Proglycem

DRUG DESCRIPTION

PROGLYCEM® (diazoxide) is a nondiuretic benzothiadiazine derivative taken orally for the management of symptomatic hypoglycemia. PROGLYCEM® Capsules contain 50 mg diazoxide, USP. The Suspension contains 50 mg of diazoxide, USP in each milliliter and has a chocolate-mint flavor; alcohol content is approximately 7.25%. Other ingredients: Sorbitol solution, chocolate cream flavor, propylene glycol, magnesium aluminum silicate, carboxymethycellulose sodium, mint flavor, sodium benzoate, methylparaben, hydrochloric acid to adjust pH, poloxamer 188, propylparaben, purified water. Diazoxide has the following structural formula:

PROGLYCEM (diazoxide) Structural Formula Illustration

Diazoxide is 7-chloro-3-methyl-2H-1,2,4-benzothiadiazine 1,1-dioxide with the empirical formula C8H7ClN2O2S and the molecular weight 230.7. It is a white powder practically insoluble to sparingly soluble in water.

What are the possible side effects of diazoxide (Proglycem)?

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

Call your doctor at once if you have a serious side effect such as:

  • shortness of breath, swelling in your hands or feet;
  • rapid pulse;
  • fast or pounding heartbeats;
  • chest pain;
  • blurred vision, eye pain, or seeing halos around lights;
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body...

Read All Potential Side Effects and See Pictures of Proglycem »

What are the precautions when taking diazoxide capsules (Proglycem)?

Before taking diazoxide, tell your doctor or pharmacist if you are allergic to it; or to other thiazides (such as hydrochlorothiazide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood minerals (low potassium blood levels), diabetes, heart disease (such as heart failure, past heart attack), kidney disease, gout, liver disease.

The suspension (liquid) form of this medication contains alcohol. Caution is advised if you have diabetes, liver disease, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor...

Read All Potential Precautions of Proglycem »


Proglycem Consumer (continued)

SIDE EFFECTS: Nausea, loss of appetite, stomach upset, and changes in sense of taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Abnormal growth of body hair, especially on the forehead/back/arms/legs, may occur. This is usually not permanent and will go away when the drug is stopped.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause sodium and water retention which can cause serious heart problems. Tell your doctor immediately if any of these serious side effects occur: swelling of arms/legs/hands/feet, unexplained weight gain, shortness of breath, unusual tiredness.

This medication may cause your blood sugar to become too high. Checking your blood sugar and urine for sugar/ketones regularly and telling your doctor the results will help prevent this side effect. High blood sugar can be very serious and worsen quickly. Tell your doctor immediately if any of these signs of very high blood sugar occur: need to urinate more often, unusual thirst, fruity breath odor, dizziness, unusual weight loss, deep/rapid breathing, extreme drowsiness/confusion, weakness.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, fainting, fast/pounding heartbeat, face/muscle twitching, toe/joint pain, unusual restlessness, muscle cramps/stiffness, shaking (tremor).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking diazoxide, tell your doctor or pharmacist if you are allergic to it; or to other thiazides (such as hydrochlorothiazide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood minerals (low potassium blood levels), diabetes, heart disease (such as heart failure, past heart attack), kidney disease, gout, liver disease.

The suspension (liquid) form of this medication contains alcohol. Caution is advised if you have diabetes, liver disease, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely.

This medication may raise your blood sugar too high under certain conditions. For example, your body may need more insulin while you are under stress due to infection, surgery, or injury. Certain medications (such as corticosteroids like hydrocortisone/prednisone, hormones such as birth control pills) may raise your blood sugar. Your dose may need to be adjusted. Consult your doctor for more details. Tell your doctor immediately if any signs of high blood sugar occur (see Side Effects section).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. If you become pregnant, think you may be pregnant, or plan to become pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Proglycem Patient Information Including Side Effects

Brand Names: Proglycem

Generic Name: diazoxide (oral) (Pronunciation: DYE az OX ide)

  • What is diazoxide (Proglycem)?
  • What are the possible side effects of diazoxide (Proglycem)?
  • What is the most important information I should know about oral diazoxide (Proglycem)?
  • What should I discuss with my health care provider before receiving diazoxide (Proglycem)?
  • How should I take diazoxide (Proglycem)?
  • What happens if I miss a dose (Proglycem)?
  • What happens if I overdose (Proglycem)?
  • What should I avoid while taking diazoxide (Proglycem)?
  • What other drugs will affect diazoxide (Proglycem)?
  • Where can I get more information?

What is diazoxide (Proglycem)?

Diazoxide given orally raises blood sugar by slowing the release of insulin from the pancreas.

Diazoxide is used to treat low blood sugar (hypoglycemia) related to certain cancers that affect the pancreas and cause it to release too much insulin.

Diazoxide may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of diazoxide (Proglycem)?

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

Call your doctor at once if you have a serious side effect such as:

  • shortness of breath, swelling in your hands or feet;
  • rapid pulse;
  • fast or pounding heartbeats;
  • chest pain;
  • blurred vision, eye pain, or seeing halos around lights;
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • urinating less than usual; or
  • feeling like you might pass out.

Less serious side effects may include:

  • temporary increase in growth of body hair (especially in women and children;
  • nausea, vomiting, stomach pain, loss of appetite;
  • diarrhea;
  • decreased sense of taste;
  • headache, dizziness, anxiety;
  • weakness; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about oral diazoxide (Proglycem)?

You should not take this medication if you are allergic to diazoxide or diuretics (water pills). Oral diazoxide should not be used to treat occasional hypoglycemia related to diet.

Before taking diazoxide, tell your doctor if you have congestive heart failure, kidney disease, gout, high cholesterol, or low potassium.

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

If your blood sugar gets too high (hyperglycemia), you may have symptoms such as increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin, nausea, and vomiting. Tell your doctor right away if you have any of these symptoms.

To be sure this medication is helping your condition and not causing harmful effects, your urine will need to be tested often for the presence of glucose (sugar) or ketones. You may be able to do this testing at home. Call your doctor if you have any abnormal test result.

Your doctor may also want you to have blood or urine tests at regular intervals. Do not miss any scheduled appointments.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are taking diazoxide.

If your condition does not improve after taking diazoxide for 2 to 3 weeks, stop taking the medication and talk to your doctor.

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