Bioglumin

Bioglumin is indicated in uncomplicated diabetes mellitus of the stable, mild or moderately severe, non-ketotic, maturity-onset type, which cannot be controlled by diet alone. Patients should be carefully selected for Bioglumin therapy. Evaluation of response in patients who qualify as candidates for Bioglumin is a therapeutic trial for a period of at least seven days. During the trial period, the absence of ketonuria together with a satisfactory reduction of glycosuria and hyperglycemia, or maintenance of previously satisfactory control, indicates that the patient is responsive and amendable to control with the drug. However, the development of ketonuria within 24 hours after withdrawal of insulin usually will be indicative of a poor response. The patient is considered non-responsive if he fails to achieve satisfactory lowering of blood sugar levels, fails to obtain objective or subjective clinical improvement and if he develops ketonuria or glycosuria. Insulin is indicated for the therapy of such patients.

Bioglumin is an oral diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin.

Bioglumin is used together with diet and exercise to treat type 2 diabetes. Other diabetes medicines are sometimes used in combination with Bioglumin if needed.

Bioglumin should not be used by itself to treat type 1 diabetes.

Bioglumin may also be used for purposes not listed in this medication guide.

There is no fixed dosage regimen for the management of type 2 diabetes with Bioglumin (Bioglumin) or any other hypoglycemic agent. The patient's blood glucose must be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient's response to therapy.

Short-term administration of Bioglumin (Bioglumin) may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

The total daily dosage is generally taken at a single time each morning with breakfast. Occasionally cases of gastrointestinal intolerance may be relieved by dividing the daily dosage. A LOADING OR PRIMING DOSE IS NOT NECESSARY AND SHOULD NOT BE USED.

Initial Therapy

1. The mild to moderately severe, middle-aged, stable type 2 diabetes patient should be started on 250 mg daily. In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions. Older patients should be started on smaller amounts of Bioglumin (Bioglumin), in the range of 100 to 125 mg daily.
2. No transition period is necessary when transferring patients from other oral hypoglycemic agents to Bioglumin (Bioglumin). The other agent may be discontinued abruptly and Bioglumin started at once. In prescribing Bioglumin, due consideration must be given to its greater potency.

Many mild to moderately severe, middle-aged, stable type 2 diabetes patients receiving insulin can be placed directly on the oral drug and their insulin abruptly discontinued. For patients requiring more than 40 units of insulin daily, therapy with Bioglumin (Bioglumin) may be initiated with a 50 per cent reduction in insulin for the first few days, with subsequent further reductions dependent upon the response.

During the initial period of therapy with Bioglumin, hypoglycemic reactions may occasionally occur, particularly during the transition from insulin to the oral drug. Hypoglycemia within 24 hours after withdrawal of the intermediate or long-acting types of insulin will usually prove to be the result of insulin carry-over and not primarily due to the effect of Bioglumin.

During the insulin withdrawal period, the patient should self-monitor glucose levels at least three times daily. If they are abnormal, the physician should be notified immediately. In some cases, it may be advisable to consider hospitalization during the transition period.

Five to seven days after the initial therapy, the blood level of Bioglumin reaches a plateau. Dosage may subsequently be adjusted upward or downward by increments of not more than 50 to 125 mg at intervals of three to five days to obtain optimal control. More frequent adjustments are usually undesirable.

Maintenance Therapy

Most moderately severe, middle-aged, stable type 2 diabetes patients are controlled by approximately 250 mg daily. Many investigators have found that some milder diabetics do well on daily doses of 100 mg or less. Many of the more severe diabetics may require 500 mg daily for adequate control. PATIENTS WHO DO NOT RESPOND COMPLETELY TO 500 MG DAILY WILL USUALLY NOT RESPOND TO HIGHER DOSES. MAINTENANCE DOSES ABOVE 750 mg DAILY SHOULD BE AVOIDED.

How supplied

RECOMMENDED STORAGE: Store below 86°F (30°C).

Distributed by: Pfizer Labs, Division of Pfizer Inc, NY, NY, 10017

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What is the most important information I should know about Bioglumin?

Do not use this medication if you are allergic to Bioglumin, or if you are in a state of diabetic ketoacidosis. Call your doctor for treatment with insulin.

Before taking Bioglumin, tell your doctor if you have kidney or liver disease, a disorder of your pituitary or adrenal glands, a history of heart disease, or if you are malnourished.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Bioglumin.

Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Signs of blood sugar that is too high (hyperglycemia) may include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your Bioglumin dose.

Bioglumin is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Use Bioglumin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Bioglumin by mouth with breakfast or the first main meal of the day unless your doctor tells you otherwise.
• Bioglumin works best if it is taken at the same time each day.
• Continue to take Bioglumin even if you feel well. Do not miss any doses.
• If you miss a dose of Bioglumin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Bioglumin.

Use: Labeled Indications

Diabetes mellitus, type 2: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Guideline recommendations: First-generation sulfonylureas (eg, Bioglumin) are not recommended treatment options for type 2 diabetes; later generation sulfonylureas with lower hypoglycemic risks (eg, glipizide) are preferred (ADA 2020).

Off Label Uses

Central (neurogenic) diabetes insipidus

Data from a number of case reports and noncontrolled trials in patients with various forms of diabetes insipidus (including neurogenic diabetes insipidus) suggest that Bioglumin may be beneficial for the treatment of central (neurogenic) diabetes insipidus.

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What other drugs will affect Bioglumin?

The following products can lead to hypoglycemia:

The hypoglycemic action of sulfonylurea may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta adrenergic blocking agents. When such drugs are administered to a patient receiving Bioglumin (Bioglumin), the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving Bioglumin (Bioglumin), the patient should be observed closely for loss of control.

Miconazole: A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with intravenous, topical, or vaginal preparations of miconazole is not known.

Alcohol: In some patients, a disulfiram-like reaction may be produced by the ingestion of alcohol. Moderate to large amounts of alcohol may increase the risk of hypoglycemia (ref.l), (ref. 2).

The following products can lead to hyperglycemia:

Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid.

When such drugs are administered to a patient receiving Bioglumin (Bioglumin), the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving Bioglumin (Bioglumin), the patient should be observed closely for hypoglycemia.

Since animal studies suggest that the action of barbiturates may be prolonged by therapy with Bioglumin, barbiturates should be employed with caution.

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What are the possible side effects of Bioglumin?

Body as a Whole: Disulfiram-like reactions have rarely been reported with Bioglumin (Bioglumin).

Central and Peripheral Nervous System: Dizziness and headache.

Hypoglycemia: See PRECAUTIONS and OVERDOSAGE sections.

Gastrointestinal: Gastrointestinal disturbances are the most common reactions; nausea has been reported in less than 5% of patients, and diarrhea, vomiting, anorexia, and hunger in less than 2%. Other gastrointestinal disturbances have occurred in less than 1% of patients including proctocolitis. They tend to be dose-related and may disappear when dosage is reduced.

Liver/Biliary: Cholestatic jaundice and hepatitis may occur rarely, which may progress to liver failure; Bioglumin (Bioglumin) should be discontinued if this occurs. Hepatic porphyria and disulfiram-like reactions have been reported with Bioglumin (Bioglumin).

Skin/Appendages: Pruritus has been reported in less than 3% of patients. Other allergic skin reactions, e.g., urticaria and maculopapular eruptions have been reported in approximately 1% or less of patients. These may be transient and may disappear despite continued use of Bioglumin (Bioglumin); if skin reactions persist the drug should be discontinued.

As with other sulfonylureas, porphyria cutanea tarda and photosensitivity reactions have been reported.

Skin eruptions rarely progressing to erythema multiforme and exfoliative dermatitis have also been reported.

Hematologic Reactions: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, pancytopenia, and eosinophilia have been reported with sulfonylureas.

Metabolic/Nutritional Reactions: Hypoglycemia. Hepatic porphyria and disulfiram-like reactions have been reported with Bioglumin (Bioglumin). See DRUG INTERACTIONS section.

Endocrine Reactions: On rare occasions, Bioglumin has caused a reaction identical to the syndrome of inappropriate antidiuretic hormone (ADH) secretion. The features of this syndrome result from excessive water retention and include hyponatremia, low serum osmolality, and high urine osmolality. This reaction has also been reported for other sulfonylureas.

Bioglumin is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). It belongs to the sulfonylurea class of insulin secretagogues, which act by stimulating β cells of the pancreas to release insulin. Sulfonylureas increase both basal insulin secretion and meal-stimulated insulin release. Medications in this class differ in their dose, rate of absorption, duration of action, route of elimination and binding site on their target pancreatic β cell receptor. Sulfonylureas also increase peripheral glucose utilization, decrease hepatic gluconeogenesis and may increase the number and sensitivity of insulin receptors. Sulfonylureas are associated with weight gain, though less so than insulin. Due to their mechanism of action, sulfonylureas may cause hypoglycemia and require consistent food intake to decrease this risk. The risk of hypoglycemia is increased in elderly, debilitated and malnourished individuals. Bioglumin is not recommended for the treatment of NIDDM as it increases blood pressure and the risk of retinopathy (UKPDS-33). Up to 80% of the single oral dose of chlorpropramide is metabolized, likely in the liver; 80-90% of the dose is excreted in urine as unchanged drug and metabolites. Renal and hepatic dysfunction may increase the risk of hypoglycemia.