Product Elements:
Lacellate solution - 500 sodium chloride, potassium chloride, sodium lactate and calcium chloride sodium chloride chloride ion sodium lactate lactic acid potassium chloride potassium cation calcium chloride calcium cation water
Drug Interactions:
Drug interactions ceftriaxone â see contraindications caution is advised when administering lactated ringerâs injection, usp to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids. caution is advised when administering lactated ringerâs injection, usp to patients treated with drugs for which renal elimination is ph dependent. due to the alkalinizing action of lactate (formation of bicarbonate), lactated ringerâs injection, usp 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 ringerâs injection, usp to patients treated with lithium. because of its pota
Read more...ssium content, lactated ringerâs injection, usp should be administered 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 ringerâs injection, usp to patients treated with thiazide diuretics or vitamin d, as these can increase the risk of hypercalcemia.
Indications and Usage:
Indications and usage lactated ringerâs injection, usp is indicated as a source of water and electrolytes or as an alkalinizing agent.
Warnings:
Warnings although lactated ringerâs injection, usp 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 ringerâs injection, usp is not for use for the treatment of lactic acidosis or severe metabolic acidosis. lactated ringerâs injection, usp 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 ringerâs injection, usp can cause fluid and
Read more.../or solute overloading resulting in 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 ringerâs injection, usp 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 ringerâs injection, usp 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 ringerâs injection, usp 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 patientâs age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations. all injections in viaflex 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 ringerâs injection, usp, aseptic technique must be used. mix the solution thoroughly when additives have been introduced. do not store solu
Read more...tions containing additives. additives may be incompatible with lactated ringerâs injection, usp. 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 ringerâs injection, usp 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 ringerâs injection, usp is contraindicated in newborns (⤠28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonateâs bloodstream). in patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including lactated ringerâs injection, usp, 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 ringerâs injection, usp 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, paresthesias, 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 ringerâs injection, usp 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 â see contraindications caution is advised when administering lactated ringerâs injection, usp to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids. caution is advised when administering lactated ringerâs injection, usp to patients treated with drugs for which renal elimination is ph dependent. due to the alkalinizing action of lactate (formation of bicarbonate), lactated ringerâs injection, usp 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 ringerâs injection, usp to patients treated with lithium. because of its pota
Read more...ssium content, lactated ringerâs injection, usp should be administered 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 ringerâs injection, usp to patients treated with thiazide diuretics or vitamin d, as these can increase the risk of hypercalcemia.
Use in Pregnancy:
Pregnancy teratogenic effects animal reproduction studies have not been conducted with lactated ringerâs injection, usp. it is also not known whether lactated ringerâs injection, usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. lactated ringerâs injection, usp should be given to a pregnant woman only if clearly needed. for hypersensitivity reactions during pregnancy â see warnings
Pediatric Use:
Pediatric use safety and effectiveness of lactated ringerâs injection, usp 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 ringerâs injection, usp 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.
Overdosage:
Overdose an excessive volume or too high a rate of administration of lactated ringerâs injection, usp 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.
Description:
Description lactated ringerâs 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 composition (g/l) ionic composition (meq/l) size (ml) sodium chloride, usp, (nacl) sodium lactate, (c 3 h 5 nao 3 ) potassium chloride, usp, (kcl) calcium chloride, usp (cacl 2 ·2h 2 o) osmolarity (mosmol/l) (calc) ph sodium potassium calcium chloride lactate caloric content (kcal/l) lactated ringerâs injection, usp 250 500 1000 6 3.1 0.3 0.2 273 6.5 (6.0 to 7.5) 130 4 2.7 109 28 9 the viaflex plastic container is fabricated from a specially formulated polyvinyl chloride (pl 146 plastic). 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 plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (dehp), up to 5 parts per million. however, the safety of the plastic has been confirmed in tests in animals according to usp biological tests for plastic containers as well as by tissue culture toxicity studies.
Clinical Pharmacology:
Clinical pharmacology lactated ringerâs injection, usp has value as a source of water and electrolytes. it is capable of inducing diuresis depending on the clinical condition of the patient. lactated ringerâs injection, usp 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 ringerâs injection, usp. studies to evaluate the possible impairment of fertility have not been performed.
How Supplied:
How supplied lactated ringerâs injection, usp in viaflex plastic container is available as follows: code size (ml) ndc 2b2323 500 70529-026-01 exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. it is recommended the product be stored at room temperature (25°c); brief exposure up to 40°c does not adversely affect the product.
Package Label Principal Display Panel:
Packaging lacelt-2