Dextrose 50% Abboject®, Ansyr™ Syringe Warnings and Precautions

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WARNINGS

50% Dextrose Injection is hypertonic and may cause phlebitis and thrombosis at the site of injection.

Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance.

The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

For peripheral vein administration:

The solution should be given slowly, preferably through a small-bore needle into a large vein, to minimize venous irritation.

For central venous administration:

Concentrated dextrose should be administered via central vein only after suitable dilution.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

Do not use unless the solution is clear and seal is intact. Discard unused portion.

Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Blood electrolyte monitoring is essential and fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals also should be provided as needed.

To minimize hyperglycemia and consequent glycosuria, it is desirable to monitor blood and urine glucose and if necessary, add insulin.

When a concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% or 10% dextrose injection to avoid rebound hypoglycemia.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.

Care should be exercised to ensure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis should occur during administration, the injection should be stopped and corrective measures instituted.

Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies with solutions in polypropylene syringes have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy:

Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 50% Dextrose Injection, USP is administered to a nursing mother.

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Find Dextrose 50% Abboject®, Ansyr™ Syringe medical information:

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Warnings and Precautions

WARNINGS

50% Dextrose Injection is hypertonic and may cause phlebitis and thrombosis at the site of injection.

Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance.

The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

For peripheral vein administration:

The solution should be given slowly, preferably through a small-bore needle into a large vein, to minimize venous irritation.

For central venous administration:

Concentrated dextrose should be administered via central vein only after suitable dilution.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

Do not use unless the solution is clear and seal is intact. Discard unused portion.

Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Blood electrolyte monitoring is essential and fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals also should be provided as needed.

To minimize hyperglycemia and consequent glycosuria, it is desirable to monitor blood and urine glucose and if necessary, add insulin.

When a concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% or 10% dextrose injection to avoid rebound hypoglycemia.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.

Care should be exercised to ensure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis should occur during administration, the injection should be stopped and corrective measures instituted.

Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies with solutions in polypropylene syringes have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy:

Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 50% Dextrose Injection, USP is administered to a nursing mother.

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