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PROGLYCEM is a brand name for Diazoxide, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PROGLYCEM (diazoxide) is indicated for 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,…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The dosage of PROGLYCEM must be individualized based on the severity of the hypoglycemic condition and the blood glucose level and the 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. 2 Recommended Dose and Dosage Adjustment Adults and Children The usual daily dosage is three to eight (3–8) mg/kg, divided into two or three equal doses every eight 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 eight hours. Thus, an average adult would receive a starting dosage of approximately 200 mg daily.
PROGLYCEM (diazoxide) Page 5 of 20 Infants and Newborns The usual daily dosage is 8 to 15 mg/kg, divided into 2 or 3 equal doses every 8 or 12 hours. An appropriate starting dosage is 10 mg/kg/day, divided into 3 equal doses every 8 hours.
4 Administration Proglycem should be taken orally. Patients should be under close clinical observation when treatment with PROGLYCEM is initiated. The clinical response and blood glucose level should be carefully monitored until the patient’s condition has stabilized satisfactorily; in most instances, this may be accomplished in several days.
If administration of PROGLYCEM is not effective after two or three weeks, the drug should be discontinued. 5 Missed Dose If a dose of Proglycem is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped, and the regular dosing schedule followed.
Doses should not be doubled.
04/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSAGE..............................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 5 7 WARNINGS AND PRECAUTIONS .................................................................................. 7 8 ADVERSE REACTIONS ..................................................................................................
9 9 DRUG INTERACTIONS .................................................................................................. 10 10 CLINICAL PHARMACOLOGY .......................................................................................
10 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 11 PART II: SCIENTIFIC INFORMATION .......................................................................................
11 13 PHARMACEUTICAL INFORMATION ............................................................................ 11 14 CLINICAL TRIALS ........................................................................................................
General Treatment with PROGLYCEM 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 or three weeks, the drug should be discontinued.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Capsule 100 mg Lactose monohydrate, magnesium stearate PROGLYCEM (diazoxide) Page 6 of 20 Cardiovascular Pericardial effusions have been observed infrequently in patients without structural heart disease receiving oral diazoxide in the post-market setting.
Cases have been mostly observed in pediatric patients, including infants. In some cases, resolution of pericardial effusion was observed upon diazoxide discontinuation. Some cases required pericardiocentesis. Pericardial effusions are serious conditions that have the potential to progress to cardiac tamponade.
Patients should be observed for signs and symptoms of pericardial effusion. Endocrine and Metabolism Ketoacidosis and non-ketotic hyperosmolar coma have been reported in patients treated with recommended doses of PROGLYCEM usually during intercurrent illness.
Prompt recognition and treatment are essential (See 5 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 health professional.
In the presence of hypokalemia, the hyperglycemic effects of diazoxide are potentiated. Hepatic/Biliary/Pancreatic PROGLYCEM may possibly displace bilirubin from albumin; this should be kept in mind particularly when treating newborns with increased bilirubinemia.
• The use of PROGLYCEM for functional hypoglycemia is contraindicated. • The drug should not be used in patients hypersensitive to diazoxide or to other thiazides or to any ingredient in the formulation, including any non-medicinal ingredients, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTH, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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11 15 MICROBIOLOGY ........................................................................................................ 11 16 NON-CLINICAL TOXICOLOGY .....................................................................................
11 PATIENT MEDICATION INFORMATION .................................................................................. 14 PROGLYCEM (diazoxide) Page 4 of 20 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS PROGLYCEM (diazoxide) is indicated for the management of hypoglycemia due to hyperinsulinism associated with the […]
Monitoring and Laboratory Tests Prolonged treatment requires regular monitoring of the urine for sugar and ketones, especially under stress conditions, with prompt reporting of any abnormalities to the health professional. Additionally, blood sugar levels should be monitored periodically by the health professional to determine the need for dose adjustment.
Tachycardia, palpitations, increased levels of serum uric acid, particularly in patients with hyperuricemia or a history of gout, thrombocytopenia with or without purpura, and neutropenia have been observed. 1 Adverse Reaction Overview).
Ophthalmologic Transient cataracts occurred in association with hyperosmolar coma in an infant and subsided on correction of the hyperosmolarity. Cataracts have been observed in several animals receiving daily doses of intravenous or oral diazoxide.
Renal 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. PROGLYCEM (diazoxide) Page 7 of 20 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. 4 Drug-Drug Interactions and 16 NON-CLINICAL TOXICOLOGY). Serious skin reactions Post-market cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a serious, life- threatening skin reaction, have been observed in patients taking PROGLYCEM®, including a case with faster onset and greater severity of DRESS upon re-exposure to PROGLYCEM®.
DRESS signs and symptoms usually occur within the first month of treatment. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. PROGLYCEM® should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Rechallenge should not be undertaken. 1 Pregnant Women PROGLYCEM should not be used in women of child-bearing age except in life-threatening situations. 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 the intravenous administration. The drug has also been demonstrated to cross the placental barrier in animals and cause degeneration of the fetal pancreatic beta cells (See 16 NON-CLINICAL 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 in pregnant women is considered, the indications should be limited to those specified above for adults (See 1 INDICATIONS) and the potential benefits to the mother must be weighed against possible harmful effects to the fetus.
2 Breast-feeding Diazoxide may pass into the breast milk of nursing mothers. 3 Pediatrics Pediatrics (birth – up to 18 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of PROGLYCEM in pediatric patients has been established.
Therefore, Health Canada has authorized an indication for pediatric use (see Cardiovascular). 4 Geriatrics No specific data are available for geriatric use. PROGLYCEM (diazoxide) Page 8 of 20