injection, USP, 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 5% Dextrose and 0.9% Sodium Chloride Injection, USP, 10% Dextrose and 0.9% Sodium Chloride Injection, USP. Ceftriaxone was not removed to any significant extent from the plasma by hemodialysis; in six of 26 dialysis patients, the elimination rate of ceftriaxone was markedly reduced. additives. The total daily dose should not exceed 4 grams. Cefazolin for Injection, USP, is supplied in 10 grams Pharmacy Bulk Package. home and discoloration prior to administration whenever solution and container permit. However, in other cases, neurological adverse reactions occurred in patients receiving an appropriate dosage adjustment. The pH of a 1% aqueous solution is approximately 6.7. In patients with diminished renal function, administration of Sodium Chloride (sodium chloride Consult with pharmacist, The flexible container is made with non-latex plastic materials specially designed for a wide range of parenteral drugs including those requiring delivery in containers made of polyolefins or polypropylene. Contact a Representative. and discoloration prior to administration whenever solution and container permit. Magnesium sulfate injection is also indicated for the prevention and control of seizures in a pre-eclampsia and eclampsia, respectively. Disappearance of the patellar reflex is a useful clinical sign to detect the onset of magnesium intoxication. In counteracting the muscle-stimulating effects of barium poisoning, the usual dose of magnesium sulfate is 1 to 2 g given IV. As with all intramuscular preparations, ceftriaxone for injection should be injected well within the body of a relatively large muscle; aspiration helps to avoid unintentional injection into a blood vessel. If supplemental medication is desired, follow directions below. The color of solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised. Reactions which may occur because of the solution or the technique of administration Using syringe with 19 to 22 gauge needle, puncture resealable medication The American Journal of Medicine - "The Green Journal" - publishes original clinical research of interest to physicians in internal medicine, both in academia and community-based practice.AJM is the official journal of the Alliance for Academic Internal Medicine, a prestigious group comprising internal medicine department chairs at more 0000009777 00000 n Ceftriaxone for injection reconstituted with 5% Dextrose or 0.9% Sodium Chloride solution at concentrations between 10 mg/mL and 40 mg/mL, and then stored in frozen state (-20C) in PVC or polyolefin containers, remains stable for 26 weeks. Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii*, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis*, Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium, Haemophilus influenzae, Neisseria meningitidis, Do not use diluents containing calcium, such as Ringer's solution or Hartmann's solution, to reconstitute ceftriaxone for injection vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. The probability of such precipitates appears to be greatest in pediatric patients. Ceftriaxone sodium, like other cephalosporins, has no activity against Chlamydia trachomatis. the fluid for examination if deemed necessary. No information provided. Data are generally insufficient to allow an estimate of incidence or to establish causation. 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 drug therapy. Compared to that in healthy adult subjects, the pharmacokinetics of ceftriaxone were only minimally altered in elderly subjects and in patients with renal impairment or hepatic dysfunction (Table 4); therefore, dosage adjustments are not necessary for these patients with ceftriaxone dosages up to 2 g per day. Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Rate of administration should be slow and cautious, to avoid producing hypermagnesemia. %PDF-1.6 % Directions for use of VIAFLEX plastic container. Antibacterial drugs should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. There is no specific antidote. USP, leakage of fluid into the surrounding tissues (extravasation), and, too much fluid in the blood (hypervolemia). Anuria. Recovery of ceftriaxone from plasma was reduced with calcium concentrations of 6 mM (24 mg/dL) or higher in adult plasma or 4 mM (16 mg/dL) or higher in neonatal plasma. You are encouraged to report negative side effects of prescription drugs to the FDA. 0000005895 00000 n In some of these cases, the same intravenous infusion line was used for both ceftriaxone for injection and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. The effects of maternal magnesium sulfate treatment on newborns: a prospective controlled study. A similar phenomenon has been observed in baboons but only after a protracted dosing period (6 months) at higher dose levels (335 mg/kg/day or more). 1988; 113(6):1078-82. Obstet Gynecol. Caution: Do not use plastic containers in series connections. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) can cause fetal harm when administered 2006;85(9):1099-103. Dextrose and Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention. Ceftriaxone for injection intramuscular solutions remain stable (loss of potency less than 10%) for the following time periods: Ceftriaxone for injection intravenous solutions, at concentrations of 10, 20 and 40 mg/mL, remain stable (loss of potency less than 10%) for the following time periods stored in glass or PVC containers: *Data available for 10 to 40 mg/mL concentrations in this diluent in PVC containers only. Consult with pharmacist, if available. After reconstitution, each 1 mL of solution contains approximately 250 mg or 350 mg equivalent of ceftriaxone according to the amount of diluent indicated below. Vials containing 2 g equivalent of ceftriaxone. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. For controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 g administered IM or IV. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. To add medication before solution administration, To add medication during solution administration, Rev Aug 2003. Normal Saline 0.9% Sodium Chloride 500ml Bag For Injection Usp; A total daily (24 hr) dose of 30 to 40 g should not be exceeded. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. NOTE: Ceftriaxone for injection USP sterile powder should be stored at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature] and protected from light. Frozen solutions of ceftriaxone for injection should be thawed at room temperature before use. 0000012887 00000 n 0000015158 00000 n For high density medication such Gynecol Obstet Invest. Safety and effectiveness of Dextrose and Sodium Chloride Injection, USP (dextrose and sodium chloride inj) in Subcutaneous physostigmine, 0.5 to 1 mg may be helpful. Digestive Disorders: Common Misconceptions, B-Cell Therapy for Multiple Sclerosis: How It Works. Moisture and some opacity of the plastic due to moisture absorption during the sterilization process may be observed. 0000004923 00000 n Box of 1 (NDC 68180-633-01) and box of 10 (NDC 68180-633-10). This product should be given cautiously to penicillin and other beta-lactam agent-sensitive patients. 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