Diabeton MV

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

Diabeton is used as a means of controlling blood glucose levels 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 as a tablet for oral administration. It can be used as monotherapy (alone) or in combination with other antidiabetic drugs or insulin.

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

Indications Diabeton MV.

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

Release form

Diabeton is usually available as tablets for oral administration. Tablets 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 hematobiological 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 analysis), analytical methods, pharmacological actions, and pharmacokinetic and pharmacodynamic properties of this drug (Al-Omary, 2017).

Pharmacodynamically, gliclazide acts selectively on the potassium channels of pancreatic beta cells without affecting the cardiovascular K_ATP channels, indicating its safety 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 generally rapidly and completely absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are usually reached 1-4 hours after administration.
2. Distribution: Gliclazide is well distributed into body tissues, including the liver, kidneys, heart, and muscle. It can also cross the placental barrier.
3. Metabolism: Gliclazide is metabolised in the liver to form inactive metabolites. However, the main metabolic pathways and the nature of the metabolites are not fully understood.
4. Elimination: The half-life of gliclazide in the body is approximately 8-12 hours. Most of the dose is excreted via the kidneys as metabolites and unmetabolized drug.

Dosing and administration

1. Directions for use:

   • 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 or she 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 reach 120 mg, but it is recommended to gradually increase the dose under the supervision of a doctor to avoid hypoglycemia.

3. Dosage adjustment:

   • The dose may 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 MV. during pregnancy

Use of gliclazide (Diabeton) during pregnancy requires caution, as data on its safety and efficacy during this period are limited. Key findings from the studies:

• Limited safety data: Gliclazide is commonly used to treat diabetes, 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 too small to draw firm conclusions (Kelty et al., 2020).
• Isolated cases: There are case reports of pregnant women accidentally exposed to gliclazide giving birth to healthy children, although such cases cannot be used as evidence of the safety of the drug (Yaris et al., 2004).

Due to limited data and potential risks, use of gliclazide during pregnancy should be under strict medical supervision. Other, more well-studied methods of blood glucose management during pregnancy are generally recommended.

Contraindications

1. Hypersensitivity to gliclazide: People with known hypersensitivity to gliclazide or any of the components of the drug should avoid its use.
2. Diabetes mellitus type 1: Gliclazide is not recommended for use in patients with diabetes mellitus type 1, which is characterized by insufficient secretion of insulin by the pancreas.
3. Diabetes mellitus requiring insulin therapy: Gliclazide should not be used in patients with diabetes mellitus requiring regular 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 be undesirable in patients with severe or decompensated diabetes mellitus (uncontrolled blood glucose levels), as it may not provide adequate control of sugar levels.
5. Pregnancy and breastfeeding: The use of gliclazide during pregnancy and breastfeeding should be discussed with a doctor, since data on its safety during these periods are limited.
6. Paediatric population: 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 MV.

1. Hypoglycemia: This is the most common side effect of gliclazide. Hypoglycemia is a condition where the blood glucose level is too low, which can cause 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 while taking gliclazide.
4. Allergic reactions: Rarely, allergic reactions such as skin rash, itching, hives or swelling of the face may occur.
5. Cardiovascular reactions: In rare cases, cardiac arrhythmias or changes in blood pressure may occur.
6. Blood reactions: Some patients may experience changes in the blood, such as a mild decrease in platelet count or other bleeding disorders.
7. Increased liver activity: Rarely, increased levels of liver enzymes in the blood may occur.

Overdose

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

Interactions with other drugs

1. Medicines that affect sugar: When gliclazide is used with other medicines that lower blood sugar (such as insulin, sulfonylurea, or metformin), the dose may need to be adjusted to avoid hypoglycemia (low blood sugar).
2. Drugs that affect liver function: Since 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 via cytochrome P450 enzymes.
3. Cardiovascular and neurostimulating drugs: Gliclazide may increase the effects of some cardiovascular and neurostimulating drugs, such as beta-blockers or antidepressants. This may lead to changes in blood pressure or heart rate.
4. Medicines that affect kidney function: Medicines that affect kidney function, such as diuretics or some nonsteroidal anti-inflammatory drugs, may change the rate at which gliclazide is eliminated from the body.