Diazoxide-capsules

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.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: need to urinate more often, unusual thirst, fruity breath odor.

PROGLYCEM® (ORAL DIAZOXIDE) is useful in the management of hypoglycemia due to hyperinsulinism associated with the following conditions:

Adults

Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy.

Infants and Children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. PROGLYCEM® may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists.

PROGLYCEM® should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When other specific medical therapy or surgical management either has been unsuccessful or is not feasible, treatment with PROGLYCEM® should be considered.

An overdosage of PROGLYCEM® causes marked hyperglycemia which may be associated with ketoacidosis. It will respond to prompt insulin administration and restoration of fluid and electrolyte balance. Because of the drug's long half-life (approximately 30 hours), the symptoms of overdosage require prolonged surveillance for periods up to seven days until the blood sugar level stabilizes within the normal range. One investigator reported successful lowering of diazoxide blood levels by peritoneal dialysis in one patient and by hemodialysis in another.

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 are allergic to any drugs, or if you have:

• congestive heart failure;
• kidney disease;
• gout;
• high cholesterol or triglycerides; or
• low levels of potassium in your blood (hypokalemia).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take diazoxide.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant before you take diazoxide.

Diazoxide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Frequent and Serious

Sodium and fluid retention is most common in young infants and in adults and may precipitate congestive heart failure in patients with compromised cardiac reserve. It usually responds to diuretic therapy (See DRUG INTERACTIONS).

Infrequent but Serious

Diabetic ketoacidosis and hyperosmolar nonketotic coma may develop very rapidly. Conventional therapy with insulin and restoration of fluid and electrolyte balance is usually effective if instituted promptly. Prolonged surveillance is essential in view of the long half-life of PROGLYCEM® (See OVERDOSAGE).

Other Frequent Adverse Reactions

Hirsutism of the lanugo type, mainly on the forehead, back and limbs, occurs most commonly in children and women and may be cosmetically unacceptable. It subsides on discontinuation of the drug.

Hyperglycemia or glycosuria may require reduction in dosage in order to avoid progression to ketoacidosis or hyperosmolar coma.

Gastrointestinal intolerance may include anorexia, nausea, vomiting, abdominal pain, ileus, diarrhea, transient loss of taste.

Tachycardia, palpitations, increased levels of serum uric acid are common.

Thrombocytopenia with or without purpura may require discontinuation of the drug. Neutropenia is transient, is not associated with increased susceptibility to infection, and ordinarily does not require discontinuation of the drug. Skin rash, headache, weakness, and malaise may also occur.

Other Adverse Reactions Which Have Been Observed Are

Cardiovascular: hypotension occurs occasionally, which may be augmented by thiazide diuretics given concurrently. A few cases of transient hypertension, for which no explanation is apparent, have been noted. Chest pain has been reported rarely. Pulmonary hypertension has been reported in neonates and young infants (see WARNINGS).

Hematologic: eosinophilia; decreased hemoglobin / hematocrit; excessive bleeding, decreased IgG.

Hepato-renal: increased AST, alkaline phosphatase; azotemia, decreased creatinine clearance, reversible nephrotic syndrome, decreased urinary output, hematuria, albuminuria. Neurologic: anxiety, dizziness, insomnia, polyneuritis, paresthesia, pruritus, extrapyramidal signs.

Ophthalmologic: transient cataracts, subconjunctival hemorrhage, ring scotoma, blurred vision, diplopia, lacrimation. Skeletal, integumentary; monilial dermatitis, herpes, advance in bone age; loss of scalp hair. Systemic: fever, lymphadenopathy. Other; gout acute pancreatitis/pancreatic necrosis, galactorrhea, enlargement of lump in breast.

Read the entire FDA prescribing information for Proglycem (Diazoxide Capsules)

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