Drugplain

PRISMASOL BGK0/2.5 20 g/L

calcium chloride, magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, and sodium bicarbonate · INJECTION · Vantive US Healthcare LLC

No Recall HistoryCurrently in Shortage
Plain English

PRISMASOL BGK0/2.5 is a injection containing calcium chloride, magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, and sodium bicarbonate at 20 g/L, taken intravenous. Manufactured by Vantive US Healthcare LLC.

Key Facts

Brand Name
PRISMASOL BGK0/2.5
Generic Name
calcium chloride, magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, and sodium bicarbonate
NDC Code (Product)
24571-108
Manufacturer
Vantive US Healthcare LLC
Strength
20 g/L
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA021703
Marketing Start
10/25/2006

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

haemorrhage15 reports
death14 reports
hypotension8 reports
device issue6 reports
cardiac arrest5 reports
acute kidney injury4 reports
blood pressure decreased4 reports
anaemia3 reports
haemodialysis complication3 reports
haemoglobin decreased3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances. PRISMASOL and PHOXILLUM solutions are indicated: As a replacement solution in Continuous Renal Replacement Therapy (CRRT) and in case of drug poisoning when CRRT is used to remove dialyzable substances ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Therapy must be individualized based on the patient's clinical condition, fluid, electrolyte, acid-base and glucose balance ( 2.2 ) Solution must be mixed prior to use ( 2.2 ) Use only with extracorporeal dialysis equipment appropriate for CRRT ( 2.3 ) 2.1 Administration Instructions Visually inspect PRISMASOL and PHOXILLUM for particulate matter and discoloration prior to administration. Administration should only be under the direction of a physician competent in intensive care treatment including CRRT. Use only with extracorporeal dialysis equipment appropriate for CRRT. The prepared solution is for single patient use only. Aseptic technique should be used throughout administration to the patient. Discard any unused solution. 2.2 Dosing Considerations PRISMASOL replacement solutions contain 4 different combinations of active ingredients (7 different products with varying ingredient amounts). PHOXILLUM replacement solutions contain 2 different combinations of active ingredients (2 different products with varying ingredient amounts). PRISMASOL and PHOXILLUM are supplied in a two-compartment bag that must be mixed immediately prior to use [see Dosage and

Contraindications

4 CONTRAINDICATIONS PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products. Known hypersensitivities to PRISMASOL and PHOXILLUM solutions ( 4 )

Drug Interactions

7 DRUG INTERACTIONS As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter. The blood concentrations of certain drugs may need to be monitored and appropriate therapy implemented to correct for removal during treatment. 7.1 Citrate When used as an anticoagulant, citrate contributes to the overall buffer load and can reduce plasma calcium levels. Select the PRISMASOL/PHOXILLUM formulation(s) accordingly.

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions have been identified during postapproval use with these or other similar products and therefore may occur with use of PHOXILLUM or PRISMASOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Metabolic acidosis Hypotension Acid-base disorders Electrolyte imbalance including calcium ionized increased (reported in PRISMASOL solutions containing calcium), hyperphosphatemia, and hypophosphatemia Fluid imbalance

Frequently Asked Questions

What is PRISMASOL BGK0/2.5 used for?

PRISMASOL BGK0/2.5 contains calcium chloride, magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, and sodium bicarbonate. It is a injection taken intravenous. Consult your doctor for specific uses.

Is PRISMASOL BGK0/2.5 a controlled substance?

PRISMASOL BGK0/2.5 is not classified as a controlled substance by the DEA.

What is the generic name for PRISMASOL BGK0/2.5?

The generic name for PRISMASOL BGK0/2.5 is calcium chloride, magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, and sodium bicarbonate. There are no other listed brand versions of calcium chloride, magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, and sodium bicarbonate.

What is the NDC code for PRISMASOL BGK0/2.5 20 g/L?

The NDC (National Drug Code) for PRISMASOL BGK0/2.5 20 g/L is 24571-108, listed by Vantive US Healthcare LLC.

Product NDC

24571-108

Package NDC

24571-108-06

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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