Tricophage Metformin Hydrochloride Tablets

Tricophage® – 500
Metformin Tablets BP 500 mg

 

COMPOSITION

Each Film coated Tablet Contains: Metformin Hydrochloride BP 500mg

 

PHARMACOLOGY

Metformin Hydrochloride tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N.N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents.

 

Mechanism of Action

Metfortoin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacological mechanism of action is 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 of 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 AND USAGE

Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin is indicated in patients 10 years of age and older. Metformin can be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).

 

DOSAGE AND ADMINISTRATION

There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin or any other pharmacologic agent. Dosage of metformin must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of metformin is 2250 mg in adults and 2000mg in pediatric patients (10 – 16 years of age). Metformin should be given in divided doses with meals.

 

CONTRAINDICATIONS

Melformin tablets are contraindicated in patients with:

1. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5mg/dL (males) ≥ 1.4 mg/dL (females) or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute mycocardial infarction, and septicemia.

2. Congestive heart failure requiring pharmacologic treatment.

3. Known hypersensitivity to Metformin Hydrochloride.

4. Acute of chronic metabolic acidosis, including diabetic acidosis, with or without coma. Diabetic ketoacidosis should be treated with Insulin.

Metformin accumulation treatment with Metformin. When it occurs, it is fatal in approximately 50% of cease.

Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia).

Lactic acidosis is a medical emergency that must be treated in a hospital setting. In a patient with lactic acidosis who is taking metformin, the drug should be discontinued immediately and general supportive measures promptly instituted. Because Metformin Hydrochloride is dialyzable (with a clearance of up to 170ml/min under good hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis and remove the accumulated Metformin. Such management often results in prompt reversal of symptoms and recovery.

 

PRECAUTIONS

General: Monitoring of renal function: Metformin is known to be substantially excreted by the kidney and the risk of metformin accumulation and lactic acidosis increases with the degree of impairment of renal function.

Thus, patients with serum creatinine levels above the upper limit of the normal should not receive metformin hydrochloride tablets.

 

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Long term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration 91 weeks) at doses up to and including 900mg/kg/day and 1500 mg/kg/day, respectively. These doses are both approximately four times the maximum recommended human daily dose of 2000mg based on body surface area comparisons. No evidence of carcinogenicity with metformin was found in either male or female mice. Similarly, there was no tumorigenic potential observed with metformin in male rats. There was, however, an increased incidence of benign stromal uterine polyps in female rats treated with 900mg/kg/day.

 

OVER DOSAGE

Hypoglycemia has not been seen even with ingestion of up to 80 grams of Matformin, although lactic acidosis has occurred in such circumstances. Metformin Is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin OVER DOSAGE is suspected.

 

STORAGE

Store in a cool, dry and dark place. Keep out of reach of children.

 

PRESENTATION

Blister pack of 14’s, Carton of 6 Blisters.

500 tablets in a HDPE Jar.

NAFDAC Reg. No.: B4-2429

Mfg. Lic. No.: G/1479-A

 

Manufactured By

BAROQUE PHARMACEUTICALS PVT. LTD.

Sokhada 388 620, Khambhat, Dist. Anand,

Gujarat India.

 

Under License From:

NOVOPHARM FORMULATIONS PVT. LTD. TRICARE PHARMA LIMITED.

105, Rajmandir, 62, Alkapuri, R. C. Dutt Road,

Vadodara 390007, Gujarat, India.

 

Manufactured for

Tricare Pharma Limited

6 Yusuf Oyero Street, Off Demurin Street,

Ketu, Lagos, Nigeria.

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