Sterile Saline Diluent Tip-Lok Syringe (Injection)

Sodium chloride 23.4% injection is used to replace water and salt that your body has lost because of certain conditions (for example, hyponatremia or low salt syndrome). It is also used as an additive in total parenteral nutrition (TPN) and IV fluids that contain carbohydrates.

This medicine should only be given by your doctor or under their supervision.

It is very important for your doctor to monitor your progress closely while you are receiving this medicine to ensure it is working correctly and to check for any side effects.

This medicine may cause serious issues (such as hypokalemia, acidosis, heart failure, pulmonary edema, or fluid retention) and these are more likely to happen if sodium chloride is given for a long time or in high doses. Discuss any concerns with your doctor.

In deciding to use this medicine, you and your doctor will need to think about the risks and benefits. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how sodium chloride 23.4% injection affects children. Its safety and effectiveness have not been established in this age group.

Geriatric

There is no information available on how sodium chloride 23.4% injection affects older patients.

Breast Feeding

Research suggests that this medication poses minimal risk to infants when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there may be an interaction. In those cases, your doctor may want to adjust the dose, or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may impact the use of this medicine. Be sure to tell your doctor about any other medical problems you have, especially:

• Bleeding problems or
• Congestive heart failure or
• Epilepsy (seizures) or
• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Severe kidney disease or
• Liver disease (e.g., cirrhosis)—Use with caution. It may worsen these conditions or increase the chance of side effects.

• 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, and its effects may be stronger due to slower removal from the body.

Along with its intended effects, a medicine can cause some unwanted effects. Not all side effects may happen, but if they do, they might need medical attention.

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

Less common

• Excessive blood loss
• fever

Rare

• Anxiety
• burning pain in lower abdomen
• severe chest pain
• chills
• confusion
• cough
• dizziness
• feeling of heat
• warmth in the lips and tongue
• severe or dull headache
• loss of consciousness
• nervousness
• numbness of the fingertips
• pain in lower back, pelvis, or stomach
• ringing in the ears
• seizures
• sweating
• sudden thirst 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
• increased 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adapts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Sterile Saline Diluent Tip-Lok Syringe
• Syrex

Available Dosage Forms:

• Solution

Therapeutic Class: Parenteral Electrolyte, Sodium

Find detailed information on biosimilars for this medication.

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.

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