Sterile Saline Diluent Tip-Lok Syringe

Sterile Saline Diluent Tip-Lok Syringe 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

Before using Sterile Saline Diluent Tip-Lok Syringe, you must know all about the risks and complications associated with it. 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: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

Drug Interactions: 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 
• Epilepsy 
• Heart or blood vessel disease 
• High blood pressure (hypertension) 
• 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

To use Sterile Saline Diluent Tip-Lok Syringe properly, you must follow all instructions given by your doctor. During the procedure, you will be awake and 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.

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

In using Sterile Saline Diluent Tip-Lok Syringe, you must be careful and take some precautions as advised by your doctor.

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.

As with many medications, there are several potential side effects associated with Sterile Saline Diluent Tip-Lok Syringe. 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:

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:

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.