Diabeton MV

Diabeton (gliclazide) is a drug that belongs to the sulfonylurea class and is used to treat type 2 diabetes mellitus. Gliclazide helps lower blood sugar levels by stimulating the release of insulin from the pancreas and improving the use of sugar by body tissues.

Diabeton is used as a blood glucose control agent in patients with type 2 diabetes mellitus, especially those who are unable to achieve desired blood sugar control through diet and exercise alone.

Gliclazide is usually available in tablet form to be taken orally. It can be used as monotherapy (in a single form) or in combination with other antidiabetic drugs or insulin.

Like any medicine, gliclazide can cause side effects, including hypoglycemia (low blood sugar), digestive problems, allergic reactions, and others. Therefore, it is important to use it only under the supervision of a physician and follow the dosage and administration recommendations.

Indications Diabeton CF

1. Type 2 diabetes mellitus: Diabetes is used to lower blood glucose levels in patients with type 2 diabetes mellitus, especially those who are unable to achieve desired glycemic levels through diet, exercise, or other medications alone.
2. Prevent complications of diabetes: Controlling blood glucose levels with gliclazide may help prevent or slow the development of complications such as diabetic retinopathy, diabetic nephropathy, diabetic neuropathy, and cardiovascular disease.
3. Combination treatment: Gliclazide may be used in combination with other antidiabetic drugs such as metformin, sulfonylureides, DPP-4 inhibitors or insulin to achieve better blood glucose control.

Release form

Diabeton is usually available in tablet form to be taken orally. Tablets can come in different strengths, usually 30 mg or 60 mg.

Pharmacodynamics

Gliclazide (Diabeton) is a second-generation drug from the sulfonylurea class and is used to treat type 2 diabetes mellitus. It stimulates insulin secretion from pancreatic beta cells by inhibiting ATP-dependent potassium channels. In addition, gliclazide has unique antioxidant properties and other beneficial hemobiological effects. This profile is a comprehensive description of the physical properties, chemical synthesis, spectroscopic characterization (FTIR, 1H NMR, 13C NMR, UV and X-ray diffraction), analytical methods, pharmacological actions, and pharmacokinetic and pharmacodynamic properties of the specified drug (Al-Omary, 2017).

Pharmacodynamically, gliclazide acts selectively on potassium channels of pancreatic beta cells without affecting cardiovascular K_ATP channels, which indicates the safety of its use in patients with coronary heart disease. In addition, gliclazide demonstrates the ability to inhibit key mechanisms in the development of diabetic angiopathy, independent of glucose control (Schernthaner, 2003).

Pharmacokinetics

1. Absorption: Gliclazide is usually rapidly and completely absorbed from the gastrointestinal tract after oral administration. Maximum plasma concentrations are usually achieved 1-4 hours after administration.
2. Distribution: Gliclazide is well distributed in body tissues, including the liver, kidneys, heart and muscles. It can also cross the placental barrier.
3. Metabolism: Gliclazide is metabolized in the liver to form inactive metabolites. However, the main metabolic pathways and the nature of the metabolites are not fully understood.
4. Excretion: The half-life of gliclazide from the body is about 8-12 hours. Most of the dose is excreted through the kidneys in the form of metabolites and unmetabolized drug.

Dosing and administration

1. Method of application:

   • Diabeton tablets should be taken during meals or immediately before meals.
   • Swallow the tablet whole with a glass of water. Do not break, chew or crush the tablet.

2. Dosage:

   • The dosage of Diabeton may depend on many factors, including the severity of diabetes, the patient's general condition and other medications he is taking.
   • The usual starting dosage for adults is 30 mg once or twice daily, before breakfast and/or before dinner.
   • The maximum daily dose can be up to 120 mg, but it is recommended to gradually increase the dose under the supervision of a physician to avoid hypoglycemia.

3. Dosage adjustment:

   • The dose can be adjusted by the doctor depending on the patient's blood glucose level.
   • Periodic monitoring of blood glucose levels and consultation with a doctor will help determine the optimal dosage.

Use Diabeton CF during pregnancy

The use of gliclazide (Diabeton) during pregnancy requires caution, as data on its safety and effectiveness during this period are limited. Key findings from the research:

• Limited safety data: Gliclazide is often used to treat diabetes mellitus, but information on its safety during pregnancy is limited. One study found no significant increase in maternal hospitalizations or adverse neonatal outcomes when compared with metformin, but the number of exposed pregnancies was insufficient to draw definitive conclusions (Kelty et al., 2020).
• Isolated Cases: There is documentation of individual cases where pregnant women accidentally exposed to gliclazide gave birth to healthy children, although such cases cannot be used to demonstrate the safety of the drug (Yaris et al., 2004).

Due to limited data and potential risks, the use of gliclazide during pregnancy should be under strict medical supervision. It is generally recommended that other, more established methods of blood glucose management be preferred during this period.

Contraindications

1. Hypersensitivity to gliclazide: People with a known hypersensitivity to gliclazide or any of the components of the drug should avoid its use.
2. Type 1 diabetes mellitus: Gliclazide is not recommended for use in patients with type 1 diabetes mellitus, which is characterized by insufficient insulin secretion from the pancreas.
3. Diabetes mellitus requiring insulin therapy: Gliclazide should not be used in patients with diabetes mellitus requiring chronic insulin therapy as it may not be effective enough to control blood sugar levels in such cases.
4. Severe or decompensated diabetes mellitus: The use of gliclazide may not be advisable in patients with severe or decompensated diabetes mellitus (uncontrolled blood glucose levels) as it may not provide sufficient control of sugar levels.
5. Pregnancy and breastfeeding: The use of gliclazide during pregnancy and breastfeeding should be discussed with your doctor as data on its safety during these periods are limited.
6. Children's age: The use of gliclazide in children requires special caution and should be carried out under medical supervision.
7. Use with other medications: Before using gliclazide in combination with other medications, you should consult your doctor to ensure there are no potential interactions.

Side effects Diabeton CF

1. Hypoglycemia: This is the most common side effect of gliclazide. Hypoglycemia is a condition where blood glucose levels are too low and can present with symptoms such as hunger, sweating, trembling, mental agitation, weakness and even loss of consciousness.
2. Digestive disorders: Some patients may experience stomach upset, nausea, vomiting, diarrhea, or constipation.
3. Headache and dizziness: Some patients may experience headache or dizziness when taking gliclazide.
4. Allergic reactions: Rarely, allergic reactions such as skin rash, itching, hives, or swelling of the face may occur.
5. Cardiovascular reactions: Rarely, cardiac arrhythmias or changes in blood pressure may occur.
6. Blood reactions: Some patients may experience changes in the blood, such as a slight decrease in the number of platelets or other blood clotting disorders.
7. Increased liver function: Rarely, increased levels of liver enzymes in the blood may occur.

Overdose

1. Hungeriness and dizziness.
2. Weakness and drowsiness.
3. Excessive sweating.
4. Anxiety or irritability.
5. Throbbing headache.
6. Unsteadiness or loss of consciousness.

Interactions with other drugs

1. Drugs that affect sugar: When gliclazide is used concomitantly with other drugs that lower blood sugar (such as insulin, sulfonylureas, or metformin), a dosage adjustment may be necessary to avoid hypoglycemia (low blood sugar).
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2. Drugs affecting liver function: Because gliclazide is metabolized in the liver, drugs that affect liver function may alter the concentration of gliclazide in the blood. This includes some antibiotics, antifungals, and other drugs metabolized through cytochrome P450 enzymes.
3. Drugs affecting the cardiovascular and nervous system: Gliclazide may enhance the effect of certain drugs affecting the cardiovascular and nervous system, such as beta-blockers or antidepressants. This may cause changes in blood pressure or heart rate.
4. Drugs that affect kidney function: Drugs that affect kidney function, such as diuretics or some non-steroidal anti-inflammatory drugs, may change the rate at which gliclazide is eliminated from the body.