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Gludiab

Al-Tinez Pharmaceuticals Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Tel: 01-4826452; 0802-307-7320, 0803-305-7978

Brand Name

Gludiab

Manufacturer

SA Okim Pharmaceuticals Joint Company, Quang Minh Industrial Zone - Me Linh - Ha Noi - Vietnam.

Therapeutic Class

Antidiabetic, Biguanides

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: A4-4430): Metformin Hydrochloride 500 mg.

Pack size: Box of 5 blisters x 10 tablets.

Pharmacology

Mechanism of action:

Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents.

Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Unlike sulfonylureas, Metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects and does not cause hyperinsulinemia. With Metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.

Indications

Gludiab, as monotherapy, is indicated as an adjunct to diet and exercise for the treatment of non-insulin dependent diabetes (type II), especially in patients with overweight or obese conditions.

Gludiab may be used concomitantly with insulin for the treatment of insulin-dependent diabetes (type I) or non-insulin dependent diabetes (type II), particularly in patients with overweight or obese conditions and insulin resistance.

Gludiab may be used concomitantly with a sulfonylurea when use of Gludiab or sulfonylurea alone does not result in adequate glycemic control.

Contra-indications

Known hypersensitivity to metformin or any components.

Patients with renal disease or renal dysfunction (serum creatinine greater than or equal to 15 mgn in males, or greater than or equal to 14 mgn in females) or abnormal creatinine clearance which may also result from some pathologic conditions.

Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

Patients with severe hepatic disease, severe cardiovascular disease (e.g., congestive heart failure, cardiovascular collapse, acute myocardial infarction), severe respiratory disease, septicemia, gangrene, alcoholism.

Metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials (2-3 days before and 2 days subsequent to procedure) because use of such products may result in acute alternation of renal function. The side effects appearing commonly include gastrointestinal disorders (such as nausea, vomiting). Metformin should only be restarted after renal function has been re-evaluated and found to be normal.

Precautions/Warnings

Drinking alcohol can increase your risk of lactic acidosis. Drinking large amounts of alcohol on a regular basis or drinking a large amount of alcohol at once (binge drinking) should be avoided while taking metformin.

Since liver disease (including liver failure and cirrhosis) can increase your risk of lactic acidosis, you should not take metformin if your liver is not functioning normally.

Your kidney function needs to be monitored while you are taking metformin. This means that you should have blood tests to check your kidneys before you start metformin and then at least once every year. If your kidney function is very poor, you should not take metformin due to increased risk of lactic acidosis.

Fever, infections, injury, or surgery can temporarily increase your blood sugar, even in people with well-controlled diabetes. Metformin may not be enough to treat your diabetes at these times, and the use of insulin may be required.

Contact your healthcare provider if you have a fever, infection, injury, or will be having surgery. Also, make sure you know the symptoms of high blood sugar and how to check your blood sugar levels.

Let your healthcare provider know if you drink a much lower amount of liquid than normal or if you have an illness that causes severe vomiting,

Diarrhea is a symptom in which watery, loose stools occur more than three times a day. These conditions can lead to severe dehydration (loss of water in your body). You may need to stop taking metformin for a short time.

Metformin can decrease your levels of vitamin B12. Your healthcare provider should monitor your vitamin B12 levels, especially if you have a vitamin B12 deficiency (including pernicious anemia).

Metformin passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about this.

Rarely, metformin can cause low blood sugar (hypoglycemia). This usually occurs when metformin is combined with other diabetes medications. Low blood sugar is reported more frequently in elderly people and in people with adrenal, pituitary, liver, or kidney problems as well as during fasting, before surgery and after prolonged exercise.

Interactions

Drugs which tend to produce hyperglycemia may lead to loss of glycemic control of metformin. These drugs include diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and isoniazid.

Furosemide increases the metformin plasma and blood concentration-max without altering metformin renal clearance when co-administered with metformin.

Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinine, quinidine, ranitidine, trimethoprim and vancomycin) that are eliminated by renal tubular secretion could have the potential for interaction with metformin by competing for common renal tubular transport systems, leading to toxicity of metformin.

Cimetidine increases (by 60%) the peak metformin plasma and whole blood concentration, therefore combination with cimetidine must be avoided.

Adverse Effects

The most common adverse effect of metformin is gastrointestinal upset, including diarrhea, cramps, nausea, vomiting and increased flatulence; metformin is more commonly associated with gastrointestinal side effects than most other antidiabetic drugs.

The most serious potential side effect of metformin use is lactic acidosis; this complication is very rare, and the vast majority of these cases seem to be related to co-morbid conditions, such as impaired liver or kidney function, rather than to the metformin itself.

Metformin has also been reported to decrease the blood levels of thyroid-stimulating hormone in people with hypothyroidism, and, in men, testosterone. The clinical significance of these changes is still unknown.

Dosage & Administration

Adult:

The usual starting dose is 1 tablet of Gludiab 500 mg per administration, twice daily, given with the morning and evening meal. Dosage increases can be made in increments of 500 mg per day every week up to a maximum of 2500 mg/day. If a dose of 2500 mg/day is required, it should be divided in 3 times, given with the morning, noon and evening meals.

The elderly:

The initial and maintenance dose should be increased conservatively, due to potential for decreased renal function. In general, elderly patients should not be titrated to the maximum dose of metformin (2500 mg).

In patients currently being treated with other antidiabetic agents:

When transferred to Gludiab therapy, no transition period generally is necessary except when transferred from Chlorpropamide. In this case, care should be exercised during the first 2 weeks because of the hypoglycemic effect.

Concomitant Gludiab and oral sulfonylurea therapy:

Patients who have not responded to 4 weeks of the maximum dose of Gludiab monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while maintaining Gludiab at the maximum dose. If patients do not satisfactorily respond to 1-3 months of concomitant therapy with the maximum dose each oral antidiabetic agents, oral antidiabetic therapy should be discontinued and insulin therapy (with or without Gludiab) instituted.

Concomitant Gludiab and Insulin therapy:

Gludiab therapy should be initiated at 500 mg once daily.

Storage/Handling Recommendations

Store in a dry and cool place below 28°C, protect from light.

Review Date

2017-10-25 04:39:07