GLICOMIN 500

GLICOMIN 500
30 May

GLICOMIN 500

Anti-Diabetes drugs

-Metformin is a biguanide anti-diabetic agent, which may acts  
 via:
 1-Reduction of hepatic glucose production by inhibiting 
 gluconeogenesis and glycogenolysis.
 2-In muscle, by increasing insulin sensitivity, improving 
 peripheral glucose uptake and utilization.
 3- Delay of intestinal glucose absorption.
-Since Metformin acts only in the presence of endogenous 
 insulin, it is effective only if there are some residual 
 functioning pancreatic islet cells.
- Hypoglycemia does not usually occur with Metformin.
- Other advantages are the lower incidence of weight gain. 
-The maximum concentration of Metformin after oral 
 administration is reached within 2.5 hours. Absolute 
 bioavailability is 50- 60% in healthy subject. About 20- 30% 
 of the dose is not absorbed and recover in faeces.
- Elimination half-life of Metformin is approximately 6.5hours. 

Indecation

- Glicomin® is used in type II diabetes mellitus: Glicomin® is 
 the drug of first choice in over weight patients in whom strict 
 dieting has failed to control diabetes. It is also used when 
 diabetes is inadequately controlled with sulphonylurea 
 treatment. Glicomin® may be administered alone or in 
 combination with other anti-diabetic or insulin. 
- Glicomin® is used for the symptomatic management of 
 polycystic ovary syndrome; it improves insulin sensitivity, 
 may aid weight reduction and helps to normalize menstrual 
 cycle.

Dosage & Administration

 - Glicomin® initial dose is 500mg two or three times daily, or 
 850 mg once or twice daily with/or after meals, gradually 
 increased if necessary to 2 to 3 g daily.
- Swallow the film coated tablet whole with sufficient amount 
 of water.
 

* Each film coated tablet of Glicomin® 850 contains:
      Metformin HCl  850 mg.
* Each film coated tablet of Glicomin® 500 contains:
      Metformin HCl  500 mg.
 

 Glicomin® is contraindicated in the following cases:- 
-Known hypersensitivity to Metformin hydrochloride.
-Ketoacidosis.
-Renal insufficiency, even if moderate.
-Infectious diseases (respiratory or urinary tract infections).
-During the two days following an x-ray examination involving 
 the use of iodinated contrast media.
-Heart failure, respiratory insufficiency.
-Hepatic insufficiency.
-Persistent diarrhoea, recurrent vomiting.
-Alcoholic beverages.
-Children.

- Glicomin® has the following interactions:
-Hypoglycemic effect of Glicomin® possibly enhanced by: ACE 
 inhibitors, disopyramide, MAO inhibitors, anabolic steroids and 
 testosterone.
-Hypoglycemic effect of Glicomin® possibly antagonized by 
 corticosteroids, diazoxide, loop diuretics, thiazides and like 
 diuretics, oestrogens and progestogens,
-Excretion of Glicomin®  is reduced by cimetidine  leading to 
 increase plasma concentration of metformin .
-Thrombocyte count depressed when Glicomin® given with 
 ketotifen.
-Warning signs of hypoglycemia (such as tremors ) with 
 anti-diabetics may be masked when given with beta-blockers.

 Glicomin®should not be used during pregnancy and lactation.
 

- Gastrointestinal Disorders: nausea, vomiting, diarrhoea 
 (usually transient), abdominal pain, loss of appetite and 
 metallic taste, are initially common with Glicomin®, and may 
 persist in some patients, particularly when very high doses 
 such as 3g daily are given.
- Metabolic and nutritional disorders: very rare: severe lactic 
 acidosis which may manifested by vomiting, muscular pain, 
 cramps, feeling of malaise and fatigue.
-Disorders of skin: Very rare: Slight erythema and pruritus.

-The danger of undesired Metformin accumulation and thus the 
 risk of over acidification of the blood (lactic acidosis) is 
 dependent of renal function.Renal function should be assessed at 
 least annually be determining serum creatinine levels.
-If patient is schedule to undergo elective surgery under general 
 or epidural anesthesia, treatment with Glicomin® should be 
 discontinued 2 days beforehand. Treatment may be resumed at the earliest 2 days after surgery or upon recommencement of 
 food.
-Elderly patients generally suffering of decreased renal function, 
 the dosage of Glicomin® should be adjusted on the basis of renal 
 function.
-Effect on ability to drive and use machines: when used alone,  
 Glicomin® dose not cause hypoglycemia. Consequently, there is 
 no particular risk when driving or using machines. However, in 
 association with other antidiabetic agents (sulphonylurea, 
 hypoglycemic agents, insulin, repaglinide) it is important to be 
 aware of the onset of hypoglycemia, and of its effects on 
 concentration.

 Glicomin® 850  (blister of 10 tablets, pack of three blisters).
 Glicomin® 500 (blister of 10 tablets, pack of three blisters).
 

-Store in a dry place at a temperature below 25 oC.