Proglycem

Proglycem oral suspension is used in adults and children to treat low blood sugar (hypoglycemia) caused by conditions where the body produces too much insulin.

Another form of diazoxide, Vykat XR (diazoxide choline) extended-release tablet is used to help control extreme hunger and constant food cravings (hyperphagia) in adults and children who are at least 4 years old with Prader-Willi syndrome (PWS).

Proglycem may also be used for purposes not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your dose needs may change if you switch to a different brand, strength, or form of Proglycem. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.

Proglycem oral suspension is usually taken every 8 to 12 hours. Take the medicine at the same time intervals each day.

Proglycem extended-release tablets are usually taken once per day with or without food, at the same time each day.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Swallow the extended-release tablet whole and do not crush, chew, or break it.

Doses are based on weight. Your dose may change if you gain or lose weight.

Do not change your dose or stop using a medicine without your doctor's advice.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests. Your treatment may change or be delayed based on the results.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Proglycem.

Proglycem is only part of a treatment program that may also include diet. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat. Store the oral suspension in the original carton, protect from light.

Keep the extended-release tablet bottle tightly closed when not in use.

You should not take Proglycem to treat occasional low blood sugar caused by diet.

Proglycem may cause high blood sugar (hyperglycemia), which can sometimes lead to a serious condition called diabetic ketoacidosis. Call your doctor right away if you have nausea, vomiting, stomach pain, weakness, tiredness, trouble breathing, increased thirst, increased urination, dry mouth, fruity breath odor.

You may develop fluid retention in your body. Tell your doctor right away if you have shortness of breath (even while lying down), swelling, or rapid weight gain (especially in your face and midsection).

You should not use this medicine if you are allergic to Proglycem or to certain diuretics such as hydrochlorothiazide, chlorthalidone, and others.

You should not take Proglycem to treat occasional low blood sugar caused by diet.

Tell your doctor if you have or have ever had:

• heart problems;
• diabetes or prediabetes;
• gout;
• swelling in your legs and other parts of the body;
• if you have a planned surgery;
• if you are sick or dehydrated;
• if you drink large amounts of alcohol; or
• liver or kidney disease.

Using Proglycem may increase the risk of developing pulmonary hypertension in newborns and infants. Ask your doctor about this risk.

It is not known if Proglycem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Proglycem may cause serious side effects. Call your doctor right away if you experience:

• blurred vision, eye pain or redness, seeing halos around lights;
• nausea, vomiting, stomach pain, weakness, trouble breathing;
• fluid build-up in or around the lungs—feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold and clammy skin, anxiety, rapid heartbeats;
• fluid retention—shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection); or
• high blood sugar—increased thirst, increased urination, dry mouth, fruity breath odor.

Your treatment may change, be delayed, or be permanently stopped if you experience certain side effects.

Common side effects of Proglycem may include:

• severely high blood sugar;
• pounding heartbeats or fluttering in your chest;
• swelling in your hands or feet, puffiness in your face;
• increased body hair growth;
• abnormal blood tests;
• rash, headache, weakness, feeling unwell;
• nausea, vomiting, stomach pain, loss of appetite, diarrhea;
• high sugar in your urine and blood; or
• decreased sense of taste.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Drinking alcohol may increase certain side effects of diazoxide.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines work less effectively.

Tell your doctor about all your other medicines, especially:

• steroids;
• phenytoin;
• growth hormones;
• insulin or oral diabetes medicine; or
• a diuretic (water pill).

This list is not complete. Other drugs may affect Proglycem, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.