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  • CLASSES

    Carbohydrate IV Solutions and Additives, 10% or less
    Glucose Products for Hypoglycemia
    Glucose/Dextrose Products for GTT
    Solutions with One Carbohydrate

    DEA CLASS

    Rx, OTC

    DESCRIPTION

    Dextrose (also known as glucose) is available in many various dosage forms
    Used orally or parenterally to treat hypoglycemia (e.g., diabetic patients) and orally for glucose tolerance tests
    Also used parenterally as a carbohydrate source in intravenous fluids and total parenteral nutrition (TPN) and as adjunctive treatment for hyperkalemia

    COMMON BRAND NAMES

    Dex4 Glucose, Glutol, Glutose 15, Glutose 45, Glutose 5

    HOW SUPPLIED

    Dex4 Glucose/Dextrose/Glucose/Glutose 15/Glutose 45/Glutose 5 Oral Gel: 15g, 24g, 40%
    Dex4 Glucose/Dextrose/Glutol Oral Sol: 15g, 100g, 180mL
    Dex4 Glucose/Glucose Oral Tab Chew: 4g
    Dextrose Intracardiac Inj Sol: 5%
    Dextrose Intravenous Inj Sol: 5%, 10%, 20%, 25%, 30%, 50%, 70%
    Dextrose Intravenous Sol: 40%

    DOSAGE & INDICATIONS

    For the treatment of hypoglycemia.
    Oral dosage
    Adults

    15 to 20 grams glucose PO. If after 15 minutes the blood glucose is still below 70 mg/dL, ingest another 15 to 20 grams of glucose. Once blood glucose returns to normal, consume a meal or snack to prevent recurrence of hypoglycemia. If symptoms of hypoglycemia persist, contact a physician. Glucose is the preferred treatment for hypoglycemia in patients who are conscious and able to take oral replacement. Intravenous dextrose can be used in conscious or unconscious patients receiving medical care. Glucagon should be prescribed for all patients at significant risk of severe hypoglycemia.

    Intravenous dosage
    Adults

    10 to 25 grams/dose (20 to 50 mL of a 50% solution) IV to restore blood glucose concentrations. In severe cases, repeat doses may be needed. Subsequent continuous IV infusion of dextrose 10% injection may be necessary to stabilize serum glucose concentrations in some individuals.

    Infants, Children, and Adolescents

    0.5 to 1 g/kg/dose (5 to 10 mL/kg/dose of a 10% solution, 2 to 4 mL/kg/dose of a 25% solution, or 1 to 2 mL/kg/dose of a 50% solution) IV (Max: 25 g/dose). Follow bolus with continuous infusion if continued therapy is indicated.

    Neonates

    200 mg/kg/dose IV of a 10% solution. Follow bolus with continuous infusion if continued therapy is indicated.

    As adjunct therapy to insulin for the treatment of hyperkalemia.
    Intravenous dosage
    Adults

    25 g (50 mL of 50% solution) IV over 5 minutes in conjunction with regular insulin. 100 g (1,000 mL of 10% solution) IV administered over 1 to 2 hours also may be used. Dextrose increases insulin release, aids in redistribution of potassium into the cells, and prevents hypoglycemia when given with insulin.[36934]

    Infants, Children, and Adolescents

    0.5 g/kg (5 mL/kg of a 10% solution) IV over 30 minutes in conjunction with regular insulin.

    For nutritional supplementation in parenteral nutrition.
    Intravenous dosage
    Adults

    Doses are determined on individual patient needs based on weight, age, and clinical condition. Clinical practice guidelines recommend the carbohydrate content of parenteral nutrition should not exceed 7 g/kg/day IV. A minimum of 2 g/kg/day IV is recommended for critically ill patients.

    For oral glucose tolerance test (GTT) to diagnose diabetes mellitis.
    The oral GTT test should not be administered if 1) the patient is ill; 2) the patient has fasted less than 10 hours or more than 16 hours, or 3) if dietary carbohydrate intake has been restricted to less than 150 grams/day for 3 days prior to testing.
    The oral GTT is to be administered in the morning. The subject is to fast overnight, usually for 8 to 14 hours. No medications, caffeine, or tobacco are to be taken until the completion of the test. Water is permitted. The patient should remain seated throughout the test. The patient's medications should be screened for drugs that may cause glucose elevations.
    For diagnosis of gestational diabetes using the 1-step approach.
    Oral dosage
    Adult and Adolescent Females

    100 grams PO of anhydrous glucose dissolved in water (or a commercially available glucose testing drink containing similar content). The beverage should be consumed in 5 minutes or less. The maximum glucose concentration in the beverage is 25 g/100 mL. The 1-step test takes a fasting sample, followed by 3 blood samples in the 3 hours following glucose ingestion. In pregnancy, in the absence of criteria that meet the traditional diagnosis of diabetes, gestational diabetes is diagnosed when 2 or more values meet or exceed the following: Fasting: 95 mg/dL; 1 hour: 180 mg/dL; 2 hours: 155 mg/dL; and 3 hours: 140 mg/dL.

    For diagnosis of gestational diabetes using the 2-step approach.
    Oral dosage
    Adult and Adolescent Females

    A modified screen may be performed using 50 grams PO of anhydrous glucose dissolved in water (or a commercially available glucose testing drink containing similar content). The beverage should be consumed in 5 minutes or less. The maximum glucose concentration in the beverage is 25 grams/100 mL. A sample is taken 1 hour after the 50-grams glucose challenge; the normal response is plasma glucose less than 140 mg/dL. Perform the usual gestational 100 grams oral GTT on those patients with a plasma glucose level that exceeds this threshold value.

    Oral dosage
    Adults, Adolescents, and Children 12 years and older

    75 grams PO of anhydrous glucose dissolved in water (or a commercially available glucose testing drink containing similar content). The beverage should be consumed in 5 minutes or less. The maximum glucose concentration in the beverage is 25 grams/100 mL. Diagnostic criteria following the oral GTT are as follows: Prediabetes (impaired glucose tolerance): 2-hour plasma glucose 140 to 199 mg/dL. Diabetes: 2-hour plasma glucose 200 mg/dL or more. Per the ADA, a fasting blood glucose (FPG) is the recommended screening test for most individuals. The oral GTT may be necessary for the diagnosis of diabetes when the FPG is normal. The FPG is preferred for screenings because it is faster and easier to perform, more convenient, acceptable to patients, and less expensive.

    Children less than 12 years

    1.75 grams/kg (not to exceed 75 grams) PO of anhydrous glucose dissolved in water (or a commercially available glucose testing drink containing similar content). The beverage should be consumed in 5 minutes or less. The maximum glucose concentration in the beverage is 25 grams/100 mL. Diagnostic criteria are the same as for adults for 2-hour sample following the test.

    MAXIMUM DOSAGE

    Dosage for dextrose is individualized to the patient's individual requirements.

    Adults

    No specific maximum dosage information is available.

    Geriatric

    No specific maximum dosage information is available.

    Adolescents

    No specific maximum dosage information is available.

    Children

    No specific maximum dosage information is available.

    Infants

    No specific maximum dosage information is available.

    Neonates

    No specific maximum dosage information is available.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Oral Administration

    Do not administer oral glucose products to anyone who is unconscious or unable to swallow.

    Oral Solid Formulations

    Glucose tablets: Chew tablets thoroughly before swallowing.
    Glucose powder: Place powder in directly into mouth or into a small glass of water and let it dissolve.
    Repeat dose if after 15 minutes glucose concentrations still test low (less than 70 mg/dL).
    Once blood glucose returns to normal, consume a meal or snack to prevent recurrence of hypoglycemia.
    If symptoms of hypoglycemia persist, contact a physician.

    Oral Liquid Formulations

    Glucose (dextrose) oral gel or liquid oral solution
    Take as directed on product label.
    Repeat dose if after 15 minutes glucose concentrations still test low (less than 70 mg/dL).
    Once blood glucose returns to normal, consume a meal or snack to prevent recurrence of hypoglycemia.
    If symptoms of hypoglycemia persist, contact a physician.
     
    Glucose (dextrose) oral solutions for diagnostic use (glucose tolerance test, GTT)
    See Dosage/Indications for more information on the GTT test and administration.

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

    Intravenous Administration

    Dilution
    Concentrated dextrose solutions (i.e., 20% to 70%) MUST be diluted with compatible IV solutions or used as an admixture. They are NOT for direct IV infusion.[62968]
    Check for specific IV compatibilities. When introducing additives to commercially prepared dextrose solutions, use aseptic technique, mix thoroughly, and do not store.
     
    IV Infusion
    Dextrose solutions are administered by slow IV infusion.
    Solutions containing more than 5% dextrose or parenteral nutrition solutions with an osmolarity of 900 mOsm/L or more should be infused via a central vein. Infusion into a peripheral vein may result in vein irritation, vein damage, thrombosis, and venous thrombophlebitis.[62968]
    Do not administer dextrose injection without electrolytes simultaneously with blood through the same infusion set because of the possibility that pseudo-agglutination of red cells may occur.
    When a concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% Dextrose Injection or 10% Dextrose Injection to avoid rebound hypoglycemia.
    The maximum rate of infusion to avoid glycosuria is 0.5 g/kg/hour. Approximately 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hour.[57123]
     
    Directions for use of flexible pharmacy bulk packages (e.g., as for parenteral nutrition admixtures)
    Slight opacity of the plastic due to moisture absorption during the sterilization process may be observed in the 2,000 mL flexible pharmacy bulk packages of 50% Dextrose Injection and 70% Dextrose Injection. The opacity will gradually diminish.
    During use, container must be stored, and all manipulations performed, an appropriate laminar flow hood.
    When ready for compounding, insert piercing pin of transfer set into outlet port at bottom of container and suspend unit in laminar flow hood. Insertion of pin should only be performed once. Once the outlet has been entered, withdraw contents promptly and in 1 continuous operation. If this is not possible, a maximum time of 4 hours from pin placement is permitted to complete fluid transfer. Discard container no later than 4 hours after pin placement.
    Compounded admixtures utilizing 2,000 mL flexible pharmacy bulk packages of 50% Dextrose Injection and 70% Dextrose Injection may be stored under refrigeration for up to 24 hours. Complete administration of admixtures within 24 hours after removal from refrigeration.[57123]

    STORAGE

    Generic:
    - Avoid excessive heat (above 104 degrees F)
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Protect from freezing
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Dex4 Glucose:
    - Avoid excessive heat (above 104 degrees F)
    - Do not freeze
    - Do not refrigerate
    - Protect from moisture
    - Store at room temperature (between 59 to 86 degrees F)
    Glutol :
    - Avoid exposure to heat
    - Protect from freezing
    - Store in a cool, dry place
    Glutose 15 :
    - Store at room temperature (between 59 to 86 degrees F)
    Glutose 45 :
    - Store at room temperature (between 59 to 86 degrees F)
    Glutose 5:
    - Store at room temperature (between 59 to 86 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Pregnancy

    Intravenous glucose (dextrose) should be given to a pregnant woman only if clearly needed, and doses should be individualized to the patient's needs to meet fluid and nutritional requirements. Frequent monitoring of serum glucose concentrations is required. Animal reproduction studies have not been conducted; it is not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. However, when used appropriately, there appears to be minimal risk to the clinical use of dextrose products during pregnancy when necessary. Oral glucose supplement products have not been assigned a pregnancy category by the FDA, but are not harmful when used as directed in the recommended doses to treat episodes of hypoglycemia in the conscious pregnant individual as per guideline recommendations. Oral glucose (15 to 20 grams) is the preferred treatment for the conscious patient, although any form of carbohydrate that contains glucose may be used.

    Breast-feeding

    Glucose and dextrose administration pose no particular risks during breast-feeding. Lactose is the major carbohydrate of human milk and is also the major osmotic constituent of human milk. Synthesis of lactose is the major determinant of the volume of milk produced by the lactating human mammary gland. Lactose is synthesized from free glucose and UDP-galactose. Thus, proper carbohydrate consumption by the mother during lactation is essential to milk production.

    Corn hypersensitivity

    Dextrose injection solutions are contraindicated in patients with a dextrose hypersensitivity. Hypersensitivity and infusion reactions, including anaphylaxis, have been reported with dextrose injection solutions. Use dextrose injection solutions with caution in patients with severe corn hypersensitivity. Some intravenous solution manufacturers caution that the dextrose in the solutions may be derived from corn.

    Dehydration, intracranial bleeding

    Concentrated intravenous dextrose solutions are contraindicated in patients with severe dehydration as hypertonic dextrose solutions can worsen the patient's hyperosmolar state. A concentrated parenteral dextrose solution should not be used when intraspinal or intracranial bleeding is present nor in the presence of delirium tremens if dehydration is present.
     

    Electrolyte imbalance, heart failure, hyponatremia, hypoxemia, pulmonary edema, refeeding syndrome

    Concentrated dextrose solutions used as part of a parenteral nutrition regimen may lead to refeeding syndrome and electrolyte imbalance (i.e., hypokalemia, hypophosphatemia, hypomagnesemia) in patients with severe malnutrition or critically ill patients when parenteral nutrition is initiated. Refeeding syndrome is characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. The intravenous administration of dextrose solutions can also cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, including hypoosmotic hyponatremia, overhydration, congested states (congestive heart failure) or pulmonary edema. Patients at high risk for developing hyponatremic encephalopathy include pediatric patients, geriatric patients, premenopausal women, patients with hypoxemia, and patients with underlying CNS disease. In high-risk patients, parenteral nutrition should be initiated gradually to minimize the potential for refeeding syndrome. Monitor electrolytes; fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals also should be provided as needed.
     

    Extravasation, intramuscular administration, subcutaneous administration

    Do not give parenteral dextrose via subcutaneous administration or intramuscular administration. Administer dextrose intravenously, taking care to insure that the needle (or catheter) is well within the lumen of the vein and that extravasation does not occur.

    Hyperosmolar hyperglycemic state (HHS), thrombophlebitis, uremia

    Administer concentrated parenteral dextrose solutions only after suitable dilution. They are not for direct IV infusion. Solutions containing more than 5% dextrose or with an osmolality of 900 mOsm/L or greater should be infused via a central vein. Infusion into a peripheral vein may result in vein irritation, vein damage, thrombosis, and venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible if thrombophlebitis develops. Hypertonic parenteral dextrose solutions should also be given slowly. Significant hyperglycemia and possible hyperosmolar hyperglycemic state (HHS) may result from too rapid administration. The physician should be aware of the symptoms of HHS, such as mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance.

    Neonates, premature neonates, renal impairment

    Use caution when administering intravenous dextrose solutions to patients with renal impairment and particularly neonates, low birth weight infants, and premature neonates since dextrose solution contains aluminum, which may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration in patients with renal impairment. 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 renal impairment, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with CNS and bone toxicity. Tissue loading may occur at even lower rates of administration. In addition, caution should be exercised with low birth weight premature neonates, who are receiving dextrose concentrations of 10% or greater, as they are most susceptible to glucose intolerance, hyperglycemia, and parenteral nutrition-associated liver disease [PNALD]. Frequent monitoring of serum glucose concentrations, electrolytes, and organ function is required. In at-risk infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

    Diabetes mellitus, hyperglycemia

    Intravenous solutions containing dextrose should be used with caution in patients with known hyperglycemia or subclinical or overt diabetes mellitus. Patients may require insulin or other measures to maintain desired serum glucose concentrations.

    Hepatic disease

    Concentrated dextrose solutions used as part of a parenteral nutrition regimen should be used with caution in patients with hepatic disease. Hepatobiliary disorders, including cholestasis, hepatic steatosis, steatohepatitis, hepatic fibrosis, and cirrhosis (parenteral nutrition-associated liver disease [PNALD]), potentially leading to hepatic failure, may occur in patients with or without preexisting hepatic disease who receive parenteral nutrition. Cholecystitis and cholelithiasis have also been observed. Premature infants may be at particular risk for PNALD. Monitor liver function tests closely in patients receiving parenteral nutrition. If liver function test abnormalities develop, consider discontinuation or dose reduction of the parenteral nutrition solution.

    Infection

    Concentrated parenteral dextrose solutions used as part of a parenteral nutrition regimen may lead to infection and related infectious complications. The risk of infection is increased in patients with malnutrition-associated immunosuppression, patients using parenteral nutrition long-term or with poor maintenance of intravenous catheters, and patients with concomitant conditions or receiving drugs associated with immunosuppression. To decrease the risk of infection, ensure adherence to aseptic techniques in catheter placement, catheter maintenance, and preparation and administration of the parenteral nutrition solution. Monitor for signs and symptoms of early infections (fever and chills), including laboratory tests that may indicate infection (leukocytosis and hyperglycemia). Frequently assess the parenteral access device and insertion site for edema, redness, and discharge.

    ADVERSE REACTIONS

    Severe

    anaphylactoid reactions / Rapid / 0-0.1
    bronchospasm / Rapid / Incidence not known
    angioedema / Rapid / Incidence not known
    cyanosis / Early / Incidence not known
    refeeding syndrome / Delayed / Incidence not known
    pulmonary edema / Early / Incidence not known
    aluminum toxicity / Delayed / Incidence not known
    cholecystitis / Delayed / Incidence not known
    pulmonary embolism / Delayed / Incidence not known

    Moderate

    hyperglycemia / Delayed / 1.0-10.0
    confusion / Early / 0-1.0
    dehydration / Delayed / 0-1.0
    glycosuria / Early / 0-1.0
    dyspnea / Early / Incidence not known
    hypotension / Rapid / Incidence not known
    hypophosphatemia / Delayed / Incidence not known
    hypokalemia / Delayed / Incidence not known
    hypomagnesemia / Delayed / Incidence not known
    hyponatremia / Delayed / Incidence not known
    hepatitis / Delayed / Incidence not known
    jaundice / Delayed / Incidence not known
    parenteral nutrition-associated liver disease / Delayed / Incidence not known
    cholestasis / Delayed / Incidence not known
    elevated hepatic enzymes / Delayed / Incidence not known
    steatosis / Delayed / Incidence not known
    cholelithiasis / Delayed / Incidence not known
    hepatomegaly / Delayed / Incidence not known

    Mild

    rash / Early / 0-0.1
    urticaria / Rapid / 0-0.1
    pruritus / Rapid / 0-0.1
    chills / Rapid / Incidence not known
    fever / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Dextrose, Glucose products.

    PREGNANCY AND LACTATION

    Pregnancy

    Intravenous glucose (dextrose) should be given to a pregnant woman only if clearly needed, and doses should be individualized to the patient's needs to meet fluid and nutritional requirements. Frequent monitoring of serum glucose concentrations is required. Animal reproduction studies have not been conducted; it is not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. However, when used appropriately, there appears to be minimal risk to the clinical use of dextrose products during pregnancy when necessary. Oral glucose supplement products have not been assigned a pregnancy category by the FDA, but are not harmful when used as directed in the recommended doses to treat episodes of hypoglycemia in the conscious pregnant individual as per guideline recommendations. Oral glucose (15 to 20 grams) is the preferred treatment for the conscious patient, although any form of carbohydrate that contains glucose may be used.

    Glucose and dextrose administration pose no particular risks during breast-feeding. Lactose is the major carbohydrate of human milk and is also the major osmotic constituent of human milk. Synthesis of lactose is the major determinant of the volume of milk produced by the lactating human mammary gland. Lactose is synthesized from free glucose and UDP-galactose. Thus, proper carbohydrate consumption by the mother during lactation is essential to milk production.

    MECHANISM OF ACTION

    Glucose is also known as dextrose. Glucose is a monosaccharide, also known as a simple sugar. As a carbohydrate, glucose supplies energy to cells, organs, and tissues. Some tissues can also use fat or protein as an energy source but others, such as the brain and red blood cells, only use glucose. Dextrose in intravenous fluids undergoes oxidation to carbon dioxide and water, and quickly provides fluid and calories. Oral glucose also works quickly (usually within 15 minutes) by raising blood glucose concentrations to alleviate symptoms of hypoglycemia.

    PHARMACOKINETICS

    Dextrose (glucose) is administered orally and intravenously. As a carbohydrate, glucose supplies energy to cells, organs, and tissues. Some tissues can also use fat or protein as an energy source but others, such as the brain and red blood cells, only use glucose. Glucose can be stored in the body as glycogen and the liver is the primary site of glycogen storage. Glycogen is mobilized from the liver and converted to glucose by gluconeogenesis when the blood glucose concentration is low. Gluconeogenesis is stimulated in response to the release of glucagon by the alpha cells of the pancreas when low blood glucose concentrations occur. Glucose may also be produced from non-carbohydrate precursors, such as pyruvate, amino acids and glycerol, by gluconeogenesis. It is gluconeogenesis that maintains blood glucose concentrations, for example during starvation or intense exercise. Cellular uptake of glucose occurs in response to insulin, and glucose is subsequently broken down through glycolysis, lowering blood sugar levels. Glycolysis is the metabolic pathway that converts glucose into pyruvate. The free energy released in this process is used to form the molecules ATP and NADH which are needed for many cellular functions/reactions.
     
    Affected Cytochrome P450 (CYP) 450 enzymes and drug transporters: None

    Oral Route

    Orally administered glucose is absorbed rapidly via transport from the intestinal lumen, across the epithelium and into blood. Onset of action usually occurs in 15 minutes.