Bula do remedy Diabinese

the package insert of the medicine Diabinese. Therapeutic class of Oral hypoglycemics. Active principlesClorpropamida.

what For?

Diabinese is indicated for use in association with a diet to reduce the blood glucose in patients with Diabetes mellitus not dependent on insulin (DMNDI, type II ), formerly known as diabetes adult type, whose hyperglycemia can not be controlled with the isolated use of the diet.

Contraindications

When should I not use?

Diabinese is contraindicated for patients with:
.known hypersensitivity to the drug;
.diabetic ketoacidosis with or without coma. This condition must be treated with insulin;
.Diabetes mellitus insulin dependent (formerly known as juvenile).

Dosage

How to use?

the initial Treatment:
The diabetic patients stable middle-age, with diabetes mellitus non-insulin dependent (DMNDI) of mild to moderately severe, it should start with a daily dose of 250mg (one tablet). Due to the fact that diabetic patients geriatric appear to be more sensitive to the hypoglycemic effect of sulfonylureas, treatment should be started with lower doses of Diabinese: 125 mg daily. You do not need a period of transition when transferring patients using other oral hypoglycemics to Diabinese. The medicine earlier may be discontinued at any time, and the clorpropamida started immediately. To prescribe the clorpropamida, should be given due consideration, the greater their power. The vast majority of patients of middle age with diabetes stable, mild or moderately severe, in treatment with insulin, can pass the direct use of the oral drug, with discontinuation of immediate insulin. In patients requiring more than 40 units daily of insulin, Diabinese may be
started with a 50% reduction of insulin during the first few days, with subsequent reductions depending on the response.

During the period of withdrawal of insulin, the patient should be subjected to urine testing for detection of glucose and ketone bodies at least three times a day, and the results should be reported frequently to the doctor. In the case of abnormal results, the doctor should be notified immediately. In some cases it is advisable to consider hospitalization during the transition period.

Five to seven days after the beginning of treatment, the serum levels of clorpropamida reaches a plateau. The dosage may subsequently be adjusted to increase or decrease, being that the increases should not be higher than the 50-125 mg at intervals of three to five days to obtain optimal control. Adjustments more frequent in general are not advisable.

maintenance Therapy:
Most of the patients of middle age with diabetes (DMNDI) stable moderately severe is controlled with approximately 250mg daily (one pill). Several researchers have found that some patients with diabetes of less intensity are well controlled with daily doses of 125 mg (1/2 tablet) or less. Many of the diabetic patients more serious may require 500 mg daily (two tablets) to a suitable control.

PATIENTS WHO do NOT RESPOND ADEQUATELY TO the DOSE OF 500 MG DAILY will USUALLY NOT RESPOND TO HIGHER DOSES.

Doses of more maintenance than the 750mg daily (three tablets) should be avoided.

Side Effects

What are the evils that can cause me?

The majority of adverse reactions is associated with the dose, it is transient and responds well to dose reduction or withdrawal of the drug. However, clinical experience has hitherto shown that, as with other sulfonylureas, some side effects associated with hypersensitivity may be severe, and some fatalities were reported.

Reactions gastrointestinal: cholestatic jaundice-cholestatic rarely can occur. If it occurs, Diabinese should be discontinued. The most common reactions are gastrointestinal disorders; less than 5% of patients have reported nausea and less than 2%, diarrhea, vomiting, anorexia, and increased appetite. Other gastrointestinal disorders have occurred in less than 1% of patients. These disorders tend to be associated with the dose and may disappear with reduction of the same.

Reactions dermatological: pruritus has been reported in less than 3% of the patients. Other reactions and skin allergic reactions, such as hives and rashes maculopapulares have been reported in approximately 1% or less of the patients. These reactions may be transient and disappear even though Diabinese continue to be used; if the reactions of the skin persist, the medication should be stopped. Porphyria cutaneous late reactions and photosensitivity have been reported with the use of sulfonylureas. Skin rashes that progress to erythema multiforme and exfoliative dermatitis have also been reported.

Reactions hematologic: leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.

metabolic Reactions: hepatic porphyria reactions and type disulfiram have been rarely reported with the use of Diabinese (See “Drug Interactions”).

Reactions endocrine: on rare occasions, Diabinese caused a reaction identical to the syndrome of secretion of inappropriate antidiuretic hormone. The features of this syndrome result from excessive water retention and include hyponatremia, low serum osmolality, and high urinary osmolality. This reaction has also been reported with other sulfonylureas.

Warnings and Precautions

what should I know before using?

General
Hypoglycemia: all sulfonylureas are capable of producing hypoglycemia severe. Selection of patients, dosage, and proper administration are important to prevent cases of hypoglycemia.

renal or hepatic Insufficiency may cause high blood levels of clorpropamida, and this also decreases the ability of gluconeogenesis, which can increase the risk of serious reactions hipoglicêmicas. Elderly patients, debilitated or malnourished, and those with adrenal insufficiency or pituitary, are particularly susceptible to the action hipoglicêmica of drugs reducing of glucose. Hypoglycemia can be difficult to be recognized in the elderly and in people under drugs blocking beta-adrenergic. Hypoglycemia commonly occurs when the deficiency of calorie intake, after intense workouts and prolonged during alcohol intake, or when it is administered more than a drug reduction of glucose.

Due to the long half-life of clorpropamida, patients who become hipoglicêmicos during treatment with Diabinese need a careful supervision of dosage and intervals of feeding at least three to five days. Hospitalization and glucose intravenous may be required.

Loss of control of blood glucose: when a patient is diabetic, stabilized under any treatment and exposed to conditions such as fever, trauma, infection, or surgery, there may be loss of control of blood glucose. In such cases it will be necessary to stop the use of Diabinese and administer insulin.

With the passing of time, the effectiveness of any hipoglicemiante oral decreases in many patients, including Diabinese, which may be due to disease progression or decrease in response to the drug. This phenomenon is considered as secondary failure to distinguish it from primary failure in which the drug is ineffective in an individual patient when the same is administered for the first time.

Information to the Patient: The patient should be informed of the potential risks and advantages of Diabinese and of alternative treatments. It must also be oriented about the importance of diet, regular exercises and tests of the dosage of sugar in the blood and urine. The risk of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. The failures of primary and secondary must also be reported. The patient should be instructed to immediately seek your doctor if there are any symptoms of hypoglycemia or other adverse reactions.

Effects on Ability to Drive and Operate Machinery
The effect of Diabinse on the ability to drive and operate machinery has not been studied.

However, there is no evidence to suggest that Diabenese can affect these skills.

Laboratory Tests
Examinations of sugar in the blood and urine should be done periodically. The dosage of hemoglobin glicosilada can be useful.

Carcinogenesis, mutagênese, disorders of fertility
Studies of chronic toxicity have been carried out in dogs and rats. The dogs were treated by six, thirteen or twenty months with doses of Diabinese twenty times greater than for humans, not having presented major histological alterations or pathological. After the treatment with 100mg/kg of Diabinese, for twenty months, a dog of no known pathological changes in liver. The rats treated continuously for six to twelve months, showed various degrees of inhibition of spermatogenesis, in high doses (up to 125mg/kg). The degree of inhibition seemed to occur shortly after the retardation in growth, when administered high doses of Diabinese in rats for prolonged periods of time.

Usage in pregnancy
Teratogenic effects: No studies have been conducted on animal reproduction with Diabinese.

it is Also not known quaended Diabinese can cause disorder of the fetus when administered during pregnancy, or if it can affect reproductive capacity. Diabinese should only be administered during pregnancy if it is really necessary. Because recent information suggests that the levels of change of sugar in the blood during pregnancy are associated with an increased incidence of irregularities, congenital, many experts recommend use of insulin during pregnancy to maintain glucose levels as close to normal as possible.

Effects non-teratogenic: Hypoglycemia severe prolonged (4 to 10 days) has been reported in newborns of mothers who received sulfonylureas at the time of the birth. This has most often been reported with the use of agents with half-lives prolonged. If Diabinese is used during pregnancy, it should be discontinued at least one month before the expected date of birth.

Use in nursing mothers
An analysis of the composition of two samples of breast milk, each taken five hours after ingestion of 500mg of clorpropamida by a patient, revealed a concentration of 5 mcg/ml. For reference, the peak normal blood after the ingestion of a single dose of 250mg of clorpropamida is 30 mcg/ml. Therefore, it is not recommended that women breastfeed while taking the medication.

Use in children
Still have not been established safety and effectiveness of Diabinese in children.

Overdose

what to do if someone use a larger amount than is recommended?

pre-clinical Testing has determined the oral LD50 of 1675 mg/kg for mice, 800 mg/kg in dogs, and 2390 mg/kg in rats.

Signs and symptoms:
The overdosage of sulfonylureas including Diabinese, can cause hypoglycemia severe.

Although little frequent, severe hypoglycemia can cause coma, convulsions or neurological disorders.

Treatment:
Symptoms of hypoglycaemia mild without loss of consciousness or neurological symptoms should be treated aggressively with glucose orally and adjustment in drug dosage and/or in the feeding pattern. Careful medical observation should be made to ensure that the patient is out of danger.

Reactions hipoglicêmicas severe with seizures, coma, or other neurological disorders do not occur with frequency, but should be considered as medical emergencies requiring immediate hospitalization. If there is a suspicion or if it is diagnosed hypoglycaemic coma, the patient should receive a rapid intravenous injection of a solution of sugar concentrated (50%).

This procedure must be followed by a continuous infusion of solution sugar more dilute (10%), a rate of infusion that you keep levels of blood glucose above 100mg/dl. These patients should be carefully observed for a minimum period of 24 to 48 hours, because hypoglycaemia may occur after apparent clinical improvement.