Product Elements:
Lactated ringers sodium chloride, sodium lactate, potassium chloride, calcium chloride sodium chloride sodium cation chloride ion sodium lactate sodium cation lactic acid potassium chloride potassium cation chloride ion calcium chloride calcium cation chloride ion water
Drug Interactions:
Drug interactions ceftriaxone (see contraindications ). caution is advised when administering lactated ringer's injection to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids. caution is advised when administering lactated ringer's injection to patients treated with drugs for which renal elimination is ph dependent. due to the alkalinizing action of lactate (formation of bicarbonate), lactated ringer's injection may interfere with the elimination of such drugs. renal clearance of acidic drugs such as salicylates and barbiturates may be increased. renal clearance of alkaline drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine) and dextroamphetamine (dexamphetamine) sulfate, may be decreased. renal clearance of lithium may also be increased. caution is advised when administering lactated ringer's injection to patients treated with lithium. because of its potassium content, lactated ringer's injection should be admi
Read more...nistered with caution in patients treated with agents or products that can cause hyperkalemia or increase risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ace inhibitors, angiotensin ii receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. caution is advised when administering lactated ringer's injection to patients treated with thiazide diuretics or vitamin d, as these can increase the risk of hypercalcemia.
Indications and Usage:
Indications and usage: lactated ringer's injection is indicated as a source of water and electrolytes or as an alkalinizing agent.
Warnings:
Warnings: although lactated ringer's injection has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency; therefore, it should not be used for this purpose. lactated ringer's injection is not for use for the treatment of lactic acidosis or severe metabolic acidosis. lactated ringer's injection should not be administered simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation. the infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. appropriate therapeutic countermeasures must be instituted as clinically indicated. hypersensitivity reactions are reported more frequently during pregnancy. depending on the volume and the rate of infusion, the intravenous administration of lactated ringer's injection can cause fluid and/or solute overloading resulting in
Read more...dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema or acid-base imbalance. the risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation. lactated ringer's injection should be administered with particular caution, if at all, to patients with hyperkalemia or conditions predisposing to hyperkalemia (such as severe renal impairment or adrenocortical insufficiency, acute dehydration, or extensive tissue injury or burns) and in patients with cardiac disease. lactated ringer's injection should be administered with particular caution, if at all, to patients with alkalosis or at risk for alkalosis. because lactate is metabolized to bicarbonate, administration may result in, or worsen, metabolic alkalosis. lactated ringer's injection should be administered with particular caution, if at all, to patients with severe renal impairment, hypervolemia, overhydration, or conditions that may cause sodium and/or potassium retention, fluid overload, or edema.
Dosage and Administration:
Dosage and administration: as directed by a physician. dosage, rate and duration of administration are to be individualized and dependent upon the indication for use, the patient's age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations. all injections in flexible plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment. after opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. do not reconnect any partially used containers. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. do not administer unless the solution is clear and seal is intact. when making additions to lactated ringer's injection, aseptic technique must be used. mix the solution thoroughly when additives have been introduced. do not store solutions contain
Read more...ing additives. additives may be incompatible with lactated ringer's injection. as with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition, by checking for a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. before adding a substance or medication, verify that it is soluble and/or stable in water and that the ph range of lactated ringer's injection is appropriate. the instructions for use of the medication to be added and other relevant literature must be consulted. additives known or determined to be incompatible should not be used.
Contraindications:
Contraindications: as for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and lactated ringer's injection is contraindicated in newborns (⤠28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate's bloodstream). in patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including lactated ringer's injection, through the same infusion line (e.g., via y-connector). if the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid. lactated ringer's injection is contraindicated in patients with a known hypersensitivity to sodium lactate.
Adverse Reactions:
Adverse reactions: post-marketing adverse reactions the following adverse reactions have been reported in the post-marketing experience, listed by meddra system organ class (soc). immune system disorders hypersensitivity/infusion reactions, including anaphylactic/anaphylactoid reactions, and the following manifestations: angioedema, chest pain, chest discomfort, decreased heart rate, tachycardia, blood pressure decreased, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, hypoesthesia oral, dysgeusia, nausea, anxiety, pyrexia, headache. metabolism and nutrition disorders hyperkalemia. general disorders and administration site conditions infusion site reactions, including phlebitis, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning. class reactions hypersensitivity reactions, including, laryngeal e
Read more...dema and sneezing hypervolemia infusion site reactions, including infection at the site of injection, extravasation, and infusion site anesthesia (numbness) overdose an excessive volume or too high a rate of administration of lactated ringer's injection may lead to fluid and sodium overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired. excessive administration of lactate may lead to metabolic alkalosis. metabolic alkalosis may be accompanied by hypokalemia. excessive administration of potassium may lead to the development of hyperkalemia, especially in patients with severe renal impairment. excessive administration of calcium salts may lead to hypercalcemia. when assessing an overdose, any additives in the solution must also be considered. the effects of an overdose may require immediate medical attention and treatment.
Drug Interactions:
Drug interactions ceftriaxone (see contraindications ). caution is advised when administering lactated ringer's injection to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids. caution is advised when administering lactated ringer's injection to patients treated with drugs for which renal elimination is ph dependent. due to the alkalinizing action of lactate (formation of bicarbonate), lactated ringer's injection may interfere with the elimination of such drugs. renal clearance of acidic drugs such as salicylates and barbiturates may be increased. renal clearance of alkaline drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine) and dextroamphetamine (dexamphetamine) sulfate, may be decreased. renal clearance of lithium may also be increased. caution is advised when administering lactated ringer's injection to patients treated with lithium. because of its potassium content, lactated ringer's injection should be admi
Read more...nistered with caution in patients treated with agents or products that can cause hyperkalemia or increase risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ace inhibitors, angiotensin ii receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. caution is advised when administering lactated ringer's injection to patients treated with thiazide diuretics or vitamin d, as these can increase the risk of hypercalcemia.
Use in Pregnancy:
Pregnancy teratogenic effects pregnancy category c. animal reproduction studies have not been conducted with lactated ringer's injection. it is also not known whether lactated ringer's injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. lactated ringer's injection should be given to a pregnant woman only if clearly needed. for hypersensitivity reactions during pregnancy (see warnings ).
Pediatric Use:
Pediatric use safety and effectiveness of lactated ringer's injection in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. the warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population. lactate-containing solutions should be administered with particular caution to neonates and infants less than 6 months of age.
Geriatric Use:
Geriatric use clinical studies of lactated ringer's injection 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.
Description:
Description: lactated ringer's injection, usp is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. it contains no antimicrobial agents. composition, osmolarity, ph, ionic concentration and caloric content are shown in table 1 . table 1 size (ml) composition (g/l) ionic composition (meq/l) caloric content (kcal/l) sodium chloride, usp (nacl) sodium lactate, usp (c 3 h 5 nao 3 ) potassium chloride, usp (kcl) calcium chloride, usp (cacl 2 â¢2h 2 o) osmolarity (mosmol/l) (calc) ph sodium potassium calcium chloride lactate lactated ringer's injection, usp 250 6 3.1 0.3 0.2 273 6.5 (6.0 to 7.5) 130 4 2.7 109 28 9 500 1,000 the flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). the amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. the suitability of the container material has been confirmed by tests in animals according to usp biological tests for plastic containers.
Clinical Pharmacology:
Clinical pharmacology: lactated ringer's injection has value as a source of water and electrolytes. it is capable of inducing diuresis depending on the clinical condition of the patient. lactated ringer's injection produces a metabolic alkalinizing effect. lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with lactated ringer's injection. studies to evaluate the possible impairment of fertility have not been performed.
How Supplied:
How supplied: lactated ringer's injection, usp in a single dose flexible plastic container, is available as follows: product each unit of sale 1727171005 ndc 17271-710-05 one 250 ml freeflex ® bag ndc 17271-710-05 sold in units of 30 1727171006 ndc 17271-710-06 one 500 ml freeflex ® bag ndc 17271-710-06 sold in units of 20 1727171007 ndc 17271-710-07 one 1,000 ml freeflex ® bag ndc 17271-710-07 sold in units of 10 exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. store at: 20 ° to 25 °c ( 68 ° to 77 °f) [see usp controlled room temperature]; brief exposure up to 40°c does not adversely affect the product. the container closure is not made with natural rubber latex. non-pvc, non-dehp, sterile.
Package Label Principal Display Panel:
Package label - principal display â lactated ringer's injection, usp 250 ml bag ndc 17271-710-05 250 ml lactated ringer's injection, usp for intravenous use. rx only meq/l: each 100 ml contains: na + 130 sodium chloride, usp 600 mg k + 4 sodium lactate, usp 310 mg ca 2+ 2.7 potassium chloride, usp 30 mg cl - 109 calcium chloride, usp 20 mg lactate 28 273 mosmol/l (calc.) ph 6.5 (6.0 to 7.5) single dose only. discard unused portion. not for use in the treatment of lactic acidosis. additives may be incompatible. consult with pharmacist. when introducing additives, use aseptic technique, mix thoroughly and do not store. use only if solution is clear and container is undamaged. must not be used in series connections. do not administer simultaneously with blood. usual dosage: see package insert. the overwrap is a moisture barrier. use immediately once removed from overwrap. store at: 20 ° to 25 °c ( 68 ° to 77 °f) [see usp controlled room temperature]. avoid excessive heat. the container closure is not made with natural rubber latex. non-pvc, non-dehp, sterile. becton, dickinson and company lot 1 becton drive franklin lakes, exp nj 07417 usa for product inquiry: 1-800-523-0502 1234567890 distributed by bd manufactured by fresenius kabi. 403507 made in norway fdh 2342 01-62-12-030 package label - principal display â lactated ringer's injection, usp 250 ml bag
Package label - principal display â lactated ringer's injection, usp 500 ml bag ndc 17271-710-06 500 ml lactated ringer's injection, usp for intravenous use. rx only meq/l: each 100 ml contains: na + 130 sodium chloride, usp 600 mg k + 4 sodium lactate, usp 310 mg ca 2+ 2.7 potassium chloride, usp 30 mg cl - 109 calcium chloride, usp 20 mg lactate 28 273 mosmol/l (calc.) ph 6.5 (6.0 to 7.5) single dose only. discard unused portion. not for use in the treatment of lactic acidosis. additives may be incompatible. consult with pharmacist. when introducing additives, use aseptic technique, mix thoroughly and do not store. use only if solution is clear and container is undamaged. must not be used in series connections. do not administer simultaneously with blood. usual dosage: see package insert. the overwrap is a moisture barrier. use immediately once removed from overwrap. store at: 20 ° to 25 °c ( 68 ° to 77 °f) [see usp controlled room temperature]. avoid excessive heat. the container closure is not made with natural rubber latex. non-pvc, non-dehp, sterile. becton, dickinson and company lot 1 becton drive franklin lakes, nj 07417 usa exp for product inquiry: 1-800-523-0502 distributed by bd 1234567890 manufactured by fresenius kabi. 403508 made in norway fdh 2343 01-62-12-031 package label - principal display â lactated ringer's injection, usp 500 ml bag
Package label - principal display â lactated ringer's injection, usp 1,000 ml bag ndc 17271-710-07 1,000 ml lactated ringer's injection, usp for intravenous use. rx only meq/l: each 100 ml contains: na + 130 sodium chloride, usp 600 mg k + 4 sodium lactate, usp 310 mg ca 2+ 2.7 potassium chloride, usp 30 mg cl - 109 calcium chloride, usp 20 mg lactate 28 273 mosmol/l (calc.) ph 6.5 (6.0 to 7.5) single dose only. discard unused portion. not for use in the treatment of lactic acidosis. additives may be incompatible. consult with pharmacist. when introducing additives, use aseptic technique, mix thoroughly and do not store. use only if solution is clear and container is undamaged. must not be used in series connections. do not administer simultaneously with blood. usual dosage: see package insert. the overwrap is a moisture barrier. use immediately once removed from overwrap. store at: 20 ° to 25 °c ( 68 ° to 77 °f) [see usp controlled room temperature]. avoid excessive heat. the container closure is not made with natural rubber latex. non-pvc, non-dehp, sterile. becton, dickinson and company 1 becton drive franklin lakes, lot nj 07417 usa for product inquiry: exp 1-800-523-0502 distributed by bd manufactured by fresenius kabi. made in norway 403509 fdh 2344 01-62-12-032 1234567890 package label - principal display â lactated ringer's injection, usp 1,000 ml bag