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REGIOCIT is a brand name for Sodium Chloride, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: REGIOCIT (sodium chloride and sodium citrate) solution is indicated for use as replacement solution for regional citrate anticoagulation (RCA) of the extracorporeal circuit in patients treated with continuous renal replacement therapy (CRRT), particularly when systemic anticoagulation with heparin is contraindicated,…
Verbatim from this product's HC label. Tap a section to expand.
For Extracorporeal use only. Not for direct intravenous infusion. REGIOCIT solution is used as a renal replacement solution. 4. 1 Dosing Considerations Dosing considerations of the drug: REGIOCIT (sodium chloride and sodium citrate) solution Page 5 of 19 • REGIOCIT solution should not be used for direct intravenous infusion.
The product must be used in pre-dilution mode only, with appropriate extracorporeal renal replacement equipment intended for CRRT, using an integrated pre-blood pump for RCA. • In addition to providing anticoagulation to the extracorporeal circuit and hemofilters, citrate also acts as a buffer source due to its metabolic conversion to bicarbonate systemically.
, dialysate and/or replacement fluid. The product must be used together with a dialysis/replacement solution at an appropriate bicarbonate concentration. • Dose reduction may be needed in patients with mild to moderate hepatic impairment.
In these patients, more frequent monitoring of citrate accumulation is advised. , during conditions such as septic shock and lactic acidosis, or in patients with severe hepatic impairment, due to limited citrate metabolism (see CONTRAINDICATIONS).
• A separate systemic infusion of calcium is always required to prevent or treat hypocalcemia. Adjust calcium infusion depending on measured serum total-to- ionized calcium ratio and ionized calcium levels, to maintain values in the physiologic range.
Adjust or stop calcium infusion according to the direction of the attending physician when REGIOCIT solution has been stopped. • Magnesium may need to be supplemented intravenously, based on systemic serum magnesium levels. 2 Recommended Dose and Dosage Adjustment The rate at which REGIOCIT solution is administered depends on the targeted citrate dose and the prescribed blood flow rate (BFR).
The prescription of the product must consider the flow rates of the effluent and other therapeutic fluids, the patient’s fluid removal requirements, additional fluid inputs and outputs, and the desired acid-base and electrolyte balance.
REGIOCIT solution should be prescribed and its administration (dose, infusion rate, and cumulative volume) established only by critical care or nephrology physicians experienced in administration of CRRT. The pre-filter infusion rate of REGIOCIT solution (based on its concentration) is indexed to the blood flow rate to achieve a target blood citrate concentration of 3 to 4 mmol/L in the blood.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In an open-label randomised study, 54 patients were administered RCA with an equimolar solution of citrate, sodium and chloride, as contained in REGIOCIT solution, and 49 received systemic anticoagulation with unfractionated heparin (UFH) while undergoing CRRT using continuous venovenous hemodiafiltration.
Adverse events related to metabolic disorders occurred in 26% of patients in the RCA-treated group, compared to 28% of patients in the UFH-treated group. These adverse events were generally transient and reversible. Metabolic alkalosis was seen in 6% of patients treated with RCA, compared to none treated with UFH, and metabolic acidosis was reported in 6% and 2% of patients in the RCA and UFH groups, respectively.
Six patients treated with RCA experienced severe hypocalcemia, compared to one patient treated with UFH. REGIOCIT (sodium chloride and sodium citrate) solution Page 11 of 19 In a second hemodiafiltration trial which evaluated 19 patients randomised to an equimolar solution of citrate, sodium and chloride, as contained in REGIOCIT solution, and 11 patients randomised to UFH anticoagulation, Hypocalcemia requiring intervention was reported in 3 patients treated with RCA, with 2 of these patients requiring treatment interruption of RCA.
6 Post-Market Adverse Reactions To date, adverse events reported in the post-marketing setting for REGIOCIT appear to be consistent with those listed above in Adverse Reaction Overview.
There have been reports of system failure due to apparent operator error during administration of CRRT with REGIOCIT solution, leading to serious adverse events, including life-threatening hypocalcemia. Plasma electrolyte and acid-base parameters should be closely monitored during CRRT, and appropriate action taken if imbalances of electrolytes or acid-base balance are detected.
Instructions for use of REGIOCIT and CRRT must be strictly followed. Cautionary statements are provided in WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hematologic, Hepatic / Biliary / Pancreatic, and Monitoring and Laboratory Tests, and in DRUG INTERACTIONS to avoid the following when performing the CRRT procedure: - Hypercalcemia - Hyponatremia - Fluid retention, dehydration - Nausea, vomiting - Muscle spasms Citrate Accumulation Special attention is required in patients with liver failure, including hepatic cirrhosis or acute hepatic failure, or in shock, since metabolism of citrate may be markedly reduced and patients may be thus exposed to citrate accumulation.
In these circumstances, more frequent monitoring of citrate accumulation should be undertaken. With systemic citrate accumulation, metabolic acidosis and ionized hypocalcemia may ensue, and the ratio of total to ionized calcium in the blood rises.
3, REGIOCIT infusion should be reduced or stopped. CRRT may then be continued without anticoagulation, or by using other means of anticoagulation. REGIOCIT is contraindicated in patients with severe hepatic impairment or in circulatory shock with muscle hypoperfusion (see CONTRAINDICATIONS).
Excessive infusion of citrate can lead to acute hypocalcemia and metabolic alkalosis, with neurologic and cardiac complications. Treatment consists of discontinuation of the citrate infusion and infusion of calcium. Endocrine and Metabolism Hypocalcemia REGIOCIT solution contains no calcium, and may lead to systemic ionized hypocalcemia, due to loss of calcium bound to citrate in the effluent and/or in the case of systemic citrate accumulation (see DOSAGE AND ADMINISTRATION, Administration).
REGIOCIT solution is contraindicated in: • patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
• severe liver failure • shock with muscle hypoperfusion
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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35 mmol / L. The patient’s systemic ionized calcium concentration should be maintained in the normal physiologic range by adjustment of calcium supplementation. 3 Administration Monitoring of the post-filter blood ionized calcium (iCa), systemic blood iCa, and total blood calcium levels in conjunction with other laboratory and clinical parameters is essential to guide appropriate REGIOCIT solution dosage based on the desired level of anticoagulation (see WARNINGS AND PRECAUTIONS).
Plasma levels of sodium, magnesium, potassium, and phosphate should also be monitored regularly and these electrolytes supplemented as needed. REGIOCIT (sodium chloride and sodium citrate) solution Page 6 of 19 REGIOCIT solution may be warmed to 37°C to enhance patient comfort.
Warming of the product prior to use should be done with dry heat only. Solution should not be heated in water or in a microwave oven due to the potential for patient injury or discomfort. REGIOCIT solution 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 the seal is intact.
Electrolyte and Acid–Base Balance REGIOCIT solution contains citrate, which can influence the patient’s electrolyte and acid–base balance. Plasma electrolyte and acid–base parameters should be closely monitored during CRRT. Closely monitor sodium, magnesium, potassium, phosphate, and calcium.
Infusion of electrolytes may be needed to supplement any loss. REGIOCIT (sodium chloride and sodium citrate) solution Page 8 of 19 Hypercalcemia Medicinal products containing calcium used for maintenance of calcium homeostasis in CRRT patients can increase the risk of hypercalcemia, and can result in a reduced anticoagulation effect.
Care should be taken to avoid excessive titration in administering calcium as this can lead to hypercalcemia. Frequent monitoring of pH, electrolytes, total-to- ionized calcium ratio, and systemic ionized calcium is important to avoid electrolyte and/or acid-base imbalance.
Hypomagnesemia REGIOCIT solution contains no magnesium. Use of the REGIOCIT solution may result in hypomagnesemia due to CRRT effluent losses (see DOSAGE AND ADMINISTRATION, Administration). Hypoglycemia REGIOCIT solution contains no dextrose.
Administration of REGIOCIT solution may lead to hypoglycemia. Blood glucose levels should be monitored regularly. Hypokalemia REGIOCIT solution contains no potassium. The serum potassium concentration must be monitored before and during CRRT.
Metabolic Alkalosis REGIOCIT solution contains citrate, which contributes to the overall buffer load. Additional sodium bicarbonate (or buffer source) contained in the CRRT fluids or in other fluids administered during therapy may increase the risk of metabolic alkalosis.
Metabolic alkalosis may occur if the net citrate administration rate exceeds that which is necessary to maintain acid–base balance. If metabolic alkalosis occurs, decrease the citrate dose, and/or increase the dialysate flow rate or change the composition of the CRRT solution.
Blood calcium levels, pH and bicarbonate should be monitored regularly in patients with metabolic alkalosis since this condition may potentiate hypocalcemia. Metabolic Acidosis Metabolic acidosis may occur if metabolic clearance of citrate by the liver or skeletal muscle is impaired (see CONTRAINDICATIONS).
If citrate accumulation develops and/or metabolic acidosis develops or worsens during therapy with REGIOCIT, the infusion rate may need to be decreased or its administration stopped. Hypo-osmolarity/Hypotonicity REGIOCIT solution is hypo-osmolar/hypotonic relative to standard CRRT replacement fluids and should be used with caution in patients with traumatic brain injury, cerebral edema, or increased intracranial pressure.
Instructions for use of REGIOCIT must be strictly followed. Incorrect use of the access ports or other restrictions to fluid flow may lead to incorrect patient weight loss and may result in machine alarms being set off. Continuing treatment without resolving the originating cause may lead to patient injury or death.
REGIOCIT (sodium chloride and sodium citrate) solution Page 9 of 19 Careful ongoing assessment is required of all solutions infused during REGIOCIT administration, whether related to CRRT dialysis fluids or to other solutions infused systemically.
REGIOCIT has a physiological sodium level of 140 mmol/L. However, sodium losses occurring during CRRT must be balanced as part of overall fluid and electrolyte management to avoid a drop in blood sodium level leading to systemic hyponatremia.
Hematologic Hemodynamic Status and Fluid Balance The patient’s hematocrit, hemodynamic status and fluid balance should be monitored throughout the procedure. - In case of hypervolemia, the net ultrafiltration rate prescribed for the CRRT device can be increased, and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be […]