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FDA Drug information

SODIUM CHLORIDE 0.9%

Read time: 1 mins
Marketing start date: 19 Apr 2025

Summary of product characteristics


Indications And Usage

INDICATIONS It is used to regulate the balance of water and electrolytes in the body.

Adverse Reactions

ADVERSE REACTIONS Excessive and rapid infusion can cause water and sodium retention, edema, elevated blood pressure, rapid heart rate, chest tightness, dyspnea, and even acute left heart failure.

Description

INGREDIENTS This product is an isotonic sterilizing aqueous solution of sodium chloride. Chemical Name: Sodium chloride Molecular Formula: NaCl Molecular Weight: 58.44 Osmolality: 260~320 mOsmol/kg.

Dosage And Administration

DOSAGE AND USAGE Intravenous infusion, dosage according to the need of the disease.

Overdosage

DRUG OVERDOSE For those with existing acidosis, a large amount of this product can cause hyperchloric acidosis.

Drug Interactions

DRUG INTERACTIONS Should not be used with drugs with known incompatibility contraindications.

Clinical Pharmacology

PHARMACOLOGY AND TOXICOLOGY Sodium and chlorine are important electrolytes in the body, mainly in the extracellular fluid, and play a very important role in maintaining the normal blood and extracellular fluid volume and osmotic pressure of the human body. The normal serum sodium concentration is 135~145mmol/L, accounting for 92% of the plasma cation and 90% of the total osmotic pressure, so the amount of plasma sodium plays a decisive role in the osmotic pressure. The normal serum chlorine concentration is 98~106mmol/L, which is mainly regulated by the human body through the hypothalamus, posterior pituitary and kidney to maintain the stability of body fluid volume and osmotic pressure.

Pharmacokinetics

PHARMACOKINETICS In the gastrointestinal tract, sodium is absorbed almost entirely through the active transport of intestinal mucosal cells. Sodium is excreted primarily by the kidneys.

Effective Time

20250307

Version

1

Spl Product Data Elements

SODIUM CHLORIDE 0.9% SODIUM CHLORIDE WATER SODIUM CHLORIDE SODIUM CATION CHLORIDE ION

Brand Name

SODIUM CHLORIDE 0.9%

Generic Name

SODIUM CHLORIDE

Product Ndc

85268-801

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL – 0.9% Sodium Chloride 1000 mL Bag Label SC 1000mL Bag

Spl Unclassified Section

SODIUM CHLORIDE INJECTION, USP BAG Sodium Chloride Injection Instructions Please read the instructions carefully and use under the guidance of a physician. Check carefully before use. Do not use if leakage is found, the drug liquid is unclear, or there are visible particles, do not use.

Geriatric Use

MEDICATION IN THE ELDERLY The amount and speed of fluid supplementation should be strictly controlled.

Pediatric Use

MEDICATION IN CHILDREN The amount and speed of fluid supplementation should be strictly controlled.

Pregnancy

MEDICATION IN PREGNANT WOMEN AND LACTATING WOMEN Not clear.

How Supplied

PACKAGE Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve and double plug). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 10O0ml/ bag. Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve double plug, double aseptic packaging). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag.

Storage And Handling

STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] . Protect from freezing.

Precautions

PRECAUTIONS Use with caution in the following cases: CD Edematous diseases, such as nephrotic syndrome, cirrhosis, ascites, congestive heart failure, acute left heart failure, brain edema, and idiopathic edema Acute renal failure, oliguria stage, chronic renal failure, urine volume decreased, and poor response to diuretic drugs Hypertension Hypokalemia Follow-up examination: CD Serum sodium, potassium, chlorine concentration Blood acid-base balance index Kidney function Blood pressure Cardiopulmonary function

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Disclaimer

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