Diazoxide Capsules (Proglycem)
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Diazoxide Capsules (Proglycem)

PROGLYCEM®
(diazoxide) Capsules Suspension, USP

FOR ORAL ADMINISTRATION

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 aches, flu symptoms;
  • urinating less than usual;...

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 »

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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® (diazoxide capsules) may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists.

PROGLYCEM® (diazoxide capsules) 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® (diazoxide capsules) should be considered.

DOSAGE AND ADMINISTRATION

Patients should be under close clinical observation when treatment with PROGLYCEM® (diazoxide capsules) is initiated. The clinical response and blood glucose level should be carefully monitored until the patient's condition has stabilized satisfactory; in most instances, this may be accomplished in several days. If administration of PROGLYCEM® (diazoxide capsules) is not effective after two or three weeks, the drug should be discontinued.

The dosage of PROGLYCEM® (diazoxide capsules) must be individualized based on the severity of the hypoglycemic condition and the blood glucose level and clinical response of the patient. The dosage should be adjusted until the desired clinical and laboratory effects are produced with the least amount of the drug. Special care should be taken to assure accuracy of dosage in infants and young children.

Adults and children

The usual daily dosage is 3 to 8 mg/kg, divided into two or three equal doses every 8 or 12 hours. In certain instances, patients with refractory hypoglycemia may require higher dosages. Ordinarily, an appropriate starting dosage is 3 mg/kg/day, divided into three equal doses every 8 hours. Thus an average adult would receive a starting dosage of approximately 200 mg daily.

Infants and newborns

The usual daily dosage is 8 to 15 mg/kg divided into two or three equal doses every 8 to 12 hours. An appropriate starting dosage is 10 mg/kg/day, divided into three equal doses every 8 hours.

HOW SUPPLIED

PROGLYCEM® (diazoxide capsules, USP), 50 mg, half opaque orange and half clear capsules, branded in black with BNP 6000: bottle of 100 (NDC 0575-6000-01).

PROGLYCEM® (diazoxide capsules) suspension, 50 mg/mL, a chocolate-mint flavored suspension; bottle of 30 ml (NDC 0575-6200-30), with dropper calibrated to deliver 10, 20, 30, 40 and 50 mg diazoxide. Shake well before each use. Protect from light. Store in carton until contents are used. Store in light resistant container as defined in the USP. Store PROGLYCEM® (diazoxide capsules) ® Capsules and Suspension at 25°C (77°F) excursions permitted 15°-30°C (59-86°F). [See USP Controlled Room Temperature].

PROGLYCEM® (diazoxide capsules, USP), manufactured by IVAX Pharmaceuticals, Inc., Miami, Florida 33137. PROGLYCEM® (diazoxide USP), Oral Suspension, manufactured by TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. Suspension Manufactured for: GATE PHARMACEUTICALS Div. of Teva Pharmaceuticals USA Sellersville, PA 18960. FDA Rev date: 12/17/2008

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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.

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 Proglycem (diazoxide capsules) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Since diazoxide is highly bound to serum proteins, it may displace other substances which are also bound to protein, such as bilirubin or coumarin and its derivatives, resulting in higher blood levels of these substances. Concomitant administration of oral diazoxide and diphenylhydantoin may result in a loss of seizure control. These potential interactions must be considered when administering PROGLYCEM® (diazoxide capsules) Capsules or Suspension.

The concomitant administration of thiazides or other commonly used diuretics may potentiate the hyperglycemic and hyperuricemic effects of diazoxide.

Drug/Laboratory Test Interactions

The hyperglycemic and hyperuricemic effects of diazoxide preclude proper assessment of these metabolic states. Increased renin secretion, IgG concentrations and decreased cortisol secretions have also been noted. Diazoxide inhibits glucagon-stimulated insulin release and causes a false-negative insulin response to glucagon.

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

The antidiuretic property of diazoxide may lead to significant fluid retention, which in patients with compromised cardiac reserve, may precipitate congestive heart failure. The fluid retention will respond to conventional therapy with diuretics. It should be noted that concomitantly administered thiazides may potentiate the hyperglycemic and hyperuricemic actions of diazoxide (See DRUG INTERACTIONS and Animal Pharmacology and/or Toxicology).

Ketoacidosis and nonketotic hyperosmolar coma have been reported in patients treated with recommended doses of PROGLYCEM® (diazoxide capsules) usually during intercurrent illness. Prompt recognition and treatment are essential (See OVERDOSAGE), and prolonged surveillance following the acute episode is necessary because of the long drug half-life of approximately 30 hours. The occurrence of these serious events may be reduced by careful education of patients regarding the need for monitoring the urine for sugar and ketones and for prompt reporting of abnormal findings and unusual symptoms to the physician. Transient cataracts occurred in association with hyperosmolar coma in an infant, and subsided on correction of the hyper-osmolarity. Cataracts have been observed in several animals receiving daily doses of intravenous or oral diazoxide.

The development of abnormal facial features in four children treated chronically ( > 4 years) with PROGLYCEM® (diazoxide capsules) for hypoglycemia hyperinsulinism in the same clinic has been reported.

PRECAUTIONS

General

treatment with PROGLYCEM® (diazoxide capsules) should be initiated under close clinical supervision, with careful monitoring of blood glucose and clinical response until the patient's condition has stabilized. This usually requires several days. If not effective in two to three weeks, the drug should be discontinued.

Prolonged treatment requires regular monitoring of the urine for sugar and ketones, especially under stress conditions, with prompt reporting of any abnormalities to the physician. Additionally, blood sugar levels should be monitored periodically by the physician to determine the need for dose adjustment.

The effects of diazoxide on the hematopoietic system and the level of serum uric acid should be kept in mind; the latter should be considered particularly in patients with hyperuricemia or a history of gout.

In some patients, higher blood levels have been observed with the oral suspension than with the capsule formulation of PROGLYCEM® (diazoxide capsules) . Dosage should be adjusted as necessary in individual patients if changed from one formulation to the other. Since the plasma half-life of diazoxide is prolonged in patients with impaired renal function, a reduced dosage should be considered. Serum electrolyte levels should also be evaluated for such patients.

The antihypertensive effect of other drugs may be enhanced by PROGLYCEM® (diazoxide capsules) , and this should be kept in mind when administering it concomitantly with antihypertensive agents.

Because of the protein binding, administration of PROGLYCEM® (diazoxide capsules) with coumarin or its derivatives may require reduction in the dosage of the anticoagulant, although there has been no reported evidence of excessive anticoagulant effect. In addition,

PROGLYCEM® (diazoxide capsules) may possibly displace bilirubin from albumin; this should be kept in mind particularly when treating newborns with increased bilirubinemia.

Laboratory tests

The following procedures may be especially important in patient monitoring (not necessarily inclusive); blood glucose determinations (recommended at periodic intervals in patients taking diazoxide orally for treatment of hypoglycemia, until stabilized); blood urea nitrogen (BUN) determinations and creatinine clearance determinations; hematocrit determinations; platelet count determinations; total and differential leukocyte counts; serum aspartate aminotransferase (AST) level determinations; serum uric acid level determinations; and urine testing for glucose and ketones (in patients being treated with diazoxide for hypoglycemia, semiquantitative estimation of sugar and ketones in serum performed by the patient and reported to the physician provides frequent and relatively inexpensive monitoring of the condition).

Carcinogenesis, mutagenesis, impairment of fertility

No long-term animal dosing study has been done to evaluate the carcinogenic potential of diazoxide. No laboratory study of mutagenic potential or animal study of effects on fertility has been done.

Pregnancy Category C

Reproduction studies using the oral preparation in rats have revealed increased fetal resorptions and delayed parturition, as well as fetal skeletal anomalies; evidence of skeletal and cardiac teratogenic effects in rabbits has been noted with intravenous administration. The drug has also been demonstrated to cross the placental barrier in animals and to cause degeneration of the fetal pancreatic beta cells (See Animal Pharmacology and/or Toxicology). Since there are no adequate data on fetal effects of this drug when given to pregnant women, safety in pregnancy has not been established. When the use of PROGLYCEM® (diazoxide capsules) is considered, the indications should be limited to those specified above for adults (See INDICATIONS), and the potential benefits to the mother must be weighed against possible harmful effects to the fetus.

Non-teratogenic effects

Diazoxide crosses the placental barrier and appears in cord blood. When given to the mother prior to delivery of the infant, the drug may produce fetal or neonatal hyperbilirubinemia, thrombocytopenia, altered carbohydrate metabolism, and possibly other side effects that have occurred in adults.

Alopecia and hypertrichosis lanuginosa have occurred in infants whose mothers received oral diazoxide during the last 19 to 60 days of pregnancy.

Labor and delivery

Since intravenous administration of the drug during labor may cause cessation of uterine contractions, and administration of oxytocic agents may be required to reinstate labor, caution is advised in administering PROGLYCEM® (diazoxide capsules) at that time.

Nursing mothers

Information is not available concerning the passage of diazoxide in breast milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions from diazoxide in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use

(See INDICATIONS).

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

An overdosage of PROGLYCEM® (diazoxide capsules) 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.

CONTRAINDICATIONS

The use of PROGLYCEM® (diazoxide capsules) for functional hypoglycemia is contraindicated. The drug should not be used in patients hypersensitive to diazoxide or to other thiazides unless the potential benefits outweigh the possible risks.

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Diazoxide administered orally produces a prompt dose-related increase in blood glucose level, due primarily to an inhibition of insulin release from the pancreas, and also to an extrapancreatic effect.

The hyperglycemic effect begins within an hour and generally lasts no more than eight hours in the presence of normal renal function.

PROGLYCEM® (diazoxide capsules) decreases the excretion of sodium and water, resulting in fluid retention which may be clinically significant. The hypotensive effect of diazoxide on blood pressure is usually not marked with the oral preparation. This contrasts with the intravenous preparation of diazoxide (see ADVERSE REACTIONS).

Other pharmacologic actions of PROGLYCEM® (diazoxide capsules) include increased pulse rate; increased serum uric acid levels due to decreased excretion; increased serum levels of free fatty acids' decreased chloride excretion; decreased para-aminohippuric acid; (PAH) clearance with no appreciable effect on glomerular filtration rate. The concomitant administration of a benzothiazide diuretic may intensify the hyperglycemic and hyperuricemic effects of

PROGLYCEM® (diazoxide capsules) . In the presence of hypokalemia, hyperglycemic effects are also potentiated.

PROGLYCEM® (diazoxide capsules) -induced hyperglycemia is reversed by the administration of insulin or tolbutamide. The inhibition of insulin release by PROGLYCEM® (diazoxide capsules) is antagonized by alpha-adrenergic blocking agents.

PROGLYCEM® (diazoxide capsules) is extensively bound (more than 90%) to serum proteins, and is excreted in the kidneys. The plasma half-life following I.V. administration is 28 ± 8.3 hours. Limited data on oral administration revealed a half-life of 24 and 36 hours in two adults. In four children aged four months to six years, the plasma half-life varied from 9.5 to 24 hours on long-term oral administration. The half-life may be prolonged following overdosage, and in patients with impaired renal function.

Animal Pharmacology and/or Toxicology

Oral diazoxide in the mouse, rat, rabbit, dog, pig, and monkey produces a rapid and transient rise in blood glucose levels. In dogs, increased blood glucose is accompanied by increased free fatty acids, lactate, and pyruvate in the serum. In mice, a marked decrease in liver glycogen and an increase in the blood urea nitrogen level occur.

In acute toxicity studies the LD50 for oral diazoxide suspension is > 5000 mg/kg in the rat, > 522 mg/kg in the neonatal rat, between 1900 and 2572 mg/kg in the mouse, and 219 mg/kg in the guinea pig. Although the oral LD50 was not determined in the dog, a dosage of up to 500 mg/kg was well tolerated.

In subacute oral toxicity studies, diazoxide at 400 mg/kg in the rat produced growth retardation, edema, increases in liver and kidney weights, and adrenal hypertrophy. Daily dosages up to 1080 mg/kg for three months produced hyperglycemia, an increase in liver weight and an increase in mortality. In dogs given oral diazoxide at approximately 40 mg/kg/day for one month, no biologically significant gross or microscopic abnormalities were observed. Cataracts, attributed to markedly disturbed carbohydrate metabolism, have been observed in a few dogs given repeated daily doses of oral or intravenous diazoxide. The lenticular changes resembled those which occur experimentally in animals with increased blood glucose levels. In chronic toxicity studies, rats given a daily dose of 200 mg/kg diazoxide for 52 weeks had a decrease in weight gain and an increase in heart, liver, adrenal and thyroid weights. Mortality in drug-treated and control groups was not different. Dogs treated with diazoxide at dosages of 50, l00, and 200 mg/kg/day for 82 weeks had higher blood glucose levels than controls. Mild bone marrow stimulation and increased pancreas weights were evident in the drug-treated dogs; several developed inguinal hernias, one had a testicular seminoma, and another had a mass near the penis. Two females had inguinal mammary swellings. The etiology of these changes was not established. There was no difference in mortality between drug-treated and control groups. In a second chronic oral toxicity study, dogs given milled diazoxide at 50, l00, and 200 mg/kg/day had anorexia and sever weight loss, causing death in a few. Hematologic, biochemical, and histologic examination did not indicate any cause of death other than inanition. After one year of treatment, there is no evidence of herniation or tissue swelling in any of the dogs. When diazoxide was administered at high dosages concomitantly with either chlorothiazide to rats or trichlormethiazide to dogs, increased toxicity was observed. In rats, the combination was nephrotoxic; epithelial hyperplasia was observed in the collecting tubules. In dogs, a diabetic syndrome was produced which resulted in ketosis and death. Neither of the drugs given alone produced these effects.

Although the data are inconclusive, reproduction and teratology studies in several species of animals indicate that diazoxide, when administered during the critical period of embryo formation, may interfere with normal fetal development, possibly through altered glucose metabolism. Parturition was occasionally prolonged in animals treated at term. Intravenous administration of diazoxide to pregnant sheep, goats, and swine produced in the fetus an appreciable increase in blood glucose level and degeneration of the beta cells of the Islets of Langerhans. The reversibility of these effects was not studied.

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

During treatment with PROGLYCEM® (diazoxide capsules) the patient should be advised to consult regularly with the physician and to cooperate in the periodic monitoring of his condition by laboratory tests. In addition, the patient should be advised: to take the drug on a regular schedule as prescribed, not to skip doses, not to take extra doses;

  • not to use this drug with other medications unless this is done with the physician's advice;
  • not to allow anyone else to take this medication;
  • to follow dietary instructions;
  • to report promptly any adverse effects (i.e., increased urinary frequency, increased thirst, fruity breath odor);
  • to report pregnancy or to discuss plans for pregnancy.

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

During treatment with PROGLYCEM® (diazoxide capsules) the patient should be advised to consult regularly with the physician and to cooperate in the periodic monitoring of his condition by laboratory tests. In addition, the patient should be advised: to take the drug on a regular schedule as prescribed, not to skip doses, not to take extra doses;

  • not to use this drug with other medications unless this is done with the physician's advice;
  • not to allow anyone else to take this medication;
  • to follow dietary instructions;
  • to report promptly any adverse effects (i.e., increased urinary frequency, increased thirst, fruity breath odor);
  • to report pregnancy or to discuss plans for pregnancy.

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Proglycem Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DIAZOXIDE - ORAL

(dye-uh-ZOX-ide)

COMMON BRAND NAME(S): Proglycem

USES: This medication is used to treat very low blood sugar levels (hypoglycemia). Certain conditions (such as tumor on the pancreas, cancer, leucine sensitivity) can cause the release of too much insulin. Insulin is a natural substance that lowers blood sugar. This drug works by preventing insulin release from the pancreas, helping to return the blood sugar to normal levels. Diazoxide is a thiazide drug, but has no diuretic ("water pill") effects like other thiazides.

Diazoxide should not be used to treat low blood sugar from poor nutrition/diet (functional hypoglycemia).

HOW TO USE: Take this medication by mouth, as directed by your doctor, usually 2 to 3 times daily (every 8 to 12 hours). Your doctor may direct you to follow a special diet for your condition. Consult your doctor, pharmacist, or dietician for more details.

Do not switch between the capsule and suspension form of this medication without talking with your doctor first. Your dose may need to be adjusted. If you are using the suspension, shake the bottle thoroughly before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Do not use the suspension if it has turned a dark color. Discard it. (See Storage section.)

Dosage is based on your weight, medical condition, and response to treatment. You will need to check your blood sugar levels and check your urine for sugar and ketones regularly. Your doctor will adjust the dose based on these tests. Your doctor may change your dose frequently when you first start taking the drug to find the best dose for you. Follow your doctor's directions carefully for dosage and blood/urine testing.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition persists or worsens after 2 to 3 weeks.

Disclaimer

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.

Read the Proglycem (diazoxide capsules) Side Effects Center for a complete guide to possible side effects »

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.

Disclaimer

Proglycem Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: drugs for high blood pressure (such as enalapril, methyldopa, prazosin), "blood thinners" (such as warfarin), phenytoin, certain "water pills" (thiazide diuretics such as hydrochlorothiazide, chlorthalidone).

This medication may interfere with certain laboratory tests (such as a glucagon test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline 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.

NOTES: Do not share this medication with others.

For best results, this medication should be used along with a doctor-approved diet plan. Consult your doctor for more details.

Laboratory and/or medical tests (such as blood sugar, urine sugar/ketones, kidney test, complete blood count, potassium/uric acid levels) should be performed periodically to monitor your progress or check for side effects. This is especially important during times of stress because a dosage adjustment may be needed. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised October 2010. Copyright(c) 2010 First Databank, Inc.

Proglycem Patient Information Including Side Effects

Brand Names: Proglycem

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

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.

Read the Proglycem (diazoxide capsules) Side Effects Center for a complete guide to possible side effects »

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.

Side Effects Centers

Proglycem Patient Information including How Should I Take

What should I discuss with my health care provider before receiving 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 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.

How should I take diazoxide (Proglycem)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with the marked medicine dropper provided, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Diazoxide usually begins to work within 1 hour, and its effects can last up to 8 hours.

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.

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

Store diazoxide at room temperature away from moisture, heat, and light.

Side Effects Centers

Proglycem Patient Information including If I Miss a Dose

What happens if I miss a dose (Proglycem)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Proglycem)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include increased thirst or urination, fruity breath odor, nausea, and vomiting, or feeling like you might pass out.

What should I avoid while taking diazoxide (Proglycem)?

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

What other drugs will affect diazoxide (Proglycem)?

The following drugs can interact with diazoxide. Tell your doctor if you have recently taken any of these:

  • a diuretic (water pill);
  • chlorpromazine (Thorazine);
  • phenytoin (Dilantin);
  • a blood thinner such as warfarin (Coumadin); or
  • drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax).

This list is not complete and there may be other drugs that can interact with diazoxide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about diazoxide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.04. Revision date: 12/15/2010.

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Side Effects Centers

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