Gliclada 30mg Krka treatment for diabetes (8 blisters x 15 tablets)

Dosage form Box of 8 blisters x 15 tablets
Specifications Gliclazide

Ingredient

Composition information	Content
Gliclazide	30mg

Uses

indications

Gliclada® 30 mg drug is indicated in the case:

Used to treat diabetes does not depend on insulin (tube 2) in adults, when there is no more control of blood glucose by diet, exercise and weight loss.

Gliclazid reduces blood sugar levels by stimulating insulin secretion from β cells of Langerhans islands. Increasing insulin after eating and C-Peptide secretion still exists after 2 years of treatment.

In addition to the characteristics of metabolism, Gliclazide also has characteristics for blood vessels.

Effective for insulin secretion

In type 2 diabetes, Giiclazid has the effect of restoring the insulin secretion of the head phase in the glucose response and increasing insulin secretion of the second phase. The significant increase in insulin response is observed when there is a stimulation caused by a meal or glucose.

Characteristics for blood vessels

GLICLAZID reduces thrombosis by two mechanisms related to diabetes complications:

Inhibit a part of the gathering and platelet adhesion, with a decrease in the markers during platelet activation (beta thromboglobulin, thromboxane B2).

An activity of endothelial fiber blood tissue with an increase in the activity of TPA.

Pharmacokinetics

absorption

The concentration increases gradually in the first 6 hours, reaching a stable state, maintained from 6 to 12 hours after using the drug.

Gliclazid is easy to absorb through the gastrointestinal tract.

Gliclazid is completely absorbed. Food does not change the speed and level of absorption.

Distribution

about 95% linked to plasma proteins. The distribution volume is about 30 liters. A single dose every day of prolonged Gliclada release maintains the concentration in gliclazid plasma more than 24 hours.

Metabolism

Gliclazid is metabolized mainly in the liver and excreted through urine: less than 1% of the formless form is found in urine. No active metabolites are found in plasma.

Elimination

Sell waste time of gliclazid from 12 to 20 hours.

There is no clinical change in pharmacokinetic parameters in elderly patients.

Before taking Gliclada 30mg Krka treatment for diabetes (8 blisters x 15 tablets)

How to use

Gliclada is taken single dose at breakfast.

Swallow of tablets with water.

Dosage

adults

Daily dose from 30 - 120 mg single dose at breakfast.

Patients must not chew or crush capsules.

If you forget to take medicine, the patient must not increase the dose on the next day.

For medications that cause hypoglycemia, the dosage should be adjusted according to the mechanism of response to each patient (blood sugar, HBA1C).

Starting dose

The starting dose is 30 mg/day.

If blood sugar is controlled, treated with this dose.

If blood sugar is not controlled, increasing the dose to 60 mg, 90 mg or 120 mg/day in the next steps. Between two consecutive dose increases, at least 1 month apart, except for patients with blood sugar not decreased after 2 weeks of treatment. In that case, the dose may increase at the second weekend of the treatment.

Maximum dose of 120 mg/day.

A long -lasting release tablet Gliclada 60 mg is equivalent to 2 long -lasting release tablets Gliclazid 30 mg (Gliclada 30 mg).

Replace Gliclazid 80 mg tablet form (cell formulation in the active ingredient immediately) with a long -lasting release of Gliclada 60 mg

A 80 mg GLICLAZID tablet is equivalent to a long -lasting release of Gliclada 30 mg. It may be replaced but need to be done with careful monitoring of blood sugar.

Replace other oral diabetes medications with a long -lasting release of Gliclada 60 mg

Gliclada can be used to replace other oral diabetes medications.

The dosage and selling time of previous diabetes medications should be calculated when replaced by a long -lasting release of Gliclada 60 mg. It is not necessary to have a period of transition between other drugs to Gliclada.

The starting dose is 30 mg and should consider adjusting the dose to suit the patient's blood glucose response, as described above.

When replacing the Sultonylura medication hypoglycemia with prolonged half -life, stopping treatment with this drug for a few days is necessary to avoid the resonance effect of two products (which can cause hypoglycemia). It is advisable to use the treatment method for initial treatment when switching to treatment with a long -lasting Gliclada, ie a dose of 30 mg/day, teasing is a step -by -step increase depending on the metabolic response.

Combining treatment with diabetes medications

Gliclada extension release may be combined with BiguanID, Alpha-glucosidase or insulin inhibitors.

In patients who are not well controlled with the Gliclada long -lasting release, can be combined with insulin under strict medical supervision.

Special Humanity group

Elderly

Gliclada extended release is indicated as the recommended medication regimen for patients under 65 years old.

Patients with mild to moderate renal failure

For these patients, the drug utensils can be used as in patients with normal kidney function with careful monitoring of patients. These data have been confirmed in clinical trials.

Patients with risk of hypoglycemia

The risk of high hypoglycemia in the following patients:

malnutrition.

Having severe or difficult hormonal disorders (pituitary insertion, hypothyroidism, adrenal impairment).

Due to stopping corticosteroids after prolonged treatment or high doses.

Severe blood vessel disease (severe coronary artery disease, severe artery disease, spreading vascular disease).

Start with a minimum dose of 30 mg/day.

Children and adolescents

There is no clinical research data on efficiency and safety for children and adolescents (under 18 years old).

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when using overdose?

Overdose of Gliclazid causes hypoglycemia.

Common symptoms of hypoglycemia without losing consciousness or no nerve signs are treated by adding carbohydrates, adjusting the dosage of the drug or changing the diet. Closely monitor until the doctor is sure that the patient has surpassed the danger.

Severe hypoglycemic reactions are accompanied by coma, convulsions, neurological disorders that may occur and require immediate emergency hospitalization.

Handling

If the case of coma hypoglycemia (has been diagnosed or suspected) occurs, patients need to be injected quickly with 50 ml intravenous veins of glucose solution (20% to 30%). Then continue to infect dilute glucose solution (10%) at an appropriate speed to maintain blood sugar levels higher than 1 g/l.

Patients should be closely monitored and depending on the condition of the patient during this time, the doctor will decide whether to continue monitoring monitoring is necessary.

Division does not work for patients due to the close connection between gliclazid and plasma protein.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Gliclada® 30 mg, you may experience unwanted effects (ADR).

The frequency is determined as follows:

Very common (≥1/10).

Common (≥1/100 to

Not common (≥1/1,000 to

Rare (≥1/10,000 to

Very rare (

Hypoglycemia

As well as other diabetes sulfamide, treatment with long -lasting Gliclazide tablets can cause hypoglycemia if the meal is irregular, especially skipping meals. The possible symptoms of hypoglycemia include: headache, intense hunger, nausea, vomiting, fatigue, sleep disorders, agitation, aggression, lack of focus, reducing awareness, slow reaction, depression, visual disorders, language, tremor, weakness, sensory disorders, dizziness, sensation of loss, loss of self -control, delusion, seizures, short -hearted heart, shallow heartbeat, shallow heartbeat Vong.

In addition, the signs of an increase in sympathetic activity are: sweating, cold skin, anxiety, tachycardia, hypertension, chest drum, angina and then arrhythmia.

Normally, symptoms will disappear after taking carbohydrates (sugar). However, artificial sweeteners are not effective. Testing with other diabetes sulfamide indicates that hypoglycemia can recur even when measures proven to be initially effective.

If the stage of hypoglycemia is severe or prolonged, and even if temporarily controlled by sugar, medical or emergency treatment is immediately required.

Other undesirable effects

Gastrointestinal disorders include abdominal pain, nausea, vomiting, indigestion, diarrhea, constipation. These symptoms occur not common. It is possible to avoid or minimize the above unwanted effect by taking Gliclazid at breakfast.

The following unwanted effects are reported as rare

Skin and subcutaneous disorders: rash, itching, urticaria, erythema, bullous reaction (Stevens-Johnson syndrome, poisoned epidermal necrosis).

Disorders of blood and lymphatic systems: Hematology changes are very rare, may include anemia, leukopenia, thrombocytopenia, and granulocytes. These disorders will recover when stopping gliclazid.

Liver-dysfunction: Hepatic hyperplation (AST, Alt enzyme alkaline phosphatase), hepatitis. Stop treatment if jaundice appears.

Eye disorders: Air visual disorders can occur, especially when starting treatment, due to changes in blood sugar.

Cases of reduced red blood cells, granulocytes, hemolytic anemia, all hemorrhage and allergic vasculitis have been described for other diabetes sulfons. In cases of other diabetes sulfonylura, observations show that there is an increase in liver enzyme and even impaired liver function (such as cholestasis, jaundice) and hepatitis after stopping the drug or liver failure, leading to death in particular cases.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Gliclada® 30 mg contraindicated drug in the following cases:

Hypersensitivity to gliclazid, other diabetes sulfonylures, sulphonamid drugs, or any excipients.

Type 1.

Diabetes coma and coma, ketone acidosis due to diabetes.

Severe infections, serious injuries, major surgery.

kidney failure or severe liver failure (in these cases, insulin is used by chases).

Miconazol treatment.

Women who are breastfeeding.

Be cautious when using

Hypoglycemia

This drug is only used for patients with a moderate diet (including breakfast). It is important to have a stable amount of carbohydrates regularly to avoid increasing the risk of hypoglycemia if eaten late, the amount of food is absorbed or low carbohydrates. Hypoglycemia can occur in a low or excessive calorie diet, drink alcohol or use in combination with other lowering drugs.

Hypoglycemia may occur after using diabetes sulfonylurine. Some cases may be serious or prolonged. Need to be hospitalized and need to monitor blood sugar for a few days.

Choose the patient carefully, the dosage and the patient's instruction are clearly necessary to reduce the risk of hypoglycemia.

Factors that increase the risk of hypoglycemia:

Patients refuse to cooperate or cannot cooperate (especially older patients).

malnutrition, not eating at the right meal, skipping meals, changing diets or fasting.

Not balanced between exercise and carbohydrates used.

kidney failure.

Severe liver failure.

Overdose Gliclada.

Some endocrine disorders: thyroid disorders, pituitary insertion, adrenal insufficiency.

Use simultaneously with some other drugs.

kidney failure and liver failure

Gliclazid pharmacokinetics and pharmacokinetics may change in patients with severe renal impairment and liver failure. The stage of hypoglycemia occurs for these patients, so the monitoring priority should be given.

Patient information

With symptoms, treatment methods, and influencing conditions are explained to patients and families. Patients need to be notified of the importance of exercise diet, and regularly monitoring blood sugar.

Control of low blood sugar

Hematuria control in diabetics can be affected by any of the following factors: fever, trauma, infection or surgical intervention. In some cases, it is necessary to use insulin.

The hypoglycemic effect of any diabetes medication, including Gliclazid, is impaired over time in these patients may be due to the severity of the severity of diabetes, or due to decrease in response to treatment. This phenomenon is called secondary failure. Different from the first failures, it is when an active ingredient is not effective in the first standard therapy. But first need to consider adjusting the appropriate dose and the compliance with the diet, then arranging the patient to the secondary defeat group.

Testing

Measure hemoglobina1c concentration (HBA1C) or venous blood sugar levels are recommended in evaluation of blood sugar control. Self -monitoring blood sugar may also be helpful. Diabetes sulfonylura can cause hemolytic anemia in patients with G6PD deficiency. Be careful for these patients and consider the replacement of drugs in case of necessity.

excipients

Gliclada release extended lactose. Patients with rare genetic problems: galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not be used.

The ability to drive and operate machinery

Patients should be warned of signs and symptoms of hypoglycemia and should be careful if driving or operating machinery, especially in the early stages of treatment.

Pregnancy

There is no study of the use of gliclazid in pregnant women, and even for other diabetes sulfonylura drugs, there are very little data.

Gliclazid does not cause teratogen on animals.

Diabetes control before pregnancy to minimize risks of birth defects related to uncontrolled diabetes.

Hypoglycemic medication is not suitable for pregnant women. Insulin is the first choice for these patients. Therefore, oral medication for diabetes should be replaced with insulin before pregnancy or as soon as you detect pregnancy.

The period of breastfeeding. Because there is a risk of neonatal hypoglycemia should be contraindicated to gliclazid for breastfeeding women.

Interactive drug

The following drugs increase the risk of hypoglycemia

Contraindications for coordination with

Miconazole (using systemic sugar or gel using oral mucosa): increases hypoglycemic effects, starts with symptoms of hypoglycemia or can cause coma.

Do not recommend

Phenylbutazon (Systemic sugar): Increases the hypoglycemic effect of sulfonylura medications for hypoglycemia (due to replacement associated with plasma proteins and reducing them).

Alcohol: Increasing hypoglycemic reaction (by inhibiting compensation reactions) can lead to the beginning of coma. Do not use alcohol or alcohol -containing drugs.

Collaborate requires preventive measures

In some cases, hypoglycemia may occur when one of the following drugs is used: other diabetes medications (insulin, acarboose, biguanid), β-blockers, fluconazol, inhibit Angiotensin metabolic enzyme (captlil enalapril), H2, MAOS, SULFONAMID, and steroid anti-inflammatory drugs.

The following drugs may be the cause of hyperglycemia

Do not recommend

Danazol: Due to the effect of Danazol's diabetes. If it is impossible to avoid the use of these drugs, warn the patient and emphasize the importance of urine and road monitoring. It is necessary to adjust the dose of diabetes medications during and after treatment with Danazol.

Collaborate requires preventive measures

chlorpromazin (sedative): high doses (> 100 mg per day of chlorpromazin) increases blood sugar levels (reduced insulin release). Warning to the patient and emphasizing the importance of blood sugar monitoring. Need to adjust the dosage of active ingredients for diabetes in and after treatment with sedatives.

Glucocorticoid (used in the body and on -site in the joints, applied to the skin and through the rectum) and tetracosactrin: hyperglycemia caused by fat metabolism (reducing carbohydrates caused by glucocorticoid). Warning to the patient and emphasizing the importance of monitoring blood sugar, especially at the beginning of treatment. Need to adjust the dose of active ingredients to treat diabetes during and after treatment with glucocorticoid.

Ritodrin, Salbutamol, Terbutalin (intravenous injection): Increasing the pathway due to the effects of β2 co -effects. Emphasize the importance of monitoring blood sugar. If necessary, switch to insulin.

Consideration

Anticoagulant treatment (such as Warfarin): Sulfonylura drugs used in diabetes can lead to an increase in the effect of anticoagulants when using, need to adjust the anticoagulant dose.

Storage

Store in a cool dry place, avoid light, temperature below 30 ° C.

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