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Dextrose 250 mg/mL Injection, Solution — NDC 70518-4452-00 package photo

Dextrose 250 mg/mL Injection, Solution

by REMEDYREPACK INC. · 1 SYRINGE, PLASTIC in 1 CARTON (70518-4452-0) / 10 mL in 1 SYRINGE, PLASTIC (70518-4452-1)
NDC 70518-4452-00
🏷️ FDA NDC (as labeled) 70518-4452-0 billing pads the package segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Dextrose Monohydrate (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0435-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0437-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0436-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70518-4452-0
Product NDC 70518-4452
11-digit billing NDC 70518445200
Application # NDA019445
SPL Set ID e2638b45-1141-4391-971d-c0dea825e41c
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-22
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DEXTROSE MONOHYDRATE
GCN Seq No 001992
GCN 06880
HICL code 000928
Ingredient (HICL) Dextrose 25 % In Water
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C5
Therapeutic class — intermediate (HIC2) Carbohydrates And/Or Proteins
HIC3 code C5J
Therapeutic class — specific (HIC3) Iv Solutions: Dextrose-Water
AHFS code 40:20.00.00
AHFS class Caloric Agents
FDB label name DEXTROSE 25%-WATER SYRINGE
FDB brand name Dextrose In Water
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 70518-4452-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70518-4452-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerREMEDYREPACK INC.
Application holderHOSPIRA INC
FDA applicationNDA019445 (NDA)
Labeler code70518
First marketedAug 2025
Product typeHuman Prescription Drug
Portfolio1,511 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DEXTROSE 25%-WATER SYRINGE Ingredient Dextrose 25 % In Water
📗 Our plain-language guide HelloPharmacist
  • Dextrose is essentially glucose — sugar — given directly into a vein. In an emergency, it's used to quickly raise dangerously low blood sugar, which can happen with too much insuli...
  • Specific formulations — Infant Dextrose (25%) and Dextrose (25% injection) — are FDA-approved to treat low blood sugar in newborns and infants up to 2 years old. That said, prematu...
  • Is dextrose safe for my baby or newborn?
  • The most common issues are high blood sugar, vein irritation or clotting at the IV site, low sodium in the blood, and infection. More serious — but less common — reactions include...
📖 Read our full Dextrose guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Infant Dextrose 250 mg/mL 00404-9844-10 Henry 1 syringe — — FDA listed —
Dextrose 250 mg/mL 00409-1775-10 Hospira, 1 syringe — — FDA listed —
25% Dextrose Infant 250 mg/mL 51662-1213-01 HF 1 syringe — — FDA listed —
Dextrose 250 mg/mLthis 70518-4452-00 REMEDYREPACK 1 syringe — — FDA listed —
Dextrose 250 mg/mL 71872-7214-01 Medical 1 syringe — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70518-4452-00 You're viewing this 1 SYRINGE, PLASTIC in 1 CARTON (70518-4452-0) / 10 mL in 1 SYRINGE, PLASTIC (70518-4452-1) 2025-08-22 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70518-4452-0, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70518-4452-00, written without dashes as 70518445200. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70518-4452-00, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (4452) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REMEDYREPACK INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 54 words ▾

1 INDICATIONS AND USAGE Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients from birth up to 2 years of age. Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients younger than 2 years old. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Only for intravenous infusion. Do not administer subcutaneously or intramuscularly. ( 2.1 ) The recommended initial dose is 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg).

If clinically indicated, additional single doses of 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg) may be administered. ( 2.2 ) Infusion rate depends on the age, weight, and clinical and metabolic conditions of the patient and concomitant therapy. ( 2.2 ) See full prescribing information for more information on preparation, administration instructions, and dosing considerations.

( 2.1 , 2.2 )

2.1Important Preparation and Administration Instructions Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration. Do not use Dextrose Injection (25%) if the solution is cloudy or the seal has been broken. Obtain blood glucose level prior to administering Dextrose Injection (25%).

However, in cases of emergency, administer Dextrose Injection (25%) promptly without awaiting blood glucose test results. Administer Dextrose Injection (25%) via slow intravenous injection into a central vein to reduce the risk of developing hyperglycemia and to minimize venous irritation [see Warnings and Precautions (5.1 , 5.3 ) ] . Do not administer Dextrose Injection (25%) simultaneously with blood through the same infusion set because pseudoagglutination of red blood cells may occur.

Administer Dextrose Injection (25%) intravenously. Do not administer Dextrose Injection (25%) subcutaneously or intramuscularly. Discard the unused portion.

2.2Recommended Dosage The recommended initial dose of Dextrose Injection (25%) is 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg). If clinically indicated, additional single doses of Dextrose Injection (25%) 250 mg/kg to 500 mg/kg (1 mL/kg to 2 mL/kg) may be administered. Select the appropriate infusion rate based on the age, weight, and clinical and metabolic conditions of the patient.

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 25% (2.5 g/10 mL) (250 mg/mL) of dextrose hydrous, in a clear, colorless solution in a single-dose Ansyr™ Plastic Syringe Injection: 25% (2.5 g/10 mL) (250 mg/mL) of dextrose hydrous in a clear, colorless solution in a single-dose Ansyr™ Plastic Syringe. ( 3 )

⛔ Contraindications 71 words ▾

4 CONTRAINDICATIONS Dextrose Injection (25%) is contraindicated in patients with: Intracranial or intraspinal hemorrhage because Dextrose Injection (25%) can worsen cerebral edema by causing a fluid shift across the blood-brain barrier. Severe dehydration because of the potential to worsen the patient’s hyperosmolar state. Known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ].

Intracranial or intraspinal hemorrhage. ( 4 ) Severe dehydration. ( 4 ) Hypersensitivity to dextrose.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose levels before and after treatment. Use caution when selecting the dosage and injection rate due to the increased risk of hyperglycemia in neonates and low birth weight infants. ( 5.1 ) Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion immediately if reaction occurs.

( 5.2 ) Phlebitis and Thrombosis : Remove catheter as soon as possible if thrombophlebitis develops. ( 2.1 , 5.3 ) Electrolyte Imbalance and Fluid Overload : Monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during administration. ( 5.4 ) Hyponatremia : Monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status.

( 5.5 ) Neonatal Adverse Reactions from Unapproved Maternal Use at Time of Delivery : Maternal hyperglycemia at the time of delivery has been associated with adverse outcomes such as neonatal hypoglycemia.

5.1Hyperglycemia and Hyperosmolar Hyperglycemic State Significant hyperglycemia and hyperosmolar hyperglycemic state may result from too rapid administration of Dextrose Injection (25%). Symptoms of hyperosmolar hyperglycemic state include mental confusion and loss of consciousness. To minimize these risks, slowly inject Dextrose Injection (25%) and monitor blood glucose levels before and after treatment with Dextrose Injection (25%).

Due to the increased risk of hyperglycemia in neonates and low birth weight infants, use caution when selecting the dosage and injection rate of Dextrose Injection (25%).

5.2Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with Dextrose Injection (25%) administration [see Adverse Reactions (6) ] . Stop administration of Dextrose Injection (25%) immediately if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

5.3Phlebitis and Thrombosis Dextrose Injection (25%) is hypertonic (has an osmolarity greater than 900 mOsm/L) and may cause phlebitis and thrombosis at the site of injection. If thrombophlebitis occurs, remove the catheter as soon as possible. Administer Dextrose Injection (25%) via slow intravenous injection into a central vein to reduce the risk of phlebitis and thrombosis.

Ensure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis occurs, stop administration of Dextrose Injection (25%) and initiate corrective measures. If central venous access cannot be obtained in these pediatric patients, consider using an alternative commercially available dextrose product with a lower concentration.

Do not administer Dextrose Injection (25%) subcutaneously or intramuscularly.

5.4Electrolyte Imbalance and Fluid Overload Electrolyte deficits, particularly serum potassium and phosphate, may occur during prolonged use of Dextrose Injection (25%). Depending on the administered volume and the infusion rate, administration of Dextrose Injection (25%) can cause fluid overload, including pulmonary edema. Avoid Dextrose Injection (25%) in patients at risk for fluid and/or solute overload.

If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations, and acid base balance, especially during prolonged use. Additional monitoring is recommended for patients with water and electrolyte disturbances that could be aggravated by increased glucose, insulin administration, and/or free water load.

5.5Hyponatremia Dextrose Injection (25%) may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. The risk of hospital-acquired hyponatremia is increased in younger pediatric patients, and patients treated with diuretics, and patients with cardiac or pulmonary failure or with the syndrome of inappropriate antidiuretic hormone (SIADH) (e.g., postoperativ…

🤒 Adverse Reactions 185 words ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are also described elsewhere in the labeling: Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.1) ] . Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] . Phlebitis and Thrombosis [see Warnings and Precautions (5.3) ] Electrolyte Imbalance and Fluid Overload [see Warnings and Precautions (5.4) ] Hyponatremia [see Warnings and Precautions (5.5) ] The following adverse reactions associated with the use of Dextrose Injection were identified in clinical trials or postmarketing reports.

Because some of these reactions were 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. Administration site conditions: blister, extravasation, phlebitis, erythema, pain, vein damage, thrombosis Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritis, pyrexia, rash Cardiovascular disorders: cyanosis, volume overload The most common adverse reactions are hyperglycemia, hypersensitivity reactions, hyponatremia, infection (both systemic and at the injection site), vein thrombosis, phlebitis, and electrolyte imbalance.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 134 words ▾

7 DRUG INTERACTIONS

7.1Drugs with Effects on Glycemic Control and Electrolyte Balance Dextrose Injection (25%) can affect glycemic control, vasopressin, and fluid and/or electrolyte balance [see Warnings and Precautions (5.1 , 5.4 , 5.5 ) ] . Monitor patients’ blood glucose concentrations, fluid balance, serum electrolyte concentrations, and acid-base balance. Concomitant administration of Dextrose Injection (25%) with drugs associated with hyponatremia may increase the risk of developing hyponatremia.

Drugs associated with hyponatremia include diuretics and those that cause SIADH (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), arginine vasopressin analogs, certain antiepileptic, psychotropic, and cytotoxic drugs). Avoid use of Dextrose Injection (25%) in patients receiving drugs associated with hyponatremia. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5) ] .

👥 Use in Specific Populations 148 words ▾

8 USE IN SPECIFIC POPULATIONS

8.4Pediatric Use Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients from birth up to 2 years of age. Dextrose Injection (25%) can increase the risk of developing hypo- or hyperglycemia in neonates, especially preterm neonates with low birth weight. Excessive or rapid administration of Dextrose Injection (25%) may also result in increased serum osmolality and increase the risk of intracerebral hemorrhage in very low birth weight neonates [see Warnings and Precautions (5.1) ] .

Monitor plasma electrolyte concentrations closely in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Pediatric patients treated with Dextrose Injection (25%) are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4 , 5.5) ] . Dextrose Injection (25%) is not indicated in pediatric patients 2 years of age and older.

🧒 Pediatric Use 143 words ▾

8.4Pediatric Use Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients from birth up to 2 years of age. Dextrose Injection (25%) can increase the risk of developing hypo- or hyperglycemia in neonates, especially preterm neonates with low birth weight. Excessive or rapid administration of Dextrose Injection (25%) may also result in increased serum osmolality and increase the risk of intracerebral hemorrhage in very low birth weight neonates [see Warnings and Precautions (5.1) ] .

Monitor plasma electrolyte concentrations closely in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Pediatric patients treated with Dextrose Injection (25%) are at increased risk of developing hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4 , 5.5) ] . Dextrose Injection (25%) is not indicated in pediatric patients 2 years of age and older.

🆘 Overdosage 94 words ▾

10 OVERDOSAGE A medication error resulting in a high infusion rate of Dextrose Injection (25%) can cause hyperglycemia, hyperosmolality, and adverse effects on fluid and electrolyte balance [see Warnings and Precautions (5.1 , 5.4 )] . Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. In the event of overdosage (overhydration or solute overload) during Dextrose Injection (25%) treatment, discontinue the infusion.

Institute corrective measures such as administration of exogenous insulin, and treat adverse effects on the CNS, respiratory, and cardiovascular systems [see Warnings and Precautions (5.1 , 5.4 )] .

🧬 Clinical Pharmacology 52 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dextrose restores blood glucose levels and provides a source of carbohydrate calories.

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of dextrose have not been fully characterized.

12.3Pharmacokinetics Dextrose is oxidized to carbon dioxide and water.

🧬 Mechanism of Action 16 words ▾

12.1Mechanism of Action Dextrose restores blood glucose levels and provides a source of carbohydrate calories.

📦 How Supplied / Storage and Handling 67 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection, USP (25%) is supplied as a clear, colorless solution in single-dose syringe as follows: NDC: 70518-4452-00 NDC: 70518-4452-01 PACKAGING: 1 in 1 CARTON PACKAGING: 10 mL in 1 SYRINGE, PLASTIC TYPE 2 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

📋 Description 143 words ▾

11 DESCRIPTION Dextrose, USP is chemically designated D-glucose monohydrate, (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water, with the following structural formula: Water for Injection, USP is chemically designated H 2 O. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. Dextrose Injection, USP (25%) is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for intravenous injection.

Each milliliter (mL) of fluid contains 0.25 grams of dextrose, hydrous, which delivers 3.4 kcal/gram (0.85 kcal/mL). The solution has an osmolarity of 1.39 mOsmol/mL (calculation) and the pH range is 3.2 to 6.5. May contain hydrochloric acid and sodium hydroxide for pH adjustment.

The solution contains no bacteriostatic, antimicrobial agent or added buffer (except for pH adjustment) and is supplied in a single-dose Ansyr™ Plastic Syringe. Dextrose is derived from corn. structural formula dextrose, usp

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70518-4451-00 · REMEDYREPACK 70518-4453-00 · REMEDYREPACK →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.