How the Drug Works

Specially treated tablets (Acetest) or plastic test strips (Chemstrip K, Ketostix) detect the presence of ketones in the urine and blood (Acetest only). Ketones are substances that are formed when the body breaks down fats and carbohydrates for energy or food. When there are too many ketones in the body, they spill over into the urine. Ketones may be found in the urine of people who are fasting, on starvation diets, or in diabetics who have a very high blood sugar level because of lack of insulin. Ketones are not present in normal urine.

Uses

To detect ketones in urine.

To monitor for diabetic ketoacidosis, a complication of diabetes that may lead to diabetic coma. Ketoacidosis occurs in uncontrolled diabetes.

Acetest only - To detect ketones in urine and in blood.

Liver and kidney function tests requiring the administration of phthalein compounds such as bromsulfophthalein, phenolsulfonphthalein (PSP), or phenyl ketones (large quantities) may interfere with the ketone tests.

Specimen Collection and Preparations: Collect fresh urine in clean dry container and test as soon as possible. If testing cannot be done within an hour, refrigerate immediately. Let urine return to room temperature (59° to 86°F) before testing. Mix urine thoroughly before testing. Urine that is not tested right away or use of urine preservatives may affect test results. Storage and handling:

For Acetest tablets - These tablets are stable in the unopened container if stored at temperatures between 59° and 86°F. Protect from heat, moisture, and light. Once opened, stability is decreased with exposure to moisture, heat, and light. The bottle must be recapped promptly after removing a tablet. Tablets should be used on a regular basis and not stored for an extended period of time after the bottle is opened. Tan-to­brown discoloration or darkening of the tablet is an indication of deterioration.

For ChemStrip K-Avoid contact with skin and mucous membranes. Keep unused test strips in the original bottle with the cap tightly closed. ChemStrip Kwill remain stable in the original capped vial until the listed expiration date. To avoid moisture, replace the original stopper, which contains a drying agent, immediately after use. Store at room temperature (59° to 86°F). Protect from heat, moisure, and light. Do not freeze.

For Ketostix-Keep fingers or other objects from touching the reagent area before testing. Store at room temperatures between 59° and 86°F. Protect from heat, moisture, and light. Keep unused test strips in the original bottle with the cap tightly closed. Always replace the cap immediately and tightly. A new bottle can be used for 6 months. Always write the date you first opened the bottle on the bottle label. Do not use the strips after the expiration date has passed. Never transfer strips to another bottle. Do not remove the drying agent from bottle. It absorbs moisture and keeps the strips dry. Never put cotton or other materials in the bottle. If the reagent area becomes discolored or darkened, throw the strip away and use a strip from a new bottle. If using the individual foil-wrapped strips, do not remove strips until just prior to use.

Drug Interactions

Tell your doctor or pharmacist if you are taking or if you are planning to take any over-the-counter or prescription medications or dietary supplements while testing for ketones. The following drugs and drug classes interact with the tests to cause questionable results.

8-hydroxyquinolone

Phthalein compounds (eg, brom sulfophthalein)

Levodopa (eg, Larodopa)

Mesna (eg, Mesnex) tions)

Nitrofurantoin (Furadantin)

Sulfhydryls

Phenazopyridine (eg, Pyridium)

Guidelines for Use

Follow the instructions on the label exactly.

Monitor urine for glucose and ketones as prescribed. Monitor urine ketones especially if your blood glucose level has been more than 250 mg/dL for 2 consecutive blood glucose determinations. Blood glucose monitoring is essential to achieve normal blood sugar levels. Keep track of your blood glucose results so that adjustments in your treatment program can be made more easily.

Ketones are not present in normal urine. Ketones in urine could be a sign of illness, stress, or poor diabetes control. Immediately report any positive test result to your doctor.

Have all of the materials you need before beginning the test: Tesfstrips or tablets, timer (stopwatch or watch with second hand), and a Clean dry container. For Acetest you will need a dropper and a clean, white piece of paper.

Color vision is needed to properly read test results. Have someone else confirm results if in doubt.

If test results seem questionable, confirm that product is within theexpiration date on the bottle. Repeat the test using a new test strip ortablet and fresh urine specimen.

Acetest-When a drop of urine is put onto a tablet, the drop should be absorbed within 30 seconds. If absorption takes more than 30 seconds, the tablets have been exposed to moisture and may not g.ive good results.

As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single result or method.

Patients with diabetes should test for ketones:

When you have a cold, the flu, or any other kind of illness. When your urine sugar test results show you are spilling large amounts of sugar (at least 2% for at least 2 tests in a row or several days).

When you feel the signs of high blood sugar (more than 240mg/dL) or when your blood sugar is well over the range your doctor or educator has set for you.

When you are under unusual physical or emotional stress. Regularly during pregnancy.

Participate in a diabetes education program so that youl1nderstand diabetes and all aspects of its treatment, including diet, exercise, personal hygiene, and how to self-monitor blood glucose.

Diabetes education materials may be obtained through your local chapter of the American Diabetes Association.

Do not use opened or unopened product after expiration date.