Syrex

Sodium chloride as a 20% solution is given by injection into the uterus to cause abortion. It is to be administered only by or under the immediate care of your doctor.

This product is available in the following dosage forms:

• Solution

In the U.S.

• Sterile Saline Diluent Tip-Lok Syringe
• Syrex

Available Dosage Forms:

• Solution

Therapeutic Class: Parenteral Electrolyte, Sodium

Sodium chloride as a 20% solution is given by injection into the uterus to cause abortion. It is to be administered only by or under the immediate care of your doctor.

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.

Pregnancy

Breast Feeding

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

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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

• Epilepsy or

• Heart or blood vessel disease or

• High blood pressure (hypertension) or

• Kidney disease—Sodium chloride injection may make these conditions worse or increase the chance of side effects occurring

• Fibroid tumors of the uterus—Large fibroid tumors may cause a problem with injecting sodium chloride into the uterus. Special injection precautions can be taken by the doctor if he knows that you have this type of tumor

• Previous major surgery of the uterus, including a cesarean—Scars in the uterus from any previous surgery of the uterus may increase the chance of medical problems occurring. Special precautions can be taken by the doctor to prevent problems from occurring

Do not have sexual intercourse and avoid using tampons or douches for 2 to 3 weeks after the abortion to allow your body time to heal. This will also help protect you from getting an infection of the vagina or uterus.

Spotting (or slight bleeding from the uterus) is normal after the abortion. This may continue for 2 weeks. Heavier spotting or uterine bleeding should be reported to your health care professional.

Contraception should be considered for the near future because you may ovulate before your first menstrual period. Your first menstrual period will occur 4 to 6 weeks after the abortion.

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:

• Excessive blood loss
• fever

• Anxiety
• burning pain in lower abdomen
• chest pain, severe
• chills
• confusion
• convulsions (seizures)
• coughing
• dizziness
• feeling of heat
• feeling of warmth in lips and tongue
• headache (severe or dull)
• nervousness
• numbness of the fingertips
• pain in lower back, pelvis, or stomach
• ringing in the ears
• shortness of breath
• sweating
• thirst (sudden) or salty taste
• unconsciousness
• vision problems
• weakness

After the procedure is completed, some side effects may occur that need medical attention. Check with your doctor if you notice any of the following side effects:

• Abdominal cramping
• bad smelling discharge from vagina
• bleeding at place of injection
• chills or shivering
• fever
• increase in bleeding from the uterus
• pain in lower abdomen
• passing of pieces of tissue from the uterus
• redness at place of injection

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.