PROGLYCEM Capsule / Suspension (2021)

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Teva Pharmaceuticals USA, Inc.

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1. 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 ...

2. 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. ...

3. Indications and Usage

PROGLYCEM (ORAL DIAZOXIDE) is useful in the management of hypoglycemia due to hyperinsulinism associated with the following conditions: <u>Adults:</u> Inoperable islet cell adenoma or carcinoma, or extrapancreatic ...

4. Contraindications

The use of PROGLYCEM 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 ...

5. 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 ...

6.1. General

Treatment with PROGLYCEM should be initiated under close clinical supervision, with careful monitoring of blood glucose and clinical response until the patients condition has stabilized. This usually requires ...

6.2. Information for Patients

During treatment with PROGLYCEM 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 ...

6.3. 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 ...

6.4. 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 ...

6.5. 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 ...

6.6. 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. Reproduction ...

6.7. Pregnancy

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, ...

6.8. 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 ...

6.9. 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 ...

6.10. Pediatric Use

(See INDICATIONS AND USAGE).

7. Adverse Reactions

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 ...

9. Overdosage

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 ...

10. Dosage and Administration

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 patients condition ...

11. 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 suspension, 50 mg/mL, a chocolate-mint ...

12. Animal Pharmacology and/or Animal 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, ...

13. Storage and Handling

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 Capsules and Suspension at 25°C (77°F) ...