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INDORIN 2 mg. 90 tablets

Brand: STADA
Product Code: INDORIN 2 mg. 90 tablets
Availability: In Stock
Product viewed: 480

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THERAPEUTIC INDICATIONS

Repaglinide is indicated in type 2 diabetic patients with hyperglycaemia no longer able to control with diet, weight loss and physical activity. Repaglinide is also shown in combination with metformin in type 2 diabetic patients when administration of ametform as monotherapy does not provide satisfactory control of blood glucose. Treatment should be started in addition to dieting and physical activity to lower blood sugar associated with nutrition.

DOSAGE AND METHOD OF ADMINISTRATION:

Repaglinide is taken before the main meal and the dose is individually determined to optimize glycemic control. In addition to the usual self-control of blood sugar and / or sugar in the urine performed by the patient, the patient's blood glucose should be monitored periodically by a physician to determine the minimum effective dose. Determination of levels of glycated hemoglobin is important in monitoring the patient's response to treatment. Periodic monitoring is necessary to detect inadequate blood glucose lowering at the maximum recommended dose and to establish the attenuation of an adequate blood glucose lowering response after the initial efficacy period.
Rapid administration of repaglinide may be sufficient for transient impairment of control in patients with type 2 diabetes, which are usually well controlled by diet.
Rapid administration of repaglinide may be sufficient for transient impairment of control in patients with type 2 diabetes, which are usually well controlled by diet.
Repaglinide should be taken immediately before the main meals.
Doses are usually taken 15 minutes before a meal, but the time may vary from just before 30 minutes before the main meal. Patients who miss a meal should be instructed to miss a dose for this meal.

Initial dose

Dosage should be determined by a physician according to the patient's needs. The recommended starting dose is 0.5 mg. Approximately one to two weeks have to go between the individual dose-setting steps.
If patients switch from other oral hypoglycaemic products, the initial recommended dose is 1 mg.

Maintenance dose

The maximum recommended single dose is 4 mg taken with the main meals. The total maximum daily dose should not exceed 16 mg.

Specific patient groups

Repaglinide is mainly emitted by the bile and therefore is not affected by renal impairment.
Only 8% of the administered single dose of repaglinide is excreted by the kidneys and the total plasma clearance of the product decreases in patients with impaired renal function. In diabetic patients with renal impairment, insulin sensitivity is increased and dose setting should be carefully monitored.
No clinical trials have been conducted in patients over 75 years of age or in patients with hepatic insufficiency.

Repaglinide is not recommended for children under 18 years of age.

Patients receiving other oral hypoglycaemic products

Patients can switch directly to repaglinide from other oral hypoglycaemic agents. however, there is no precise correlation between doses of repaglinide and other oral hypoglycemic products. The recommended maximum starting dose for patients switching to repaglinide is 1 mg taken prior to main meals.
Repaglinide can be given in combination with metformin when blood glucose is not controlled only with metformin. In this case, the dose of metformin should be preserved and repaglinide given concurrently. The initial dose of repaglinide is 0.5 mg taken prior to the main meals, with dose setting depending on the blood glucose response as for monotherapy.


CONTRAINDICATIONS

- Hypersensitivity to repaglinide or any of the other ingredients in Indorin
- Diabetes mellitus type 1, C-peptide negative
- Diabetic ketoacidosis, with or without coma
- Severe hepatic impairment
- Concomitant use with gemfibrozil
PREGNANCY AND BREAST
Repaglinide clinical studies in pregnant and lactating women have not been conducted. therefore safety in pregnancy can not be assessed. So far, in animal studies, repaglinide did not have a teratogenic effect. In rats exposed to high doses during the last stage of pregnancy and during breastfeeding, embryotoxicity is observed, malformations in the development of the limbs in fetuses and neonates. Repaglinide is found in the breast of experimental animals. For this reason, repaglinide should be avoided during pregnancy and not used by women who are breast-feeding.

UNWANTED REACTIONS
Immune system disorders:
Very rare - allergy
Generalized hypersensitivity reactions

Metabolism and nutrition disorders:

Common - hypoglycaemia
Not known - Hypoglycaemic coma and unconsciousness due to hypoglycaemia.

Gastrointestinal disorders:

Common - abdominal pain and diarrhea
Very rare - vomiting and constipation
Not known - nausea
Gastrointestinal complaints such as abdominal pain, diarrhea, nausea, vomiting and constipation have been reported from clinical trials.

Skin and subcutaneous tissue disorders:

Not known - hypersensitivity
Skin reactions of hypersensitivity such as erythema, itching, rashes and urticaria may occur.

Eye disorders:

Very rare - visual disturbances

Cardiac disorders:

Rare - cardiovascular disease.


Hepatobiliary disorders:

Very rare - impaired liver function

 

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