Sodium Acetate 400 meq/100mL
Sodium Acetate Injection, USP, 400 mEq/100 mL · INJECTION, SOLUTION, CONCENTRATE · MILLA PHARMACEUTICALS INC.
Sodium Acetate is a injection, solution, concentrate containing sodium acetate injection, usp, 400 meq/100 ml at 400 meq/100mL, taken intravenous. Manufactured by MILLA PHARMACEUTICALS INC..
Key Facts
- Brand Name
- Sodium Acetate
- Generic Name
- Sodium Acetate Injection, USP, 400 mEq/100 mL
- NDC Code (Product)
71357-009- Manufacturer
- MILLA PHARMACEUTICALS INC.
- Strength
- 400 meq/100mL
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA214805
- Marketing Start
- 12/06/2024
Recall History
Coast Quality Pharmacy LLC
Lack of Assurance of Sterility
Baptist Health Medical Towers Pharmacy and Infusion Services
Lack of Sterility Assurance.
Fresenius Kabi USA, LLC
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Sodium Acetate Injection, USP 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
Dosage & Administration
DOSAGE AND ADMINISTRATION Sodium Acetate Injection, USP 40 mEq is administered intravenously only after dilution in a larger volume of fluid . The dose and rate of administration are dependent upon the individual needs of the patient. Serum sodium should be monitored as a guide to dosage. Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of milliequivalents (mEq) of sodium (Na + ) with an equal number of acetate (CH 3 COO - ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. See PRECAUTIONS .
Warnings
WARNINGS Sodium Acetate Injection, USP 40 mEq must be diluted before use. To avoid sodium overload and water retention, infuse sodium-containing solutions slowly. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. Solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Excessive administration of potassium free solutions may result in significant hypokalemia. WARNING: This product contains aluminum that may be toxic. Alu…
Contraindications
CONTRAINDICATIONS Sodium Acetate Injection, USP 40 mEq is contraindicated in patients with hypernatremia or fluid retention.
Adverse Reactions
ADVERSE REACTIONS Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions. See WARNINGS and PRECAUTIONS .
Frequently Asked Questions
What is Sodium Acetate used for?
Sodium Acetate contains Sodium Acetate Injection, USP, 400 mEq/100 mL. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.
Is Sodium Acetate a controlled substance?
Sodium Acetate is not classified as a controlled substance by the DEA.
What is the generic name for Sodium Acetate?
The generic name for Sodium Acetate is Sodium Acetate Injection, USP, 400 mEq/100 mL. There are no other listed brand versions of Sodium Acetate Injection, USP, 400 mEq/100 mL.
What is the NDC code for Sodium Acetate 400 meq/100mL?
The NDC (National Drug Code) for Sodium Acetate 400 meq/100mL is 71357-009, listed by MILLA PHARMACEUTICALS INC..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)