Pronunciation:

SOE-dee-um KLOR-ide

Brand Names:

• Sterile Saline Diluent Tip-Lok Syringe
• Syrex

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Parenteral Electrolyte, Sodium

Uses of This Medicine:

Sodium chloride 23.4% injection is used to replenish lost water and salt in your body due to certain conditions (eg, hyponatremia or low salt syndrome). It is also used as an additive for total parenteral nutrition (TPN) and carbohydrate-containing IV fluids.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sodium chloride 23.4% injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of sodium chloride 23.4% injection in geriatric patients.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Congestive heart failure or
• Epilepsy (seizures) or
• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Kidney disease, severe or
• Liver disease (eg, cirrhosis)—Use with caution. May make these conditions worse or increase the chance of side effects occurring.

• Fluid retention (swelling) or
• Hypernatremia (high sodium in the blood)—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. Sodium chloride 23.4% contains aluminum, which may be toxic. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins after it has been diluted.

During the procedure, you will be awake and be asked questions about how you are doing by the health care team. This helps them to react quickly to any problems you might have and to keep side effects to a minimum.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that the medicine is working properly and to check for unwanted effects.

This medicine may cause serious problems (eg, hypokalemia, acidosis, heart failure, pulmonary edema, or fluid retention) and are more likely to occur if sodium chloride is given for a long time or in high doses. Talk to your doctor if you have concerns.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Excessive blood loss

fever

Rare

Anxiety

burning pain in lower abdomen

chest pain, severe

chills

confusion

cough

dizziness

feeling of heat

feeling of warmth in the lips and tongue

headache (severe or dull)

loss of consciousness

nervousness

numbness of the fingertips

pain in lower back, pelvis, or stomach

ringing in the ears

seizures

sweating

thirst (sudden) or salty taste

vision problems

weakness

Incidence not known

Bad smelling discharge from the vagina

bleeding or redness at the injection site

decrease in the amount of urine

decreased urine output

dilated neck veins

extreme tiredness or weakness

full or bloated feeling

increase in bleeding from the uterus

irregular breathing or heartbeat

pain in the lower abdomen

passing of pieces of tissue from the uterus

pressure in the stomach

stomach cramping

swelling of the abdominal or stomach area

swelling of the face, fingers, feet, or lower legs

tightness in the chest

troubled breathing

weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Drowsiness

nausea

usual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Loss of appetite

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.