INDORIN 1 mg. 90 tablets

STADA
INDORIN 1 mg. 90 tablets
€ 18.00
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INDICATION
Repaglinide is indicated in patients with type 2 diabetes by diet, weight reduction and exercise hyperglycaemia can no longer be controlled satisfactorily. Repaglinide is also indicated in combination with metformin in patients with type 2 diabetes, when the application of ametformin alone does not provide adequate control of blood sugar. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

DOSAGE AND METHOD OF APPLICATION:
Repaglinide it is taken before a meal and is titrated individually to optimize glycemic control. In addition to the usual self-monitoring of blood sugar and / or sugar in the urine made by the patient, patient's blood glucose must be monitored periodically by the physician to determine the minimum effective dose. The determination of glycosylated hemoglobin levels is important in monitoring the patient's response to treatment. Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the maximum recommended dose and to detect loss of adequate blood glucose-lowering response after an initial period of effectiveness.
Term administration of repaglinide may be sufficient during periods of transient loss of control in patients with type 2 diabetes, which is usually well controlled with diet.
Term administration of repaglinide may be sufficient during periods of transient loss of control in patients with type 2 diabetes, which is usually well controlled with diet.
Repaglinide should be taken immediately before meals.
Doses are usually taken 15 minutes before a meal, but time may vary from immediately before to 30 minutes before the main meal. Patients who skip meals should be instructed to skip a dose for that meal.

Initial dose
The dosage should be determined by the physician, according to the patient. The recommended starting dose is 0.5 mg. About one to two weeks should elapse between the different stages of determining the dose.
If patients are transferred from another oral hypoglycaemic agents, the recommended starting dose is 1 mg.

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

Specific patient groups
Primary repaglinide is excreted in the bile and therefore not affected by renal disorders.
Only 8% of the administered one dose of repaglinide is excreted through the kidneys and total plasma clearance of the product reduced in patients with impaired renal function. In diabetic patients with renal impairment insulin sensitivity is increased and the dosage must be done carefully.
No clinical studies in patients over 75 years or in patients with hepatic insufficiency.

Repaglinide is not recommended for children under 18 years.

Patients receiving other oral hypoglycaemic products
Patients can switch directly repaglinide from other oral hypoglycaemic products. However, no exact relationship between doses of repaglinide and the other oral hypoglycaemic products. The recommended maximum starting dose of patients transferred to repaglinide is 1 mg given before main meals.
Repaglinide may be administered in combination with metformin, when the blood glucose is not controlled with metformin alone. In this case, the dosage of metformin should be maintained and repaglinide administered concomitantly. The starting dose of repaglinide is 0.5 mg taken before meals, as the dosage depends on the blood glucose response as for monotherapy.

CONTRAINDICATIONS
- Hypersensitivity to repaglinide or any of the excipients in Indorin
- Type 1 diabetes mellitus, C-peptide negative
- Diabetic ketoacidosis with or without coma
- Severe hepatic impairment
- Concomitant use of gemfibrozil


Pregnancy and lactation
Clinical studies of repaglinide in pregnant and lactating women have not been conducted. therefore the safety during pregnancy can not be evaluated. So far in animal studies, repaglinide had shown no teratogenic effect. In rats exposed to high doses in the last stage of pregnancy and during lactation was observed embryo - malformations in limb development in fetuses and newborns. In the milk of experimental animals opens repaglinide. For that reason repaglinide should be avoided during pregnancy and should not be used by women who are breastfeeding.


SIDE EFFECTS

Immune system disorders:
Very rare - allergy
Generalized hypersensitivity reactions


Metabolism and nutrition disorders:
Common - hypoglycemia
Not known - Hypoglycaemic coma and unconsciousness due to hypoglycemia.


Gastrointestinal disorders:
Common - abdominal pain and diarrhea
Very rare - vomiting and constipation
Not known - nausea
Gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, vomiting and constipation have been reported in clinical studies.

Skin and subcutaneous tissue disorders:
Not known - Hypersensitivity
May occur skin hypersensitivity reactions such as erythema, itching, rashes and urticaria.

Eye disorders:
Very rare - visual disturbances


Cardiac disorders:
Rare - cardiovascular disease.


Hepatobiliary disorders
Very rare - impaired liver function
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