Glicla-Natrapharm

Glicla-Natrapharm Uses, Dosage, Side Effects, Food Interaction and all others data.

Glicla-Natrapharm stimulates the release of insulin from pancreatic beta-cells by facilitating Ca++ transport across the beta-cell membranes. It lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Extrapancreatic effects also may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. Two extrapancreatic effects shown to be important in the action of Glicla-Natrapharm are an increase in insulin sensitivity and a decrease in hepatic glucose production. The anti-oxidant, platelet inhibiting and fibrinolytic actions of Glicla-Natrapharm involve processes which have been implicated in the pathogenesis of vascular complications of type 2 diabetes.

Based on the pharmacological properties, gliclazide is a second generation sulphonylurea which acts as a hypoglycemic agent. It stimulates β cells of the islet of Langerhans in the pancreas to release insulin. It also enhances peripheral insulin sensitivity. Overall, it potentiates insulin release and improves insulin dynamics.

Trade Name Glicla-Natrapharm
Generic Gliclazide
Gliclazide Other Names Gliclazida, Gliclazide, Gliclazidum
Type
Formula C15H21N3O3S
Weight Average: 323.41
Monoisotopic: 323.130362722
Protein binding

94%, highly bound to plasma proteins

Groups Approved
Therapeutic Class Sulfonylureas
Manufacturer
Available Country Philippines
Last Updated: September 19, 2023 at 7:00 am
Glicla-Natrapharm
Glicla-Natrapharm

Uses

Glicla-Natrapharm is used for control of blood glucose in patients with non-insulin dependent diabetes mellitus (Type-II, maturity onset diabetes mellitus) whose hyperglycemia cannot be controlled by diet alone.

Glicla-Natrapharm is also used to associated treatment for these conditions: Type 2 Diabetes Mellitus

How Glicla-Natrapharm works

Glicla-Natrapharm binds to the β cell sulfonyl urea receptor (SUR1). This binding subsequently blocks the ATP sensitive potassium channels. The binding results in closure of the channels and leads to a resulting decrease in potassium efflux leads to depolarization of the β cells. This opens voltage-dependent calcium channels in the β cell resulting in calmodulin activation, which in turn leads to exocytosis of insulin containing secretorty granules.

Dosage

Glicla-Natrapharm dosage

Adult: The usual initial dose of Glicla-Natrapharmis 40 to 80 mg daily, gradually increased, if necessary up to 320 mg daily until adequate control is achieved. A single dose should not exceed 160 mg. When higher doses are required it should be taken twice daily, according to the main meals of the day. For extended release tablet the initial recommended dose is 30 mg daily, even in elderly patients (>65 years); the daily dose may vary from 30 to 120 mg taken orally, once daily.

Glicla-Natrapharm extend release tablet should be taken with food because there is increased risk of hypoglycemia if a meal is taken late. It is recommended that the medication be taken at breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased. Dose titration should be carried out in steps of 30 mg, according to the fasting blood glucose response. Each step should last for at least two weeks. Glicla-Natrapharm extend release tabletshould be neither broken nor chewed. Glicla-Natrapharm extend release tablet30 mg, can replace Glicla-Natrapharm 80 mg tabletsfor doses of 1 to 4 tablets per day.

Elderly: Plasma clearance of Glicla-Natrapharm is not altered in the elderly and steady state plasma levels are similar to those in adults under 65 years. Clinical experience in the elderly shows that it is effective and well tolerated.

Children: Glicla-Natrapharm as with other sulfonylureas is not indicated for the treatment of juvenile onset diabetes mellitus.

Side Effects

Hypoglycemia may occur in concurrent conditions such as hepatic & renal diseases, alcohol intoxication and adrenal and pituitary insufficiency. Mild gastro-intestinal disturbances including nausea, dyspepsia, diarrhea, and constipation have been reported but these types of adverse reactions can be avoided if Glicla-Natrapharm is taken during a meal. Allergic dermatological reactions including rash, prurits, erythema, bullous eruption have been reported during treatment with the drug but are not known to be directly attributable to it. More serious reactions like leucopenia, thrombocytopenia, agranulocytosis, pancytopenia, hemolytic anemia, cholestatic jaundice, GI hemorrhage have not been reported with Glicla-Natrapharm.

Toxicity

LD50=3000 mg/kg (orally in mice). Glicla-Natrapharm and its metabolites may accumulate in those with severe hepatic and/or renal dysfunction. Symptoms of hypoglycemia include: dizziness, lack of energy, drowsiness, headache and sweating.

Precaution

Glicla-Natrapharm should be used carefully in patients with hepatic impairment. If there is definite hepatic disease then gliclazide should not be used. Consucon (Glicla-Natrapharm) can be used safely in patients with renal insufficiency as it is extensively metabolized. Consucon has less sudden hypoglycaemic episode than other sulfonylurea group of drugs.

Interaction

The hypoglycemic effect of Glicla-Natrapharm may be potentiated by NSAID (in particular aspirin), phenylbutazone, sulfonamides, coumarin derivatives, MAOIs, beta-adrenergic blockers, tetracyclines, chloramphenicol, clofibrate, cimetidine and miconazole tablets. Ingestion of alcohol may also increase the hypoglycemic effect of Glicla-Natrapharm. Some drugs may on the contrary, reduce its activity e.g. barbiturates, corticosteroides, thiazide diuretics, thyroid hormones, laxatives and oral contraceptives.

Food Interaction

  • Avoid alcohol.
  • Take with or without food. Consistent food intake reduces the risk of hypoglycemia.

Elimination Route

Rapidly and well absorbed but may have wide inter- and intra-individual variability. Peak plasma concentrations occur within 4-6 hours of oral administration.

Half Life

10.4 hours. Duration of action is 10-24 hours.

Elimination Route

Metabolites and conjugates are eliminated primarily by the kidneys (60-70%) and also in the feces (10-20%).

Pregnancy & Breastfeeding use

Pregnant Women: Glicla-Natrapharm should not be used in pregnant women although animal studies of Glicla-Natrapharm have not shown any teratogenic effect.

Nursing Mothers: This drug is contraindicated when breast feeding.

Contraindication

Hypersensitivity to sulfonylurea, diabetes complicated by ketoacidosis with coma, as a sole therapy of insulin-dependent (Type-1) diabetes mellitus, diabetes when complicated by pregnancy & breast-feeding.

Special Warning

Elderly: Plasma clearance of Glicla-Natrapharm is not altered in the elderly and steady state plasma levels are similar to those in adults under 65 years. Clinical experience in the elderly shows that it is effective and well tolerated.

Children: Glicla-Natrapharm as with other sulfonylureas is not indicated for the treatment of juvenile onset diabetes mellitus.

Acute Overdose

Symptoms: Hypoglycaemia with or without coma, convulsions or other neurological disorders.

Management: Carbohydrate intake, dosage adjustment and/or change of diet may be helpful. Admin rapid IV inj of concentrated glucose soln for hypoglycaemic coma.

Storage Condition

Store in a cool and dry place, below 30° C and away from light.

Innovators Monograph

You find simplified version here Glicla-Natrapharm

Glicla-Natrapharm contains Gliclazide see full prescribing information from innovator Glicla-Natrapharm Monograph, Glicla-Natrapharm MSDS, Glicla-Natrapharm FDA label

FAQ

What is Glicla-Natrapharm used for?

Glicla-Natrapharm is a sulfonylurea type of anti-diabetic medication, used to treat type 2 diabetes. It is used when dietary changes, exercise, and weight loss are not enough.

How safe is Glicla-Natrapharm?

Glicla-Natrapharm is safe to take for a long time. There's no evidence it harms your pancreas or your general health. But Glicla-Natrapharm may stop working properly after a while. Your doctor may then want to stop it or add a different medicine to help keep your blood sugar level stable.

How does Glicla-Natrapharm work?

Glicla-Natrapharm works by increasing the amount of insulin your body makes.

What are the common side effects of Glicla-Natrapharm?

Common side effects of Glicla-Natrapharm are include:

  • stomach ache or indigestion.
  • feeling sick (nausea)
  • being sick (vomiting) or diarrhoea.
  • constipation.


Is Glicla-Natrapharm safe during pregnancy?

Glicla-Natrapharm is not generally recommended in pregnancy and while breastfeeding. It's not clear whether Glicla-Natrapharm harms an unborn baby. For safety, your doctor will probably change your medicine to insulin before you become pregnant or as soon as you find out you're pregnant.

Is Glicla-Natrapharm safe during breastfeeding?

Glicla-Natrapharm is not generally recommended in pregnancy and while breastfeeding.

Can I drink alcohol with Glicla-Natrapharm?

Yes, you can drink alcohol while taking Glicla-Natrapharm, but it's best for men and women to drink no more than 2 units a day. Drinking more than this can increase the risk of low blood sugar.

Can I drive after taking Glicla-Natrapharm?

If your blood sugar levels are stable, your ability to drive, cycle or use machines or tools should not be affected by Glicla-Natrapharm. But if your blood sugar levels become too low, this can reduce your concentration. If this happens to you, do not drive, cycle or use machines or tools until you feel better.

When should be taken of Glicla-Natrapharm?

If you take Glicla-Natrapharm once a day, it's best to take it in the morning with breakfast. Glicla-Natrapharm can sometimes make your blood sugar level too low . Carry some sweets or fruit juice with you to help when this happens.

Can I take Glicla-Natrapharm on an empty stomach?

Glicla-Natrapharm tablets should be taken before food , either with breakfast or the first main meal of the day.

How long does Glicla-Natrapharm take to work?

When taken 30 minutes before breakfast, Glicla-Natrapharm produced a peak of IRI 30 minutes after the meal; taken immediately before or after, it took twice to three times as long to produce an IRI peak.

How long does Glicla-Natrapharm last in the body?

Glicla-Natrapharm is more effective when administered about 30 minutes before a meal. Blood sugar control persists for up to 24 hours following a single dose, even though levels of Glicla-Natrapharm in the blood are barely detectable.

How often can I take Glicla-Natrapharm?

For standard-release Glicla-Natrapharm, the maximum daily dose is 320mg. If you need to take more than 160mg a day, take the tablets twice a day with your morning and evening meals.

Who should not take Glicla-Natrapharm?

Glicla-Natrapharm is only for adults. Do not give this medicine to children under 18 years.

What happen If I missed Glicla-Natrapharm?

If you missed a dose of Glicla-Natrapharm, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take two doses together to make up for a missed dose.

What happen if I overdose of Glicla-Natrapharm?

Never take more than the prescribed dose of Glicla-Natrapharm. If you suspect that you might have taken an overdose of this medicine, go to the nearest emergency medical department/hospital.

Can Glicla-Natrapharm affects my heart ?

If you have problems with the heart and blood vessels, use Glicla-Natrapharm with caution as it can increase the risk of heart failure.

Will Glicla-Natrapharm affect my fertility?

There's no firm evidence to suggest that taking Glicla-Natrapharm will reduce fertility in either men or women.

Does Glicla-Natrapharm affect kidney function?

Glicla-Natrapharm can be considered in renal impairment if appropriate attention is paid to the dose.

Can Glicla-Natrapharm cause liver damage?

This case strongly suggests that Glicla-Natrapharm can induce acute icteric liver necro-inflammation which may be misdiagnosed clinically as acute viral hepatitis. In patients who show abnormal liver function tests, the immediate discontinuation of Glicla-Natrapharm is recommended.

*** Taking medicines without doctor's advice can cause long-term problems.
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