WARNING - FDA records indicate that this drug has been recalled.

Baxter Healthcare Corp.

Product Description:	5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02
Status:	Ongoing
City:	Deerfield
State:	IL
Country:	US
Voluntary/Mandated:	Voluntary: Firm Initiated
Initial Firm Notification:	Letter
Distribution Pattern:	US, Puerto Rico, and Bermuda
Classification:	Class I
Product Quantity:	402,284 bags
Reason For Recall:	Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recall Initiation Date:	20150324
Report Date:	20150715

Dextrose

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Side Effects & Adverse Reactions

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.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels.

The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to insure proper utilization of dextrose and avoid production of hyperglycemia.

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History

There is currently no drug history available for this drug.

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Other Information

50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher.

Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4 kcal/gram. The solution has an osmolarity of 2.53 mOsmol/mL (calc.), a pH of 3.2 to 6.5 and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment.

The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit.

Dextrose, USP is chemically designated C6H12O6 • H2O (D-glucose monohydrate), a hexose sugar freely soluble in water.

Dextrose, hydrous has the following structural formula:

Water for Injection, USP is chemically designated H2O.

The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

Sources

Dextrose Manufacturers

Remedyrepack Inc.

Dextrose | Remedyrepack Inc.

For peripheral vein administration:

Injection of the solution should be made slowly.

The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.

In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results.

For central venous administration:

For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS.

No Recall
Hospira, Inc.

Dextrose | Hospira, Inc.

For peripheral vein administration:

Injection of the solution should be made slowly.

The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.

In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results.

For central venous administration:

For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS.

No Recall
Mckesson Packaging Services Business Unit Of Mckesson Corporation

Dextrose | Mckesson Packaging Services Business Unit Of Mckesson Corporation

For peripheral vein administration:

Injection of the solution should be made slowly.

The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.

In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results.

For central venous administration:

For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS.

No Recall
Hospira, Inc.

Dextrose | Hospira, Inc.

When possible, glucose concentrations of greater than 12% should be administered by central vein to reduce the risk for phlebitis and thrombosis. 25% Dextrose Injection, USP is administered only by slow intravenous injection.

The dosage and constant infusion rate of intravenous dextrose must be selected with caution, particularly in neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. In the neonate, an injection of 250 to 500 mg (1 to 2 mL)/kg/dose (5 to 10 mL of 25% dextrose in a 5 kg infant) is recommended to control acute symptomatic hypoglycemia (tremors, convulsions, etc.).

Larger or repeated single doses (up to 10 or 12 mL of 25% dextrose) may be required in severe cases or older infants. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results.

Subsequent continuous intravenous infusion of 10% dextrose injection may be needed to stabilize blood glucose levels. Further treatment should be guided by evaluation of the underlying disorder.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)

No Recall
Physicians Total Care, Inc.

Dextrose | Physicians Total Care, Inc.

For peripheral vein administration:

Injection of the solution should be made slowly.

The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused ata rate of 0.8 g/kg/hr.

In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results.

For central venous administration:

For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS.

No Recall
Physicians Total Care, Inc.

Dextrose | Physicians Total Care, Inc.

The dose is dependent upon the age, weight and clinical condition of the patient.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Drug Interactions

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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

INSTRUCTIONS FOR USE

To Open:

Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration.

To Add Medication

Prepare additive port.

Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.

The additive port may be protected by covering with an additive cap.

Mix container contents thoroughly.

Preparation for Administration

(Use aseptic technique)

Close flow control clamp of administration set.

Remove cover from outlet port at bottom of container.

Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: When using a vented administration set, replace bacterial retentive air filter with piercing pin cover. Insert piercing pin with twisting motion until shoulder of air filter housing rests against the outlet port flange.

Suspend container from hanger.

Squeeze and release drip chamber to establish proper fluid level in chamber.

Attach venipuncture device to set.

Open clamp to expel air from set and venipuncture device. Close clamp.

Perform venipuncture.

Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

No Recall
Agrilabs

Dextrose | Agrilabs

For intravenous administration only.

No Recall
Agripharm

Dextrose | Agripharm

The usual dose is 50 mL per 100 lbs. of body weight. It should be administered intravenously only. Dosage may be repeated every 8 to 10 hours or successive days if necessary.

No Recall
Mwi (Vetone)

Dextrose | Mwi (vetone)

Cattle: 100 to 500 mL depending on size and condition of animal. For intravenous use only. Solution should be warmed to body temperature and administered slowly. This product is sterile in unopened container. Contains no preservative. If entire contents are not used, discard unused portion. Handle under strict aseptic conditions.

No Recall
General Injectables & Vaccines, Inc

Dextrose | General Injectables & Vaccines, Inc

For peripheral vein administration:
Injection of the solution should be made slowly. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused ata rate of 0.8 g/kg/hr. In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results.

For central venous administration:
For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements. Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS.

No Recall
General Injectables & Vaccines, Inc

Dextrose | General Injectables & Vaccines, Inc

For peripheral vein administration:
Injection of the solution should be made slowly. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused ata rate of 0.8 g/kg/hr. In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results.

For central venous administration:
For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) After dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS.

No Recall
General Injectables & Vaccines, Inc.

Dextrose | General Injectables & Vaccines, Inc.

For peripheral vein administration:
Injection of the solution should be made slowly.
The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the
dextrose is retained when infused ata rate of 0.8 g/kg/hr.
In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually
adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination
should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting
pretreatment test results.
For central venous administration:
For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with
amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b)
after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte
concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such
evaluation.
The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever
solution and container permit. See CONTRAINDICATIONS.

No Recall
Cantrell Drug Company

Dextrose | Cantrell Drug Company

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
B. Braun Medical Inc.

Dextrose | B. Braun Medical Inc.

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Cardinal Health

Dextrose | Cardinal Health

The dose is dependent upon the age, weight and clinical condition of the patient.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Drug Interactions

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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)

INSTRUCTIONS FOR USE

To Open:

Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration.

To Add Medication
Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly.
Preparation for Administration

(Use aseptic technique)
Close flow control clamp of administration set. Remove cover from outlet port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: When using a vented administration set, replace bacterial retentive air filter with piercing pin cover. Insert piercing pin with twisting motion until shoulder of air filter housing rests against the outlet port flange. Suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber. Attach venipuncture device to set. Open clamp to expel air from set and venipuncture device. Close clamp. Perform venipuncture. Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container in series connections.

No Recall
Baxter Healthcare Corporation

Dextrose | Skinfix, Inc.

Apply balm liberally as needed, especially after bathing.

No Recall
Hospira, Inc.

Dextrose | Hospira, Inc.

Concentrated Dextrose in Water is administered by slow intravenous infusion (a) after admixture with amino acid solutions or (b) after dilution with other compatible IV fluids. Dosage should be adjusted to meet the requirements of each individual patient.

50% and 70% Dextrose Injection, USP in the 2000 mL flexible Pharmacy Bulk Package are designed for use with automated compounding devices for preparing intravenous nutritional admixtures. Dosages will be in accordance with the recommendation of the prescribing physician. 50% and 70% Dextrose Injection, USP are not intended for direct infusion. Admixtures should be made by, or under the direction of, a pharmacist using strict aseptic technique under a laminar flow hood. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration.

The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hr. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)

Drug Interactions

Additives may be incompatible with the fluid withdrawn from this container. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique, mix thoroughly and do not store.

Some opacity of the plastic due to moisture absorption during sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

Recommended Directions for Use of the Pharmacy Bulk Package Use Aseptic Technique

During use, container must be stored, and all manipulations performed, in an appropriate laminar flow hood.

Remove cover from outlet port at bottom of container.

Insert piercing pin of transfer set and suspend unit in a laminar flow hood. Insertion of a piercing pin into the outlet port should be performed only once in a Pharmacy Bulk Package solution. Once the outlet site has been entered, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from transfer set pin or implement insertion is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture.

Sequentially dispense aliquots of 50% or 70% Dextrose Injection, USP into IV containers using appropriate transfer set. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling.

No Recall
Hospira, Inc.

Dextrose | Hospira, Inc.

Concentrated Dextrose in Water is administered by slow intravenous infusion (a) after admixture with amino acid solutions or (b) after dilution with other compatible IV fluids. Dosage should be adjusted to meet the requirements of each individual patient.

The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight /hr. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

A list of nutritional admixture values is appended.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS).
Drug Interaction
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Some opacity of the plastic due to moisture absorption during sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

WARNING: Do not use flexible container in series connections.

No Recall
Hospira, Inc.

Dextrose | Hospira, Inc.

The dose is dependent upon the age, weight and clinical condition of the patient.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Drug Interactions

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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)

INSTRUCTIONS FOR USE

To Open:

Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration.

To Add Medication

Prepare additive port.

Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.

The additive port may be protected by covering with an additive cap.

Mix container contents thoroughly.

Preparation for Administration

(Use aseptic technique)

Close flow control clamp of administration set.

Remove cover from outlet port at bottom of container.

Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: When using a vented administration set, replace bacterial retentive air filter with piercing pin cover. Insert piercing pin with twisting motion until shoulder of air filter housing rests against the outlet port flange.

Suspend container from hanger.

Squeeze and release drip chamber to establish proper fluid level in chamber.

Attach venipuncture device to set.

Open clamp to expel air from set and venipuncture device. Close clamp.

Perform venipuncture.

Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

No Recall
B. Braun Medical Inc.

Dextrose | B. Braun Medical Inc.

This solution is for intravenous use only.

As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations.

Do not use plastic container in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information of the drug to be used.

Addition of medication should be accomplished using aseptic technique in order to assure sterility.

Physicochemical studies have shown that the container and solution can withstand freezing.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Pediatric Use
As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. See WARNINGS and PRECAUTIONS.

No Recall
Cardinal Health

Dextrose | Cardinal Health

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

The dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

Additives may be incompatible. Complete information is not available.

Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

No Recall
Hospira, Inc.

Dextrose | Hospira, Inc.

Concentrated Dextrose in Water is administered by slow intravenous infusion (a) After admixture with amino acid solutions or (b) After dilution with other compatible I.V. fluids. Dosage should be adjusted to meet the requirements of each individual patient.

The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight /hr. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

A list of nutritional admixture values is appended.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

Drug Interaction

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

Some opacity of the plastic due to moisture absorption during sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

WARNING: Do not use flexible container in series connections.

No Recall
Hospira, Inc.

Dextrose | Mylan Specialty L.p.

Selection of the appropriate dosage strength (EpiPen 0.3 mg or EpiPen Jr 0.15 mg) is determined according to patient body weight.
• Patients greater than or equal to 30 kg (approximately 66 pounds or more): EpiPen 0.3 mg • Patients 15 to 30 kg (33 pounds to 66 pounds): EpiPen Jr 0.15 mg
Inject EpiPen or EpiPen Jr intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary.

Each EpiPen or EpiPen Jr contains a single dose of epinephrine for single-use injection. Since the doses of epinephrine delivered from EpiPen or EpiPen Jr are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.

The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. With severe persistent anaphylaxis, repeat injections with an additional EpiPen or EpiPen Jr may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Warnings and Precautions (5.1)].

The epinephrine solution in the clear window of the EpiPen Auto-Injector should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light [see How Supplied/Storage and Handling (16.2)].

No Recall
Durvet

Dextrose | Durvet

The usual dose is 50 mL per 100 lbs. of body weight. It may be injected intravenously, intramuscularly, intraperitoneally or subcutaneously. May be repeated in 8 to 10 hours or on successive days. If administered intramuscularly or subcutaneously, the dosage should be divided among several locations and the point of injection massaged to aid in absorption.

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Cardinal Health

Dextrose | Pd-rx Pharmaceuticals, Inc.

(see INDICATIONS AND USAGE for Indicated Pathogens)

The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, Cefdinir Capsules should be administered twice daily in these infections. Cefdinir Capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration Community-Acquired Pneumonia 300 mg q12h 10 days Acute Exacerbations of Chronic Bronchitis 300 mg q12h
or
600 mg q24h 5 to 10 days

10 days Acute Maxillary Sinusitis 300 mg q12h
or
600 mg q24h 10 days

10 days Pharyngitis/Tonsillitis 300 mg q12h
or
600 mg q24h 5 to 10 days

10 days Uncomplicated Skin and Skin Structure Infections 300 mg q12h 10 days Patients With Renal Insufficiency
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.

Males:                    CLcr = (weight) (140 – age)

                                          (72) (serum creatinine)

Females:                CLcr = 0.85 x above value

where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL6.

The following formula may be used to estimate creatinine clearance in pediatric patients:

                            CLcr = K x body length or height

                                          serum creatinine

where K = 0.55 for pediatric patients older than 1 year7 and 0.45 for infants (up to 1 year)8.

In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.

For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
6 Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41. 7 Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976; 58:259-63. 8 Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984; 104:849-54. Patients on Hemodialysis
Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.

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Durvet

Dextrose | Durvet

The usual dose is 50 mL per 100 lbs. of body weight. It may be injected intravenously, intramuscularly, intraperitoneally or subcutaneously. May be repeated in 8 to 10 hours or on successive days. If administered intramuscularly or subcutaneously, the dosage should be divided among several locations and the point of injection massaged to aid in absorption.

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Vettek

Dextrose | Vettek

For intravenous administration only.

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Baxter Healthcare Corporation

Dextrose | Cantrell Drug Company

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Baxter Healthcare Corporation

Dextrose | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Adult Dosage

Patients 8 years of age and older who have received no previous treatment may be started on primidone according to the following regimen using either 50 mg or scored 250 mg primidone tablets.

Days 1 to 3: 100 to 125 mg at bedtime

Days 4 to 6: 100 to 125 mg b.i.d.

Days 7 to 9: 100 to 125 mg t.i.d.

Day 10 to maintenance: 250 mg t.i.d.

For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg primidone tablets in divided doses (250 mg t.i.d. or q.i.d.). If required, an increase to five or six 250 mg tablets daily may be made but daily doses should not exceed 500 mg q.i.d.
INITIAL: ADULTS AND CHILDREN OVER 8 KEY: * = 50 mg tablet; • = 250 mg tablet DAY 1 2 3 4 5 6 AM ** ** ** NOON PM ** ** ** ** ** ** DAY 7 8 9 10 11 12 AM ** ** ** • Adjust to Maintenance NOON ** ** ** • PM ** ** ** •
Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations of primidone may be necessary for optimal dosage adjustment. The clinically effective serum level for primidone is between 5 to 12 mcg/mL.

In Patients Already Receiving Other Anticonvulsants

Primidone should be started at 100 to 125 mg at bedtime and gradually increased to maintenance level as the other drug is gradually decreased. This regimen should be continued until satisfactory dosage level is achieved for the combination, or the other medication is completely withdrawn. When therapy with primidone alone is the objective, the transition from concomitant therapy should not be completed in less than two weeks.

Pediatric Dosage

For children under 8 years of age, the following regimen may be used:

Days 1 to 3: 50 mg at bedtime

Days 4 to 6: 50 mg b.i.d.

Days 7 to 9: 100 mg b.i.d.

Day 10 to maintenance: 125 mg t.i.d. to 250 mg t.i.d.

For children under 8 years of age, the usual maintenance dosage is 125 to 250 mg three times daily or, 10 to 25 mg/kg/day in divided doses.

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Baxter Healthcare Corporation

Dextrose | Baxter Healthcare Corporation

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

Do not administer unless solution is clear and seal is intact.

All injections in AVIVA plastic containers are intended for intravenous administration using sterile equipment.

The dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

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Animart

Dextrose | Animart

The usual dose is 50 mL per 100 lbs of body weight. Administer intravenously only. Dosage may be repeated in 8 to 10 hours or on successive days if necessary.

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B. Braun Medical Inc.

Dextrose | B. Braun Medical Inc.

This solution is for intravenous use only. Hypertonic, administer only after dilution via central venous catheter.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Dextrose may be administered to normal individuals at a rate of 0.5 g/kg/hour without producing glycosuria. At the maximum infusion rate of 0.8 g/kg/hour, approximately 95% of the dextrose is retained.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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Baxter Healthcare Corporation

Dextrose | Topical Biomedics, Inc.

Apply generously 3-4 times daily or more often as needed 3 inches on and around sunburn/burn area.

Gently massage in until absorbed.

Odorless, soothing and moisturizing.

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Hospira, Inc.

Dextrose | Hospira, Inc.

The dose is dependent upon the age, weight and clinical condition of the patient.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Drug Interactions

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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

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Cardinal Health

Dextrose | Cardinal Health

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

The dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

Additives may be incompatible. Complete information is not available.

Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

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Cardinal Health

Dextrose | Cardinal Health

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

The dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

Additives may be incompatible. Complete information is not available.

Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

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